HL7 PT FHIR Implementation Guide: Example IG Release 1 | STU1
0.0.1 - STU1 International flag

HL7 PT FHIR Implementation Guide: Example IG Release 1 | STU1, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/core/ and changes regularly. See the Directory of published versions

Resource Profile: PT_DeviceDefinition

Official URL: http://hl7.pt/fhir/core/StructureDefinition/PTDeviceDefinition Version: 0.0.1
Active as of 2024-09-23 Computable Name: PT_DeviceDefinition

A generic DeviceDefinition resource for Portugal

Usage:

  • This Resource Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... 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
.... regulatoryIdentifier 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/RegulatoryIdentifier-DeviceDefinition
.... packaging 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Packaging-DeviceDefinition
.... guideline 0..1 (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Guideline-DeviceDefinition
.... chargeItem 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/ChargeItem-DeviceDefinition
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored

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..* DeviceDefinition An instance of a medical-related component of a medical device
... 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 BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... regulatoryIdentifier 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/RegulatoryIdentifier-DeviceDefinition
.... packaging 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Packaging-DeviceDefinition
.... guideline 0..1 (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Guideline-DeviceDefinition
.... chargeItem 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/ChargeItem-DeviceDefinition
... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... marketDistribution 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/MarketDistribution-DeviceDefiniton
.... 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] 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName 0..* 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 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.

... 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 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 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
DeviceDefinition.typeexampleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard
DeviceDefinition.safetyexampleDeviceSafety
http://hl7.org/fhir/ValueSet/device-safety
from the FHIR Standard

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()

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... 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
.... regulatoryIdentifier 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/RegulatoryIdentifier-DeviceDefinition
.... packaging 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Packaging-DeviceDefinition
.... guideline 0..1 (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Guideline-DeviceDefinition
.... chargeItem 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/ChargeItem-DeviceDefinition
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored

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..* DeviceDefinition An instance of a medical-related component of a medical device
... 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 BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... regulatoryIdentifier 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/RegulatoryIdentifier-DeviceDefinition
.... packaging 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Packaging-DeviceDefinition
.... guideline 0..1 (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/Guideline-DeviceDefinition
.... chargeItem 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/ChargeItem-DeviceDefinition
... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... marketDistribution 0..* (Complex) Extension
URL: http://hl7.pt/fhir/core/StructureDefinition/MarketDistribution-DeviceDefiniton
.... 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] 0..1 Name of device manufacturer
.... manufacturerString string
.... manufacturerReference Reference(Organization)
... deviceName 0..* 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 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.

... 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 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 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
DeviceDefinition.typeexampleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard
DeviceDefinition.safetyexampleDeviceSafety
http://hl7.org/fhir/ValueSet/device-safety
from the FHIR Standard

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()

 

Other representations of profile: CSV, Excel, Schematron