R6 Checklist for DeviceDefinition

Artifact DeviceDefinition (DeviceDefinition)

Urgent Item Checklist

Confirm workgroup disposition vote has been recorded and sent to FMG!
CodeSystem: version-algorithm (VersionAlgorithm) referenced by ValueSet version-algorithm bound to element DeviceDefinition.versionAlgorithm[x] is never bound to a code-type element. Should it move to THO?
CodeSystem: device-nametype (DeviceNameType) referenced by ValueSet device-nametype bound to element DeviceDefinition.deviceName.type is never bound to a code-type element. Should it move to THO?
CodeSystem: device-specification-category (FHIRDeviceSpecializationCategory) referenced by ValueSet device-specification-category bound to element DeviceDefinition.conformsTo.category is never bound to a code-type element. Should it move to THO?
CodeSystem: device-property-type (DevicePropertyType) referenced by ValueSet device-property-type bound to element DeviceDefinition.property.type is never bound to a code-type element. Should it move to THO?
CodeSystem: devicedefinition-relationtype (DeviceDefinitionRelationType) referenced by ValueSet devicedefinition-relationtype bound to element DeviceDefinition.link.relation is never bound to a code-type element. Should it move to THO?
CodeSystem: device-productidentifierinudi (DeviceProductionIdentifierInUDI) referenced by ValueSet device-productidentifierinudi bound to element DeviceDefinition.productionIdentifierInUDI is never bound to a code-type element. Should it move to THO?

All Analysis Information

The following content was generated to assist in the review of this artifact for R6 compliance.

Information Page

General Information:

Page File Name	`devicedefinition-introduction.xml`
Responsible Workgroup	`oo`
Maturity Label	`Active`
Maturity Level	`1`
Standards Status	`normative`
Management Comments
Workgroup Comments
Exists In `publish.ini`	`No`
Exists In Source Directory	`Yes`
'`deprecated`' Literal Count	`0`
Zulip Link Count	`0`
Confluence Link Count	`0`

Conformance Language Summary

'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.

Literal	Conformant	Non-Conformant
SHALL	0	2
SHALL NOT	0	1
SHOULD	0	1
SHOULD NOT	0	0
MAY	0	26
MAY NOT	0	0

Possibly Removed FHIR Artifact Literals Found on Page

Word	Artifact Class
`DeviceDefinition.owner.`	Element

Unknown Words Found on Page

Word	Known Typo
`(DTx)`	No
`(PHDs)`	No
`(PoCD)`	No
`21CFR`	No
`MDR`	No
`PHDs`	No
`PHDs,`	No
`PHDs:`	No
`PoCDs`	No
`cellphone,`	No
`homogenuous`	No
`laryngoscopes.`	No
`spirometers`	No
`standalone`	No

Images with Issues

Source	Missing Alt Text	Not In Figure Tag
`external.png`	Yes	Yes

Possible Incomplete Markers Found on Page

Reader Review Notes Found on Page

Balloters

Notes Page

General Information:

Page File Name	`devicedefinition-notes.xml`
Responsible Workgroup	`oo`
Maturity Label	`Active`
Maturity Level	`1`
Standards Status	`normative`
Management Comments
Workgroup Comments
Exists In `publish.ini`	`No`
Exists In Source Directory	`Yes`
'`deprecated`' Literal Count	`0`
Zulip Link Count	`0`
Confluence Link Count	`0`

Conformance Language Summary

'Conformant' conformance language appears in all-upper case. 'Non-conformant' covers all other cases appearing in the content.

Literal	Conformant	Non-Conformant
SHALL	0	0
SHALL NOT	0	0
SHOULD	0	0
SHOULD NOT	0	0
MAY	0	0
MAY NOT	0	0

Possibly Removed FHIR Artifact Literals Found on Page

Word	Artifact Class

Unknown Words Found on Page

Word	Known Typo

Images with Issues

Source	Missing Alt Text	Not In Figure Tag

Possible Incomplete Markers Found on Page

Reader Review Notes Found on Page

Element Review

Path	Is Required	Max Cardinality	Required Binding	Check `meaningWhenMissing`	Is Modifier
`DeviceDefinition`		`*`
`DeviceDefinition.url`		`1`
`DeviceDefinition.identifier`		`*`
`DeviceDefinition.version`		`1`
`DeviceDefinition.versionAlgorithm[x]`		`1`
`DeviceDefinition.name`		`1`
`DeviceDefinition.title`		`1`
`DeviceDefinition.status`	X	`1`	Has 'unknown'		X
`DeviceDefinition.experimental`		`1`
`DeviceDefinition.date`		`1`
`DeviceDefinition.publisher`		`1`
`DeviceDefinition.contact`		`*`
`DeviceDefinition.description`		`1`
`DeviceDefinition.useContext`		`*`
`DeviceDefinition.jurisdiction`		`*`
`DeviceDefinition.purpose`		`1`
`DeviceDefinition.copyright`		`1`
`DeviceDefinition.copyrightLabel`		`1`
`DeviceDefinition.approvalDate`		`1`
`DeviceDefinition.lastReviewDate`		`1`
`DeviceDefinition.effectivePeriod`		`1`
`DeviceDefinition.partNumber`		`1`
`DeviceDefinition.manufacturer`		`1`
`DeviceDefinition.modelNumber`		`1`
`DeviceDefinition.udiDeviceIdentifier`		`*`
`DeviceDefinition.udiDeviceIdentifier.deviceIdentifier`	X	`1`
`DeviceDefinition.udiDeviceIdentifier.issuer`	X	`1`
`DeviceDefinition.udiDeviceIdentifier.jurisdiction`	X	`1`
`DeviceDefinition.udiDeviceIdentifier.marketDistribution`		`*`
`DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod`	X	`1`
`DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction`	X	`1`
`DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem`		`1`
`DeviceDefinition.regulatoryIdentifier`		`*`
`DeviceDefinition.regulatoryIdentifier.type`	X	`1`	NO 'other' or 'unknown'
`DeviceDefinition.regulatoryIdentifier.identifier`	X	`1`
`DeviceDefinition.regulatoryIdentifier.issuer`	X	`1`
`DeviceDefinition.regulatoryIdentifier.jurisdiction`	X	`1`
`DeviceDefinition.regulatoryIdentifier.identifierSystem`		`1`
`DeviceDefinition.deviceName`		`*`
`DeviceDefinition.deviceName.name`	X	`1`
`DeviceDefinition.deviceName.type`	X	`1`
`DeviceDefinition.classification`		`*`
`DeviceDefinition.classification.type`	X	`1`
`DeviceDefinition.classification.justification`		`*`
`DeviceDefinition.conformsTo`		`*`
`DeviceDefinition.conformsTo.category`		`1`
`DeviceDefinition.conformsTo.specification`	X	`1`
`DeviceDefinition.conformsTo.version`		`*`
`DeviceDefinition.conformsTo.source`		`*`
`DeviceDefinition.hasPart`		`*`
`DeviceDefinition.hasPart.definition[x]`	X	`1`
`DeviceDefinition.hasPart.count`		`1`
`DeviceDefinition.packaging`		`*`
`DeviceDefinition.packaging.identifier`		`1`
`DeviceDefinition.packaging.type`		`1`
`DeviceDefinition.packaging.count`		`1`
`DeviceDefinition.packaging.distributor`		`*`
`DeviceDefinition.packaging.distributor.name`		`1`
`DeviceDefinition.packaging.distributor.organizationReference`		`*`
`DeviceDefinition.packaging.udiDeviceIdentifier`		`*`
`DeviceDefinition.packaging.packaging`		`*`
`DeviceDefinition.deviceVersion`		`*`
`DeviceDefinition.deviceVersion.type`		`1`
`DeviceDefinition.deviceVersion.component`		`1`
`DeviceDefinition.deviceVersion.value`	X	`1`
`DeviceDefinition.safety`		`*`
`DeviceDefinition.shelfLifeStorage`		`*`
`DeviceDefinition.outputLanguage`		`*`	optional - NO 'other' or 'unknown'	X
`DeviceDefinition.property`		`*`
`DeviceDefinition.property.type`	X	`1`
`DeviceDefinition.property.value[x]`	X	`1`
`DeviceDefinition.link`		`*`
`DeviceDefinition.link.relation`	X	`1`
`DeviceDefinition.link.relatedDevice[x]`	X	`1`
`DeviceDefinition.note`		`*`
`DeviceDefinition.material`		`*`
`DeviceDefinition.material.substance`	X	`1`
`DeviceDefinition.material.alternate`		`1`		X
`DeviceDefinition.material.allergenicIndicator`		`1`		X
`DeviceDefinition.productionIdentifierInUDI`		`*`
`DeviceDefinition.guideline`		`1`
`DeviceDefinition.guideline.useContext`		`*`
`DeviceDefinition.guideline.usageInstruction`		`1`
`DeviceDefinition.guideline.relatedArtifact`		`*`
`DeviceDefinition.guideline.indication`		`*`
`DeviceDefinition.guideline.contraindication`		`*`
`DeviceDefinition.guideline.warning`		`*`
`DeviceDefinition.guideline.intendedUse`		`1`
`DeviceDefinition.correctiveAction`		`1`
`DeviceDefinition.correctiveAction.recall`	X	`1`
`DeviceDefinition.correctiveAction.scope`		`1`	optional - NO 'other' or 'unknown'	X
`DeviceDefinition.correctiveAction.period`	X	`1`
`DeviceDefinition.chargeItem`		`*`
`DeviceDefinition.chargeItem.chargeItemCode`	X	`1`
`DeviceDefinition.chargeItem.count`	X	`1`
`DeviceDefinition.chargeItem.effectivePeriod`		`1`
`DeviceDefinition.chargeItem.useContext`		`*`

Operations

No operations found.

Search Parameters

Id	Name	Publication Status	Standards Status	IsExperimental	WorkGroup	Search Type	Description
`CanonicalResource-identifier`	`identifier`	Active	normative	False	cds	token	Multiple Resources: * [ActivityDefinition](http://hl7.org/fhir/R6/activitydefinition.html): External identifier for the activity definition * [ActorDefinition](http://hl7.org/fhir/R6/actordefinition.html): External identifier for the Actor Definition * [CapabilityStatement](http://hl7.org/fhir/R6/capabilitystatement.html): External identifier for the capability statement * [CodeSystem](http://hl7.org/fhir/R6/codesystem.html): External identifier for the code system * [ConceptMap](http://hl7.org/fhir/R6/conceptmap.html): External identifier for the concept map * [DeviceDefinition](http://hl7.org/fhir/R6/devicedefinition.html): The identifier of the component * [EventDefinition](http://hl7.org/fhir/R6/eventdefinition.html): External identifier for the event definition * [Evidence](http://hl7.org/fhir/R6/evidence.html): External identifier for the evidence * [EvidenceVariable](http://hl7.org/fhir/R6/evidencevariable.html): External identifier for the evidence variable * [ExampleScenario](http://hl7.org/fhir/R6/examplescenario.html): External identifier for the example scenario * [Group](http://hl7.org/fhir/R6/group.html): Unique id * [ImplementationGuide](http://hl7.org/fhir/R6/implementationguide.html): External identifier for the implementation guide * [Library](http://hl7.org/fhir/R6/library.html): External identifier for the library * [Measure](http://hl7.org/fhir/R6/measure.html): External identifier for the measure * [MessageDefinition](http://hl7.org/fhir/R6/messagedefinition.html): External identifier for the message definition * [NamingSystem](http://hl7.org/fhir/R6/namingsystem.html): External identifier for the naming system * [ObservationDefinition](http://hl7.org/fhir/R6/observationdefinition.html): The unique identifier associated with the specimen definition * [OperationDefinition](http://hl7.org/fhir/R6/operationdefinition.html): External identifier for the search parameter * [PlanDefinition](http://hl7.org/fhir/R6/plandefinition.html): External identifier for the plan definition * [Questionnaire](http://hl7.org/fhir/R6/questionnaire.html): External identifier for the questionnaire * [Requirements](http://hl7.org/fhir/R6/requirements.html): External identifier for the requirements * [SearchParameter](http://hl7.org/fhir/R6/searchparameter.html): External identifier for the search parameter * [SpecimenDefinition](http://hl7.org/fhir/R6/specimendefinition.html): The unique identifier associated with the SpecimenDefinition * [StructureDefinition](http://hl7.org/fhir/R6/structuredefinition.html): External identifier for the structure definition * [StructureMap](http://hl7.org/fhir/R6/structuremap.html): External identifier for the structure map * [SubscriptionTopic](http://hl7.org/fhir/R6/subscriptiontopic.html): Business Identifier for SubscriptionTopic * [TerminologyCapabilities](http://hl7.org/fhir/R6/terminologycapabilities.html): External identifier for the terminology capabilities * [ValueSet](http://hl7.org/fhir/R6/valueset.html): External identifier for the value set
`CanonicalResource-publisher`	`publisher`	Active	normative	False	cds	string	Multiple Resources: * [ActivityDefinition](http://hl7.org/fhir/R6/activitydefinition.html): Name of the publisher of the activity definition * [ActorDefinition](http://hl7.org/fhir/R6/actordefinition.html): Name of the publisher of the Actor Definition * [CapabilityStatement](http://hl7.org/fhir/R6/capabilitystatement.html): Name of the publisher of the capability statement * [CodeSystem](http://hl7.org/fhir/R6/codesystem.html): Name of the publisher of the code system * [CompartmentDefinition](http://hl7.org/fhir/R6/compartmentdefinition.html): Name of the publisher of the compartment definition * [ConceptMap](http://hl7.org/fhir/R6/conceptmap.html): Name of the publisher of the concept map * [DeviceDefinition](http://hl7.org/fhir/R6/devicedefinition.html): The contact for the publisher of the device definition * [EventDefinition](http://hl7.org/fhir/R6/eventdefinition.html): Name of the publisher of the event definition * [Evidence](http://hl7.org/fhir/R6/evidence.html): Name of the publisher of the evidence * [EvidenceVariable](http://hl7.org/fhir/R6/evidencevariable.html): Name of the publisher of the evidence variable * [ExampleScenario](http://hl7.org/fhir/R6/examplescenario.html): Name of the publisher of the example scenario * [ImplementationGuide](http://hl7.org/fhir/R6/implementationguide.html): Name of the publisher of the implementation guide * [Library](http://hl7.org/fhir/R6/library.html): Name of the publisher of the library * [Measure](http://hl7.org/fhir/R6/measure.html): Name of the publisher of the measure * [MessageDefinition](http://hl7.org/fhir/R6/messagedefinition.html): Name of the publisher of the message definition * [NamingSystem](http://hl7.org/fhir/R6/namingsystem.html): Name of the publisher of the naming system * [OperationDefinition](http://hl7.org/fhir/R6/operationdefinition.html): Name of the publisher of the operation definition * [PlanDefinition](http://hl7.org/fhir/R6/plandefinition.html): Name of the publisher of the plan definition * [Questionnaire](http://hl7.org/fhir/R6/questionnaire.html): Name of the publisher of the questionnaire * [Requirements](http://hl7.org/fhir/R6/requirements.html): Name of the publisher of the requirements * [SearchParameter](http://hl7.org/fhir/R6/searchparameter.html): Name of the publisher of the search parameter * [StructureDefinition](http://hl7.org/fhir/R6/structuredefinition.html): Name of the publisher of the structure definition * [StructureMap](http://hl7.org/fhir/R6/structuremap.html): Name of the publisher of the structure map * [TerminologyCapabilities](http://hl7.org/fhir/R6/terminologycapabilities.html): Name of the publisher of the terminology capabilities * [ValueSet](http://hl7.org/fhir/R6/valueset.html): Name of the publisher of the value set
`CanonicalResource-url`	`url`	Active	normative	False	cds	uri	Multiple Resources: * [ActivityDefinition](http://hl7.org/fhir/R6/activitydefinition.html): The uri that identifies the activity definition * [ActorDefinition](http://hl7.org/fhir/R6/actordefinition.html): The uri that identifies the Actor Definition * [CapabilityStatement](http://hl7.org/fhir/R6/capabilitystatement.html): The uri that identifies the capability statement * [CodeSystem](http://hl7.org/fhir/R6/codesystem.html): The uri that identifies the code system * [CompartmentDefinition](http://hl7.org/fhir/R6/compartmentdefinition.html): The uri that identifies the compartment definition * [ConceptMap](http://hl7.org/fhir/R6/conceptmap.html): The URI that identifies the concept map * [DeviceDefinition](http://hl7.org/fhir/R6/devicedefinition.html): The uri that identifies the code system * [EventDefinition](http://hl7.org/fhir/R6/eventdefinition.html): The uri that identifies the event definition * [Evidence](http://hl7.org/fhir/R6/evidence.html): The uri that identifies the evidence * [EvidenceVariable](http://hl7.org/fhir/R6/evidencevariable.html): The uri that identifies the evidence variable * [ExampleScenario](http://hl7.org/fhir/R6/examplescenario.html): The uri that identifies the example scenario * [Group](http://hl7.org/fhir/R6/group.html): The uri that identifies the Group * [ImplementationGuide](http://hl7.org/fhir/R6/implementationguide.html): The uri that identifies the implementation guide * [Library](http://hl7.org/fhir/R6/library.html): The uri that identifies the library * [Measure](http://hl7.org/fhir/R6/measure.html): The uri that identifies the measure * [MessageDefinition](http://hl7.org/fhir/R6/messagedefinition.html): The uri that identifies the message definition * [NamingSystem](http://hl7.org/fhir/R6/namingsystem.html): The uri that identifies the naming system * [ObservationDefinition](http://hl7.org/fhir/R6/observationdefinition.html): The uri that identifies the observation definition * [OperationDefinition](http://hl7.org/fhir/R6/operationdefinition.html): The uri that identifies the operation definition * [PlanDefinition](http://hl7.org/fhir/R6/plandefinition.html): The uri that identifies the plan definition * [Questionnaire](http://hl7.org/fhir/R6/questionnaire.html): The uri that identifies the questionnaire * [Requirements](http://hl7.org/fhir/R6/requirements.html): The uri that identifies the requirements * [SearchParameter](http://hl7.org/fhir/R6/searchparameter.html): The uri that identifies the search parameter * [SpecimenDefinition](http://hl7.org/fhir/R6/specimendefinition.html): The uri that identifies the specimen definition * [StructureDefinition](http://hl7.org/fhir/R6/structuredefinition.html): The uri that identifies the structure definition * [StructureMap](http://hl7.org/fhir/R6/structuremap.html): The uri that identifies the structure map * [SubscriptionTopic](http://hl7.org/fhir/R6/subscriptiontopic.html): Logical canonical URL to reference this SubscriptionTopic (globally unique) * [TerminologyCapabilities](http://hl7.org/fhir/R6/terminologycapabilities.html): The uri that identifies the terminology capabilities * [ValueSet](http://hl7.org/fhir/R6/valueset.html): The uri that identifies the value set
`CanonicalResource-version`	`version`	Active	normative	False	cds	token	Multiple Resources: * [ActivityDefinition](http://hl7.org/fhir/R6/activitydefinition.html): The business version of the activity definition * [ActorDefinition](http://hl7.org/fhir/R6/actordefinition.html): The business version of the Actor Definition * [CapabilityStatement](http://hl7.org/fhir/R6/capabilitystatement.html): The business version of the capability statement * [CodeSystem](http://hl7.org/fhir/R6/codesystem.html): The business version of the code system * [CompartmentDefinition](http://hl7.org/fhir/R6/compartmentdefinition.html): The business version of the compartment definition * [ConceptMap](http://hl7.org/fhir/R6/conceptmap.html): The business version of the concept map * [DeviceDefinition](http://hl7.org/fhir/R6/devicedefinition.html): The specific version of the device * [EventDefinition](http://hl7.org/fhir/R6/eventdefinition.html): The business version of the event definition * [Evidence](http://hl7.org/fhir/R6/evidence.html): The business version of the evidence * [EvidenceVariable](http://hl7.org/fhir/R6/evidencevariable.html): The business version of the evidence variable * [ExampleScenario](http://hl7.org/fhir/R6/examplescenario.html): The business version of the example scenario * [ImplementationGuide](http://hl7.org/fhir/R6/implementationguide.html): The business version of the implementation guide * [Library](http://hl7.org/fhir/R6/library.html): The business version of the library * [Measure](http://hl7.org/fhir/R6/measure.html): The business version of the measure * [MessageDefinition](http://hl7.org/fhir/R6/messagedefinition.html): The business version of the message definition * [NamingSystem](http://hl7.org/fhir/R6/namingsystem.html): The business version of the naming system * [OperationDefinition](http://hl7.org/fhir/R6/operationdefinition.html): The business version of the operation definition * [PlanDefinition](http://hl7.org/fhir/R6/plandefinition.html): The business version of the plan definition * [Questionnaire](http://hl7.org/fhir/R6/questionnaire.html): The business version of the questionnaire * [Requirements](http://hl7.org/fhir/R6/requirements.html): The business version of the requirements * [SearchParameter](http://hl7.org/fhir/R6/searchparameter.html): The business version of the search parameter * [StructureDefinition](http://hl7.org/fhir/R6/structuredefinition.html): The business version of the structure definition * [StructureMap](http://hl7.org/fhir/R6/structuremap.html): The business version of the structure map * [SubscriptionTopic](http://hl7.org/fhir/R6/subscriptiontopic.html): Business version of the SubscriptionTopic * [TerminologyCapabilities](http://hl7.org/fhir/R6/terminologycapabilities.html): The business version of the terminology capabilities * [ValueSet](http://hl7.org/fhir/R6/valueset.html): The business version of the value set
`DeviceDefinition-conforms-to-category`	`conforms-to-category`	Active	normative	False	oo	token	The category of the conformance
`DeviceDefinition-device-name`	`device-name`	Active	normative	False	oo	string	A server defined search that may match any of the string fields in DeviceDefinition.name or DeviceDefinition.classification.type - the latter to search for 'generic' devices.
`DeviceDefinition-experimental`	`experimental`	Active	normative	False	oo	token	Whether the DeviceDefinition is experimental
`DeviceDefinition-has-part-canonical`	`has-part-canonical`	Active	normative	False	oo	reference	The component part device definition
`DeviceDefinition-has-part-code`	`has-part-code`	Active	normative	False	oo	token	The component part device type
`DeviceDefinition-manufacturer`	`manufacturer`	Active	normative	False	oo	reference	The manufacturer of the device
`DeviceDefinition-model-number`	`model-number`	Active	normative	False	oo	token	The model of the device
`DeviceDefinition-part-number`	`part-number`	Active	normative	False	oo	string	The part number or catalog number of the device.
`DeviceDefinition-specification`	`specification`	Active	normative	False	oo	token	The specification that the device conforms to
`DeviceDefinition-specification-version`	`specification-version`	Active	normative	False	oo	composite	A composite of both specification and version
`DeviceDefinition-type`	`type`	Active	normative	False	oo	token	The device type
`DeviceDefinition-version-type`	`version-type`	Active	normative	False	oo	composite	Value and type of version