Resource type: devicedefinition

Description

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

Elements

PathShortDefinitionComments
An instance of a medical-related component of a medical deviceThe characteristics, operational status and capabilities of a medical-related component of a medical device.For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
identifierInstance identifierUnique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.
udiDeviceIdentifierUnique Device Identifier (UDI) Barcode stringUnique 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.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
udiDeviceIdentifier.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
udiDeviceIdentifier.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
udiDeviceIdentifier.deviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.
udiDeviceIdentifier.issuerThe organization that assigns the identifier algorithmThe organization that assigns the identifier algorithm.
udiDeviceIdentifier.jurisdictionThe jurisdiction to which the deviceIdentifier appliesThe jurisdiction to which the deviceIdentifier applies.
manufacturer[x]Name of device manufacturerA name of the manufacturer.
deviceNameA name given to the device to identify itA name given to the device to identify it.
deviceName.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
deviceName.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
deviceName.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
deviceName.nameThe name of the deviceThe name of the device.
deviceName.typeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | otherThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
modelNumberThe model number for the deviceThe model number for the device.
typeWhat kind of device or device system this isWhat kind of device or device system this is.
specializationThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communicationThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
specialization.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
specialization.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
specialization.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
specialization.systemTypeThe standard that is used to operate and communicateThe standard that is used to operate and communicate.
specialization.versionThe version of the standard that is used to operate and communicateThe version of the standard that is used to operate and communicate.
versionAvailable versionsThe available versions of the device, e.g., software versions.
safetySafety characteristics of the deviceSafety characteristics of the device.
shelfLifeStorageShelf Life and storage informationShelf Life and storage information.
physicalCharacteristicsDimensions, color etc.Dimensions, color etc.
languageCodeLanguage code for the human-readable text strings produced by the device (all supported)Language code for the human-readable text strings produced by the device (all supported).
capabilityDevice capabilitiesDevice capabilities.
capability.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
capability.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
capability.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
capability.typeType of capabilityType of capability.
capability.descriptionDescription of capabilityDescription of capability.
propertyThe actual configuration settings of a device as it actually operates, e.g., regulation status, time propertiesThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
property.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
property.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
property.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
property.typeCode that specifies the property DeviceDefinitionPropetyCode (Extensible)Code that specifies the property DeviceDefinitionPropetyCode (Extensible).
property.valueQuantityProperty value as a quantityProperty value as a quantity.
property.valueCodeProperty value as a code, e.g., NTP4 (synced to NTP)Property value as a code, e.g., NTP4 (synced to NTP).
ownerOrganization responsible for deviceAn organization that is responsible for the provision and ongoing maintenance of the device.
contactDetails for human/organization for supportContact details for an organization or a particular human that is responsible for the device.used for troubleshooting etc.
urlNetwork address to contact deviceA network address on which the device may be contacted directly.If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
onlineInformationAccess to on-line informationAccess to on-line information about the device.
noteDevice notes and commentsDescriptive information, usage information or implantation information that is not captured in an existing element.
quantityThe 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)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).
parentDeviceThe parent device it can be part ofThe parent device it can be part of.
materialA substance used to create the material(s) of which the device is madeA substance used to create the material(s) of which the device is made.
material.idUnique id for inter-element referencingUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
material.extensionAdditional content defined by implementationsMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
material.modifierExtensionExtensions that cannot be ignored even if unrecognizedMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
material.substanceThe substanceThe substance.
material.alternateIndicates an alternative material of the deviceIndicates an alternative material of the device.
material.allergenicIndicatorWhether the substance is a known or suspected allergenWhether the substance is a known or suspected allergen.

Scope and Usage

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

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.

Background and Context

Notes:

Search Parameters

identifierThe identifier of the componentDeviceDefinition.identifier
parentThe parent DeviceDefinition resourceDeviceDefinition.parentDevice
typeThe device component typeDeviceDefinition.type

Extension Definitions

These are extension definitions for this resource defined by the spec