MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR MTB Panel DeviceDefinition

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-panel-devicedefinition Version: 2027.0.0-ballot.1
Active as of 2026-09-15 Computable Name: MII_PR_MTB_Panel_DeviceDefinition

Katalog-Template eines Sequenzier-Panel-Produkts (Genpanel): Hersteller, Produktname/Version, analytische Faehigkeiten und Genliste(n). Konkrete Geraete/Kits einer Einrichtung verweisen via Device.definition auf ihr Template.

Written during migration - review before release. New modeling proposal (2026-09-14): the panel product catalog as DeviceDefinition templates, generated from the module team's panel metadata inventory. Review before release.

Content

This profile carries the sequencing-panel product catalog at the definition level: one DeviceDefinition template per panel product (manufacturer, product name/version, analytical capabilities, and the panel's gene list(s) as canonical references to HGNC ValueSets — separated by SNV and fusion scope where the product distinguishes them).

A site's concrete device or kit instance points at its template via Device.definition and attaches to the sequencing workflow through the Genomics-Reporting extension genomic-study-analysis-device, as before.

The shipped catalog covers eleven products (Oncomine Focus/Focus Plus, Qiagen DHS-3501Z, Agilent MH IVD 600+ and SureSelect Cancer CGP, DKTK/MASTER WGS, generic WGS, FusionPlex Archer Lung V2, TCM NGS, Basic-NGS, TruSight Oncology 500) with nine gene-list ValueSets (17–602 genes, coded with stable HGNC IDs; displays are the current approved symbols, outdated source symbols were remapped and annotated).

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... manufacturer[x] S 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName S 1..* BackboneElement A name given to the device to identify it
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string The name of the device
.... type S 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.
... 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 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 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... version S 0..* string Available versions
... capability S 0..* BackboneElement Device capabilities
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
... onlineInformation S 0..1 uri Herstellerseite / Produktdokumentation
... note S 0..* Annotation Device notes and comments

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.
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG

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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... manufacturer[x] S 0..1 string, Reference(Organization) Name of device manufacturer
.... name S 1..1 string The name of the device
.... type S 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
... type S 1..1 CodeableConcept What kind of device or device system this is
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
... version S 0..* string Available versions
... capability S 0..* BackboneElement Device capabilities
.... type S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
... onlineInformation S 0..1 uri Herstellerseite / Produktdokumentation
... note S 0..* Annotation Device notes and comments

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... id Σ 0..1 id Logical id of this artifact
... meta 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 Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 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
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
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 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... 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
... manufacturer[x] S 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName S 1..* BackboneElement A name given to the device to identify it
.... 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 S 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.
... modelNumber 0..1 string The model number for the device
... 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 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 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... 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 Available versions
... 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 S 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 S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
.... 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 S 0..1 uri Herstellerseite / Produktdokumentation
... note S 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

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.
DeviceDefinition.safety Base example Device safety 📍4.0.1 FHIR Std.
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG

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: 2 elements
Must-Support: 13 elements

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... meta SΣ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... manufacturer[x] S 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName S 1..* BackboneElement A name given to the device to identify it
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 1..1 string The name of the device
.... type S 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.
... 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 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 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... version S 0..* string Available versions
... capability S 0..* BackboneElement Device capabilities
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
... onlineInformation S 0..1 uri Herstellerseite / Produktdokumentation
... note S 0..* Annotation Device notes and comments

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.
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... manufacturer[x] S 0..1 string, Reference(Organization) Name of device manufacturer
.... name S 1..1 string The name of the device
.... type S 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
... type S 1..1 CodeableConcept What kind of device or device system this is
Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
... version S 0..* string Available versions
... capability S 0..* BackboneElement Device capabilities
.... type S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
... onlineInformation S 0..1 uri Herstellerseite / Produktdokumentation
... note S 0..* Annotation Device notes and comments

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... id Σ 0..1 id Logical id of this artifact
... meta 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 Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 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
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
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 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:geneList S 0..* (Complex) MII EX MTB Panel Gene List
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-panel-gene-list
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... 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
... manufacturer[x] S 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName S 1..* BackboneElement A name given to the device to identify it
.... 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 S 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.
... modelNumber 0..1 string The model number for the device
... 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 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 1..1 uri Identity of the terminology system
Fixed Value: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/CodeSystem/mii-cs-mtb-genomicanalysis-devicefunction
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: gene-panel
..... display 0..1 string Representation defined by the system
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... 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 Available versions
... 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 S 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 S 1..1 CodeableConcept Type of capability
Binding: MII VS MTB Panel Capability (required)
.... 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 S 0..1 uri Herstellerseite / Produktdokumentation
... note S 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

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.
DeviceDefinition.safety Base example Device safety 📍4.0.1 FHIR Std.
DeviceDefinition.capability.​type Base required MII VS MTB Panel Capability 📦2027.0.0-ballot.1 This IG

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: 2 elements
Must-Support: 13 elements

Extensions

This structure refers to these extensions:

 

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