Order Catalog Implementation Guide
1.0.0-ballot - CI Build International flag

Order Catalog Implementation Guide, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. 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

Resource Profile: DeviceModel Profile

Official URL: http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 2 Computable Name: DeviceModel
Other Identifiers: OID:2.16.840.1.113883.4.642.40.999.42.2

This profile constrains the base resource DeviceDefinition to represent a model of device in a catalog of medical devices

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... extension: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 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.deviceName.​type Base required Device Name Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:gmdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:snomed.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:emdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.safety Base example Device Safety 📍5.0.0 FHIR Std.
DeviceDefinition.property.​type Base example Device Property Type 📍5.0.0 FHIR Std.
DeviceDefinition.productionIdentifierInUDI Base required Device Production Identifier In UDI 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... extension: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
.... 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension: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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.language Base required All Languages 📍5.0.0 FHIR Std.
DeviceDefinition.regulatoryIdentifier.​type Base required Device Definition Regulatory Identifier Type 📍5.0.0 FHIR Std.
DeviceDefinition.deviceName.​type Base required Device Name Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:gmdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:snomed.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:emdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.conformsTo.​category Base example Device Specification Category 📍5.0.0 FHIR Std.
DeviceDefinition.conformsTo.​specification Base example Device Specification Type 📍5.0.0 FHIR Std.
DeviceDefinition.safety Base example Device Safety 📍5.0.0 FHIR Std.
DeviceDefinition.property.​type Base example Device Property Type 📍5.0.0 FHIR Std.
DeviceDefinition.link.​relation Base extensible Device Definition Relation Type 📍5.0.0 FHIR Std.
DeviceDefinition.productionIdentifierInUDI Base required Device Production Identifier In UDI 📍5.0.0 FHIR Std.
DeviceDefinition.correctiveAction.​scope Base required Device Corrective Action Scope 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

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:

  • The element 1 is sliced based on the value of DeviceDefinition.classification

Maturity: 2

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... extension: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 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.deviceName.​type Base required Device Name Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:gmdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:snomed.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:emdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.safety Base example Device Safety 📍5.0.0 FHIR Std.
DeviceDefinition.property.​type Base example Device Property Type 📍5.0.0 FHIR Std.
DeviceDefinition.productionIdentifierInUDI Base required Device Production Identifier In UDI 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

Differential View

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... extension: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
.... 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

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension: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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.language Base required All Languages 📍5.0.0 FHIR Std.
DeviceDefinition.regulatoryIdentifier.​type Base required Device Definition Regulatory Identifier Type 📍5.0.0 FHIR Std.
DeviceDefinition.deviceName.​type Base required Device Name Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:gmdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:snomed.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.classification:emdn.​type Base example Device Type 📍5.0.0 FHIR Std.
DeviceDefinition.conformsTo.​category Base example Device Specification Category 📍5.0.0 FHIR Std.
DeviceDefinition.conformsTo.​specification Base example Device Specification Type 📍5.0.0 FHIR Std.
DeviceDefinition.safety Base example Device Safety 📍5.0.0 FHIR Std.
DeviceDefinition.property.​type Base example Device Property Type 📍5.0.0 FHIR Std.
DeviceDefinition.link.​relation Base extensible Device Definition Relation Type 📍5.0.0 FHIR Std.
DeviceDefinition.productionIdentifierInUDI Base required Device Production Identifier In UDI 📍5.0.0 FHIR Std.
DeviceDefinition.correctiveAction.​scope Base required Device Corrective Action Scope 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()

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:

  • The element 1 is sliced based on the value of DeviceDefinition.classification

Maturity: 2

 

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