Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

8.15 Resource DeviceDefinition - Content

Orders and Observations Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

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

The DeviceDefinition resource is used to describe the characteristics and capabilities of a medical device. It also includes packaging information; For kits that can be assembled and repackaged, the packaging is defined at the kit level, but the custom repackaging of that kit is not covered.

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the regulatory entities, or it is a local definition that includes assembled device configurations. The DeviceDefinition allows defining 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, which the DeviceDefinition resource does not have.

This resource is referenced by AdministrableProductDefinition, CatalogEntry, ClinicalUseDefinition, ClinicalUseIssue, Device, itself, MedicationKnowledge, ObservationDefinition and RegulatedAuthorization.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TUDomainResourceAn instance of a medical-related component of a medical device
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] 0..1Name of device manufacturer
.... manufacturerStringstring
.... manufacturerReferenceReference(Organization)
.... name 1..1stringA name that is used to refer to the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... classification 0..*BackboneElementWhat kind of device or device system this is
.... type 1..1CodeableConceptA classification or risk class of the device model
Device Type (Example)
.... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... hasPart 0..*BackboneElementA device, part of the current one
.... reference 1..1Reference(DeviceDefinition)Reference to the part
.... count 0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged
.... identifier 0..1IdentifierBusiness identifier of the packaged medication
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count 0..1integerThe number of items contained in the package (devices or sub-packages)
.... distributor 0..*BackboneElementAn organization that distributes the packaged device
..... name 0..1stringDistributor's human-readable name
..... organizationReference 0..*Reference()Distributor as an Organization resource
.... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... deviceIdentifier 1..1stringIdentifier to be associated with every instance for issuer and jurisdiction
..... issuer 1..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... packaging 0..*see packagingAllows packages within packages
... version 0..*BackboneElementThe version of the device or software
.... type 0..1CodeableConceptThe type of the device version, e.g. manufacturer, approved, internal
.... component 0..1IdentifierThe hardware or software module of the device to which the version applies
.... value 1..1stringThe version text
... safety Σ0..*CodeableConceptSafety characteristics of the device
Safety (Example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicPhysical characteristics to define or specify the product - for example dimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementAdditional capabilities of the device
.... type 1..1CodeableConceptThe type of capability - whether it is a physical attribute, a customization needed
.... description 0..*CodeableConceptThe actual capability of the device
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... link 0..*BackboneElementAn associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
.... relation 1..1CodingThe type indicates the relationship of the related device to the device instance
DeviceDefinitionRelationType (Extensible)
.... relatedDevice 1..1CodeableReference(DeviceDefinition)A reference to the linked device
... note 0..*AnnotationDevice notes and comments
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material 0..*BackboneElementA substance used to create the material(s) of which the device is made
.... substance 1..1CodeableConceptA relevant substance that the device contains, may contain, or is made of
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen
... guideline 0..1BackboneElementInformation aimed at providing directions for the usage of this model of device
.... useContext 0..*UsageContextThe circumstances that form the setting for using the device
.... usageInstruction 0..1markdownDetailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..*RelatedArtifactA source of information or reference for this guideline
.... indication 0..*CodeableReference(ClinicalUseDefinition)A clinical condition for which the device was designed to be used
.... contraindication 0..*CodeableReference(ClinicalUseDefinition)A specific situation when a device should not be used because it may cause harm
.... warning 0..*CodeableReference(ClinicalUseDefinition)Specific hazard alert information that a user needs to know before using the device
.... intendedUse 0..1stringA description of the general purpose or medical use of the device or its function
... chargeItem 0..*BackboneElementBilling code or reference associated with the device
.... chargeItemCode 1..1CodeableReference(ChargeItemDefinition)The code or reference for the charge item
.... count 1..1QuantityCoefficient applicable to the billing code
.... effectivePeriod 0..1PeriodA specific time period in which this charge item applies
.... useContext 0..*UsageContextThe context to which this charge item applies

doco Documentation for this format

UML Diagram (Legend)

DeviceDefinition (DomainResource)Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle IDidentifier : Identifier [0..*]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[x] : DataType [0..1] « string|Reference(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)Safety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Physical characteristics to define or specify the product - for example dimensions, color etc. These can be defined by the manufacturer or labeler, or can be used to specify characteristics when orderingphysicalCharacteristics : ProdCharacteristic [0..1]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..*]The parent device it can be part ofparentDevice : Reference [0..1] « DeviceDefinition »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided 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]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. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « null (Strength=Required)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..*]SpecializationThe standard that is used to operate and communicatesystemType : string [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]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]DistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « »UdiDeviceIdentifierIdentifier to be associated with every instance for issuer and jurisdictiondeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]VersionThe 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]CapabilityThe type of capability - whether it is a physical attribute, a customization needed. For exampl e "water ingress protection"type : CodeableConcept [1..1]The actual capability of the device e.g. IP67description : CodeableConcept [0..*]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuantity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]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 : DataType [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]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 : DataType [0..*] « ClinicalUseDefinition »A specific situation when a device should not be used because it may cause harmcontraindication : DataType [0..*] « ClinicalUseDefinition »Specific hazard alert information that a user needs to know before using the devicewarning : DataType [0..*] « ClinicalUseDefinition »A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]ChargeItemThe code or reference for the charge itemchargeItemCode : DataType [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..*]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..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[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 softwareversion[0..*]Additional capabilities that the device is defined or required to have e.g. "water resistant", "long life"capability[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[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]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 -->
 <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 jurisdication porvided 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 -->
 </udiDeviceIdentifier>
 <manufacturer[x]><!-- 0..1 string|Reference(Organization) Name of device manufacturer --></manufacturer[x]>
 <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 value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other -->
 </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>
 <specialization>  <!-- 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication -->
  <systemType value="[string]"/><!-- 1..1 The standard that is used to operate and communicate -->
  <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate -->
 </specialization>
 <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 Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string on the packaging -->
   <deviceIdentifier value="[string]"/><!-- 1..1 Identifier to be associated with every instance for issuer and jurisdiction -->
   <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
   <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  </udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <version>  <!-- 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 -->
 </version>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device  --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Physical characteristics to define or specify the product - for example dimensions, color etc. --></physicalCharacteristics>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <capability>  <!-- 0..* Additional capabilities of the device -->
  <type><!-- 1..1 CodeableConcept The type of capability - whether it is a physical attribute, a customization needed --></type>
  <description><!-- 0..* CodeableConcept The actual capability of the device --></description>
 </capability>
 <property>  <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type>
  <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </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>
 <parentDevice><!-- 0..1 Reference(DeviceDefinition) The parent device it can be part of --></parentDevice>
 <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>
 <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..* CodeableReference(ClinicalUseDefinition) A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableReference(ClinicalUseDefinition) A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableReference(ClinicalUseDefinition) 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>
 <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
  "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 jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  // manufacturer[x]: Name of device manufacturer. One of these 2:
  "manufacturerString" : "<string>",
  "manufacturerReference" : { Reference(Organization) },
  "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" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "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
  }],
  "specialization" : [{ // The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    "systemType" : "<string>", // R!  The standard that is used to operate and communicate
    "version" : "<string>" // The version of the standard that is used to operate and communicate
  }],
  "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 }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string on the packaging
      "deviceIdentifier" : "<string>", // R!  Identifier to be associated with every instance for issuer and jurisdiction
      "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
      "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
    }],
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "version" : [{ // 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
  "physicalCharacteristics" : { ProdCharacteristic }, // Physical characteristics to define or specify the product - for example dimensions, color etc.
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "capability" : [{ // Additional capabilities of the device
    "type" : { CodeableConcept }, // R!  The type of capability - whether it is a physical attribute, a customization needed
    "description" : [{ CodeableConcept }] // The actual capability of the device
  }],
  "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    "type" : { CodeableConcept }, // R!  Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    "valueQuantity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "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
  "parentDevice" : { Reference(DeviceDefinition) }, // The parent device it can be part of
  "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
  }],
  "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" : [{ CodeableReference(ClinicalUseDefinition) }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableReference(ClinicalUseDefinition) }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableReference(ClinicalUseDefinition) }], // 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
  },
  "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:DeviceDefinition.identifier [ Identifier ], ... ; # 0..* Instance identifier
  fhir:DeviceDefinition.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:DeviceDefinition.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
    fhir:DeviceDefinition.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm
    fhir:DeviceDefinition.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ], ...;
  # DeviceDefinition.manufacturer[x] : 0..1 Name of device manufacturer. One of these 2
    fhir:DeviceDefinition.manufacturerString [ string ]
    fhir:DeviceDefinition.manufacturerReference [ Reference(Organization) ]
  fhir:DeviceDefinition.deviceName [ # 0..* The name or names of the device as given by the manufacturer
    fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 A name that is used to refer to the device
    fhir:DeviceDefinition.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  ], ...;
  fhir:DeviceDefinition.modelNumber [ string ]; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:DeviceDefinition.classification [ # 0..* What kind of device or device system this is
    fhir:DeviceDefinition.classification.type [ CodeableConcept ]; # 1..1 A classification or risk class of the device model
    fhir:DeviceDefinition.classification.justification [ RelatedArtifact ], ... ; # 0..* Further information qualifying this classification of the device model
  ], ...;
  fhir:DeviceDefinition.specialization [ # 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    fhir:DeviceDefinition.specialization.systemType [ string ]; # 1..1 The standard that is used to operate and communicate
    fhir:DeviceDefinition.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate
  ], ...;
  fhir:DeviceDefinition.hasPart [ # 0..* A device, part of the current one
    fhir:DeviceDefinition.hasPart.reference [ Reference(DeviceDefinition) ]; # 1..1 Reference to the part
    fhir:DeviceDefinition.hasPart.count [ integer ]; # 0..1 Number of occurrences of the part
  ], ...;
  fhir:DeviceDefinition.packaging [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:DeviceDefinition.packaging.identifier [ Identifier ]; # 0..1 Business identifier of the packaged medication
    fhir:DeviceDefinition.packaging.type [ CodeableConcept ]; # 0..1 A code that defines the specific type of packaging
    fhir:DeviceDefinition.packaging.count [ integer ]; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:DeviceDefinition.packaging.distributor [ # 0..* An organization that distributes the packaged device
      fhir:DeviceDefinition.packaging.distributor.name [ string ]; # 0..1 Distributor's human-readable name
      fhir:DeviceDefinition.packaging.distributor.organizationReference [ Reference ], ... ; # 0..* Distributor as an Organization resource
    ], ...;
    fhir:DeviceDefinition.packaging.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 Identifier to be associated with every instance for issuer and jurisdiction
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies
    ], ...;
    fhir:DeviceDefinition.packaging.packaging [ See DeviceDefinition.packaging ], ... ; # 0..* Allows packages within packages
  ], ...;
  fhir:DeviceDefinition.version [ # 0..* The version of the device or software
    fhir:DeviceDefinition.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:DeviceDefinition.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies
    fhir:DeviceDefinition.version.value [ string ]; # 1..1 The version text
  ], ...;
  fhir:DeviceDefinition.safety [ CodeableConcept ], ... ; # 0..* Safety characteristics of the device
  fhir:DeviceDefinition.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
  fhir:DeviceDefinition.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Physical characteristics to define or specify the product - for example dimensions, color etc.
  fhir:DeviceDefinition.languageCode [ CodeableConcept ], ... ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:DeviceDefinition.capability [ # 0..* Additional capabilities of the device
    fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 The type of capability - whether it is a physical attribute, a customization needed
    fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* The actual capability of the device
  ], ...;
  fhir:DeviceDefinition.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    fhir:DeviceDefinition.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    fhir:DeviceDefinition.property.valueQuantity [ Quantity ], ... ; # 0..* Property value as a quantity
    fhir:DeviceDefinition.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP)
  ], ...;
  fhir:DeviceDefinition.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device
  fhir:DeviceDefinition.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support
  fhir:DeviceDefinition.link [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:DeviceDefinition.link.relation [ Coding ]; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:DeviceDefinition.link.relatedDevice [ CodeableReference(DeviceDefinition) ]; # 1..1 A reference to the linked device
  ], ...;
  fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:DeviceDefinition.parentDevice [ Reference(DeviceDefinition) ]; # 0..1 The parent device it can be part of
  fhir:DeviceDefinition.material [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:DeviceDefinition.material.substance [ CodeableConcept ]; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:DeviceDefinition.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device
    fhir:DeviceDefinition.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen
  ], ...;
  fhir:DeviceDefinition.guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:DeviceDefinition.guideline.useContext [ UsageContext ], ... ; # 0..* The circumstances that form the setting for using the device
    fhir:DeviceDefinition.guideline.usageInstruction [ markdown ]; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:DeviceDefinition.guideline.relatedArtifact [ RelatedArtifact ], ... ; # 0..* A source of information or reference for this guideline
    fhir:DeviceDefinition.guideline.indication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* A clinical condition for which the device was designed to be used
    fhir:DeviceDefinition.guideline.contraindication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:DeviceDefinition.guideline.warning [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:DeviceDefinition.guideline.intendedUse [ string ]; # 0..1 A description of the general purpose or medical use of the device or its function
  ];
  fhir:DeviceDefinition.chargeItem [ # 0..* Billing code or reference associated with the device
    fhir:DeviceDefinition.chargeItem.chargeItemCode [ CodeableReference(ChargeItemDefinition) ]; # 1..1 The code or reference for the charge item
    fhir:DeviceDefinition.chargeItem.count [ Quantity ]; # 1..1 Coefficient applicable to the billing code
    fhir:DeviceDefinition.chargeItem.effectivePeriod [ Period ]; # 0..1 A specific time period in which this charge item applies
    fhir:DeviceDefinition.chargeItem.useContext [ UsageContext ], ... ; # 0..* The context to which this charge item applies
  ], ...;
]

Changes since R3

DeviceDefinition
DeviceDefinition.deviceName.type
  • Change value set from http://hl7.org/fhir/ValueSet/device-nametype|4.0.0 to http://hl7.org/fhir/ValueSet/device-nametype|4.6.0
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Added Mandatory Element
DeviceDefinition.classification.justification
  • 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.udiDeviceIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.packaging.udiDeviceIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.version
  • Type changed from string to BackboneElement
DeviceDefinition.version.type
  • Added Element
DeviceDefinition.version.component
  • Added Element
DeviceDefinition.version.value
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Added Element
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added 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.type
  • deleted
DeviceDefinition.url
  • deleted
DeviceDefinition.onlineInformation
  • deleted
DeviceDefinition.quantity
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TUDomainResourceAn instance of a medical-related component of a medical device
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier 1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] 0..1Name of device manufacturer
.... manufacturerStringstring
.... manufacturerReferenceReference(Organization)
.... name 1..1stringA name that is used to refer to the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe catalog or model number for the device for example as defined by the manufacturer
... classification 0..*BackboneElementWhat kind of device or device system this is
.... type 1..1CodeableConceptA classification or risk class of the device model
Device Type (Example)
.... justification 0..*RelatedArtifactFurther information qualifying this classification of the device model
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... hasPart 0..*BackboneElementA device, part of the current one
.... reference 1..1Reference(DeviceDefinition)Reference to the part
.... count 0..1integerNumber of occurrences of the part
... packaging 0..*BackboneElementInformation about the packaging of the device, i.e. how the device is packaged
.... identifier 0..1IdentifierBusiness identifier of the packaged medication
.... type 0..1CodeableConceptA code that defines the specific type of packaging
.... count 0..1integerThe number of items contained in the package (devices or sub-packages)
.... distributor 0..*BackboneElementAn organization that distributes the packaged device
..... name 0..1stringDistributor's human-readable name
..... organizationReference 0..*Reference()Distributor as an Organization resource
.... udiDeviceIdentifier 0..*BackboneElementUnique Device Identifier (UDI) Barcode string on the packaging
..... deviceIdentifier 1..1stringIdentifier to be associated with every instance for issuer and jurisdiction
..... issuer 1..1uriThe organization that assigns the identifier algorithm
..... jurisdiction 1..1uriThe jurisdiction to which the deviceIdentifier applies
.... packaging 0..*see packagingAllows packages within packages
... version 0..*BackboneElementThe version of the device or software
.... type 0..1CodeableConceptThe type of the device version, e.g. manufacturer, approved, internal
.... component 0..1IdentifierThe hardware or software module of the device to which the version applies
.... value 1..1stringThe version text
... safety Σ0..*CodeableConceptSafety characteristics of the device
Safety (Example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicPhysical characteristics to define or specify the product - for example dimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementAdditional capabilities of the device
.... type 1..1CodeableConceptThe type of capability - whether it is a physical attribute, a customization needed
.... description 0..*CodeableConceptThe actual capability of the device
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... link 0..*BackboneElementAn associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
.... relation 1..1CodingThe type indicates the relationship of the related device to the device instance
DeviceDefinitionRelationType (Extensible)
.... relatedDevice 1..1CodeableReference(DeviceDefinition)A reference to the linked device
... note 0..*AnnotationDevice notes and comments
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material 0..*BackboneElementA substance used to create the material(s) of which the device is made
.... substance 1..1CodeableConceptA relevant substance that the device contains, may contain, or is made of
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen
... guideline 0..1BackboneElementInformation aimed at providing directions for the usage of this model of device
.... useContext 0..*UsageContextThe circumstances that form the setting for using the device
.... usageInstruction 0..1markdownDetailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..*RelatedArtifactA source of information or reference for this guideline
.... indication 0..*CodeableReference(ClinicalUseDefinition)A clinical condition for which the device was designed to be used
.... contraindication 0..*CodeableReference(ClinicalUseDefinition)A specific situation when a device should not be used because it may cause harm
.... warning 0..*CodeableReference(ClinicalUseDefinition)Specific hazard alert information that a user needs to know before using the device
.... intendedUse 0..1stringA description of the general purpose or medical use of the device or its function
... chargeItem 0..*BackboneElementBilling code or reference associated with the device
.... chargeItemCode 1..1CodeableReference(ChargeItemDefinition)The code or reference for the charge item
.... count 1..1QuantityCoefficient applicable to the billing code
.... effectivePeriod 0..1PeriodA specific time period in which this charge item applies
.... useContext 0..*UsageContextThe context to which this charge item applies

doco Documentation for this format

UML Diagram (Legend)

DeviceDefinition (DomainResource)Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle IDidentifier : Identifier [0..*]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[x] : DataType [0..1] « string|Reference(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)Safety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Physical characteristics to define or specify the product - for example dimensions, color etc. These can be defined by the manufacturer or labeler, or can be used to specify characteristics when orderingphysicalCharacteristics : ProdCharacteristic [0..1]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..*]The parent device it can be part ofparentDevice : Reference [0..1] « DeviceDefinition »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided 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]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. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « null (Strength=Required)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..*]SpecializationThe standard that is used to operate and communicatesystemType : string [1..1]The version of the standard that is used to operate and communicateversion : string [0..1]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]DistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « »UdiDeviceIdentifierIdentifier to be associated with every instance for issuer and jurisdictiondeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]VersionThe 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]CapabilityThe type of capability - whether it is a physical attribute, a customization needed. For exampl e "water ingress protection"type : CodeableConcept [1..1]The actual capability of the device e.g. IP67description : CodeableConcept [0..*]PropertyCode that specifies the property DeviceDefinitionPropetyCode (Extensible)type : CodeableConcept [1..1]Property value as a quantityvalueQuantity : Quantity [0..*]Property value as a code, e.g., NTP4 (synced to NTP)valueCode : CodeableConcept [0..*]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 : DataType [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]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 : DataType [0..*] « ClinicalUseDefinition »A specific situation when a device should not be used because it may cause harmcontraindication : DataType [0..*] « ClinicalUseDefinition »Specific hazard alert information that a user needs to know before using the devicewarning : DataType [0..*] « ClinicalUseDefinition »A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]ChargeItemThe code or reference for the charge itemchargeItemCode : DataType [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..*]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..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[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 softwareversion[0..*]Additional capabilities that the device is defined or required to have e.g. "water resistant", "long life"capability[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[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]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 -->
 <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 jurisdication porvided 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 -->
 </udiDeviceIdentifier>
 <manufacturer[x]><!-- 0..1 string|Reference(Organization) Name of device manufacturer --></manufacturer[x]>
 <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 value="[code]"/><!-- 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other -->
 </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>
 <specialization>  <!-- 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication -->
  <systemType value="[string]"/><!-- 1..1 The standard that is used to operate and communicate -->
  <version value="[string]"/><!-- 0..1 The version of the standard that is used to operate and communicate -->
 </specialization>
 <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 Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string on the packaging -->
   <deviceIdentifier value="[string]"/><!-- 1..1 Identifier to be associated with every instance for issuer and jurisdiction -->
   <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
   <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  </udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <version>  <!-- 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 -->
 </version>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device  --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Physical characteristics to define or specify the product - for example dimensions, color etc. --></physicalCharacteristics>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <capability>  <!-- 0..* Additional capabilities of the device -->
  <type><!-- 1..1 CodeableConcept The type of capability - whether it is a physical attribute, a customization needed --></type>
  <description><!-- 0..* CodeableConcept The actual capability of the device --></description>
 </capability>
 <property>  <!-- 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible) --></type>
  <valueQuantity><!-- 0..* Quantity Property value as a quantity --></valueQuantity>
  <valueCode><!-- 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP) --></valueCode>
 </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>
 <parentDevice><!-- 0..1 Reference(DeviceDefinition) The parent device it can be part of --></parentDevice>
 <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>
 <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..* CodeableReference(ClinicalUseDefinition) A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableReference(ClinicalUseDefinition) A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableReference(ClinicalUseDefinition) 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>
 <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
  "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 jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  // manufacturer[x]: Name of device manufacturer. One of these 2:
  "manufacturerString" : "<string>",
  "manufacturerReference" : { Reference(Organization) },
  "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" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "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
  }],
  "specialization" : [{ // The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    "systemType" : "<string>", // R!  The standard that is used to operate and communicate
    "version" : "<string>" // The version of the standard that is used to operate and communicate
  }],
  "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 }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string on the packaging
      "deviceIdentifier" : "<string>", // R!  Identifier to be associated with every instance for issuer and jurisdiction
      "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
      "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
    }],
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "version" : [{ // 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
  "physicalCharacteristics" : { ProdCharacteristic }, // Physical characteristics to define or specify the product - for example dimensions, color etc.
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "capability" : [{ // Additional capabilities of the device
    "type" : { CodeableConcept }, // R!  The type of capability - whether it is a physical attribute, a customization needed
    "description" : [{ CodeableConcept }] // The actual capability of the device
  }],
  "property" : [{ // The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    "type" : { CodeableConcept }, // R!  Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    "valueQuantity" : [{ Quantity }], // Property value as a quantity
    "valueCode" : [{ CodeableConcept }] // Property value as a code, e.g., NTP4 (synced to NTP)
  }],
  "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
  "parentDevice" : { Reference(DeviceDefinition) }, // The parent device it can be part of
  "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
  }],
  "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" : [{ CodeableReference(ClinicalUseDefinition) }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableReference(ClinicalUseDefinition) }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableReference(ClinicalUseDefinition) }], // 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
  },
  "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:DeviceDefinition.identifier [ Identifier ], ... ; # 0..* Instance identifier
  fhir:DeviceDefinition.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:DeviceDefinition.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
    fhir:DeviceDefinition.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm
    fhir:DeviceDefinition.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ], ...;
  # DeviceDefinition.manufacturer[x] : 0..1 Name of device manufacturer. One of these 2
    fhir:DeviceDefinition.manufacturerString [ string ]
    fhir:DeviceDefinition.manufacturerReference [ Reference(Organization) ]
  fhir:DeviceDefinition.deviceName [ # 0..* The name or names of the device as given by the manufacturer
    fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 A name that is used to refer to the device
    fhir:DeviceDefinition.deviceName.type [ code ]; # 1..1 udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  ], ...;
  fhir:DeviceDefinition.modelNumber [ string ]; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:DeviceDefinition.classification [ # 0..* What kind of device or device system this is
    fhir:DeviceDefinition.classification.type [ CodeableConcept ]; # 1..1 A classification or risk class of the device model
    fhir:DeviceDefinition.classification.justification [ RelatedArtifact ], ... ; # 0..* Further information qualifying this classification of the device model
  ], ...;
  fhir:DeviceDefinition.specialization [ # 0..* The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
    fhir:DeviceDefinition.specialization.systemType [ string ]; # 1..1 The standard that is used to operate and communicate
    fhir:DeviceDefinition.specialization.version [ string ]; # 0..1 The version of the standard that is used to operate and communicate
  ], ...;
  fhir:DeviceDefinition.hasPart [ # 0..* A device, part of the current one
    fhir:DeviceDefinition.hasPart.reference [ Reference(DeviceDefinition) ]; # 1..1 Reference to the part
    fhir:DeviceDefinition.hasPart.count [ integer ]; # 0..1 Number of occurrences of the part
  ], ...;
  fhir:DeviceDefinition.packaging [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:DeviceDefinition.packaging.identifier [ Identifier ]; # 0..1 Business identifier of the packaged medication
    fhir:DeviceDefinition.packaging.type [ CodeableConcept ]; # 0..1 A code that defines the specific type of packaging
    fhir:DeviceDefinition.packaging.count [ integer ]; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:DeviceDefinition.packaging.distributor [ # 0..* An organization that distributes the packaged device
      fhir:DeviceDefinition.packaging.distributor.name [ string ]; # 0..1 Distributor's human-readable name
      fhir:DeviceDefinition.packaging.distributor.organizationReference [ Reference ], ... ; # 0..* Distributor as an Organization resource
    ], ...;
    fhir:DeviceDefinition.packaging.udiDeviceIdentifier [ # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.deviceIdentifier [ string ]; # 1..1 Identifier to be associated with every instance for issuer and jurisdiction
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.issuer [ uri ]; # 1..1 The organization that assigns the identifier algorithm
      fhir:DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction [ uri ]; # 1..1 The jurisdiction to which the deviceIdentifier applies
    ], ...;
    fhir:DeviceDefinition.packaging.packaging [ See DeviceDefinition.packaging ], ... ; # 0..* Allows packages within packages
  ], ...;
  fhir:DeviceDefinition.version [ # 0..* The version of the device or software
    fhir:DeviceDefinition.version.type [ CodeableConcept ]; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:DeviceDefinition.version.component [ Identifier ]; # 0..1 The hardware or software module of the device to which the version applies
    fhir:DeviceDefinition.version.value [ string ]; # 1..1 The version text
  ], ...;
  fhir:DeviceDefinition.safety [ CodeableConcept ], ... ; # 0..* Safety characteristics of the device
  fhir:DeviceDefinition.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
  fhir:DeviceDefinition.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Physical characteristics to define or specify the product - for example dimensions, color etc.
  fhir:DeviceDefinition.languageCode [ CodeableConcept ], ... ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:DeviceDefinition.capability [ # 0..* Additional capabilities of the device
    fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 The type of capability - whether it is a physical attribute, a customization needed
    fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* The actual capability of the device
  ], ...;
  fhir:DeviceDefinition.property [ # 0..* The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    fhir:DeviceDefinition.property.type [ CodeableConcept ]; # 1..1 Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
    fhir:DeviceDefinition.property.valueQuantity [ Quantity ], ... ; # 0..* Property value as a quantity
    fhir:DeviceDefinition.property.valueCode [ CodeableConcept ], ... ; # 0..* Property value as a code, e.g., NTP4 (synced to NTP)
  ], ...;
  fhir:DeviceDefinition.owner [ Reference(Organization) ]; # 0..1 Organization responsible for device
  fhir:DeviceDefinition.contact [ ContactPoint ], ... ; # 0..* Details for human/organization for support
  fhir:DeviceDefinition.link [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:DeviceDefinition.link.relation [ Coding ]; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:DeviceDefinition.link.relatedDevice [ CodeableReference(DeviceDefinition) ]; # 1..1 A reference to the linked device
  ], ...;
  fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:DeviceDefinition.parentDevice [ Reference(DeviceDefinition) ]; # 0..1 The parent device it can be part of
  fhir:DeviceDefinition.material [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:DeviceDefinition.material.substance [ CodeableConcept ]; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:DeviceDefinition.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device
    fhir:DeviceDefinition.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen
  ], ...;
  fhir:DeviceDefinition.guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:DeviceDefinition.guideline.useContext [ UsageContext ], ... ; # 0..* The circumstances that form the setting for using the device
    fhir:DeviceDefinition.guideline.usageInstruction [ markdown ]; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:DeviceDefinition.guideline.relatedArtifact [ RelatedArtifact ], ... ; # 0..* A source of information or reference for this guideline
    fhir:DeviceDefinition.guideline.indication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* A clinical condition for which the device was designed to be used
    fhir:DeviceDefinition.guideline.contraindication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:DeviceDefinition.guideline.warning [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:DeviceDefinition.guideline.intendedUse [ string ]; # 0..1 A description of the general purpose or medical use of the device or its function
  ];
  fhir:DeviceDefinition.chargeItem [ # 0..* Billing code or reference associated with the device
    fhir:DeviceDefinition.chargeItem.chargeItemCode [ CodeableReference(ChargeItemDefinition) ]; # 1..1 The code or reference for the charge item
    fhir:DeviceDefinition.chargeItem.count [ Quantity ]; # 1..1 Coefficient applicable to the billing code
    fhir:DeviceDefinition.chargeItem.effectivePeriod [ Period ]; # 0..1 A specific time period in which this charge item applies
    fhir:DeviceDefinition.chargeItem.useContext [ UsageContext ], ... ; # 0..* The context to which this charge item applies
  ], ...;
]

Changes since Release 3

DeviceDefinition
DeviceDefinition.deviceName.type
  • Change value set from http://hl7.org/fhir/ValueSet/device-nametype|4.0.0 to http://hl7.org/fhir/ValueSet/device-nametype|4.6.0
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Added Mandatory Element
DeviceDefinition.classification.justification
  • 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.udiDeviceIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.packaging.udiDeviceIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.packaging.udiDeviceIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.version
  • Type changed from string to BackboneElement
DeviceDefinition.version.type
  • Added Element
DeviceDefinition.version.component
  • Added Element
DeviceDefinition.version.value
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Added Element
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added 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.type
  • deleted
DeviceDefinition.url
  • deleted
DeviceDefinition.onlineInformation
  • deleted
DeviceDefinition.quantity
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
DeviceDefinition.deviceName.type RequiredDeviceNameType
DeviceDefinition.classification.type ExampleDeviceType
DeviceDefinition.safety Examplehttp://hl7.org/fhir/ValueSet/device-safety
DeviceDefinition.link.relation ExtensibleDeviceDefinitionRelationType

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
identifiertokenThe identifier of the componentDeviceDefinition.identifier
parentreferenceThe parent DeviceDefinition resourceDeviceDefinition.parentDevice
(DeviceDefinition)
typetokenThe device component typeDeviceDefinition.classification.type