This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples

Resource Profile: DeviceDefinition - Drug

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

Usage:

• Use this Resource Profile: Bundle – Analytical Procedure PQ, Bundle - Product Manufacturing PQ and Bundle - Product Process Validation PQ
• Examples for this Resource Profile: DeviceDefinition/devicedefinition-drug-pq-ex1

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from DeviceDefinition

Name	Flags	Card.	Type	Description & Constraints
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: ValueSet - 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: ValueSet - Device Property (example)
value[x]	S	1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)

Name	Flags	Card.	Type	Description & Constraints
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
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
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: ValueSet - 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: ValueSet - Device Property (example)
value[x]	S	1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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: ValueSet - 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: ValueSet - Device Property (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.language	required	AllLanguages
DeviceDefinition.regulatoryIdentifier.type	required	DeviceDefinitionRegulatoryIdentifierType
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.conformsTo.category	example	DeviceSpecificationCategory
DeviceDefinition.conformsTo.specification	example	DeviceSpecificationType
DeviceDefinition.safety	example	DeviceSafety
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)
DeviceDefinition.link.relation	extensible	DeviceDefinitionRelationType
DeviceDefinition.productionIdentifierInUDI	required	DeviceProductionIdentifierInUDI
DeviceDefinition.correctiveAction.scope	required	DeviceCorrectiveActionScope

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

This structure is derived from DeviceDefinition

Summary

Must-Support: 6 elements

Differential View

This structure is derived from DeviceDefinition

Name	Flags	Card.	Type	Description & Constraints
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: ValueSet - 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: ValueSet - Device Property (example)
value[x]	S	1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
deviceName	SΣ	0..*	BackboneElement	The name or names of the device as given by the manufacturer
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: ValueSet - 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: ValueSet - Device Property (example)
value[x]	S	1..1		Value of the property
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueAttachment			Attachment
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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: ValueSet - 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: ValueSet - Device Property (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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
DeviceDefinition.language	required	AllLanguages
DeviceDefinition.regulatoryIdentifier.type	required	DeviceDefinitionRegulatoryIdentifierType
DeviceDefinition.deviceName.type	required	DeviceNameType
DeviceDefinition.classification.type	example	VsDeviceTypePQ (a valid code from CodeSystem - Device Type)
DeviceDefinition.conformsTo.category	example	DeviceSpecificationCategory
DeviceDefinition.conformsTo.specification	example	DeviceSpecificationType
DeviceDefinition.safety	example	DeviceSafety
DeviceDefinition.property.type	example	VsDevicePropertyPQ (a valid code from CodeSystem - Device Property)
DeviceDefinition.link.relation	extensible	DeviceDefinitionRelationType
DeviceDefinition.productionIdentifierInUDI	required	DeviceProductionIdentifierInUDI
DeviceDefinition.correctiveAction.scope	required	DeviceCorrectiveActionScope

Constraints

Id	Grade	Path(s)	Details	Requirements
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().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-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()

This structure is derived from DeviceDefinition

Summary

Must-Support: 6 elements

Other representations of profile: CSV, Excel, Schematron