Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: DeviceDefinition - Drug

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq Version: 1.0.0
Active as of 2024-05-08 Computable Name: DeviceDefinitionDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.24

This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.

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 0..* DeviceDefinition An instance of a medical-related component of a medical device
... deviceName S 0..* BackboneElement The name or names of the device as given by the manufacturer
... classification S 0..* BackboneElement What kind of device or device system this is
.... type S 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... type S 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG
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
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... classification SΣ 0..* BackboneElement What kind of device or device system this is
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|5.0.0
from the FHIR Standard
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... description 0..1 markdown Additional information to describe the device
... identifier Σ 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 jurisdiction provided 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
.... marketDistribution 0..* BackboneElement Indicates whether and when the device is available on the market
..... 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
..... marketPeriod 1..1 Period Begin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1 uri National state or territory where the device is commercialized
... regulatoryIdentifier 0..* BackboneElement Regulatory identifier(s) associated with this device
.... 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 code basic | master | license
Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type.

.... deviceIdentifier 1..1 string The identifier itself
.... issuer 1..1 uri The organization that issued this identifier
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
... partNumber 0..1 string The part number or catalog number of the device
... manufacturer Σ 0..1 Reference(Organization) Name of device manufacturer
... deviceName SΣ 0..* BackboneElement The name or names of the device as given by the manufacturer
.... 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 Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... classification SΣ 0..* BackboneElement What kind of device or device system this is
.... 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 SΣ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
.... justification 0..* RelatedArtifact Further information qualifying this classification of the device model
... conformsTo Σ 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... 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
.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: DeviceSpecificationCategory (example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: DeviceSpecificationType (example)
.... version Σ 0..* string The specific form or variant of the standard, specification or formal guidance
.... source 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
... hasPart Σ 0..* BackboneElement A device, part of the current one
.... 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
.... reference Σ 1..1 Reference(DeviceDefinition) Reference to the part
.... count 0..1 integer Number of occurrences of the part
... packaging 0..* BackboneElement Information about the packaging of the device, i.e. how the device is packaged
.... 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
.... identifier 0..1 Identifier Business identifier of the packaged medication
.... type 0..1 CodeableConcept A code that defines the specific type of packaging
.... count 0..1 integer The number of items contained in the package (devices or sub-packages)
.... distributor 0..* BackboneElement An organization that distributes the packaged device
..... 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 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource
.... udiDeviceIdentifier 0..* See udiDeviceIdentifier (DeviceDefinition) Unique Device Identifier (UDI) Barcode string on the packaging
.... packaging 0..* See packaging (DeviceDefinition) Allows packages within packages
... version 0..* BackboneElement The version of the device or software
.... 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 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... value 1..1 string The version text
... safety Σ 0..* CodeableConcept Safety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
... languageCode 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... 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 Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... link 0..* BackboneElement An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
.... 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
.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device.

.... relatedDevice 1..1 CodeableReference(DeviceDefinition) A reference to the linked device
... note 0..* Annotation Device notes and comments
... 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 A relevant substance that the device contains, may contain, or is made of
.... alternate 0..1 boolean Indicates an alternative material of the device
.... allergenicIndicator 0..1 boolean Whether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..* code lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier.


... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... 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
.... useContext 0..* UsageContext The circumstances that form the setting for using the device
.... usageInstruction 0..1 markdown Detailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..* RelatedArtifact A source of information or reference for this guideline
.... indication 0..* CodeableConcept A clinical condition for which the device was designed to be used
.... contraindication 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm
.... warning 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device
.... intendedUse 0..1 string A description of the general purpose or medical use of the device or its function
... correctiveAction 0..1 BackboneElement Tracking of latest field safety corrective action
.... 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
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action.

.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device
.... 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
.... chargeItemCode 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item
.... count 1..1 Quantity Coefficient applicable to the billing code
.... effectivePeriod 0..1 Period A specific time period in which this charge item applies
.... useContext 0..* UsageContext The context to which this charge item applies

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
DeviceDefinition.regulatoryIdentifier.typerequiredDeviceDefinitionRegulatoryIdentifierType
http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0
from the FHIR Standard
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|5.0.0
from the FHIR Standard
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.conformsTo.categoryexampleDeviceSpecificationCategory
http://hl7.org/fhir/ValueSet/device-specification-category
from the FHIR Standard
DeviceDefinition.conformsTo.specificationexampleDeviceSpecificationType
http://hl7.org/fhir/ValueSet/device-specification-type
from the FHIR Standard
DeviceDefinition.safetyexampleDeviceSafety
http://hl7.org/fhir/ValueSet/device-safety
from the FHIR Standard
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG
DeviceDefinition.link.relationextensibleDeviceDefinitionRelationType
http://hl7.org/fhir/ValueSet/devicedefinition-relationtype
from the FHIR Standard
DeviceDefinition.productionIdentifierInUDIrequiredDeviceProductionIdentifierInUDI
http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0
from the FHIR Standard
DeviceDefinition.correctiveAction.scoperequiredDeviceCorrectiveActionScope
http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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

Must-Support: 6 elements

Differential View

This structure is derived from DeviceDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition 0..* DeviceDefinition An instance of a medical-related component of a medical device
... deviceName S 0..* BackboneElement The name or names of the device as given by the manufacturer
... classification S 0..* BackboneElement What kind of device or device system this is
.... type S 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... type S 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

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
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... classification SΣ 0..* BackboneElement What kind of device or device system this is
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type SΣ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|5.0.0
from the FHIR Standard
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... description 0..1 markdown Additional information to describe the device
... identifier Σ 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 jurisdiction provided 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
.... marketDistribution 0..* BackboneElement Indicates whether and when the device is available on the market
..... 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
..... marketPeriod 1..1 Period Begin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1 uri National state or territory where the device is commercialized
... regulatoryIdentifier 0..* BackboneElement Regulatory identifier(s) associated with this device
.... 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 code basic | master | license
Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type.

.... deviceIdentifier 1..1 string The identifier itself
.... issuer 1..1 uri The organization that issued this identifier
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
... partNumber 0..1 string The part number or catalog number of the device
... manufacturer Σ 0..1 Reference(Organization) Name of device manufacturer
... deviceName SΣ 0..* BackboneElement The name or names of the device as given by the manufacturer
.... 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 Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 code registered-name | user-friendly-name | patient-reported-name
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... classification SΣ 0..* BackboneElement What kind of device or device system this is
.... 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 SΣ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (example)
.... justification 0..* RelatedArtifact Further information qualifying this classification of the device model
... conformsTo Σ 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
.... 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
.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: DeviceSpecificationCategory (example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: DeviceSpecificationType (example)
.... version Σ 0..* string The specific form or variant of the standard, specification or formal guidance
.... source 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
... hasPart Σ 0..* BackboneElement A device, part of the current one
.... 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
.... reference Σ 1..1 Reference(DeviceDefinition) Reference to the part
.... count 0..1 integer Number of occurrences of the part
... packaging 0..* BackboneElement Information about the packaging of the device, i.e. how the device is packaged
.... 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
.... identifier 0..1 Identifier Business identifier of the packaged medication
.... type 0..1 CodeableConcept A code that defines the specific type of packaging
.... count 0..1 integer The number of items contained in the package (devices or sub-packages)
.... distributor 0..* BackboneElement An organization that distributes the packaged device
..... 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 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource
.... udiDeviceIdentifier 0..* See udiDeviceIdentifier (DeviceDefinition) Unique Device Identifier (UDI) Barcode string on the packaging
.... packaging 0..* See packaging (DeviceDefinition) Allows packages within packages
... version 0..* BackboneElement The version of the device or software
.... 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 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... value 1..1 string The version text
... safety Σ 0..* CodeableConcept Safety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
... languageCode 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported)
... property S 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
.... 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 Code that specifies the property being represented
Binding: Device Properties (example)
.... value[x] S 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... link 0..* BackboneElement An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
.... 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
.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device.

.... relatedDevice 1..1 CodeableReference(DeviceDefinition) A reference to the linked device
... note 0..* Annotation Device notes and comments
... 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 A relevant substance that the device contains, may contain, or is made of
.... alternate 0..1 boolean Indicates an alternative material of the device
.... allergenicIndicator 0..1 boolean Whether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..* code lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier.


... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... 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
.... useContext 0..* UsageContext The circumstances that form the setting for using the device
.... usageInstruction 0..1 markdown Detailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..* RelatedArtifact A source of information or reference for this guideline
.... indication 0..* CodeableConcept A clinical condition for which the device was designed to be used
.... contraindication 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm
.... warning 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device
.... intendedUse 0..1 string A description of the general purpose or medical use of the device or its function
... correctiveAction 0..1 BackboneElement Tracking of latest field safety corrective action
.... 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
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action.

.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device
.... 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
.... chargeItemCode 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item
.... count 1..1 Quantity Coefficient applicable to the billing code
.... effectivePeriod 0..1 Period A specific time period in which this charge item applies
.... useContext 0..* UsageContext The context to which this charge item applies

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
DeviceDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
DeviceDefinition.regulatoryIdentifier.typerequiredDeviceDefinitionRegulatoryIdentifierType
http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0
from the FHIR Standard
DeviceDefinition.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|5.0.0
from the FHIR Standard
DeviceDefinition.classification.typeexampleVsDeviceTypePQ (a valid code from Device Type - example)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq
from this IG
DeviceDefinition.conformsTo.categoryexampleDeviceSpecificationCategory
http://hl7.org/fhir/ValueSet/device-specification-category
from the FHIR Standard
DeviceDefinition.conformsTo.specificationexampleDeviceSpecificationType
http://hl7.org/fhir/ValueSet/device-specification-type
from the FHIR Standard
DeviceDefinition.safetyexampleDeviceSafety
http://hl7.org/fhir/ValueSet/device-safety
from the FHIR Standard
DeviceDefinition.property.typeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG
DeviceDefinition.link.relationextensibleDeviceDefinitionRelationType
http://hl7.org/fhir/ValueSet/devicedefinition-relationtype
from the FHIR Standard
DeviceDefinition.productionIdentifierInUDIrequiredDeviceProductionIdentifierInUDI
http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0
from the FHIR Standard
DeviceDefinition.correctiveAction.scoperequiredDeviceCorrectiveActionScope
http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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

Must-Support: 6 elements

 

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