Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link Constraints: ext-1
Slices for extension	S	2..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:relation	S	1..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"relation"
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension Constraints: ext-1
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:concept		0..1	Extension	Reference to a concept (by class) Constraints: ext-1
url		1..1	uri	"concept"
extension:reference	S	0..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reference"
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
extension:_datatype		0..1	(Complex)	Data type name for DeviceDefinition.link.relatedDevice from FHIR R5 URL: http://hl7.org/fhir/StructureDefinition/_datatype Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/_datatype"
value[x]		1..1	string	Value of extension Fixed Value: CodeableReference
url		1..1	uri	"relatedDevice"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link"
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	SΣ	1..1	string	The value that is unique Example General: 123456
Slices for manufacturer[x]	S	0..1		Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturerString			string
manufacturerReference			Reference(Organization)
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
display	SΣ	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device
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.
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	The name of the device
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. Fixed Value: user-friendly-name
version	S	0..*	string	Version
value	S	1..1	string	Interface Version Max Length:1048576
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG
DeviceDefinition.identifier:hiisId.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName:userFriendlyName.​type	Base	required	DeviceNameType	📍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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link
extension	S	2..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:relation	S	1..1	Extension	Extension
extension		0..0		Extension
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension
extension	S	0..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:reference	S	0..1	Extension	Extension
extension		0..0		Extension
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
value[x]		0..0		Value of extension
value[x]		0..0		Value of extension
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
system	S	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	S	1..1	string	The value that is unique
Slices for manufacturer[x]	S	0..1	string, Reference(Organization)	Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
reference	S	1..1	string	Literal reference, Relative, internal or absolute URL
display	S	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Fixed Value: user-friendly-name
version	S	0..*	string	Version
value	S	1..1	string	Interface Version
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension	S	2..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:relation	S	1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"relation"
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:concept		0..1	Extension	Reference to a concept (by class) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"concept"
value[x]		0..1	CodeableConcept	Reference to a concept (by class)
extension:reference	S	0..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reference"
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
extension:_datatype		0..1	(Complex)	Data type name for DeviceDefinition.link.relatedDevice from FHIR R5 URL: http://hl7.org/fhir/StructureDefinition/_datatype Constraints: ext-1
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/_datatype"
value[x]		1..1	string	Value of extension Fixed Value: CodeableReference
url		1..1	uri	"relatedDevice"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link"
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	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.
system	SΣ	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
udiDeviceIdentifier		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 jurisdication porvided 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
Slices for manufacturer[x]	S	0..1		Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturerString			string
manufacturerReference			Reference(Organization)
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	SΣ	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName: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
name		1..1	string	The name of the device
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.
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
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	S	1..1	string	The name of the device
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. Fixed Value: user-friendly-name
modelNumber		0..1	string	The model number for the device
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.
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
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
systemType		1..1	string	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version	S	0..*	string	Version
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	Extension	Additional content defined by implementations
value	S	1..1	string	Interface Version Max Length:1048576
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
capability		0..*	BackboneElement	Device capabilities
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	Type of capability
description		0..*	CodeableConcept	Description of capability
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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 DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
onlineInformation		0..1	uri	Access to on-line information
note		0..*	Annotation	Device notes and comments
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)
parentDevice	Σ	0..1	Reference(DeviceDefinition)	The parent device it can be part of
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	The substance
alternate		0..1	boolean	Indicates an alternative material of the device
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.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG
DeviceDefinition.identifier:hiisId.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:hiisId.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
DeviceDefinition.manufacturer[x]:manufacturerReference.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName:userFriendlyName.​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()

Summary

Mandatory: 0 element(4 nested mandatory elements)
Must-Support: 24 elements
Fixed: 2 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• HiisPersonalHealthDeviceDefinition (https://fhir.bfarm.de/StructureDefinition/HiisPersonalHealthDeviceDefinition)
• HiisManufacturer (https://fhir.bfarm.de/StructureDefinition/HiisManufacturer)

Extensions

This structure refers to these extensions:

• https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
• http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link
• https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of DeviceDefinition.identifier
• The element 1 is sliced based on the value of DeviceDefinition.manufacturer[x]
• The element 1 is sliced based on the value of DeviceDefinition.deviceName

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link Constraints: ext-1
Slices for extension	S	2..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:relation	S	1..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"relation"
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension Constraints: ext-1
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:concept		0..1	Extension	Reference to a concept (by class) Constraints: ext-1
url		1..1	uri	"concept"
extension:reference	S	0..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reference"
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
extension:_datatype		0..1	(Complex)	Data type name for DeviceDefinition.link.relatedDevice from FHIR R5 URL: http://hl7.org/fhir/StructureDefinition/_datatype Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/_datatype"
value[x]		1..1	string	Value of extension Fixed Value: CodeableReference
url		1..1	uri	"relatedDevice"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link"
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	SΣ	1..1	string	The value that is unique Example General: 123456
Slices for manufacturer[x]	S	0..1		Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturerString			string
manufacturerReference			Reference(Organization)
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
display	SΣ	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device
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.
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	The name of the device
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. Fixed Value: user-friendly-name
version	S	0..*	string	Version
value	S	1..1	string	Interface Version Max Length:1048576
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG
DeviceDefinition.identifier:hiisId.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName:userFriendlyName.​type	Base	required	DeviceNameType	📍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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link
extension	S	2..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:relation	S	1..1	Extension	Extension
extension		0..0		Extension
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension
extension	S	0..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:reference	S	0..1	Extension	Extension
extension		0..0		Extension
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
value[x]		0..0		Value of extension
value[x]		0..0		Value of extension
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
system	S	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	S	1..1	string	The value that is unique
Slices for manufacturer[x]	S	0..1	string, Reference(Organization)	Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
reference	S	1..1	string	Literal reference, Relative, internal or absolute URL
display	S	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
name	S	1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Fixed Value: user-friendly-name
version	S	0..*	string	Version
value	S	1..1	string	Interface Version
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
DeviceDefinition.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
DeviceDefinition	S	0..*	DeviceDefinition	Medical Aid Interface
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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:endpoint	S	0..*	Reference(HiisDeviceDataRecorderEndpoint)	Endpoints URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
extension:link	S	0..*	(Complex)	Supported Medical Aids URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension	S	2..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:relation	S	1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"relation"
value[x]	S	0..1	Coding	The type indicates the relationship of the related device to the device instance Binding: ValueSet for HiisDeviceDefinitionRelationType (required)
extension:relatedDevice	S	1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Closed by value:url Constraints: ext-1
extension:concept		0..1	Extension	Reference to a concept (by class) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"concept"
value[x]		0..1	CodeableConcept	Reference to a concept (by class)
extension:reference	S	0..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reference"
value[x]	S	0..1	Reference(HiisPersonalHealthDeviceDefinition)	Reference to a resource (by instance)
extension:_datatype		0..1	(Complex)	Data type name for DeviceDefinition.link.relatedDevice from FHIR R5 URL: http://hl7.org/fhir/StructureDefinition/_datatype Constraints: ext-1
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/_datatype"
value[x]		1..1	string	Value of extension Fixed Value: CodeableReference
url		1..1	uri	"relatedDevice"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link"
extension:mivSet	S	0..*	(Complex)	MIV Set URL: https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	S	0..*	Identifier	Identifiers Slice: Unordered, Open by value:system
identifier:hiisId	S	0..1	Identifier	HIIS ID
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	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.
system	SΣ	1..1	uri	The namespace for the identifier value Fixed Value: https://fhir.bfarm.de/Identifier/HiisId
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
udiDeviceIdentifier		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 jurisdication porvided 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
Slices for manufacturer[x]	S	0..1		Name of device manufacturer Slice: Unordered, Open by type:$this
manufacturerString			string
manufacturerReference			Reference(Organization)
manufacturer[x]:manufacturerReference	S	0..1	Reference(HiisManufacturer)	Manufacturer
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	SΣ	0..1	string	Text alternative for the resource
Slices for deviceName	S	0..*	BackboneElement	Device Name Slice: Unordered, Open by value:type
deviceName: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
name		1..1	string	The name of the device
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.
deviceName:userFriendlyName	S	0..1	BackboneElement	Interface Name
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	S	1..1	string	The name of the device
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. Fixed Value: user-friendly-name
modelNumber		0..1	string	The model number for the device
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.
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
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
systemType		1..1	string	The standard that is used to operate and communicate
version		0..1	string	The version of the standard that is used to operate and communicate
version	S	0..*	string	Version
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	Extension	Additional content defined by implementations
value	S	1..1	string	Interface Version Max Length:1048576
safety	Σ	0..*	CodeableConcept	Safety characteristics of the device Binding: DeviceSafety (example)
shelfLifeStorage		0..*	ProductShelfLife	Shelf Life and storage information
physicalCharacteristics		0..1	ProdCharacteristic	Dimensions, color etc.
languageCode		0..*	CodeableConcept	Language code for the human-readable text strings produced by the device (all supported)
capability		0..*	BackboneElement	Device capabilities
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	Type of capability
description		0..*	CodeableConcept	Description of capability
property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
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 DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
onlineInformation		0..1	uri	Access to on-line information
note		0..*	Annotation	Device notes and comments
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)
parentDevice	Σ	0..1	Reference(DeviceDefinition)	The parent device it can be part of
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	The substance
alternate		0..1	boolean	Indicates an alternative material of the device
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.extension:link.​extension:relation.value[x]	Base	required	ValueSet for HiisDeviceDefinitionRelationType	📦3.0.2-RC1	This IG
DeviceDefinition.identifier:hiisId.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
DeviceDefinition.identifier:hiisId.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
DeviceDefinition.manufacturer[x]:manufacturerReference.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName.​type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
DeviceDefinition.deviceName:userFriendlyName.​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()

Summary

Mandatory: 0 element(4 nested mandatory elements)
Must-Support: 24 elements
Fixed: 2 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

• HiisPersonalHealthDeviceDefinition (https://fhir.bfarm.de/StructureDefinition/HiisPersonalHealthDeviceDefinition)
• HiisManufacturer (https://fhir.bfarm.de/StructureDefinition/HiisManufacturer)

Extensions

This structure refers to these extensions:

• https://fhir.bfarm.de/StructureDefinition/HiisDeviceDataRecorderEndpointLink
• http://hl7.org/fhir/5.0/StructureDefinition/extension-DeviceDefinition.link
• https://fhir.bfarm.de/StructureDefinition/HiisDeviceDefinitionMivSet

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of DeviceDefinition.identifier
• The element 1 is sliced based on the value of DeviceDefinition.manufacturer[x]
• The element 1 is sliced based on the value of DeviceDefinition.deviceName