{
"description": "This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices",
"_filename": "StructureDefinition-DeviceModel.json",
"package_name": "hl7.fhir.uv.order-catalog",
"date": "2022-02-20T18:06:45+01:00",
"derivation": "constraint",
"publisher": "HL7 International / Orders and Observations",
"fhirVersion": "5.0.0",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm"
} ]
} ],
"name": "DeviceModel",
"mapping": [ {
"uri": "https://ec.europa.eu/tools/eudamed",
"name": "Europe Union EUDAMED",
"comment": "maps DeviceDefinition elements to EUDAMED UDI data dictionary field IDs|labels",
"identity": "devicedefinition-to-eudamed"
}, {
"uri": "https://accessgudid.nlm.nih.gov/",
"name": "US GUDID",
"comment": "maps DeviceDefinition elements to AccessGUDID section titles and field labels",
"identity": "devicedefinition-to-gudid"
}, {
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping",
"identity": "w5"
}, {
"uri": "http://hl7.org/v3",
"name": "RIM Mapping",
"identity": "rim"
} ],
"abstract": false,
"type": "DeviceDefinition",
"experimental": null,
"resourceType": "StructureDefinition",
"title": "Device Model",
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "oo"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 2,
"_valueInteger": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/order-catalog/ImplementationGuide/ig-uv-order-catalog"
} ]
}
} ],
"snapshot": {
"element": [ {
"constraint": [ {
"key": "dom-2",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.contained.empty()"
}, {
"key": "dom-3",
"human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"
}, {
"key": "dom-4",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"
}, {
"key": "dom-5",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "error",
"expression": "contained.meta.security.empty()"
}, {
"key": "dom-6",
"human": "A resource should have narrative for robust management",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource",
"severity": "warning",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
} ],
"expression": "text.`div`.exists()"
} ],
"path": "DeviceDefinition",
"min": 0,
"definition": "The characteristics, operational status and capabilities of a medical-related component of a medical device.",
"isModifier": false,
"short": "An instance of a medical-related component of a medical device",
"mapping": [ {
"map": "EUDAMED data dictionary field IDs/labels",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "AccessGUDID section titles and field labels",
"identity": "devicedefinition-to-gudid"
}, {
"map": "Entity, Role, or Act",
"identity": "rim"
}, {
"map": "administrative.device",
"identity": "w5"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition",
"comment": "For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition"
},
"isSummary": false
}, {
"path": "DeviceDefinition.id",
"min": 0,
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"isModifier": false,
"short": "Logical id of this artifact",
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.id",
"comment": "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.id"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.meta",
"min": 0,
"definition": "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"isModifier": false,
"short": "Metadata about the resource",
"type": [ {
"code": "Meta"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.meta",
"base": {
"max": "1",
"min": 0,
"path": "Resource.meta"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.implicitRules",
"min": 0,
"definition": "A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.",
"isModifier": true,
"short": "A set of rules under which this content was created",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.implicitRules",
"comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.",
"base": {
"max": "1",
"min": 0,
"path": "Resource.implicitRules"
},
"isModifierReason": "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.language",
"min": 0,
"definition": "The base language in which the resource is written.",
"isModifier": false,
"short": "Language of the resource content",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/all-languages|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
} ],
"additional": [ {
"purpose": "starter",
"valueSet": "http://hl7.org/fhir/ValueSet/languages|5.0.0"
} ],
"description": "IETF language tag for a human language"
},
"max": "1",
"id": "DeviceDefinition.language",
"comment": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).",
"base": {
"max": "1",
"min": 0,
"path": "Resource.language"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.text",
"min": 0,
"definition": "A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.",
"isModifier": false,
"short": "Text summary of the resource, for human interpretation",
"mapping": [ {
"map": "Act.text?",
"identity": "rim"
} ],
"type": [ {
"code": "Narrative"
} ],
"mustSupport": false,
"alias": [ "narrative", "html", "xhtml", "display" ],
"max": "1",
"id": "DeviceDefinition.text",
"condition": [ "dom-6" ],
"comment": "Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.",
"base": {
"max": "1",
"min": 0,
"path": "DomainResource.text"
},
"isSummary": false
}, {
"path": "DeviceDefinition.contained",
"min": 0,
"definition": "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"isModifier": false,
"short": "Contained, inline Resources",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Resource"
} ],
"mustSupport": false,
"alias": [ "inline resources", "anonymous resources", "contained resources" ],
"max": "*",
"id": "DeviceDefinition.contained",
"condition": [ "dom-2", "dom-4", "dom-3", "dom-5" ],
"comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.contained"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.extension",
"min": 0,
"definition": "An Extension",
"isModifier": false,
"short": "Extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.extension",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.extension",
"min": 0,
"definition": "This extension to PlanDefinition, MedicationKnowledge and DeviceDefinition conveys the reference to a catalog containing the extended resource",
"isModifier": false,
"short": "Reference to a catalog",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference" ]
} ],
"mustSupport": false,
"sliceName": "CatalogReference",
"max": "*",
"id": "DeviceDefinition.extension:CatalogReference",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"mustSupport": false,
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "DomainResource.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.description",
"min": 0,
"definition": "Additional information to describe the device.",
"isModifier": false,
"short": "Additional information to describe the device",
"mapping": [ {
"map": "FLD-UDID-175|Additional product description",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Device Description",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "markdown"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.description",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.description"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.identifier",
"min": 0,
"definition": "This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI.\nidentifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier.",
"isModifier": false,
"short": "Instance identifier",
"mapping": [ {
"map": "FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.identifier",
"identity": "w5"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.identifier",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.identifier"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier",
"min": 0,
"definition": "Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.",
"isModifier": false,
"short": "Unique Device Identifier (UDI) Barcode string",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.udiDeviceIdentifier"
},
"isSummary": false
}, {
"path": "DeviceDefinition.udiDeviceIdentifier.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"min": 1,
"definition": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.",
"isModifier": false,
"short": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier",
"mapping": [ {
"map": "FLD-UDID-178|UDI-DI code",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Primary DI Number",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.issuer",
"min": 1,
"definition": "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found",
"isModifier": false,
"short": "The organization that assigns the identifier algorithm",
"mapping": [ {
"map": "FLD-UDID-291|Issuing Entity UDI-DI",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Primary DI Number - Issuing Agency",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.issuer",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.issuer"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"min": 1,
"definition": "The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are:\n1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150,\n2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en",
"isModifier": false,
"short": "The jurisdiction to which the deviceIdentifier applies",
"mapping": [ {
"map": "https://ec.europa.eu/health/medical-devices-sector_en",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"min": 0,
"definition": "Indicates where and when the device is available on the market.",
"isModifier": false,
"short": "Indicates whether and when the device is available on the market",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution"
},
"isSummary": false
}, {
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"min": 1,
"definition": "Begin and end dates for the commercial distribution of the device.",
"isModifier": false,
"short": "Begin and end dates for the commercial distribution of the device",
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod"
},
"isSummary": false
}, {
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"min": 0,
"definition": "The start of the period. The boundary is inclusive.",
"isModifier": false,
"short": "Starting time with inclusive boundary",
"mapping": [ {
"map": "FLD-UDID-250|Start date",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "DEVICE RECORD STATUS - DI Record Publish Date",
"identity": "devicedefinition-to-gudid"
}, {
"map": "DR.1",
"identity": "v2"
}, {
"map": "./low",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"condition": [ "per-1" ],
"comment": "If the low element is missing, the meaning is that the low boundary is not known.",
"base": {
"max": "1",
"min": 0,
"path": "Period.start"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"min": 0,
"definition": "The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.",
"isModifier": false,
"short": "End time with inclusive boundary, if not ongoing",
"mapping": [ {
"map": "FLD-UDID-251|End date",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Commercial Distribution End Date",
"identity": "devicedefinition-to-gudid"
}, {
"map": "DR.2",
"identity": "v2"
}, {
"map": "./high",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"meaningWhenMissing": "If the end of the period is missing, it means that the period is ongoing",
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"condition": [ "per-1" ],
"comment": "The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.",
"base": {
"max": "1",
"min": 0,
"path": "Period.end"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"min": 1,
"definition": "National state or territory to which the marketDistribution recers, typically where the device is commercialized.",
"isModifier": false,
"short": "National state or territory where the device is commercialized",
"mapping": [ {
"map": "FLD-UDID-141|Countries were the devices is made available",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.regulatoryIdentifier",
"min": 0,
"definition": "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.",
"isModifier": false,
"short": "Regulatory identifier(s) associated with this device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.regulatoryIdentifier",
"comment": "This should not be used for regulatory authorization numbers which are to be captured elsewhere.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.regulatoryIdentifier"
},
"isSummary": false
}, {
"path": "DeviceDefinition.regulatoryIdentifier.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.regulatoryIdentifier.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.regulatoryIdentifier.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.regulatoryIdentifier.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.type",
"min": 1,
"definition": "The type of identifier itself.",
"isModifier": false,
"short": "basic | master | license",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceRegulatoryIdentifierType"
} ],
"description": "Device regulatory identifier type."
},
"max": "1",
"id": "DeviceDefinition.regulatoryIdentifier.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.regulatoryIdentifier.type"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"min": 1,
"definition": "The identifier itself.",
"isModifier": false,
"short": "The identifier itself",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.regulatoryIdentifier.deviceIdentifier"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.issuer",
"min": 1,
"definition": "The organization that issued this identifier.",
"isModifier": false,
"short": "The organization that issued this identifier",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.regulatoryIdentifier.issuer",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.regulatoryIdentifier.issuer"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"min": 1,
"definition": "The jurisdiction to which the deviceIdentifier applies.",
"isModifier": false,
"short": "The jurisdiction to which the deviceIdentifier applies",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.regulatoryIdentifier.jurisdiction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.partNumber",
"min": 0,
"definition": "The part number or catalog number of the device.",
"isModifier": false,
"short": "The part number or catalog number of the device",
"mapping": [ {
"map": "FLD-UDID-163|Reference / Catalogue Number",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Catalog Number",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": ".playedRole[typeCode=MANU].id",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.partNumber",
"comment": "Alphanumeric Maximum 20.",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.partNumber"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.manufacturer",
"min": 0,
"definition": "A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.",
"isModifier": false,
"short": "Name of device manufacturer",
"mapping": [ {
"map": "FLD-UDID-10|Legal Manufacturer SRN",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Company Name",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": ".playedRole[typeCode=MANU].scoper.name",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization|5.0.0" ]
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.manufacturer",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.manufacturer"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.deviceName",
"min": 0,
"definition": "The name or names of the device as given by the manufacturer.",
"isModifier": false,
"short": "The name or names of the device as given by the manufacturer",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.deviceName",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.deviceName"
},
"isSummary": true
}, {
"path": "DeviceDefinition.deviceName.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.deviceName.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.deviceName.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.deviceName.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.deviceName.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.deviceName.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.deviceName.name",
"min": 1,
"definition": "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.",
"isModifier": false,
"short": "A name that is used to refer to the device",
"mapping": [ {
"map": "FLD-UDID-22|Device Name",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Brand Name",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"alias": [ "Σ" ],
"max": "1",
"id": "DeviceDefinition.deviceName.name",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.deviceName.name"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.deviceName.type",
"min": 1,
"definition": "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.",
"isModifier": false,
"short": "registered-name | user-friendly-name | patient-reported-name",
"mapping": [ {
"map": "[registered-name]",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "[registered-name]",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": ".playedRole[typeCode=MANU].code",
"identity": "rim"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceNameType"
} ],
"description": "The type of name the device is referred by."
},
"max": "1",
"id": "DeviceDefinition.deviceName.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.deviceName.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.modelNumber",
"min": 0,
"definition": "The model number for the device for example as defined by the manufacturer or labeler, or other agency.",
"isModifier": false,
"short": "The catalog or model number for the device for example as defined by the manufacturer",
"mapping": [ {
"map": "FLD-UDID-20|Device Model",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Version or Model",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.what[x]",
"identity": "w5"
}, {
"map": ".softwareName (included as part)",
"identity": "rim"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.modelNumber",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.modelNumber"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification",
"min": 0,
"definition": "What kind of device or device system this is.",
"isModifier": false,
"short": "What kind of device or device system this is",
"slicing": {
"rules": "open",
"description": "Slice based on classification coding system",
"discriminator": [ {
"path": "type.coding.system",
"type": "value"
} ]
},
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.classification",
"comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.classification.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type",
"min": 1,
"definition": "A classification or risk class of the device model.",
"isModifier": false,
"short": "A classification or risk class of the device model",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceKind"
} ],
"description": "Type of device e.g. according to official classification."
},
"max": "1",
"id": "DeviceDefinition.classification.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.classification.type"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.justification",
"min": 0,
"definition": "Further information qualifying this classification of the device model.",
"isModifier": false,
"short": "Further information qualifying this classification of the device model",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.classification.justification",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification.justification"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification",
"min": 0,
"definition": "Global Medical Device Nomenclature classification",
"isModifier": false,
"short": "GMDN classification",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "gmdn",
"max": "*",
"id": "DeviceDefinition.classification:gmdn",
"comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:gmdn.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.classification:gmdn.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type",
"min": 1,
"definition": "A classification or risk class of the device model.",
"isModifier": false,
"short": "A classification or risk class of the device model",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceKind"
} ],
"description": "Type of device e.g. according to official classification."
},
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.classification.type"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:gmdn.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "DeviceDefinition.classification:gmdn.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.coding.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.coding.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:gmdn.type.coding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.system",
"requirements": "Need to be unambiguous about the source of the definition of the symbol.",
"min": 1,
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"isModifier": false,
"short": "Identity of the terminology system",
"mapping": [ {
"map": "http://terminology.hl7.org/CodeSystem/GMDN",
"identity": "devicedefinition-to-gudid"
}, {
"map": "C*E.3",
"identity": "v2"
}, {
"map": "./codeSystem",
"identity": "rim"
}, {
"map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
"identity": "orim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.system",
"comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.system"
},
"patternUri": "http://terminology.hl7.org/CodeSystem/GMDN",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.version",
"min": 0,
"definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"isModifier": false,
"short": "Version of the system - if relevant",
"mapping": [ {
"map": "C*E.7",
"identity": "v2"
}, {
"map": "./codeSystemVersion",
"identity": "rim"
}, {
"map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.version",
"comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.code",
"requirements": "Need to refer to a particular code in the system.",
"min": 0,
"definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"isModifier": false,
"short": "Symbol in syntax defined by the system",
"mapping": [ {
"map": "[GMDN code]",
"identity": "devicedefinition-to-gudid"
}, {
"map": "C*E.1",
"identity": "v2"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
"identity": "orim"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.code",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.display",
"requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min": 0,
"definition": "A representation of the meaning of the code in the system, following the rules of the system.",
"isModifier": false,
"short": "Representation defined by the system",
"mapping": [ {
"map": "GMDN Preferred Term Name",
"identity": "devicedefinition-to-gudid"
}, {
"map": "C*E.2 - but note this is not well followed",
"identity": "v2"
}, {
"map": "CV.displayName",
"identity": "rim"
}, {
"map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.display",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.display"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.userSelected",
"requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min": 0,
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"isModifier": false,
"short": "If this coding was chosen directly by the user",
"mapping": [ {
"map": "Sometimes implied by being first",
"identity": "v2"
}, {
"map": "CD.codingRationale",
"identity": "rim"
}, {
"map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]",
"identity": "orim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.coding.userSelected",
"comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.userSelected"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:gmdn.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.justification",
"min": 0,
"definition": "Further information qualifying this classification of the device model.",
"isModifier": false,
"short": "Further information qualifying this classification of the device model",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.classification:gmdn.justification",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification.justification"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification",
"min": 0,
"definition": "Systematized nomenclature of medicine - clinical terms",
"isModifier": false,
"short": "SNOMED CT",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "snomed",
"max": "1",
"id": "DeviceDefinition.classification:snomed",
"comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:snomed.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.classification:snomed.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type",
"min": 1,
"definition": "A classification or risk class of the device model.",
"isModifier": false,
"short": "A classification or risk class of the device model",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceKind"
} ],
"description": "Type of device e.g. according to official classification."
},
"max": "1",
"id": "DeviceDefinition.classification:snomed.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.classification.type"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:snomed.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "DeviceDefinition.classification:snomed.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.coding.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.coding.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:snomed.type.coding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.system",
"requirements": "Need to be unambiguous about the source of the definition of the symbol.",
"min": 1,
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"isModifier": false,
"short": "Identity of the terminology system",
"mapping": [ {
"map": "C*E.3",
"identity": "v2"
}, {
"map": "./codeSystem",
"identity": "rim"
}, {
"map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
"identity": "orim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.system",
"comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.system"
},
"patternUri": "http://snomed.info/sct",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.version",
"min": 0,
"definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"isModifier": false,
"short": "Version of the system - if relevant",
"mapping": [ {
"map": "C*E.7",
"identity": "v2"
}, {
"map": "./codeSystemVersion",
"identity": "rim"
}, {
"map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.version",
"comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.code",
"requirements": "Need to refer to a particular code in the system.",
"min": 0,
"definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"isModifier": false,
"short": "Symbol in syntax defined by the system",
"mapping": [ {
"map": "C*E.1",
"identity": "v2"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
"identity": "orim"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.code",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.display",
"requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min": 0,
"definition": "A representation of the meaning of the code in the system, following the rules of the system.",
"isModifier": false,
"short": "Representation defined by the system",
"mapping": [ {
"map": "C*E.2 - but note this is not well followed",
"identity": "v2"
}, {
"map": "CV.displayName",
"identity": "rim"
}, {
"map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.display",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.display"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.userSelected",
"requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min": 0,
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"isModifier": false,
"short": "If this coding was chosen directly by the user",
"mapping": [ {
"map": "Sometimes implied by being first",
"identity": "v2"
}, {
"map": "CD.codingRationale",
"identity": "rim"
}, {
"map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]",
"identity": "orim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.coding.userSelected",
"comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.userSelected"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:snomed.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.justification",
"min": 0,
"definition": "Further information qualifying this classification of the device model.",
"isModifier": false,
"short": "Further information qualifying this classification of the device model",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.classification:snomed.justification",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification.justification"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification",
"min": 0,
"definition": "European Medical Device Nomenclature",
"isModifier": false,
"short": "EMDN",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"sliceName": "emdn",
"max": "1",
"id": "DeviceDefinition.classification:emdn",
"comment": "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:emdn.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.classification:emdn.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type",
"min": 1,
"definition": "A classification or risk class of the device model.",
"isModifier": false,
"short": "A classification or risk class of the device model",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceKind"
} ],
"description": "Type of device e.g. according to official classification."
},
"max": "1",
"id": "DeviceDefinition.classification:emdn.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.classification.type"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:emdn.type.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
"min": 0,
"definition": "A reference to a code defined by a terminology system.",
"isModifier": false,
"short": "Code defined by a terminology system",
"mapping": [ {
"map": "C*E.1-8, C*E.10-22",
"identity": "v2"
}, {
"map": "union(., ./translation)",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding",
"identity": "orim"
} ],
"type": [ {
"code": "Coding"
} ],
"max": "*",
"id": "DeviceDefinition.classification:emdn.type.coding",
"comment": "Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.",
"base": {
"max": "*",
"min": 0,
"path": "CodeableConcept.coding"
},
"isSummary": true
}, {
"path": "DeviceDefinition.classification.type.coding.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.classification.type.coding.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.classification:emdn.type.coding.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.system",
"requirements": "Need to be unambiguous about the source of the definition of the symbol.",
"min": 1,
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"isModifier": false,
"short": "Identity of the terminology system",
"mapping": [ {
"map": "urn:oid:1.2.250.1.213.2.68",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "C*E.3",
"identity": "v2"
}, {
"map": "./codeSystem",
"identity": "rim"
}, {
"map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem",
"identity": "orim"
} ],
"type": [ {
"code": "uri"
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.system",
"comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.system"
},
"patternUri": "urn:oid:1.2.250.1.213.2.68",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.version",
"min": 0,
"definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
"isModifier": false,
"short": "Version of the system - if relevant",
"mapping": [ {
"map": "C*E.7",
"identity": "v2"
}, {
"map": "./codeSystemVersion",
"identity": "rim"
}, {
"map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.version",
"comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.code",
"requirements": "Need to refer to a particular code in the system.",
"min": 0,
"definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
"isModifier": false,
"short": "Symbol in syntax defined by the system",
"mapping": [ {
"map": "[EMDN code]",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "C*E.1",
"identity": "v2"
}, {
"map": "./code",
"identity": "rim"
}, {
"map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code",
"identity": "orim"
} ],
"type": [ {
"code": "code"
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.code",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.code"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.display",
"requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know the system.",
"min": 0,
"definition": "A representation of the meaning of the code in the system, following the rules of the system.",
"isModifier": false,
"short": "Representation defined by the system",
"mapping": [ {
"map": "EMDN name",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "C*E.2 - but note this is not well followed",
"identity": "v2"
}, {
"map": "CV.displayName",
"identity": "rim"
}, {
"map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.display",
"condition": [ "cod-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Coding.display"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.coding.userSelected",
"requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
"min": 0,
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"isModifier": false,
"short": "If this coding was chosen directly by the user",
"mapping": [ {
"map": "Sometimes implied by being first",
"identity": "v2"
}, {
"map": "CD.codingRationale",
"identity": "rim"
}, {
"map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [ fhir:source \"true\"; fhir:target dt:CDCoding.codingRationale\\#O ]",
"identity": "orim"
} ],
"type": [ {
"code": "boolean"
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.coding.userSelected",
"comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
"base": {
"max": "1",
"min": 0,
"path": "Coding.userSelected"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.type.text",
"requirements": "The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.",
"min": 0,
"definition": "A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.",
"isModifier": false,
"short": "Plain text representation of the concept",
"mapping": [ {
"map": "C*E.9. But note many systems use C*E.2 for this",
"identity": "v2"
}, {
"map": "./originalText[mediaType/code=\"text/plain\"]/data",
"identity": "rim"
}, {
"map": "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText",
"identity": "orim"
} ],
"type": [ {
"code": "string"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean": true
} ],
"max": "1",
"id": "DeviceDefinition.classification:emdn.type.text",
"comment": "Very often the text is the same as a displayName of one of the codings.",
"base": {
"max": "1",
"min": 0,
"path": "CodeableConcept.text"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.classification.justification",
"min": 0,
"definition": "Further information qualifying this classification of the device model.",
"isModifier": false,
"short": "Further information qualifying this classification of the device model",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.classification:emdn.justification",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification.justification"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.conformsTo",
"min": 0,
"definition": "Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.",
"isModifier": false,
"short": "Identifies the standards, specifications, or formal guidances for the capabilities supported by the device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.conformsTo",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.conformsTo"
},
"isSummary": true
}, {
"path": "DeviceDefinition.conformsTo.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.conformsTo.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.conformsTo.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.conformsTo.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.conformsTo.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.conformsTo.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.conformsTo.category",
"min": 0,
"definition": "Describes the type of the standard, specification, or formal guidance.",
"isModifier": false,
"short": "Describes the common type of the standard, specification, or formal guidance",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-specification-category|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceSpecificationCategory"
} ]
},
"max": "1",
"id": "DeviceDefinition.conformsTo.category",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.conformsTo.category"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.conformsTo.specification",
"min": 1,
"definition": "Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.",
"isModifier": false,
"short": "Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-specification-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceSpecificationType"
} ]
},
"max": "1",
"id": "DeviceDefinition.conformsTo.specification",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.conformsTo.specification"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.conformsTo.version",
"min": 0,
"definition": "Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.",
"isModifier": false,
"short": "The specific form or variant of the standard, specification or formal guidance",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.conformsTo.version",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.conformsTo.version"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.conformsTo.source",
"min": 0,
"definition": "Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.",
"isModifier": false,
"short": "Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.conformsTo.source",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.conformsTo.source"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.hasPart",
"min": 0,
"definition": "A device that is part (for example a component) of the present device.",
"isModifier": false,
"short": "A device, part of the current one",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.hasPart",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.hasPart"
},
"isSummary": true
}, {
"path": "DeviceDefinition.hasPart.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.hasPart.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.hasPart.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.hasPart.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.hasPart.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.hasPart.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.hasPart.reference",
"min": 1,
"definition": "Reference to the device that is part of the current device.",
"isModifier": false,
"short": "Reference to the part",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition|5.0.0" ]
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.hasPart.reference",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.hasPart.reference"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.hasPart.count",
"min": 0,
"definition": "Number of instances of the component device in the current device.",
"isModifier": false,
"short": "Number of occurrences of the part",
"type": [ {
"code": "integer"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.hasPart.count",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.hasPart.count"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging",
"min": 0,
"definition": "Information about the packaging of the device, i.e. how the device is packaged.",
"isModifier": false,
"short": "Information about the packaging of the device, i.e. how the device is packaged",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.packaging",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.packaging"
},
"isSummary": false
}, {
"path": "DeviceDefinition.packaging.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.packaging.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.packaging.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.packaging.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.identifier",
"min": 0,
"definition": "The business identifier of the packaged medication.",
"isModifier": false,
"short": "Business identifier of the packaged medication",
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.identifier",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.packaging.identifier"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.type",
"min": 0,
"definition": "A code that defines the specific type of packaging.",
"isModifier": false,
"short": "A code that defines the specific type of packaging",
"mapping": [ {
"map": "Package Type",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.type",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.packaging.type"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.count",
"min": 0,
"definition": "The number of items contained in the package (devices or sub-packages).",
"isModifier": false,
"short": "The number of items contained in the package (devices or sub-packages)",
"mapping": [ {
"map": "FLD-UDID-121|Quantity of item(s)",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Quantity per Package",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "integer"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.packaging.count",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.packaging.count"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.distributor",
"min": 0,
"definition": "An organization that distributes the packaged device.",
"isModifier": false,
"short": "An organization that distributes the packaged device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.packaging.distributor",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.packaging.distributor"
},
"isSummary": false
}, {
"path": "DeviceDefinition.packaging.distributor.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.packaging.distributor.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.distributor.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.packaging.distributor.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.distributor.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.packaging.distributor.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.distributor.name",
"min": 0,
"definition": "Distributor's human-readable name.",
"isModifier": false,
"short": "Distributor's human-readable name",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.distributor.name",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.packaging.distributor.name"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.distributor.organizationReference",
"min": 0,
"definition": "Distributor as an Organization resource.",
"isModifier": false,
"short": "Distributor as an Organization resource",
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization|5.0.0" ]
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.packaging.distributor.organizationReference",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.packaging.distributor.organizationReference"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier",
"min": 0,
"definition": "Unique Device Identifier (UDI) Barcode string on the packaging.",
"isModifier": false,
"short": "Unique Device Identifier (UDI) Barcode string on the packaging",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.packaging.udiDeviceIdentifier"
},
"isSummary": false
}, {
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
"min": 1,
"definition": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.",
"isModifier": false,
"short": "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier",
"mapping": [ {
"map": "FLD-UDID-120|Package UDI-DI",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Package DI Number",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
"min": 1,
"definition": "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found",
"isModifier": false,
"short": "The organization that assigns the identifier algorithm",
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.issuer"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
"min": 1,
"definition": "The jurisdiction to which the deviceIdentifier applies.",
"isModifier": false,
"short": "The jurisdiction to which the deviceIdentifier applies",
"mapping": [ {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution",
"min": 0,
"definition": "Indicates where and when the device is available on the market.",
"isModifier": false,
"short": "Indicates whether and when the device is available on the market",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution"
},
"isSummary": false
}, {
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod",
"min": 1,
"definition": "Begin and end dates for the commercial distribution of the device.",
"isModifier": false,
"short": "Begin and end dates for the commercial distribution of the device",
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod"
},
"isSummary": false
}, {
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"slicing": {
"rules": "open",
"description": "Extensions are always sliced by (at least) url",
"discriminator": [ {
"path": "url",
"type": "value"
} ]
},
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"min": 0,
"definition": "The start of the period. The boundary is inclusive.",
"isModifier": false,
"short": "Starting time with inclusive boundary",
"mapping": [ {
"map": "DR.1",
"identity": "v2"
}, {
"map": "./low",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"condition": [ "per-1" ],
"comment": "If the low element is missing, the meaning is that the low boundary is not known.",
"base": {
"max": "1",
"min": 0,
"path": "Period.start"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"min": 0,
"definition": "The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.",
"isModifier": false,
"short": "End time with inclusive boundary, if not ongoing",
"mapping": [ {
"map": "Package Discontinue Date",
"identity": "devicedefinition-to-gudid"
}, {
"map": "DR.2",
"identity": "v2"
}, {
"map": "./high",
"identity": "rim"
} ],
"type": [ {
"code": "dateTime"
} ],
"meaningWhenMissing": "If the end of the period is missing, it means that the period is ongoing",
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"condition": [ "per-1" ],
"comment": "The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.",
"base": {
"max": "1",
"min": 0,
"path": "Period.end"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"min": 1,
"definition": "National state or territory to which the marketDistribution recers, typically where the device is commercialized.",
"isModifier": false,
"short": "National state or territory where the device is commercialized",
"mapping": [ {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "uri"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.packaging.packaging",
"min": 0,
"definition": "Allows packages within packages.",
"isModifier": false,
"short": "Allows packages within packages",
"contentReference": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition#DeviceDefinition.packaging",
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.packaging.packaging",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.packaging.packaging"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.version",
"min": 0,
"definition": "The version of the device or software.",
"isModifier": false,
"short": "The version of the device or software",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.version",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.version"
},
"isSummary": false
}, {
"path": "DeviceDefinition.version.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.version.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.version.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.version.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.version.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.version.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.version.type",
"min": 0,
"definition": "The type of the device version, e.g. manufacturer, approved, internal.",
"isModifier": false,
"short": "The type of the device version, e.g. manufacturer, approved, internal",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"alias": [ "Σ" ],
"max": "1",
"id": "DeviceDefinition.version.type",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.version.type"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.version.component",
"min": 0,
"definition": "The hardware or software module of the device to which the version applies.",
"isModifier": false,
"short": "The hardware or software module of the device to which the version applies",
"mapping": [ {
"map": "FiveWs.what[x]",
"identity": "w5"
} ],
"type": [ {
"code": "Identifier"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.version.component",
"comment": "Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.version.component"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.version.value",
"min": 1,
"definition": "The version text.",
"isModifier": false,
"short": "The version text",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.version.value",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.version.value"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.safety",
"min": 0,
"definition": "Safety characteristics of the device.",
"isModifier": false,
"short": "Safety characteristics of the device",
"mapping": [ {
"map": "FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices}; FLD-UDID-156|Containing latex (Boolean)",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "What MRI safety information does the labeling contain?; Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437); Device labeled as 'Not made with natural rubber latex'",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": true,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-safety|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Safety"
} ]
},
"max": "*",
"id": "DeviceDefinition.safety",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.safety"
},
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.shelfLifeStorage",
"min": 0,
"definition": "Shelf Life and storage information.",
"isModifier": false,
"short": "Shelf Life and storage information",
"type": [ {
"code": "ProductShelfLife"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.shelfLifeStorage",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.shelfLifeStorage"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.languageCode",
"min": 0,
"definition": "Language code for the human-readable text strings produced by the device (all supported).",
"isModifier": false,
"short": "Language code for the human-readable text strings produced by the device (all supported)",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.languageCode",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.languageCode"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.property",
"min": 0,
"definition": "Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.",
"isModifier": false,
"short": "Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc",
"mapping": [ {
"map": "FLD-UDID-16|Risk Class; FLD-UDID-18|Animal tissues (Boolean); FLD-UDID-34|Microbial origin (Boolean); FLD-UDID-23|Human tissues (Boolean); FLD-UDID-28|Active Device (Boolean); FLD-UDID-29|Administer/Remove medicinal product (Boolean); FLD-UDID-30|Implantable (Boolean); FLD-UDID-31|Measuring Function (Boolean); FLD-UDID-32|Reusable Surgical Instruments (Boolean); FLD-UDID-33|Companion Diagnostic (Boolean); FLD-UDID-35|Near Patient Testing (Boolean); FLD-UDID-36|Patient Self Testing (Boolean); FLD-UDID-155|Medicinal product from blood/plasma (Boolean); FLD-UDID-158|Medicinal product (Boolean); FLD-UDID-262|Reagent (Boolean); FLD-UDID-263|Professional Testing (Boolean); FLD-UDID-264|Instrument (Boolean); FLD-UDID-356|Kit (Boolean); FLD-UDID-12|Device/Procedure pack/System; FLD-UDID-167|Single use (Boolean); FLD-UDID-169|Sterile; FLD-UDID-170|Sterilisation before use; FLD-UDID-146|Clinical Sizes; Handling Environment Temperature",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "For Single-Use; Prescription Use (Rx); Over the Counter (OTC); Kit; Combination Product; Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P); Device Packaged as Sterile; Requires Sterilization Prior to Use; Storage Environment Temperature; Handling Environment Temperature; Size - Length; Size - Width; Size - Heigth; Size - Angle",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "*",
"id": "DeviceDefinition.property",
"comment": "Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.property"
},
"isSummary": false
}, {
"path": "DeviceDefinition.property.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.property.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.property.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.property.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.property.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.property.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.property.type",
"min": 1,
"definition": "Code that specifies the property such as a resolution or color being represented.",
"isModifier": false,
"short": "Code that specifies the property being represented",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"binding": {
"strength": "example",
"valueSet": "http://hl7.org/fhir/ValueSet/device-property-type|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DevicePropertyType"
} ],
"description": "Device property type."
},
"max": "1",
"id": "DeviceDefinition.property.type",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.property.type"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.property.value[x]",
"min": 1,
"definition": "The value of the property specified by the associated property.type code.",
"isModifier": false,
"short": "Value of the property",
"type": [ {
"code": "Quantity"
}, {
"code": "CodeableConcept"
}, {
"code": "string"
}, {
"code": "boolean"
}, {
"code": "integer"
}, {
"code": "Range"
}, {
"code": "Attachment"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.property.value[x]",
"comment": "This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.property.value[x]"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.owner",
"min": 0,
"definition": "An organization that is responsible for the provision and ongoing maintenance of the device.",
"isModifier": false,
"short": "Organization responsible for device",
"mapping": [ {
"map": "FiveWs.source",
"identity": "w5"
}, {
"map": ".playedRole[typeCode=OWN].scoper",
"identity": "rim"
} ],
"type": [ {
"code": "Reference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization|5.0.0" ]
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.owner",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.owner"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.contact",
"min": 0,
"definition": "Contact details for an organization or a particular human that is responsible for the device.",
"isModifier": false,
"short": "Details for human/organization for support",
"mapping": [ {
"map": "FLD-UDID-354|Contact Details",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "CUSTOMER CONTACT",
"identity": "devicedefinition-to-gudid"
}, {
"map": "FiveWs.source",
"identity": "w5"
}, {
"map": ".scopedRole[typeCode=CON].player",
"identity": "rim"
} ],
"type": [ {
"code": "ContactPoint"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.contact",
"comment": "used for troubleshooting etc.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.contact"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.link",
"min": 0,
"definition": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.",
"isModifier": false,
"short": "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.link",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.link"
},
"isSummary": false
}, {
"path": "DeviceDefinition.link.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.link.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.link.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.link.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.link.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.link.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.link.relation",
"min": 1,
"definition": "The type indicates the relationship of the related device to the device instance.",
"isModifier": false,
"short": "The type indicates the relationship of the related device to the device instance",
"type": [ {
"code": "Coding"
} ],
"mustSupport": false,
"binding": {
"strength": "extensible",
"valueSet": "http://hl7.org/fhir/ValueSet/devicedefinition-relationtype|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceDefinitionRelationType"
} ],
"description": "The type of relation between this and the linked device."
},
"max": "1",
"id": "DeviceDefinition.link.relation",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.link.relation"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.link.relatedDevice",
"min": 1,
"definition": "A reference to the linked device.",
"isModifier": false,
"short": "A reference to the linked device",
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/DeviceDefinition|5.0.0" ]
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.link.relatedDevice",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.link.relatedDevice"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.note",
"min": 0,
"definition": "Descriptive information, usage information or implantation information that is not captured in an existing element.",
"isModifier": false,
"short": "Device notes and comments",
"mapping": [ {
"map": ".text",
"identity": "rim"
} ],
"type": [ {
"code": "Annotation"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.note",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.note"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.material",
"min": 0,
"definition": "A substance used to create the material(s) of which the device is made.",
"isModifier": false,
"short": "A substance used to create the material(s) of which the device is made",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.material",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.material"
},
"isSummary": false
}, {
"path": "DeviceDefinition.material.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.material.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.material.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.material.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.material.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.material.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.material.substance",
"min": 1,
"definition": "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.",
"isModifier": false,
"short": "A relevant substance that the device contains, may contain, or is made of",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.material.substance",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.material.substance"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.material.alternate",
"min": 0,
"definition": "Indicates an alternative material of the device.",
"isModifier": false,
"short": "Indicates an alternative material of the device",
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.material.alternate",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.material.alternate"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.material.allergenicIndicator",
"min": 0,
"definition": "Whether the substance is a known or suspected allergen.",
"isModifier": false,
"short": "Whether the substance is a known or suspected allergen",
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.material.allergenicIndicator",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.material.allergenicIndicator"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.productionIdentifierInUDI",
"min": 0,
"definition": "Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.",
"isModifier": false,
"short": "lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version",
"mapping": [ {
"map": "PRODUCTION IDENTIFIER(S) IN UDI",
"identity": "devicedefinition-to-gudid"
} ],
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceProductionIdentifierInUDI"
} ],
"description": "The production identifier(s) that are expected to appear in the UDI carrier."
},
"max": "*",
"id": "DeviceDefinition.productionIdentifierInUDI",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.productionIdentifierInUDI"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline",
"min": 0,
"definition": "Information aimed at providing directions for the usage of this model of device.",
"isModifier": false,
"short": "Information aimed at providing directions for the usage of this model of device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true,
"max": "1",
"id": "DeviceDefinition.guideline",
"comment": "For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.guideline"
},
"isSummary": false
}, {
"path": "DeviceDefinition.guideline.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.guideline.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.guideline.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.guideline.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.guideline.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.guideline.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.useContext",
"min": 0,
"definition": "The circumstances that form the setting for using the device.",
"isModifier": false,
"short": "The circumstances that form the setting for using the device",
"type": [ {
"code": "UsageContext"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.guideline.useContext",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.guideline.useContext"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.usageInstruction",
"min": 0,
"definition": "Detailed written and visual directions for the user on how to use the device.",
"isModifier": false,
"short": "Detailed written and visual directions for the user on how to use the device",
"type": [ {
"code": "markdown"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.guideline.usageInstruction",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.guideline.usageInstruction"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.relatedArtifact",
"min": 0,
"definition": "A source of information or reference for this guideline.",
"isModifier": false,
"short": "A source of information or reference for this guideline",
"type": [ {
"code": "RelatedArtifact"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.guideline.relatedArtifact",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.guideline.relatedArtifact"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.indication",
"min": 0,
"definition": "A clinical condition for which the device was designed to be used.",
"isModifier": false,
"short": "A clinical condition for which the device was designed to be used",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.guideline.indication",
"comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.guideline.indication"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.contraindication",
"min": 0,
"definition": "A specific situation when a device should not be used because it may cause harm.",
"isModifier": false,
"short": "A specific situation when a device should not be used because it may cause harm",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.guideline.contraindication",
"comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.guideline.contraindication"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.warning",
"min": 0,
"definition": "Specific hazard alert information that a user needs to know before using the device.",
"isModifier": false,
"short": "Specific hazard alert information that a user needs to know before using the device",
"type": [ {
"code": "CodeableConcept"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.guideline.warning",
"comment": "A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.guideline.warning"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.guideline.intendedUse",
"min": 0,
"definition": "A description of the general purpose or medical use of the device or its function.",
"isModifier": false,
"short": "A description of the general purpose or medical use of the device or its function",
"type": [ {
"code": "string"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.guideline.intendedUse",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.guideline.intendedUse"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.correctiveAction",
"min": 0,
"definition": "Tracking of latest field safety corrective action.",
"isModifier": false,
"short": "Tracking of latest field safety corrective action",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.correctiveAction",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.correctiveAction"
},
"isSummary": false
}, {
"path": "DeviceDefinition.correctiveAction.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.correctiveAction.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.correctiveAction.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.correctiveAction.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.correctiveAction.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.correctiveAction.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.correctiveAction.recall",
"min": 1,
"definition": "Whether the last corrective action known for this device was a recall.",
"isModifier": false,
"short": "Whether the corrective action was a recall",
"type": [ {
"code": "boolean"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.correctiveAction.recall",
"comment": "When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.correctiveAction.recall"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.correctiveAction.scope",
"min": 0,
"definition": "The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.",
"isModifier": false,
"short": "model | lot-numbers | serial-numbers",
"type": [ {
"code": "code"
} ],
"mustSupport": false,
"binding": {
"strength": "required",
"valueSet": "http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "DeviceCorrectiveActionScope"
} ],
"description": "The type or scope of the corrective action."
},
"max": "1",
"id": "DeviceDefinition.correctiveAction.scope",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.correctiveAction.scope"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.correctiveAction.period",
"min": 1,
"definition": "Start and end dates of the corrective action.",
"isModifier": false,
"short": "Start and end dates of the corrective action",
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.correctiveAction.period",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.correctiveAction.period"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.chargeItem",
"min": 0,
"definition": "Billing code or reference associated with the device.",
"isModifier": false,
"short": "Billing code or reference associated with the device",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.chargeItem",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.chargeItem"
},
"isSummary": false
}, {
"path": "DeviceDefinition.chargeItem.id",
"min": 0,
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"isModifier": false,
"short": "Unique id for inter-element referencing",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "http://hl7.org/fhirpath/System.String",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
} ]
} ],
"representation": [ "xmlAttr" ],
"max": "1",
"id": "DeviceDefinition.chargeItem.id",
"condition": [ "ele-1" ],
"base": {
"max": "1",
"min": 0,
"path": "Element.id"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.chargeItem.extension",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"isModifier": false,
"short": "Additional content defined by implementations",
"mapping": [ {
"map": "n/a",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content" ],
"max": "*",
"id": "DeviceDefinition.chargeItem.extension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "Element.extension"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
}, {
"key": "ext-1",
"human": "Must have either extensions or value[x], not both",
"source": "http://hl7.org/fhir/StructureDefinition/Extension",
"severity": "error",
"expression": "extension.exists() != value.exists()"
} ],
"path": "DeviceDefinition.chargeItem.modifierExtension",
"requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).",
"min": 0,
"definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"isModifier": true,
"short": "Extensions that cannot be ignored even if unrecognized",
"mapping": [ {
"map": "N/A",
"identity": "rim"
} ],
"type": [ {
"code": "Extension"
} ],
"alias": [ "extensions", "user content", "modifiers" ],
"max": "*",
"id": "DeviceDefinition.chargeItem.modifierExtension",
"comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.",
"base": {
"max": "*",
"min": 0,
"path": "BackboneElement.modifierExtension"
},
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary": true
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.chargeItem.chargeItemCode",
"min": 1,
"definition": "The code or reference for the charge item.",
"isModifier": false,
"short": "The code or reference for the charge item",
"type": [ {
"code": "CodeableReference",
"targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ChargeItemDefinition|5.0.0" ]
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.chargeItem.chargeItemCode",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.chargeItem.chargeItemCode"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.chargeItem.count",
"min": 1,
"definition": "Coefficient applicable to the billing code.",
"isModifier": false,
"short": "Coefficient applicable to the billing code",
"type": [ {
"code": "Quantity"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.chargeItem.count",
"base": {
"max": "1",
"min": 1,
"path": "DeviceDefinition.chargeItem.count"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.chargeItem.effectivePeriod",
"min": 0,
"definition": "A specific time period in which this charge item applies.",
"isModifier": false,
"short": "A specific time period in which this charge item applies",
"type": [ {
"code": "Period"
} ],
"mustSupport": false,
"max": "1",
"id": "DeviceDefinition.chargeItem.effectivePeriod",
"base": {
"max": "1",
"min": 0,
"path": "DeviceDefinition.chargeItem.effectivePeriod"
},
"isSummary": false
}, {
"constraint": [ {
"key": "ele-1",
"human": "All FHIR elements must have a @value or children",
"source": "http://hl7.org/fhir/StructureDefinition/Element",
"severity": "error",
"expression": "hasValue() or (children().count() > id.count())"
} ],
"path": "DeviceDefinition.chargeItem.useContext",
"min": 0,
"definition": "The context to which this charge item applies.",
"isModifier": false,
"short": "The context to which this charge item applies",
"type": [ {
"code": "UsageContext"
} ],
"mustSupport": false,
"max": "*",
"id": "DeviceDefinition.chargeItem.useContext",
"base": {
"max": "*",
"min": 0,
"path": "DeviceDefinition.chargeItem.useContext"
},
"isSummary": false
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "5.0.0"
} ]
},
"status": "active",
"id": "f5ee2219-2a21-4a3b-aa79-731016ec9de4",
"kind": "resource",
"url": "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.55.42.2",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0",
"differential": {
"element": [ {
"id": "DeviceDefinition",
"path": "DeviceDefinition",
"mapping": [ {
"map": "EUDAMED data dictionary field IDs/labels",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "AccessGUDID section titles and field labels",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.extension",
"path": "DeviceDefinition.extension",
"slicing": {
"rules": "open",
"ordered": false,
"discriminator": [ {
"path": "url",
"type": "value"
} ]
}
}, {
"id": "DeviceDefinition.extension:CatalogReference",
"max": "*",
"min": 0,
"path": "DeviceDefinition.extension",
"type": [ {
"code": "Extension",
"profile": [ "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference" ]
} ],
"sliceName": "CatalogReference"
}, {
"id": "DeviceDefinition.description",
"path": "DeviceDefinition.description",
"mapping": [ {
"map": "FLD-UDID-175|Additional product description",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Device Description",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.identifier",
"path": "DeviceDefinition.identifier",
"mapping": [ {
"map": "FLD-UDID-136|Secondary UDI - DI code [use = secondary, type = DISTID]; FLD-UDID-138|Direct Marking UDI-DI code [type = DIRECT-MARKING]; FLD-UDID-135|Unit of Use DI code [type = SINGLE-ITEM]",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Secondary DI Number [use = secondary, type = DISTID]; DM DI Number [type = DIRECT-MARKING]; Unit of Use DI Number [type = SINGLE-ITEM]",
"identity": "devicedefinition-to-gudid"
} ],
"definition": "This repeatable element is used in catalogs of devices to convey any kind of identifier assigned to the model of device, other than the primary UDI DI.\nidentifier may convey for instance, the secondary UDI-DI, the direct-marking UDI-DI, the unit-of-use UDI-DI or any additional non-UDI identifier.",
"mustSupport": true
}, {
"id": "DeviceDefinition.udiDeviceIdentifier",
"path": "DeviceDefinition.udiDeviceIdentifier",
"mustSupport": true
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"path": "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"mapping": [ {
"map": "FLD-UDID-178|UDI-DI code",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Primary DI Number",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.issuer",
"path": "DeviceDefinition.udiDeviceIdentifier.issuer",
"mapping": [ {
"map": "FLD-UDID-291|Issuing Entity UDI-DI",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Primary DI Number - Issuing Agency",
"identity": "devicedefinition-to-gudid"
} ],
"definition": "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found"
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"path": "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"mapping": [ {
"map": "https://ec.europa.eu/health/medical-devices-sector_en",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ],
"definition": "The jurisdiction to which the deviceIdentifier applies. Known jurisdictions are:\n1. US Food & Drug Administration (FDA): urn:oid:2.16.840.1.113883.3.150,\n2. Europe Union EUDAMED: https://ec.europa.eu/health/medical-devices-sector_en"
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"mustSupport": true
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.start",
"mapping": [ {
"map": "FLD-UDID-250|Start date",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "DEVICE RECORD STATUS - DI Record Publish Date",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"mapping": [ {
"map": "FLD-UDID-251|End date",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Commercial Distribution End Date",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"path": "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"mapping": [ {
"map": "FLD-UDID-141|Countries were the devices is made available",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.partNumber",
"path": "DeviceDefinition.partNumber",
"mapping": [ {
"map": "FLD-UDID-163|Reference / Catalogue Number",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Catalog Number",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.manufacturer",
"path": "DeviceDefinition.manufacturer",
"mapping": [ {
"map": "FLD-UDID-10|Legal Manufacturer SRN",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Company Name",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.deviceName",
"path": "DeviceDefinition.deviceName",
"mustSupport": true
}, {
"id": "DeviceDefinition.deviceName.name",
"path": "DeviceDefinition.deviceName.name",
"mapping": [ {
"map": "FLD-UDID-22|Device Name",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Brand Name",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.deviceName.type",
"path": "DeviceDefinition.deviceName.type",
"mapping": [ {
"map": "[registered-name]",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "[registered-name]",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.modelNumber",
"path": "DeviceDefinition.modelNumber",
"mapping": [ {
"map": "FLD-UDID-20|Device Model",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Version or Model",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.classification",
"path": "DeviceDefinition.classification",
"slicing": {
"rules": "open",
"description": "Slice based on classification coding system",
"discriminator": [ {
"path": "type.coding.system",
"type": "value"
} ]
}
}, {
"id": "DeviceDefinition.classification:gmdn",
"max": "*",
"min": 0,
"path": "DeviceDefinition.classification",
"short": "GMDN classification",
"sliceName": "gmdn",
"definition": "Global Medical Device Nomenclature classification"
}, {
"id": "DeviceDefinition.classification:gmdn.type.coding.system",
"min": 1,
"path": "DeviceDefinition.classification.type.coding.system",
"mapping": [ {
"map": "http://terminology.hl7.org/CodeSystem/GMDN",
"identity": "devicedefinition-to-gudid"
} ],
"patternUri": "http://terminology.hl7.org/CodeSystem/GMDN"
}, {
"id": "DeviceDefinition.classification:gmdn.type.coding.code",
"path": "DeviceDefinition.classification.type.coding.code",
"mapping": [ {
"map": "[GMDN code]",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.classification:gmdn.type.coding.display",
"path": "DeviceDefinition.classification.type.coding.display",
"mapping": [ {
"map": "GMDN Preferred Term Name",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.classification:snomed",
"max": "1",
"min": 0,
"path": "DeviceDefinition.classification",
"short": "SNOMED CT",
"sliceName": "snomed",
"definition": "Systematized nomenclature of medicine - clinical terms"
}, {
"id": "DeviceDefinition.classification:snomed.type.coding.system",
"min": 1,
"path": "DeviceDefinition.classification.type.coding.system",
"patternUri": "http://snomed.info/sct"
}, {
"id": "DeviceDefinition.classification:emdn",
"max": "1",
"min": 0,
"path": "DeviceDefinition.classification",
"short": "EMDN",
"sliceName": "emdn",
"definition": "European Medical Device Nomenclature"
}, {
"id": "DeviceDefinition.classification:emdn.type.coding.system",
"min": 1,
"path": "DeviceDefinition.classification.type.coding.system",
"mapping": [ {
"map": "urn:oid:1.2.250.1.213.2.68",
"identity": "devicedefinition-to-eudamed"
} ],
"patternUri": "urn:oid:1.2.250.1.213.2.68"
}, {
"id": "DeviceDefinition.classification:emdn.type.coding.code",
"path": "DeviceDefinition.classification.type.coding.code",
"mapping": [ {
"map": "[EMDN code]",
"identity": "devicedefinition-to-eudamed"
} ]
}, {
"id": "DeviceDefinition.classification:emdn.type.coding.display",
"path": "DeviceDefinition.classification.type.coding.display",
"mapping": [ {
"map": "EMDN name",
"identity": "devicedefinition-to-eudamed"
} ]
}, {
"id": "DeviceDefinition.hasPart.count",
"path": "DeviceDefinition.hasPart.count",
"mustSupport": true
}, {
"id": "DeviceDefinition.packaging.type",
"path": "DeviceDefinition.packaging.type",
"mapping": [ {
"map": "Package Type",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.packaging.count",
"path": "DeviceDefinition.packaging.count",
"mapping": [ {
"map": "FLD-UDID-121|Quantity of item(s)",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Quantity per Package",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier",
"type": [ {
"code": "BackboneElement"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier",
"mapping": [ {
"map": "FLD-UDID-120|Package UDI-DI",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "Package DI Number",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.issuer",
"definition": "Organization accredited by the jurisdictional authority to operate a system for the issuance of UDIs. Main issuers referenced in the US and/or in EU include:\n1. GS1 GTIN: urn:oid:1.3.160,\n2. HIBCC: urn:oid:2.16.840.1.113883.6.40,\n3. ICCBBA Information Standard for Blood and Transplant (ISBT) 128: urn:oid:2.16.840.1.113883.6.18,\n4. ICCBBA for other devices: to be found,\n5. IFA (Europe Union only): to be found"
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction",
"mapping": [ {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.marketPeriod.end",
"mapping": [ {
"map": "Package Discontinue Date",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"path": "DeviceDefinition.packaging.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"mapping": [ {
"map": "urn:oid:2.16.840.1.113883.3.150",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.safety",
"path": "DeviceDefinition.safety",
"mapping": [ {
"map": "FLD-UDID-212|Critical Warnings type: {CW025:MR SAFE, CW026:MR CONDITIONAL, CW027:MR UNSAFE, CW023:Consider hazards from magnetic fields, CW024:Do not store near magnets or magnetic devices}; FLD-UDID-156|Containing latex (Boolean)",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "What MRI safety information does the labeling contain?; Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437); Device labeled as 'Not made with natural rubber latex'",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.property",
"path": "DeviceDefinition.property",
"mapping": [ {
"map": "FLD-UDID-16|Risk Class; FLD-UDID-18|Animal tissues (Boolean); FLD-UDID-34|Microbial origin (Boolean); FLD-UDID-23|Human tissues (Boolean); FLD-UDID-28|Active Device (Boolean); FLD-UDID-29|Administer/Remove medicinal product (Boolean); FLD-UDID-30|Implantable (Boolean); FLD-UDID-31|Measuring Function (Boolean); FLD-UDID-32|Reusable Surgical Instruments (Boolean); FLD-UDID-33|Companion Diagnostic (Boolean); FLD-UDID-35|Near Patient Testing (Boolean); FLD-UDID-36|Patient Self Testing (Boolean); FLD-UDID-155|Medicinal product from blood/plasma (Boolean); FLD-UDID-158|Medicinal product (Boolean); FLD-UDID-262|Reagent (Boolean); FLD-UDID-263|Professional Testing (Boolean); FLD-UDID-264|Instrument (Boolean); FLD-UDID-356|Kit (Boolean); FLD-UDID-12|Device/Procedure pack/System; FLD-UDID-167|Single use (Boolean); FLD-UDID-169|Sterile; FLD-UDID-170|Sterilisation before use; FLD-UDID-146|Clinical Sizes; Handling Environment Temperature",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "For Single-Use; Prescription Use (Rx); Over the Counter (OTC); Kit; Combination Product; Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P); Device Packaged as Sterile; Requires Sterilization Prior to Use; Storage Environment Temperature; Handling Environment Temperature; Size - Length; Size - Width; Size - Heigth; Size - Angle",
"identity": "devicedefinition-to-gudid"
} ],
"mustSupport": true
}, {
"id": "DeviceDefinition.contact",
"path": "DeviceDefinition.contact",
"mapping": [ {
"map": "FLD-UDID-354|Contact Details",
"identity": "devicedefinition-to-eudamed"
}, {
"map": "CUSTOMER CONTACT",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.productionIdentifierInUDI",
"path": "DeviceDefinition.productionIdentifierInUDI",
"mapping": [ {
"map": "PRODUCTION IDENTIFIER(S) IN UDI",
"identity": "devicedefinition-to-gudid"
} ]
}, {
"id": "DeviceDefinition.guideline",
"path": "DeviceDefinition.guideline",
"mustSupport": true
} ]
},
"contact": [ {
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/orders",
"system": "url"
} ]
} ],
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/DeviceDefinition"
}