ePA Laboratory Report Implementation Guide
Version 1.0.0-ballot.1 - ballot

Ressourcenprofil: Device Definition Specimen Subject dgLP

Offizielle URL: https://gematik.de/fhir/epa-laboratory/StructureDefinition/device-definition-specimen-subject-dglp Version: 1.0.0
Active Stand: 2026-09-30 Maschinenlesbarer Name: DeviceDefinitionSpecimenSubjectdgLP

Copyright/Rechtliches: gematik GmbH / Dieses Artefakt ist lizenziert unter Apache License, Version 2.0.

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NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* TIDeviceDefinitionSpecimenSubject An instance of a medical-related component of a medical device
Constraints: dom-2, dom-3, dom-4, dom-5, dom-6
... meta SΣ 0..1 Meta Metadata about the resource
.... versionId SΣ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource version last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... type S 1..1 CodeableConcept What kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding SΣ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version SΣ 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code SΣ 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display SΣ 1..1 string Representation defined by the system
Fixed Value: Device used

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.deviceName.​type Base required DeviceNameType 📍4.0.1 FHIR Std.
DeviceDefinition.type Base example FHIR Device Types 📍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()

Diese Struktur ist abgeleitet von TIDeviceDefinitionSpecimenSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition TIDeviceDefinitionSpecimenSubject
... identifier 0..0 Instance identifier
... udiDeviceIdentifier 0..0 Unique Device Identifier (UDI) Barcode string
... deviceName 0..0 A name given to the device to identify it
... type 1..1 CodeableConcept What kind of device or device system this is
Required Pattern: At least the following
.... coding 1..1 Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display 1..1 string Representation defined by the system
Fixed Value: Device used
..... userSelected 0..0 If this coding was chosen directly by the user
.... text 0..0 Plain text representation of the concept
... specialization 0..0 The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
... version 0..0 Available versions
... safety 0..0 Safety characteristics of the device
... shelfLifeStorage 0..0 Shelf Life and storage information
... physicalCharacteristics 0..0 Dimensions, color etc.
... languageCode 0..0 Language code for the human-readable text strings produced by the device (all supported)
... capability 0..0 Device capabilities
... property 0..0 The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
... owner 0..0 Organization responsible for device
... contact 0..0 Details for human/organization for support
... url 0..0 Network address to contact device
... onlineInformation 0..0 Access to on-line information
... note 0..0 Device notes and comments
... quantity 0..0 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 0..0 The parent device it can be part of
... material 0..0 A substance used to create the material(s) of which the device is made

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* TIDeviceDefinitionSpecimenSubject An instance of a medical-related component of a medical device
Constraints: dom-2, dom-3, dom-4, dom-5, dom-6
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId SΣ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... manufacturer[x] S 0..1 string Name of device manufacturer
... type S 1..1 CodeableConcept What kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding SΣ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version SΣ 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code SΣ 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display SΣ 1..1 string Representation defined by the system
Fixed Value: Device used

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.meta.​security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
DeviceDefinition.meta.​tag Base example Common Tags 📍4.0.1 FHIR Std.
DeviceDefinition.language Base preferred Common Languages 📍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.

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()
qty-3 error DeviceDefinition.property.valueQuantity If a code for the unit is present, the system SHALL also be present code.empty() or system.exists()

Diese Struktur ist abgeleitet von TIDeviceDefinitionSpecimenSubject

Summary

Mandatory: 6 elements
Prohibited: 22 elements

Schlüsselelemente-Ansicht

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* TIDeviceDefinitionSpecimenSubject An instance of a medical-related component of a medical device
Constraints: dom-2, dom-3, dom-4, dom-5, dom-6
... meta SΣ 0..1 Meta Metadata about the resource
.... versionId SΣ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource version last changed
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... type S 1..1 CodeableConcept What kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding SΣ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version SΣ 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code SΣ 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display SΣ 1..1 string Representation defined by the system
Fixed Value: Device used

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.deviceName.​type Base required DeviceNameType 📍4.0.1 FHIR Std.
DeviceDefinition.type Base example FHIR Device Types 📍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-Ansicht

Diese Struktur ist abgeleitet von TIDeviceDefinitionSpecimenSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition TIDeviceDefinitionSpecimenSubject
... identifier 0..0 Instance identifier
... udiDeviceIdentifier 0..0 Unique Device Identifier (UDI) Barcode string
... deviceName 0..0 A name given to the device to identify it
... type 1..1 CodeableConcept What kind of device or device system this is
Required Pattern: At least the following
.... coding 1..1 Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display 1..1 string Representation defined by the system
Fixed Value: Device used
..... userSelected 0..0 If this coding was chosen directly by the user
.... text 0..0 Plain text representation of the concept
... specialization 0..0 The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
... version 0..0 Available versions
... safety 0..0 Safety characteristics of the device
... shelfLifeStorage 0..0 Shelf Life and storage information
... physicalCharacteristics 0..0 Dimensions, color etc.
... languageCode 0..0 Language code for the human-readable text strings produced by the device (all supported)
... capability 0..0 Device capabilities
... property 0..0 The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
... owner 0..0 Organization responsible for device
... contact 0..0 Details for human/organization for support
... url 0..0 Network address to contact device
... onlineInformation 0..0 Access to on-line information
... note 0..0 Device notes and comments
... quantity 0..0 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 0..0 The parent device it can be part of
... material 0..0 A substance used to create the material(s) of which the device is made

doco Documentation for this format

Snapshot-AnsichtView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* TIDeviceDefinitionSpecimenSubject An instance of a medical-related component of a medical device
Constraints: dom-2, dom-3, dom-4, dom-5, dom-6
... id Σ 0..1 id Logical id of this artifact
... meta SΣ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId SΣ 0..1 id Version specific identifier
.... lastUpdated SΣ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... 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
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... manufacturer[x] S 0..1 string Name of device manufacturer
... type S 1..1 CodeableConcept What kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.
Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding SΣ 1..1 Coding Code defined by a terminology system

Fixed Value: (Complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
Fixed Value: http://snomed.info/sct
..... version SΣ 1..1 string Version of the system - if relevant
Fixed Value: http://snomed.info/sct/11000274103/version/20260515
..... code SΣ 1..1 code Symbol in syntax defined by the system
Fixed Value: 371882005
..... display SΣ 1..1 string Representation defined by the system
Fixed Value: Device used

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
DeviceDefinition.meta.​security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
DeviceDefinition.meta.​tag Base example Common Tags 📍4.0.1 FHIR Std.
DeviceDefinition.language Base preferred Common Languages 📍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.

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()
qty-3 error DeviceDefinition.property.valueQuantity If a code for the unit is present, the system SHALL also be present code.empty() or system.exists()

Diese Struktur ist abgeleitet von TIDeviceDefinitionSpecimenSubject

Summary

Mandatory: 6 elements
Prohibited: 22 elements

 

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