Release 4B Snapshot #1
AdministrationThis page is part of the FHIR Specification v4.3.0-snapshot1: R4B Snapshot to support the Jan 2022 Connectathon. About the R4B version of FHIR. The current officially released version is 4.3.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4
| 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.
The DeviceDefinition resource is used to describe the characteristics and capabilities of a medical device.
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, ClinicalUseDefinition, Device, itself, PackagedProductDefinition and RegulatedAuthorization.
This resource does not implement any patterns.
Structure
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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) | |||
| deviceName | 0..* | BackboneElement | A name given to the device to identify it | |
| 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 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 | |
| Documentation for this format | ||||
UML Diagram (Legend)
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir"><!-- 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
JSON Template
{
"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/> .
Changes since R3
| DeviceDefinition | |
| DeviceDefinition.deviceName.type |
|
See the Full Difference for further information
Structure
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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) | |||
| deviceName | 0..* | BackboneElement | A name given to the device to identify it | |
| 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 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 | |
| Documentation for this format | ||||
XML Template
<DeviceDefinition xmlns="http://hl7.org/fhir">
JSON Template
{
"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/> .
Changes since Release 3
| DeviceDefinition | |
| DeviceDefinition.deviceName.type |
|
See the Full Difference for further information
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
| Path | Definition | Type | Reference |
|---|---|---|---|
| DeviceDefinition.deviceName.type | Required | DeviceNameType | |
| DeviceDefinition.type | Example | FHIRDeviceTypes | |
| DeviceDefinition.safety | Example | http://hl7.org/fhir/ValueSet/device-safety |
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 |
FHIR ®© HL7.org 2011+. FHIR R4B Ballot #1 hl7.fhir.core#4.3.0-snapshot1 generated on Mon, Dec 20, 2021 14:13+1100.
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