Order Catalog Implementation Guide
current - CI Build
Order Catalog Implementation Guide
current - CI Build
Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel | Version: current | |||
| Draft as of 2022-02-20 | Computable Name: DeviceModel | |||
This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from DeviceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
 description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | S | 0..* | Identifier | Instance identifier |
 udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
 deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
 marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
 marketPeriod | ||||
| start | 0..1 | dateTime | Starting time with inclusive boundary | |
 end | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
| manufacturer | S | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | S | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| name | 1..1 | string | A name that is used to refer to the device | |
| type | 1..1 | code | registered-name | user-friendly-name | patient-reported-name | |
| modelNumber | S | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
 Slices for classification | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system | |
 classification:gmdn | 0..* | BackboneElement | GMDN classification | |
  type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN | |
| code | 0..1 | code | Symbol in syntax defined by the system | |
| display | 0..1 | string | Representation defined by the system | |
| classification:snomed | 0..1 | BackboneElement | SNOMED CT | |
| type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: http://snomed.info/sct | |
 classification:emdn | 0..1 | BackboneElement | EMDN | |
| type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68 | |
| code | 0..1 | code | Symbol in syntax defined by the system | |
| display | 0..1 | string | Representation defined by the system | |
| hasPart | ||||
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | ||||
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
 udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | ||||
| marketPeriod | ||||
| end | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| safety | S | 0..* | CodeableConcept | Safety characteristics of the device |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | SΣ | 0..* | Identifier | Instance identifier |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
 manufacturer | SΣ | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | A name that is used to refer to the device |
| type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
| modelNumber | SΣ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
| Slices for classification | Σ | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system |
| classification:All Slices | Content/Rules for all slices | |||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
 type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:gmdn | Σ | 0..* | BackboneElement | GMDN classification |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
 type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:snomed | Σ | 0..1 | BackboneElement | SNOMED CT |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:emdn | Σ | 0..1 | BackboneElement | EMDN |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| hasPart | Σ | 0..* | BackboneElement | A device, part of the current one |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| reference | Σ | 1..1 | Reference(DeviceDefinition) | Reference to the part |
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| safety | SΣ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |
 value[x] | 1..1 | Value of the property | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueAttachment | Attachment | |||
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| DeviceDefinition.deviceName.type | required | DeviceNameType |
| DeviceDefinition.classification.type | example | DeviceType |
| DeviceDefinition.classification:gmdn.type | example | DeviceType |
| DeviceDefinition.classification:snomed.type | example | DeviceType |
| DeviceDefinition.classification:emdn.type | example | DeviceType |
| DeviceDefinition.safety | example | DeviceSafety |
| DeviceDefinition.property.type | example | DeviceType |
| DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDI |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | 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 : 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() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | SΣ | 0..* | Identifier | Instance identifier |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| regulatoryIdentifier | 0..* | BackboneElement | Regulatory identifier(s) associated with this device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | code | basic | master | license Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type. | |
| deviceIdentifier | 1..1 | string | The identifier itself | |
| issuer | 1..1 | uri | The organization that issued this identifier | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
| manufacturer | SΣ | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | A name that is used to refer to the device |
| type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
| modelNumber | SΣ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
| Slices for classification | Σ | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system |
| classification:All Slices | Content/Rules for all slices | |||
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:gmdn | Σ | 0..* | BackboneElement | GMDN classification |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
 type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
 id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:snomed | Σ | 0..1 | BackboneElement | SNOMED CT |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://snomed.info/sct |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:emdn | Σ | 0..1 | BackboneElement | EMDN |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68 |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| conformsTo | Σ | 0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| category | Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance Binding: DeviceSpecificationCategory (example) |
| specification | Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: DeviceSpecificationType (example) |
| version | Σ | 0..* | string | The specific form or variant of the standard, specification or formal guidance |
| source | 0..* | RelatedArtifact | Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance | |
| hasPart | Σ | 0..* | BackboneElement | A device, part of the current one |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| reference | Σ | 1..1 | Reference(DeviceDefinition) | Reference to the part |
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier | 0..1 | Identifier | Business identifier of the packaged medication | |
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
| distributor | 0..* | BackboneElement | An organization that distributes the packaged device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | 0..1 | string | Distributor's human-readable name | |
| organizationReference | 0..* | Reference(Organization) | Distributor as an Organization resource | |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | 0..* | BackboneElement | Indicates whether and when the device is available on the market | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| packaging | 0..* | See packaging (DeviceDefinition) | Allows packages within packages | |
| version | 0..* | BackboneElement | The version of the device or software | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
| component | 0..1 | Identifier | The hardware or software module of the device to which the version applies | |
| value | 1..1 | string | The version text | |
| safety | SΣ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
| languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |
| value[x] | 1..1 | Value of the property | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueAttachment | Attachment | |||
| owner | 0..1 | Reference(Organization) | Organization responsible for device | |
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| link | 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation | 1..1 | Coding | The type indicates the relationship of the related device to the device instance Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device. | |
| relatedDevice | 1..1 | CodeableReference(DeviceDefinition) | A reference to the linked device | |
| note | 0..* | Annotation | Device notes and comments | |
| material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |
| alternate | 0..1 | boolean | Indicates an alternative material of the device | |
| allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| useContext | 0..* | UsageContext | The circumstances that form the setting for using the device | |
| usageInstruction | 0..1 | markdown | Detailed written and visual directions for the user on how to use the device | |
| relatedArtifact | 0..* | RelatedArtifact | A source of information or reference for this guideline | |
| indication | 0..* | CodeableConcept | A clinical condition for which the device was designed to be used | |
| contraindication | 0..* | CodeableConcept | A specific situation when a device should not be used because it may cause harm | |
| warning | 0..* | CodeableConcept | Specific hazard alert information that a user needs to know before using the device | |
| intendedUse | 0..1 | string | A description of the general purpose or medical use of the device or its function | |
| correctiveAction | 0..1 | BackboneElement | Tracking of latest field safety corrective action | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| recall | 1..1 | boolean | Whether the corrective action was a recall | |
| scope | 0..1 | code | model | lot-numbers | serial-numbers Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action. | |
| period | 1..1 | Period | Start and end dates of the corrective action | |
| chargeItem | 0..* | BackboneElement | Billing code or reference associated with the device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| chargeItemCode | 1..1 | CodeableReference(ChargeItemDefinition) | The code or reference for the charge item | |
| count | 1..1 | Quantity | Coefficient applicable to the billing code | |
| effectivePeriod | 0..1 | Period | A specific time period in which this charge item applies | |
| useContext | 0..* | UsageContext | The context to which this charge item applies | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| DeviceDefinition.language | required | AllLanguages |
| DeviceDefinition.regulatoryIdentifier.type | required | DeviceDefinitionRegulatoryIdentifierType |
| DeviceDefinition.deviceName.type | required | DeviceNameType |
| DeviceDefinition.classification.type | example | DeviceType |
| DeviceDefinition.classification:gmdn.type | example | DeviceType |
| DeviceDefinition.classification:snomed.type | example | DeviceType |
| DeviceDefinition.classification:emdn.type | example | DeviceType |
| DeviceDefinition.conformsTo.category | example | DeviceSpecificationCategory |
| DeviceDefinition.conformsTo.specification | example | DeviceSpecificationType |
| DeviceDefinition.safety | example | DeviceSafety |
| DeviceDefinition.property.type | example | DeviceType |
| DeviceDefinition.link.relation | extensible | DeviceDefinitionRelationType |
| DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDI |
| DeviceDefinition.correctiveAction.scope | required | DeviceCorrectiveActionScope |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Summary
Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 14 elements
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from DeviceDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
| description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | S | 0..* | Identifier | Instance identifier |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
| marketPeriod | ||||
| start | 0..1 | dateTime | Starting time with inclusive boundary | |
| end | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
| manufacturer | S | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | S | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| name | 1..1 | string | A name that is used to refer to the device | |
| type | 1..1 | code | registered-name | user-friendly-name | patient-reported-name | |
| modelNumber | S | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
| Slices for classification | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system | |
| classification:gmdn | 0..* | BackboneElement | GMDN classification | |
| type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN | |
| code | 0..1 | code | Symbol in syntax defined by the system | |
| display | 0..1 | string | Representation defined by the system | |
| classification:snomed | 0..1 | BackboneElement | SNOMED CT | |
| type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: http://snomed.info/sct | |
| classification:emdn | 0..1 | BackboneElement | EMDN | |
| type | ||||
| coding | ||||
| system | 1..1 | uri | Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68 | |
| code | 0..1 | code | Symbol in syntax defined by the system | |
| display | 0..1 | string | Representation defined by the system | |
| hasPart | ||||
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | ||||
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | ||||
| marketPeriod | ||||
| end | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| safety | S | 0..* | CodeableConcept | Safety characteristics of the device |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | SΣ | 0..* | Identifier | Instance identifier |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
| manufacturer | SΣ | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | A name that is used to refer to the device |
| type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
| modelNumber | SΣ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
| Slices for classification | Σ | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system |
| classification:All Slices | Content/Rules for all slices | |||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:gmdn | Σ | 0..* | BackboneElement | GMDN classification |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:snomed | Σ | 0..1 | BackboneElement | SNOMED CT |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| classification:emdn | Σ | 0..1 | BackboneElement | EMDN |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| hasPart | Σ | 0..* | BackboneElement | A device, part of the current one |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| reference | Σ | 1..1 | Reference(DeviceDefinition) | Reference to the part |
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| safety | SΣ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |
| value[x] | 1..1 | Value of the property | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueAttachment | Attachment | |||
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| DeviceDefinition.deviceName.type | required | DeviceNameType |
| DeviceDefinition.classification.type | example | DeviceType |
| DeviceDefinition.classification:gmdn.type | example | DeviceType |
| DeviceDefinition.classification:snomed.type | example | DeviceType |
| DeviceDefinition.classification:emdn.type | example | DeviceType |
| DeviceDefinition.safety | example | DeviceSafety |
| DeviceDefinition.property.type | example | DeviceType |
| DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDI |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | DeviceDefinition | 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 : 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() | |
| dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
| id | Σ | 0..1 | id | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| CatalogReference | 0..* | Reference(Catalog Header) | Reference to a catalog URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| description | S | 0..1 | markdown | Additional information to describe the device |
| identifier | SΣ | 0..* | Identifier | Instance identifier |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | S | 0..* | BackboneElement | Indicates whether and when the device is available on the market |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| regulatoryIdentifier | 0..* | BackboneElement | Regulatory identifier(s) associated with this device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | code | basic | master | license Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type. | |
| deviceIdentifier | 1..1 | string | The identifier itself | |
| issuer | 1..1 | uri | The organization that issued this identifier | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| partNumber | S | 0..1 | string | The part number or catalog number of the device |
| manufacturer | SΣ | 0..1 | Reference(Organization) | Name of device manufacturer |
| deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | Σ | 1..1 | string | A name that is used to refer to the device |
| type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
| modelNumber | SΣ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer |
| Slices for classification | Σ | 0..* | BackboneElement | What kind of device or device system this is Slice: Unordered, Open by pattern:type.coding.system |
| classification:All Slices | Content/Rules for all slices | |||
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:gmdn | Σ | 0..* | BackboneElement | GMDN classification |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://terminology.hl7.org/CodeSystem/GMDN |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:snomed | Σ | 0..1 | BackboneElement | SNOMED CT |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: http://snomed.info/sct |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| classification:emdn | Σ | 0..1 | BackboneElement | EMDN |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | Σ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: DeviceType (example): Type of device e.g. according to official classification. |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| coding | Σ | 0..* | Coding | Code defined by a terminology system |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| system | Σ | 1..1 | uri | Identity of the terminology system Required Pattern: urn:oid:1.2.250.1.213.2.68 |
| version | Σ | 0..1 | string | Version of the system - if relevant |
| code | ΣC | 0..1 | code | Symbol in syntax defined by the system |
| display | ΣC | 0..1 | string | Representation defined by the system |
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user |
| text | Σ | 0..1 | string | Plain text representation of the concept |
| justification | 0..* | RelatedArtifact | Further information qualifying this classification of the device model | |
| conformsTo | Σ | 0..* | BackboneElement | Identifies the standards, specifications, or formal guidances for the capabilities supported by the device |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| category | Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance Binding: DeviceSpecificationCategory (example) |
| specification | Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: DeviceSpecificationType (example) |
| version | Σ | 0..* | string | The specific form or variant of the standard, specification or formal guidance |
| source | 0..* | RelatedArtifact | Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance | |
| hasPart | Σ | 0..* | BackboneElement | A device, part of the current one |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| reference | Σ | 1..1 | Reference(DeviceDefinition) | Reference to the part |
| count | S | 0..1 | integer | Number of occurrences of the part |
| packaging | 0..* | BackboneElement | Information about the packaging of the device, i.e. how the device is packaged | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier | 0..1 | Identifier | Business identifier of the packaged medication | |
| type | 0..1 | CodeableConcept | A code that defines the specific type of packaging | |
| count | S | 0..1 | integer | The number of items contained in the package (devices or sub-packages) |
| distributor | 0..* | BackboneElement | An organization that distributes the packaged device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| name | 0..1 | string | Distributor's human-readable name | |
| organizationReference | 0..* | Reference(Organization) | Distributor as an Organization resource | |
| udiDeviceIdentifier | S | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string on the packaging |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| deviceIdentifier | 1..1 | string | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier | |
| issuer | 1..1 | uri | The organization that assigns the identifier algorithm | |
| jurisdiction | 1..1 | uri | The jurisdiction to which the deviceIdentifier applies | |
| marketDistribution | 0..* | BackboneElement | Indicates whether and when the device is available on the market | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| marketPeriod | 1..1 | Period | Begin and end dates for the commercial distribution of the device | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |
| start | ΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| end | ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing |
| subJurisdiction | 1..1 | uri | National state or territory where the device is commercialized | |
| packaging | 0..* | See packaging (DeviceDefinition) | Allows packages within packages | |
| version | 0..* | BackboneElement | The version of the device or software | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 0..1 | CodeableConcept | The type of the device version, e.g. manufacturer, approved, internal | |
| component | 0..1 | Identifier | The hardware or software module of the device to which the version applies | |
| value | 1..1 | string | The version text | |
| safety | SΣ | 0..* | CodeableConcept | Safety characteristics of the device Binding: DeviceSafety (example) |
| shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |
| languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |
| property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: DeviceType (example): Device property type. | |
| value[x] | 1..1 | Value of the property | ||
| valueQuantity | Quantity | |||
| valueCodeableConcept | CodeableConcept | |||
| valueString | string | |||
| valueBoolean | boolean | |||
| valueInteger | integer | |||
| valueRange | Range | |||
| valueAttachment | Attachment | |||
| owner | 0..1 | Reference(Organization) | Organization responsible for device | |
| contact | 0..* | ContactPoint | Details for human/organization for support | |
| link | 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation | 1..1 | Coding | The type indicates the relationship of the related device to the device instance Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device. | |
| relatedDevice | 1..1 | CodeableReference(DeviceDefinition) | A reference to the linked device | |
| note | 0..* | Annotation | Device notes and comments | |
| material | 0..* | BackboneElement | A substance used to create the material(s) of which the device is made | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |
| alternate | 0..1 | boolean | Indicates an alternative material of the device | |
| allergenicIndicator | 0..1 | boolean | Whether the substance is a known or suspected allergen | |
| productionIdentifierInUDI | 0..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |
| guideline | S | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| useContext | 0..* | UsageContext | The circumstances that form the setting for using the device | |
| usageInstruction | 0..1 | markdown | Detailed written and visual directions for the user on how to use the device | |
| relatedArtifact | 0..* | RelatedArtifact | A source of information or reference for this guideline | |
| indication | 0..* | CodeableConcept | A clinical condition for which the device was designed to be used | |
| contraindication | 0..* | CodeableConcept | A specific situation when a device should not be used because it may cause harm | |
| warning | 0..* | CodeableConcept | Specific hazard alert information that a user needs to know before using the device | |
| intendedUse | 0..1 | string | A description of the general purpose or medical use of the device or its function | |
| correctiveAction | 0..1 | BackboneElement | Tracking of latest field safety corrective action | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| recall | 1..1 | boolean | Whether the corrective action was a recall | |
| scope | 0..1 | code | model | lot-numbers | serial-numbers Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action. | |
| period | 1..1 | Period | Start and end dates of the corrective action | |
| chargeItem | 0..* | BackboneElement | Billing code or reference associated with the device | |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| chargeItemCode | 1..1 | CodeableReference(ChargeItemDefinition) | The code or reference for the charge item | |
| count | 1..1 | Quantity | Coefficient applicable to the billing code | |
| effectivePeriod | 0..1 | Period | A specific time period in which this charge item applies | |
| useContext | 0..* | UsageContext | The context to which this charge item applies | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet |
| DeviceDefinition.language | required | AllLanguages |
| DeviceDefinition.regulatoryIdentifier.type | required | DeviceDefinitionRegulatoryIdentifierType |
| DeviceDefinition.deviceName.type | required | DeviceNameType |
| DeviceDefinition.classification.type | example | DeviceType |
| DeviceDefinition.classification:gmdn.type | example | DeviceType |
| DeviceDefinition.classification:snomed.type | example | DeviceType |
| DeviceDefinition.classification:emdn.type | example | DeviceType |
| DeviceDefinition.conformsTo.category | example | DeviceSpecificationCategory |
| DeviceDefinition.conformsTo.specification | example | DeviceSpecificationType |
| DeviceDefinition.safety | example | DeviceSafety |
| DeviceDefinition.property.type | example | DeviceType |
| DeviceDefinition.link.relation | extensible | DeviceDefinitionRelationType |
| DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDI |
| DeviceDefinition.correctiveAction.scope | required | DeviceCorrectiveActionScope |
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Summary
Mandatory: 0 element (3 nested mandatory elements)
Must-Support: 14 elements
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International - Orders and Observations Work Group. Package hl7.fhir.uv.order-catalog#current based on FHIR 5.0.0. Generated 2023-07-08
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