The 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.

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.

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.

The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.

The organization that assigns the identifier algorithm.

The jurisdiction to which the deviceIdentifier applies.

A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.

The name or names of the device as given by the manufacturer.

A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

The model number for the device for example as defined by the manufacturer or labeler, or other agency.

What kind of device or device system this is.

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

The standard that is used to operate and communicate.

The version of the standard that is used to operate and communicate.

A device that is part (for example a component) of the present device.

Reference to the device that is part of the current device.

Number of instances of the component device in the current device.

Information about the packaging of the device, i.e. how the device is packaged.

The business identifier of the packaged medication.

A code that defines the specific type of packaging.

The number of items contained in the package (devices or sub-packages).

An organization that distributes the packaged device.

Distributor's human-readable name.

Distributor as an Organization resource.

Unique Device Identifier (UDI) Barcode string on the packaging.

Identifier to be associated with every instance for issuer and jurisdiction.

The organization that assigns the identifier algorithm.

The jurisdiction to which the deviceIdentifier applies.

Allows packages within packages.

The version of the device or software.

The type of the device version, e.g. manufacturer, approved, internal.

The hardware or software module of the device to which the version applies.

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

The version text.

Safety characteristics of the device.

Shelf Life and storage information.

Physical characteristics to define or specify the product - for example dimensions, color etc. These can be defined by the manufacturer or labeler, or can be used to specify characteristics when ordering.

Language code for the human-readable text strings produced by the device (all supported).

Additional capabilities that the device is defined or required to have e.g. "water resistant", "long life".

The type of capability - whether it is a physical attribute, a customization needed. For exampl e "water ingress protection".

The actual capability of the device e.g. IP67.

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Property value as a quantity.

Property value as a code, e.g., NTP4 (synced to NTP).

An organization that is responsible for the provision and ongoing maintenance of the device.

Contact details for an organization or a particular human that is responsible for the device.

used for troubleshooting etc.

Access to on-line information about the device.

Descriptive information, usage information or implantation information that is not captured in an existing element.

The parent device it can be part of.

A substance used to create the material(s) of which the device is made.

A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.

Indicates an alternative material of the device.

Whether the substance is a known or suspected allergen.