Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4

8.15 Resource DeviceDefinition - Content

Orders and Observations Work GroupMaturity Level: 0 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.

8.15.1 Scope and Usage

The DeviceDefinition resource is used to describe the characteristics and capabilities of a medical device.

8.15.2 Boundaries and Relationships

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.

8.15.3 Background and Context

8.15.3.1

8.15.4 References

This resource is referenced by AdministrableProductDefinition, ClinicalUseIssue, Device, itself and RegulatedAuthorization.

This resource does not implement any patterns.

8.15.5 Resource Content

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..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
FHIR Device Types (Example)
... 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
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Safety (Example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementDevice capabilities
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... 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
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... 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..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

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 manufacturermanufacturer[x] : Element [0..1] « string|Reference(Organization) »The model number for the devicemodelNumber : string [0..1]What kind of device or device system this istype : CodeableConcept [0..1] « Type of device e.g. according to official classification. (Strength=Example)FHIRDeviceTypes?? »The available versions of the device, e.g., software versionsversion : string [0..*]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)Safety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Dimensions, color etcphysicalCharacteristics : 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..*]A network address on which the device may be contacted directlyurl : uri [0..1]Access to on-line information about the deviceonlineInformation : uri [0..1]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)quantity : Quantity [0..1]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]DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »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]CapabilityType of capabilitytype : CodeableConcept [1..1]Description of capabilitydescription : 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..*]MaterialThe substancesubstance : 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]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..*]A name given to the device to identify itdeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]Device capabilitiescapability[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]A substance used to create the material(s) of which the device is madematerial[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..* A name given to the device to identify it -->
  <name value="[string]"/><!-- 1..1 The name of 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 model number for the device -->
 <type><!-- 0..1 CodeableConcept What kind of device or device system this is --></type>
 <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>
 <version value="[string]"/><!-- 0..* Available versions -->
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device  --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <capability>  <!-- 0..* Device capabilities -->
  <type><!-- 1..1 CodeableConcept Type of capability --></type>
  <description><!-- 0..* CodeableConcept Description of capability --></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>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <onlineInformation value="[uri]"/><!-- 0..1 Access to on-line information -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <quantity><!-- 0..1 Quantity The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) --></quantity>
 <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 The substance --></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>
</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" : [{ // A name given to the device to identify it
    "name" : "<string>", // R!  The name of the device
    "type" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "modelNumber" : "<string>", // The model number for the device
  "type" : { CodeableConcept }, // What kind of device or device system this is
  "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
  }],
  "version" : ["<string>"], // Available versions
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device 
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "capability" : [{ // Device capabilities
    "type" : { CodeableConcept }, // R!  Type of capability
    "description" : [{ CodeableConcept }] // Description of capability
  }],
  "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
  "url" : "<uri>", // Network address to contact device
  "onlineInformation" : "<uri>", // Access to on-line information
  "note" : [{ Annotation }], // Device notes and comments
  "quantity" : { Quantity }, // The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
  "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!  The substance
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }]
}

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..* A name given to the device to identify it
    fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 The name of 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 model number for the device
  fhir:DeviceDefinition.type [ CodeableConcept ]; # 0..1 What kind of device or device system this is
  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.version [ string ], ... ; # 0..* Available versions
  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 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..* Device capabilities
    fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 Type of capability
    fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* Description of capability
  ], ...;
  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.url [ uri ]; # 0..1 Network address to contact device
  fhir:DeviceDefinition.onlineInformation [ uri ]; # 0..1 Access to on-line information
  fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:DeviceDefinition.quantity [ Quantity ]; # 0..1 The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
  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 The substance
    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
  ], ...;
]

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|4.1.0

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..1stringThe name of the device
.... type 1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType (Required)
... modelNumber 0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
FHIR Device Types (Example)
... 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
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Safety (Example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability 0..*BackboneElementDevice capabilities
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... 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
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... 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..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

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 manufacturermanufacturer[x] : Element [0..1] « string|Reference(Organization) »The model number for the devicemodelNumber : string [0..1]What kind of device or device system this istype : CodeableConcept [0..1] « Type of device e.g. according to official classification. (Strength=Example)FHIRDeviceTypes?? »The available versions of the device, e.g., software versionsversion : string [0..*]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)Safety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Dimensions, color etcphysicalCharacteristics : 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..*]A network address on which the device may be contacted directlyurl : uri [0..1]Access to on-line information about the deviceonlineInformation : uri [0..1]Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)quantity : Quantity [0..1]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]DeviceNameThe name of the devicename : string [1..1]The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelNametype : code [1..1] « The type of name the device is referred by. (Strength=Required)DeviceNameType! »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]CapabilityType of capabilitytype : CodeableConcept [1..1]Description of capabilitydescription : 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..*]MaterialThe substancesubstance : 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]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..*]A name given to the device to identify itdeviceName[0..*]The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationspecialization[0..*]Device capabilitiescapability[0..*]The actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesproperty[0..*]A substance used to create the material(s) of which the device is madematerial[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..* A name given to the device to identify it -->
  <name value="[string]"/><!-- 1..1 The name of 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 model number for the device -->
 <type><!-- 0..1 CodeableConcept What kind of device or device system this is --></type>
 <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>
 <version value="[string]"/><!-- 0..* Available versions -->
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device  --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
 <languageCode><!-- 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported) --></languageCode>
 <capability>  <!-- 0..* Device capabilities -->
  <type><!-- 1..1 CodeableConcept Type of capability --></type>
  <description><!-- 0..* CodeableConcept Description of capability --></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>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <onlineInformation value="[uri]"/><!-- 0..1 Access to on-line information -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <quantity><!-- 0..1 Quantity The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) --></quantity>
 <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 The substance --></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>
</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" : [{ // A name given to the device to identify it
    "name" : "<string>", // R!  The name of the device
    "type" : "<code>" // R!  udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
  }],
  "modelNumber" : "<string>", // The model number for the device
  "type" : { CodeableConcept }, // What kind of device or device system this is
  "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
  }],
  "version" : ["<string>"], // Available versions
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device 
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
  "languageCode" : [{ CodeableConcept }], // Language code for the human-readable text strings produced by the device (all supported)
  "capability" : [{ // Device capabilities
    "type" : { CodeableConcept }, // R!  Type of capability
    "description" : [{ CodeableConcept }] // Description of capability
  }],
  "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
  "url" : "<uri>", // Network address to contact device
  "onlineInformation" : "<uri>", // Access to on-line information
  "note" : [{ Annotation }], // Device notes and comments
  "quantity" : { Quantity }, // The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
  "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!  The substance
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }]
}

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..* A name given to the device to identify it
    fhir:DeviceDefinition.deviceName.name [ string ]; # 1..1 The name of 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 model number for the device
  fhir:DeviceDefinition.type [ CodeableConcept ]; # 0..1 What kind of device or device system this is
  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.version [ string ], ... ; # 0..* Available versions
  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 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..* Device capabilities
    fhir:DeviceDefinition.capability.type [ CodeableConcept ]; # 1..1 Type of capability
    fhir:DeviceDefinition.capability.description [ CodeableConcept ], ... ; # 0..* Description of capability
  ], ...;
  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.url [ uri ]; # 0..1 Network address to contact device
  fhir:DeviceDefinition.onlineInformation [ uri ]; # 0..1 Access to on-line information
  fhir:DeviceDefinition.note [ Annotation ], ... ; # 0..* Device notes and comments
  fhir:DeviceDefinition.quantity [ Quantity ]; # 0..1 The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
  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 The substance
    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
  ], ...;
]

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|4.1.0

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 dependency analysis

8.15.5.1 Terminology Bindings

PathDefinitionTypeReference
DeviceDefinition.deviceName.type The type of name the device is referred by.RequiredDeviceNameType
DeviceDefinition.type Type of device e.g. according to official classification.ExampleFHIRDeviceTypes
DeviceDefinition.safety Examplehttp://hl7.org/fhir/ValueSet/device-safety

8.15.6 Notes:

8.15.7 Search Parameters

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.type