CH LAB-Report (R4)
0.1.1 - draft Switzerland flag

This page is part of the CH LAB-Report (R4) (v0.1.1: DSTU 1 Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: ChLabReportDeviceDefinition

Official URL: http://fhir.ch/ig/ch-lab-report/StructureDefinition/ch-lab-report-device-definition Version: 0.1.1
Active as of 2023-12-28 Computable Name: ChLabReportDeviceDefinition

Copyright/Legal: CC0-1.0

Holds udiDeviceIdentifier from Test , regulatoryIdentifier,

Usage:

Formal Views of Profile Content

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

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition DeviceDefinition
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
... manufacturer[x] 0..1Reference(CH Core Organization)Name of device manufacturer
... deviceName
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Required Pattern: 30234008

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceDefinitionIf 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-4errorDeviceDefinitionIf 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-5errorDeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] 0..1Reference(CH Core Organization)Name of device manufacturer
... deviceName 0..*BackboneElementA name given to the device to identify it
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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.


Required Pattern: 30234008
... modelNumber 0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.

... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementDevice capabilities
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe 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 Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material 0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DeviceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
DeviceDefinition.deviceName.typerequiredPattern: 30234008
DeviceDefinition.typeexampleFHIRDeviceTypes
DeviceDefinition.safetyexampleDeviceSafety

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceDefinitionIf 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-4errorDeviceDefinitionIf 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-5errorDeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from DeviceDefinition

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

Differential View

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition DeviceDefinition
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
... manufacturer[x] 0..1Reference(CH Core Organization)Name of device manufacturer
... deviceName
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Required Pattern: 30234008

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies

doco Documentation for this format

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceDefinitionIf 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-4errorDeviceDefinitionIf 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-5errorDeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..*DeviceDefinitionAn instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier 1..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier 1..1stringThe 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..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] 0..1Reference(CH Core Organization)Name of device manufacturer
... deviceName 0..*BackboneElementA name given to the device to identify it
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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.


Required Pattern: 30234008
... modelNumber 0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example): Type of device e.g. according to official classification.

... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementDevice capabilities
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe 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 Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material 0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
DeviceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
DeviceDefinition.deviceName.typerequiredPattern: 30234008
DeviceDefinition.typeexampleFHIRDeviceTypes
DeviceDefinition.safetyexampleDeviceSafety

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorDeviceDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceDefinitionIf 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-4errorDeviceDefinitionIf 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-5errorDeviceDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from DeviceDefinition

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron