ERA FHIR specification - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: DIPKO Device Definition ( Experimental )

DIPKO-omisteinen DeviceDefinition-pohjainen profiili, joka noudattaa Kanta-tyylisiä konventioita (FI-jurisdiction ja UDI-identifier-slicing EUDAMED-OID:llä). Pohjaprofiili katalogiresursseille, jotka tarvitsevat Kanta-yhteensopivuuden.

Usages:

• Derived from this Profile: DIPKO Digital Health Service
• CapabilityStatements using this Profile: ERA Capability Statement

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.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
DeviceDefinition.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.use	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported. Σ This element is included in summaries.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported. Σ This element is included in summaries.	1..1	string	The value that is unique Example General: 123456
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.identifier:udi.​use	Base	required	IdentifierUse	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported.	1..1	string	The value that is unique
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
DeviceDefinition.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
DeviceDefinition.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
DeviceDefinition.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
DeviceDefinition.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
DeviceDefinition.contained		0..*	Resource	Contained, inline Resources
DeviceDefinition.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.Slices for identifier.identifier:udi.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
DeviceDefinition.Slices for identifier.identifier:udi.use	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
DeviceDefinition.Slices for identifier.identifier:udi.type	Σ This element is included in summaries.	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported. Σ This element is included in summaries.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported. Σ This element is included in summaries.	1..1	string	The value that is unique Example General: 123456
DeviceDefinition.Slices for identifier.identifier:udi.period	Σ This element is included in summaries.	0..1	Period	Time period when id is/was valid for use
DeviceDefinition.Slices for identifier.identifier:udi.assigner	Σ This element is included in summaries.	0..1	Reference(Organization)	Organization that issued id (may be just text)
DeviceDefinition.udiDeviceIdentifier		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
DeviceDefinition.udiDeviceIdentifier.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.udiDeviceIdentifier.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.udiDeviceIdentifier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier		1..1	string	The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
DeviceDefinition.udiDeviceIdentifier.issuer		1..1	uri	The organization that assigns the identifier algorithm
DeviceDefinition.udiDeviceIdentifier.jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
DeviceDefinition.manufacturer[x]		0..1		Name of device manufacturer
DeviceDefinition.manufacturer[x].manufacturerString			string
DeviceDefinition.manufacturer[x].manufacturerReference			Reference(Organization)
DeviceDefinition.deviceName		0..*	BackboneElement	A name given to the device to identify it
DeviceDefinition.deviceName.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.deviceName.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.deviceName.name		1..1	string	The name of the device
DeviceDefinition.deviceName.type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
DeviceDefinition.modelNumber		0..1	string	The model number for the device
DeviceDefinition.type		0..1	CodeableConcept	What kind of device or device system this is Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
DeviceDefinition.specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
DeviceDefinition.specialization.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.specialization.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.specialization.systemType		1..1	string	The standard that is used to operate and communicate
DeviceDefinition.specialization.version		0..1	string	The version of the standard that is used to operate and communicate
DeviceDefinition.version		0..*	string	Available versions
DeviceDefinition.safety	Σ This element is included in summaries.	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
DeviceDefinition.shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
DeviceDefinition.physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
DeviceDefinition.languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
DeviceDefinition.capability		0..*	BackboneElement	Device capabilities
DeviceDefinition.capability.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.capability.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.capability.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.capability.type		1..1	CodeableConcept	Type of capability
DeviceDefinition.capability.description		0..*	CodeableConcept	Description of capability
DeviceDefinition.property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
DeviceDefinition.property.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.property.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
DeviceDefinition.property.valueQuantity		0..*	Quantity	Property value as a quantity
DeviceDefinition.property.valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
DeviceDefinition.owner		0..1	Reference(Organization)	Organization responsible for device
DeviceDefinition.contact		0..*	ContactPoint	Details for human/organization for support
DeviceDefinition.url		0..1	uri	Network address to contact device
DeviceDefinition.onlineInformation		0..1	uri	Access to on-line information
DeviceDefinition.note		0..*	Annotation	Device notes and comments
DeviceDefinition.quantity		0..1	Quantity	The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
DeviceDefinition.parentDevice	Σ This element is included in summaries.	0..1	Reference(DeviceDefinition)	The parent device it can be part of
DeviceDefinition.material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
DeviceDefinition.material.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.material.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.material.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.material.substance		1..1	CodeableConcept	The substance
DeviceDefinition.material.alternate		0..1	boolean	Indicates an alternative material of the device
DeviceDefinition.material.allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:udi.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:udi.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.type	Base	example	FHIR Device Types	📍4.0.1	FHIR Std.
DeviceDefinition.safety	Base	example	Device safety	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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(2 nested mandatory elements)
Must-Support: 3 elements
Fixed: 1 element

Slices

This structure defines the following Slices:

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

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
DeviceDefinition.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.use	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported. Σ This element is included in summaries.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported. Σ This element is included in summaries.	1..1	string	The value that is unique Example General: 123456
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.identifier:udi.​use	Base	required	IdentifierUse	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported.	1..1	string	The value that is unique
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition		0..*	DeviceDefinition	An instance of a medical-related component of a medical device
DeviceDefinition.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
DeviceDefinition.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
DeviceDefinition.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
DeviceDefinition.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
DeviceDefinition.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
DeviceDefinition.contained		0..*	Resource	Contained, inline Resources
DeviceDefinition.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
DeviceDefinition.Slices for identifier		0..*	Identifier	Instance identifier Slice: Unordered, Open by value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
DeviceDefinition.Slices for identifier.identifier:udi	S This element must be supported.	0..*	Identifier	UDI-tunniste (EUDAMED-OID urn:oid:1.2.246.537.6.12.999.2003.34).
DeviceDefinition.Slices for identifier.identifier:udi.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.Slices for identifier.identifier:udi.extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
DeviceDefinition.Slices for identifier.identifier:udi.use	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
DeviceDefinition.Slices for identifier.identifier:udi.type	Σ This element is included in summaries.	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
DeviceDefinition.Slices for identifier.identifier:udi.system	S This element must be supported. Σ This element is included in summaries.	1..1	uri	The namespace for the identifier value Fixed Value: urn:oid:1.2.246.537.6.12.999.2003.34 (no extensions allowed)
DeviceDefinition.Slices for identifier.identifier:udi.value	S This element must be supported. Σ This element is included in summaries.	1..1	string	The value that is unique Example General: 123456
DeviceDefinition.Slices for identifier.identifier:udi.period	Σ This element is included in summaries.	0..1	Period	Time period when id is/was valid for use
DeviceDefinition.Slices for identifier.identifier:udi.assigner	Σ This element is included in summaries.	0..1	Reference(Organization)	Organization that issued id (may be just text)
DeviceDefinition.udiDeviceIdentifier		0..*	BackboneElement	Unique Device Identifier (UDI) Barcode string
DeviceDefinition.udiDeviceIdentifier.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.udiDeviceIdentifier.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.udiDeviceIdentifier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier		1..1	string	The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
DeviceDefinition.udiDeviceIdentifier.issuer		1..1	uri	The organization that assigns the identifier algorithm
DeviceDefinition.udiDeviceIdentifier.jurisdiction		1..1	uri	The jurisdiction to which the deviceIdentifier applies
DeviceDefinition.manufacturer[x]		0..1		Name of device manufacturer
DeviceDefinition.manufacturer[x].manufacturerString			string
DeviceDefinition.manufacturer[x].manufacturerReference			Reference(Organization)
DeviceDefinition.deviceName		0..*	BackboneElement	A name given to the device to identify it
DeviceDefinition.deviceName.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.deviceName.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.deviceName.name		1..1	string	The name of the device
DeviceDefinition.deviceName.type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
DeviceDefinition.modelNumber		0..1	string	The model number for the device
DeviceDefinition.type		0..1	CodeableConcept	What kind of device or device system this is Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
DeviceDefinition.specialization		0..*	BackboneElement	The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
DeviceDefinition.specialization.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.specialization.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.specialization.systemType		1..1	string	The standard that is used to operate and communicate
DeviceDefinition.specialization.version		0..1	string	The version of the standard that is used to operate and communicate
DeviceDefinition.version		0..*	string	Available versions
DeviceDefinition.safety	Σ This element is included in summaries.	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
DeviceDefinition.shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
DeviceDefinition.physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
DeviceDefinition.languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
DeviceDefinition.capability		0..*	BackboneElement	Device capabilities
DeviceDefinition.capability.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.capability.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.capability.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.capability.type		1..1	CodeableConcept	Type of capability
DeviceDefinition.capability.description		0..*	CodeableConcept	Description of capability
DeviceDefinition.property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
DeviceDefinition.property.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.property.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
DeviceDefinition.property.valueQuantity		0..*	Quantity	Property value as a quantity
DeviceDefinition.property.valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
DeviceDefinition.owner		0..1	Reference(Organization)	Organization responsible for device
DeviceDefinition.contact		0..*	ContactPoint	Details for human/organization for support
DeviceDefinition.url		0..1	uri	Network address to contact device
DeviceDefinition.onlineInformation		0..1	uri	Access to on-line information
DeviceDefinition.note		0..*	Annotation	Device notes and comments
DeviceDefinition.quantity		0..1	Quantity	The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
DeviceDefinition.parentDevice	Σ This element is included in summaries.	0..1	Reference(DeviceDefinition)	The parent device it can be part of
DeviceDefinition.material		0..*	BackboneElement	A substance used to create the material(s) of which the device is made
DeviceDefinition.material.id		0..1	string	Unique id for inter-element referencing
DeviceDefinition.material.extension		0..*	Extension	Additional content defined by implementations
DeviceDefinition.material.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
DeviceDefinition.material.substance		1..1	CodeableConcept	The substance
DeviceDefinition.material.alternate		0..1	boolean	Indicates an alternative material of the device
DeviceDefinition.material.allergenicIndicator		0..1	boolean	Whether the substance is a known or suspected allergen
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:udi.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:udi.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.type	Base	example	FHIR Device Types	📍4.0.1	FHIR Std.
DeviceDefinition.safety	Base	example	Device safety	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(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(2 nested mandatory elements)
Must-Support: 3 elements
Fixed: 1 element

Slices

This structure defines the following Slices:

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

Other representations of profile: CSV, Excel, Schematron