R6 Ballot (2nd Draft)

Publish-box (todo)

8.18 Resource DeviceDefinition - Content

Orders and Observations icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

The characteristics, operational status and capabilities of a medical-related component of a medical device.

8.18.1 Scope and Usage

Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health, as well as devices such as a machine, cellphone, computer, software, application, etc. The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn.

Devices can also be subdivded as follows:

Implantable device

Patient-use device

8.18.2 Boundaries and Relationships

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).

Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, operational status which the DeviceDefinition resource does not have.

8.18.3 Background and Context

8.18.4 References to this Resource

8.18.5 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TU DomainResource An instance of a medical-related component of a medical device

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: CanonicalResource
... 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

.... 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

..... 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
.... type 1..1 code basic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... 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 Σ 0..* BackboneElement The name or names of the device as given by the manufacturer

.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Extensible)
... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... classification Σ 0..* BackboneElement What kind of device or device system this is

.... type Σ 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

.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (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

.... 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

.... 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

..... name 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource

.... udiDeviceIdentifier 0..* see udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..* see packaging Allows packages within packages

... deviceVersion 0..* BackboneElement The version of the device or software

.... 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: Device Safety (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 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 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

.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... 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

.... substance 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of
Binding: Substance Code (Example)
.... 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..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Extensible)

... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... 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
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device

.... 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 icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceDefinition (DomainResource) +CanonicalResourceAdditional information to describe the devicedescription : markdown [0..1]Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.typeidentifier : Identifier [0..*]The part number or catalog number of the devicepartNumber : string [0..1]A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdictionmanufacturer : Reference [0..1] « Organization »The model number for the device for example as defined by the manufacturer or labeler, or other agencymodelNumber : string [0..1]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)DeviceSafety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Language code for the human-readable text strings produced by the device (all supported)languageCode : CodeableConcept [0..*]An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device labelproductionIdentifierInUDI : CodeableConcept [0..*] « null (Strength=Extensible) DeviceProductionIdentifierInU...+ »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifierdeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]UdiDeviceIdentifierMarketDistributionBegin and end dates for the commercial distribution of the devicemarketPeriod : Period [1..1]National state or territory to which the marketDistribution recers, typically where the device is commercializedsubJurisdiction : uri [1..1]RegulatoryIdentifierThe type of identifier itselftype : code [1..1] « null (Strength=Required)DeviceDefinitionRegulatoryIde...! »The identifier itselfdeviceIdentifier : string [1..1]The organization that issued this identifierissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]DeviceNameA human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or othername : string [1..1]The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedNametype : CodeableConcept [1..1] « null (Strength=Extensible)DeviceNameType+ »ClassificationA classification or risk class of the device modeltype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »Further information qualifying this classification of the device modeljustification : RelatedArtifact [0..*]ConformsToDescribes the type of the standard, specification, or formal guidancecategory : CodeableConcept [0..1] « null (Strength=Example)DeviceSpecificationCategory?? »Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheresspecification : CodeableConcept [1..1] « null (Strength=Example)DeviceSpecificationType?? »Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other labelversion : string [0..*]Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformancesource : RelatedArtifact [0..*]HasPartReference to the device that is part of the current devicereference : Reference [1..1] « DeviceDefinition »Number of instances of the component device in the current devicecount : integer [0..1]PackagingThe business identifier of the packaged medicationidentifier : Identifier [0..1]A code that defines the specific type of packagingtype : CodeableConcept [0..1]The number of items contained in the package (devices or sub-packages)count : integer [0..1]PackagingDistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « Organization »DeviceVersionThe type of the device version, e.g. manufacturer, approved, internaltype : CodeableConcept [0..1]The hardware or software module of the device to which the version appliescomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property such as a resolution or color being representedtype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »The value of the property specified by the associated property.type codevalue[x] : DataType [1..1] « Quantity|CodeableConcept|string|boolean| integer|Range|Attachment »LinkThe type indicates the relationship of the related device to the device instancerelation : Coding [1..1] « null (Strength=Extensible)DeviceDefinitionRelationType+ »A reference to the linked devicerelatedDevice : CodeableReference [1..1] « DeviceDefinition »MaterialA substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materialssubstance : CodeableConcept [1..1] « null (Strength=Example)SubstanceCode?? »Indicates an alternative material of the devicealternate : boolean [0..1]Whether the substance is a known or suspected allergenallergenicIndicator : boolean [0..1]GuidelineThe circumstances that form the setting for using the deviceuseContext : UsageContext [0..*]Detailed written and visual directions for the user on how to use the deviceusageInstruction : markdown [0..1]A source of information or reference for this guidelinerelatedArtifact : RelatedArtifact [0..*]A clinical condition for which the device was designed to be usedindication : CodeableConcept [0..*]A specific situation when a device should not be used because it may cause harmcontraindication : CodeableConcept [0..*]Specific hazard alert information that a user needs to know before using the devicewarning : CodeableConcept [0..*]A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]CorrectiveActionWhether the last corrective action known for this device was a recallrecall : boolean [1..1]The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial namescope : code [0..1] « null (Strength=Required)DeviceCorrectiveActionScope! »Start and end dates of the corrective actionperiod : Period [1..1]ChargeItemThe code or reference for the charge itemchargeItemCode : CodeableReference [1..1] « ChargeItemDefinition »Coefficient applicable to the billing codecount : Quantity [1..1]A specific time period in which this charge item applieseffectivePeriod : Period [0..1]The context to which this charge item appliesuseContext : UsageContext [0..*]Indicates where and when the device is available on the marketmarketDistribution[0..*]Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been soldudiDeviceIdentifier[0..*]Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in EuroperegulatoryIdentifier[0..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standardsconformsTo[0..*]A device that is part (for example a component) of the present devicehasPart[0..*]An organization that distributes the packaged devicedistributor[0..*]Unique Device Identifier (UDI) Barcode string on the packagingudiDeviceIdentifier[0..*]Allows packages within packagespackaging[0..*]Information about the packaging of the device, i.e. how the device is packagedpackaging[0..*]The version of the device or softwaredeviceVersion[0..*]Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributesproperty[0..*]An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal devicelink[0..*]A substance used to create the material(s) of which the device is madematerial[0..*]Information aimed at providing directions for the usage of this model of deviceguideline[0..1]Tracking of latest field safety corrective actioncorrectiveAction[0..1]Billing code or reference associated with the devicechargeItem[0..*]

XML Template

<DeviceDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <description value="[markdown]"/><!-- 0..1 Additional information to describe the device -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 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 value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* 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 --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 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 --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

JSON Template

{doco
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "description" : "<markdown>", // Additional information to describe the device
  "identifier" : [{ Identifier }], // Instance identifier
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  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" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:description [ markdown ] ; # 0..1 Additional information to describe the device
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:languageCode  ( [ CodeableConcept ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

DeviceDefinition
DeviceDefinition.description
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  • Added Mandatory Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier
  • Added Element
DeviceDefinition.regulatoryIdentifier.type
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.partNumber
  • Added Element
DeviceDefinition.manufacturer
  • Renamed from manufacturer[x] to manufacturer
  • Remove Type string
DeviceDefinition.deviceName.type
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Moved from DeviceDefinition to DeviceDefinition.classification
  • Min Cardinality changed from 0 to 1
DeviceDefinition.classification.justification
  • Added Element
DeviceDefinition.conformsTo
  • Renamed from specialization to conformsTo
DeviceDefinition.conformsTo.category
  • Added Element
DeviceDefinition.conformsTo.specification
  • Added Mandatory Element
DeviceDefinition.conformsTo.version
  • Moved from DeviceDefinition.specialization to DeviceDefinition.conformsTo
  • Max Cardinality changed from 1 to *
DeviceDefinition.conformsTo.source
  • Added Element
DeviceDefinition.hasPart
  • Added Element
DeviceDefinition.hasPart.reference
  • Added Mandatory Element
DeviceDefinition.hasPart.count
  • Added Element
DeviceDefinition.packaging
  • Added Element
DeviceDefinition.packaging.identifier
  • Added Element
DeviceDefinition.packaging.type
  • Added Element
DeviceDefinition.packaging.count
  • Added Element
DeviceDefinition.packaging.distributor
  • Added Element
DeviceDefinition.packaging.distributor.name
  • Added Element
DeviceDefinition.packaging.distributor.organizationReference
  • Added Element
DeviceDefinition.packaging.udiDeviceIdentifier
  • Added Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.deviceVersion
  • Added Element
DeviceDefinition.deviceVersion.type
  • Added Element
DeviceDefinition.deviceVersion.component
  • Added Element
DeviceDefinition.deviceVersion.value
  • Added Mandatory Element
DeviceDefinition.property.value[x]
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.productionIdentifierInUDI
  • Added Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Moved from DeviceDefinition.onlineInformation to relatedArtifact
  • Max Cardinality changed from 1 to *
  • Type changed from uri to RelatedArtifact
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added Element
DeviceDefinition.correctiveAction
  • Added Element
DeviceDefinition.correctiveAction.recall
  • Added Mandatory Element
DeviceDefinition.correctiveAction.scope
  • Added Element
DeviceDefinition.correctiveAction.period
  • Added Mandatory Element
DeviceDefinition.chargeItem
  • Added Element
DeviceDefinition.chargeItem.chargeItemCode
  • Added Mandatory Element
DeviceDefinition.chargeItem.count
  • Added Mandatory Element
DeviceDefinition.chargeItem.effectivePeriod
  • Added Element
DeviceDefinition.chargeItem.useContext
  • Added Element
DeviceDefinition.specialization.systemType
  • Deleted
DeviceDefinition.version
  • Deleted
DeviceDefinition.physicalCharacteristics
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.capability
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.property.valueQuantity
  • Deleted
DeviceDefinition.property.valueCode
  • Deleted
DeviceDefinition.url
  • Deleted (Removed - only instances have addressable endpoints)
DeviceDefinition.quantity
  • Deleted (-> DeviceDefinition.packaging.count or DeviceDefinition.hasPart.count)
DeviceDefinition.parentDevice
  • Deleted (Removed - to establish relations, use hasPArt)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TU DomainResource An instance of a medical-related component of a medical device

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: CanonicalResource
... 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

.... 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

..... 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
.... type 1..1 code basic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... 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 Σ 0..* BackboneElement The name or names of the device as given by the manufacturer

.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Extensible)
... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... classification Σ 0..* BackboneElement What kind of device or device system this is

.... type Σ 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

.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (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

.... 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

.... 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

..... name 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource

.... udiDeviceIdentifier 0..* see udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..* see packaging Allows packages within packages

... deviceVersion 0..* BackboneElement The version of the device or software

.... 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: Device Safety (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 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 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

.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... 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

.... substance 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of
Binding: Substance Code (Example)
.... 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..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Extensible)

... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... 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
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device

.... 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 icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceDefinition (DomainResource) +CanonicalResourceAdditional information to describe the devicedescription : markdown [0..1]Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.typeidentifier : Identifier [0..*]The part number or catalog number of the devicepartNumber : string [0..1]A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdictionmanufacturer : Reference [0..1] « Organization »The model number for the device for example as defined by the manufacturer or labeler, or other agencymodelNumber : string [0..1]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)DeviceSafety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Language code for the human-readable text strings produced by the device (all supported)languageCode : CodeableConcept [0..*]An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device labelproductionIdentifierInUDI : CodeableConcept [0..*] « null (Strength=Extensible) DeviceProductionIdentifierInU...+ »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifierdeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]UdiDeviceIdentifierMarketDistributionBegin and end dates for the commercial distribution of the devicemarketPeriod : Period [1..1]National state or territory to which the marketDistribution recers, typically where the device is commercializedsubJurisdiction : uri [1..1]RegulatoryIdentifierThe type of identifier itselftype : code [1..1] « null (Strength=Required)DeviceDefinitionRegulatoryIde...! »The identifier itselfdeviceIdentifier : string [1..1]The organization that issued this identifierissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]DeviceNameA human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or othername : string [1..1]The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedNametype : CodeableConcept [1..1] « null (Strength=Extensible)DeviceNameType+ »ClassificationA classification or risk class of the device modeltype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »Further information qualifying this classification of the device modeljustification : RelatedArtifact [0..*]ConformsToDescribes the type of the standard, specification, or formal guidancecategory : CodeableConcept [0..1] « null (Strength=Example)DeviceSpecificationCategory?? »Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheresspecification : CodeableConcept [1..1] « null (Strength=Example)DeviceSpecificationType?? »Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other labelversion : string [0..*]Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformancesource : RelatedArtifact [0..*]HasPartReference to the device that is part of the current devicereference : Reference [1..1] « DeviceDefinition »Number of instances of the component device in the current devicecount : integer [0..1]PackagingThe business identifier of the packaged medicationidentifier : Identifier [0..1]A code that defines the specific type of packagingtype : CodeableConcept [0..1]The number of items contained in the package (devices or sub-packages)count : integer [0..1]PackagingDistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « Organization »DeviceVersionThe type of the device version, e.g. manufacturer, approved, internaltype : CodeableConcept [0..1]The hardware or software module of the device to which the version appliescomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property such as a resolution or color being representedtype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »The value of the property specified by the associated property.type codevalue[x] : DataType [1..1] « Quantity|CodeableConcept|string|boolean| integer|Range|Attachment »LinkThe type indicates the relationship of the related device to the device instancerelation : Coding [1..1] « null (Strength=Extensible)DeviceDefinitionRelationType+ »A reference to the linked devicerelatedDevice : CodeableReference [1..1] « DeviceDefinition »MaterialA substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materialssubstance : CodeableConcept [1..1] « null (Strength=Example)SubstanceCode?? »Indicates an alternative material of the devicealternate : boolean [0..1]Whether the substance is a known or suspected allergenallergenicIndicator : boolean [0..1]GuidelineThe circumstances that form the setting for using the deviceuseContext : UsageContext [0..*]Detailed written and visual directions for the user on how to use the deviceusageInstruction : markdown [0..1]A source of information or reference for this guidelinerelatedArtifact : RelatedArtifact [0..*]A clinical condition for which the device was designed to be usedindication : CodeableConcept [0..*]A specific situation when a device should not be used because it may cause harmcontraindication : CodeableConcept [0..*]Specific hazard alert information that a user needs to know before using the devicewarning : CodeableConcept [0..*]A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]CorrectiveActionWhether the last corrective action known for this device was a recallrecall : boolean [1..1]The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial namescope : code [0..1] « null (Strength=Required)DeviceCorrectiveActionScope! »Start and end dates of the corrective actionperiod : Period [1..1]ChargeItemThe code or reference for the charge itemchargeItemCode : CodeableReference [1..1] « ChargeItemDefinition »Coefficient applicable to the billing codecount : Quantity [1..1]A specific time period in which this charge item applieseffectivePeriod : Period [0..1]The context to which this charge item appliesuseContext : UsageContext [0..*]Indicates where and when the device is available on the marketmarketDistribution[0..*]Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been soldudiDeviceIdentifier[0..*]Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in EuroperegulatoryIdentifier[0..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standardsconformsTo[0..*]A device that is part (for example a component) of the present devicehasPart[0..*]An organization that distributes the packaged devicedistributor[0..*]Unique Device Identifier (UDI) Barcode string on the packagingudiDeviceIdentifier[0..*]Allows packages within packagespackaging[0..*]Information about the packaging of the device, i.e. how the device is packagedpackaging[0..*]The version of the device or softwaredeviceVersion[0..*]Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributesproperty[0..*]An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal devicelink[0..*]A substance used to create the material(s) of which the device is madematerial[0..*]Information aimed at providing directions for the usage of this model of deviceguideline[0..1]Tracking of latest field safety corrective actioncorrectiveAction[0..1]Billing code or reference associated with the devicechargeItem[0..*]

XML Template

<DeviceDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <description value="[markdown]"/><!-- 0..1 Additional information to describe the device -->
 <identifier><!-- 0..* Identifier Instance identifier --></identifier>
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 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 value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* 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 --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 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 --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

JSON Template

{doco
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "description" : "<markdown>", // Additional information to describe the device
  "identifier" : [{ Identifier }], // Instance identifier
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  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" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:description [ markdown ] ; # 0..1 Additional information to describe the device
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Instance identifier
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:languageCode  ( [ CodeableConcept ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:owner [ Reference(Organization) ] ; # 0..1 Organization responsible for device
  fhir:contact  ( [ ContactPoint ] ... ) ; # 0..* Details for human/organization for support
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

DeviceDefinition
DeviceDefinition.description
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  • Added Mandatory Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier
  • Added Element
DeviceDefinition.regulatoryIdentifier.type
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.partNumber
  • Added Element
DeviceDefinition.manufacturer
  • Renamed from manufacturer[x] to manufacturer
  • Remove Type string
DeviceDefinition.deviceName.type
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Moved from DeviceDefinition to DeviceDefinition.classification
  • Min Cardinality changed from 0 to 1
DeviceDefinition.classification.justification
  • Added Element
DeviceDefinition.conformsTo
  • Renamed from specialization to conformsTo
DeviceDefinition.conformsTo.category
  • Added Element
DeviceDefinition.conformsTo.specification
  • Added Mandatory Element
DeviceDefinition.conformsTo.version
  • Moved from DeviceDefinition.specialization to DeviceDefinition.conformsTo
  • Max Cardinality changed from 1 to *
DeviceDefinition.conformsTo.source
  • Added Element
DeviceDefinition.hasPart
  • Added Element
DeviceDefinition.hasPart.reference
  • Added Mandatory Element
DeviceDefinition.hasPart.count
  • Added Element
DeviceDefinition.packaging
  • Added Element
DeviceDefinition.packaging.identifier
  • Added Element
DeviceDefinition.packaging.type
  • Added Element
DeviceDefinition.packaging.count
  • Added Element
DeviceDefinition.packaging.distributor
  • Added Element
DeviceDefinition.packaging.distributor.name
  • Added Element
DeviceDefinition.packaging.distributor.organizationReference
  • Added Element
DeviceDefinition.packaging.udiDeviceIdentifier
  • Added Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.deviceVersion
  • Added Element
DeviceDefinition.deviceVersion.type
  • Added Element
DeviceDefinition.deviceVersion.component
  • Added Element
DeviceDefinition.deviceVersion.value
  • Added Mandatory Element
DeviceDefinition.property.value[x]
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.productionIdentifierInUDI
  • Added Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Moved from DeviceDefinition.onlineInformation to relatedArtifact
  • Max Cardinality changed from 1 to *
  • Type changed from uri to RelatedArtifact
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added Element
DeviceDefinition.correctiveAction
  • Added Element
DeviceDefinition.correctiveAction.recall
  • Added Mandatory Element
DeviceDefinition.correctiveAction.scope
  • Added Element
DeviceDefinition.correctiveAction.period
  • Added Mandatory Element
DeviceDefinition.chargeItem
  • Added Element
DeviceDefinition.chargeItem.chargeItemCode
  • Added Mandatory Element
DeviceDefinition.chargeItem.count
  • Added Mandatory Element
DeviceDefinition.chargeItem.effectivePeriod
  • Added Element
DeviceDefinition.chargeItem.useContext
  • Added Element
DeviceDefinition.specialization.systemType
  • Deleted
DeviceDefinition.version
  • Deleted
DeviceDefinition.physicalCharacteristics
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.capability
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.property.valueQuantity
  • Deleted
DeviceDefinition.property.valueCode
  • Deleted
DeviceDefinition.url
  • Deleted (Removed - only instances have addressable endpoints)
DeviceDefinition.quantity
  • Deleted (-> DeviceDefinition.packaging.count or DeviceDefinition.hasPart.count)
DeviceDefinition.parentDevice
  • Deleted (Removed - to establish relations, use hasPArt)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) , the spreadsheet version & the dependency analysis

8.18.5.1 Terminology Bindings

Path ValueSet Type Documentation
DeviceDefinition.regulatoryIdentifier.type DeviceDefinitionRegulatoryIdentifierType (a valid code from Device Regulatory Identifier Type) Required

Regulatory Identifier type
DeviceDefinition.deviceName.type DeviceNameType Extensible

The type of name the device is referred by.
DeviceDefinition.classification.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.conformsTo.category DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category) Example

The kind of standards used by the device.
DeviceDefinition.conformsTo.specification DeviceSpecificationType Example

The type or specification of a standard that devices can adhere to
DeviceDefinition.safety DeviceSafety Example

Codes used to identify medical devices safety characteristics. These codes are taken from the NCI Thesaurus icon and are provided here as a suggestive example.
DeviceDefinition.property.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.link.relation DeviceDefinitionRelationType Extensible

Description Needed Here
DeviceDefinition.material.substance SubstanceCode Example

This value set contains concept codes for specific substances. It includes codes from SNOMED icon where concept is-a 105590001 (Substance (substance))
DeviceDefinition.productionIdentifierInUDI DeviceProductionIdentifierInUDI Extensible

Device Production Identifier in UDI
DeviceDefinition.correctiveAction.scope DeviceCorrectiveActionScope Required

Device - Corrective action scope

8.18.6 Notes:

8.18.7 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
device-name 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.deviceName.name | DeviceDefinition.classification.type.coding.display | DeviceDefinition.classification.type.text
has-part reference The manufacturer of the device DeviceDefinition.hasPart.reference
(DeviceDefinition)
identifier token The identifier of the component DeviceDefinition.identifier | DeviceDefinition.udiDeviceIdentifier 36 Resources
manufacturer reference The manufacturer of the device DeviceDefinition.manufacturer
(Organization)
model token The model of the device DeviceDefinition.modelNumber
organization reference The organization responsible for the device DeviceDefinition.owner
(Organization)
part-number string The part number or catalog number of the device. DeviceDefinition.partNumber
specification token The specification that the device conforms to DeviceDefinition.conformsTo.specification
specification-version composite A composite of both specification and version On DeviceDefinition.conformsTo:
  specification: specification
  version: version
type token The device type DeviceDefinition.conformsTo.category
version token The specific version of the device DeviceDefinition.deviceVersion.value 31 Resources
version-type composite Value and type of version On DeviceDefinition.deviceVersion:
  type: type
  value: value