Release 4 4B

This page is part of the FHIR Specification (v4.0.1: R4 (v4.3.0: R4B - Mixed Normative and STU ) in it's permanent home (it will always be available at this URL). ). 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 R4B R4

8.15 Resource DeviceDefinition - Content

Orders and Observations Work Group Maturity Level : 0   Trial Use Security 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 , ClinicalUseDefinition , Device , itself, MedicinalProductPackaged PackagedProductDefinition and MedicinalProductPharmaceutical RegulatedAuthorization .

This resource does not implement any patterns.

8.15.4 8.15.5 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . DeviceDefinition TU DomainResource An instance of a medical-related component of a medical device
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance identifier
. . . udiDeviceIdentifier 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
. . . . deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
. . . . issuer 1..1 uri The organization that assigns the identifier algorithm
. . . . jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
. . . manufacturer[x] 0..1 Name of device manufacturer
. . . . manufacturerString string
. . . . manufacturerReference Reference ( Organization )
. . . . name 1..1 string The name of the device
. . . . type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType ( Required )
. . . modelNumber 0..1 string The model number for the device
. . . type 0..1 CodeableConcept What kind of device or device system this is
FHIR Device Types ( Example )
. . . specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
. . . . systemType 1..1 string The standard that is used to operate and communicate
. . . . version 0..1 string The version of the standard that is used to operate and communicate
. . . version 0..* string Available versions
. . . safety Σ 0..* CodeableConcept Safety characteristics of the device
Device safety Safety ( Example )
. . . shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
. . . physicalCharacteristics 0..1 ProdCharacteristic Dimensions, color etc.
. . . languageCode 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported)
. . . capability 0..* BackboneElement Device capabilities
. . . . type 1..1 CodeableConcept Type of capability
. . . . description 0..* CodeableConcept Description of capability
. . . property 0..* BackboneElement 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)
. . . . valueQuantity 0..* Quantity Property value as a quantity
. . . . valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
. . . owner 0..1 Reference ( Organization ) Organization responsible for device
. . . contact 0..* ContactPoint Details for human/organization for support
. . . url 0..1 uri Network address to contact device
. . . onlineInformation 0..1 uri Access to on-line information
. . . note 0..* Annotation Device notes and comments
. . . 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)
. . . parentDevice Σ 0..1 Reference ( DeviceDefinition ) The parent device it can be part of
. . . material 0..* BackboneElement A substance used to create the material(s) of which the device is made
. . . . substance 1..1 CodeableConcept The substance
. . . . alternate 0..1 boolean Indicates an alternative material of the device
. . . . allergenicIndicator 0..1 boolean Whether 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 ID identifier : Identifier [0..*] A name of the manufacturer manufacturer[x] : Type Element [0..1] « string | Reference ( Organization ) » The model number for the device modelNumber : string [0..1] What kind of device or device system this is type : CodeableConcept [0..1] « Type of device e.g. according to official classification. null (Strength=Example) FHIRDeviceTypes ?? » The available versions of the device, e.g., software versions version : string [0..*] Safety characteristics of the device safety : CodeableConcept [0..*] « null (Strength=Example) DeviceSafety Safety ?? » Shelf Life and storage information shelfLifeStorage : ProductShelfLife [0..*] Dimensions, color etc physicalCharacteristics : 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 device owner : Reference [0..1] « Organization » Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] A network address on which the device may be contacted directly url : uri [0..1] Access to on-line information about the device onlineInformation : uri [0..1] Descriptive information, usage information or implantation information that is not captured in an existing element note : 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 of parentDevice : Reference [0..1] « DeviceDefinition » UdiDeviceIdentifier The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier deviceIdentifier : string [1..1] The organization that assigns the identifier algorithm issuer : uri [1..1] The jurisdiction to which the deviceIdentifier applies jurisdiction : uri [1..1] DeviceName The name of the device name : string [1..1] The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName type : code [1..1] « The type of name the device is referred by. null (Strength=Required) DeviceNameType ! » Specialization The standard that is used to operate and communicate systemType : string [1..1] The version of the standard that is used to operate and communicate version : string [0..1] Capability Type of capability type : CodeableConcept [1..1] Description of capability description : CodeableConcept [0..*] Property Code that specifies the property DeviceDefinitionPropetyCode (Extensible) type : CodeableConcept [1..1] Property value as a quantity valueQuantity : Quantity [0..*] Property value as a code, e.g., NTP4 (synced to NTP) valueCode : CodeableConcept [0..*] Material The substance substance : CodeableConcept [1..1] Indicates an alternative material of the device alternate : boolean [0..1] Whether the substance is a known or suspected allergen allergenicIndicator : 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 sold udiDeviceIdentifier [0..*] A name given to the device to identify it deviceName [0..*] The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication specialization [0..*] Device capabilities capability [0..*] The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties property [0..*] A substance used to create the material(s) of which the device is made material [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>

 <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 R4

DeviceDefinition
  • No Changes

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

Structure

Name Flags Card. Type Description & Constraints doco
. . DeviceDefinition TU DomainResource An instance of a medical-related component of a medical device
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier 0..* Identifier Instance identifier
. . . udiDeviceIdentifier 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
. . . . deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
. . . . issuer 1..1 uri The organization that assigns the identifier algorithm
. . . . jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
. . . manufacturer[x] 0..1 Name of device manufacturer
. . . . manufacturerString string
. . . . manufacturerReference Reference ( Organization )
. . . . name 1..1 string The name of the device
. . . . type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
DeviceNameType ( Required )
. . . modelNumber 0..1 string The model number for the device
. . . type 0..1 CodeableConcept What kind of device or device system this is
FHIR Device Types ( Example )
. . . specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
. . . . systemType 1..1 string The standard that is used to operate and communicate
. . . . version 0..1 string The version of the standard that is used to operate and communicate
. . . version 0..* string Available versions
. . . safety Σ 0..* CodeableConcept Safety characteristics of the device
Device safety Safety ( Example )
. . . shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information
. . . physicalCharacteristics 0..1 ProdCharacteristic Dimensions, color etc.
. . . languageCode 0..* CodeableConcept Language code for the human-readable text strings produced by the device (all supported)
. . . capability 0..* BackboneElement Device capabilities
. . . . type 1..1 CodeableConcept Type of capability
. . . . description 0..* CodeableConcept Description of capability
. . . property 0..* BackboneElement 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)
. . . . valueQuantity 0..* Quantity Property value as a quantity
. . . . valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
. . . owner 0..1 Reference ( Organization ) Organization responsible for device
. . . contact 0..* ContactPoint Details for human/organization for support
. . . url 0..1 uri Network address to contact device
. . . onlineInformation 0..1 uri Access to on-line information
. . . note 0..* Annotation Device notes and comments
. . . 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)
. . . parentDevice Σ 0..1 Reference ( DeviceDefinition ) The parent device it can be part of
. . . material 0..* BackboneElement A substance used to create the material(s) of which the device is made
. . . . substance 1..1 CodeableConcept The substance
. . . . alternate 0..1 boolean Indicates an alternative material of the device
. . . . allergenicIndicator 0..1 boolean Whether 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 ID identifier : Identifier [0..*] A name of the manufacturer manufacturer[x] : Type Element [0..1] « string | Reference ( Organization ) » The model number for the device modelNumber : string [0..1] What kind of device or device system this is type : CodeableConcept [0..1] « Type of device e.g. according to official classification. null (Strength=Example) FHIRDeviceTypes ?? » The available versions of the device, e.g., software versions version : string [0..*] Safety characteristics of the device safety : CodeableConcept [0..*] « null (Strength=Example) DeviceSafety Safety ?? » Shelf Life and storage information shelfLifeStorage : ProductShelfLife [0..*] Dimensions, color etc physicalCharacteristics : 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 device owner : Reference [0..1] « Organization » Contact details for an organization or a particular human that is responsible for the device contact : ContactPoint [0..*] A network address on which the device may be contacted directly url : uri [0..1] Access to on-line information about the device onlineInformation : uri [0..1] Descriptive information, usage information or implantation information that is not captured in an existing element note : 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 of parentDevice : Reference [0..1] « DeviceDefinition » UdiDeviceIdentifier The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier deviceIdentifier : string [1..1] The organization that assigns the identifier algorithm issuer : uri [1..1] The jurisdiction to which the deviceIdentifier applies jurisdiction : uri [1..1] DeviceName The name of the device name : string [1..1] The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName type : code [1..1] « The type of name the device is referred by. null (Strength=Required) DeviceNameType ! » Specialization The standard that is used to operate and communicate systemType : string [1..1] The version of the standard that is used to operate and communicate version : string [0..1] Capability Type of capability type : CodeableConcept [1..1] Description of capability description : CodeableConcept [0..*] Property Code that specifies the property DeviceDefinitionPropetyCode (Extensible) type : CodeableConcept [1..1] Property value as a quantity valueQuantity : Quantity [0..*] Property value as a code, e.g., NTP4 (synced to NTP) valueCode : CodeableConcept [0..*] Material The substance substance : CodeableConcept [1..1] Indicates an alternative material of the device alternate : boolean [0..1] Whether the substance is a known or suspected allergen allergenicIndicator : 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 sold udiDeviceIdentifier [0..*] A name given to the device to identify it deviceName [0..*] The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication specialization [0..*] Device capabilities capability [0..*] The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties property [0..*] A substance used to create the material(s) of which the device is made material [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>

 <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 4

DeviceDefinition
  • No Changes

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

 

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

8.15.4.1 8.15.5.1 Terminology Bindings

Path Definition Type Reference
DeviceDefinition.deviceName.type The type of name the device is referred by. Required DeviceNameType
DeviceDefinition.type Type of device e.g. according to official classification. Example FHIRDeviceTypes
DeviceDefinition.safety Example DeviceSafety http://hl7.org/fhir/ValueSet/device-safety

8.15.5 8.15.6 Notes:

8.15.6 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.

Name Type Description Expression In Common
identifier token The identifier of the component DeviceDefinition.identifier
parent reference The parent DeviceDefinition resource DeviceDefinition.parentDevice
( DeviceDefinition )
type token The device component type DeviceDefinition.type