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.

Additional information to describe the device.

Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

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 jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.

The organization that assigns the identifier algorithm.

The jurisdiction to which the deviceIdentifier applies.

Indicates where and when the device is available on the market.

Begin and end dates for the commercial distribution of the device.

National state or territory to which the marketDistribution recers, typically where the device is commercialized.

Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.

This should not be used for regulatory authorization numbers which are to be captured elsewhere.

The type of identifier itself.

The identifier itself.

The organization that issued this identifier.

The jurisdiction to which the deviceIdentifier applies.

The part number or catalog number of the device.

Alphanumeric Maximum 20.

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. RegisteredName | UserFriendlyName | PatientReportedName.

The implementation or jurisdiction must clarify which name is to be used as the registered-name. As a result a device definition may have multiple names that are the same, but then used for different purposes per the name type and jurisdictional guidance.

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.

In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.

A classification or risk class of the device model.

Further information qualifying this classification of the device model.

Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

Describes the type of the standard, specification, or formal guidance.

Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.

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.

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.

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

Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.

Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.

Code that specifies the property such as a resolution or color being represented.

The value of the property specified by the associated property.type code.

This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.

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.

An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.

The type indicates the relationship of the related device to the device instance.

A reference to the linked device.

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

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.

Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.

Jurisdictions may define other production identifier types and by way of regulation and/or implementation guidance indicate which identifier(s) are to be used for that jurisdiction.

Information aimed at providing directions for the usage of this model of device.

For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.

The circumstances that form the setting for using the device.

Detailed written and visual directions for the user on how to use the device.

A source of information or reference for this guideline.

A clinical condition for which the device was designed to be used.

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

A specific situation when a device should not be used because it may cause harm.

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

Specific hazard alert information that a user needs to know before using the device.

A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.

A description of the general purpose or medical use of the device or its function.

Tracking of latest field safety corrective action.

Whether the last corrective action known for this device was a recall.

When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.

The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.

Start and end dates of the corrective action.

Billing code or reference associated with the device.

The code or reference for the charge item.

Coefficient applicable to the billing code.

A specific time period in which this charge item applies.

The context to which this charge item applies.