The definition of a kind of device or device component. Typically, this definition corresponds to a device model although it may be a broader category of 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.

An absolute URI that is used to identify this DeviceDefinition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this DeviceDefinition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the DeviceDefinition is stored on different servers.

Allows the DeviceDefinition to be referenced by a single globally unique identifier.

Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version. The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions. In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

A formal identifier that is used to identify this DeviceDefinition when it is represented in other formats, or referenced in a specification, model, design or an instance.

Allows externally provided and/or usable business identifiers to be easily associated with the DeviceDefinition.

The identifier that is used to identify this version of the DeviceDefinition when it is referenced in a specification.

There may be different DeviceDefinitions that have the same url but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the DeviceDefinition with the format [url]|[version]. The version SHOULD NOT contain a '#' - see Business Version.

Indicates the mechanism used to compare versions to determine which is more current.

If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.

A natural language name identifying the DeviceDefinition. This name should be usable as an identifier for the resource by machine processing applications such as code generation.

Supports code generation.

The name is not expected to be globally unique. The name should be a simple alphanumeric type no-whitespace name to ensure that it is machine-processing friendly.

A short, descriptive, user-friendly title for the DeviceDefinition.

This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

The current state of this DeviceDefinition.

Enables tracking the life-cycle of the content and filtering of DeviceDefinitions that are appropriate for use versus not.

A nominal state-transition diagram can be found in the Definition pattern documentation. Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. See guidance around (not) making local changes to elements here. If a server wishes to reflect whether a given canonical resource is 'supported' or 'enabled' on that server, this is NOT done with status. Instead, expose support for the resource using a 'feature' in the server's CapabilityStatement. (Not all supported canonical resources will necessarily be searchable on a server, and availability of a canonical resource in a search result does not imply support of the resource for any particular usage.)

A Boolean value to indicate that this DeviceDefinition is authored for testing purposes (or education/evaluation/marketing) and no version of this resource will ever be intended for genuine usage.

Enables experimental content to be developed following the same lifecycle that would be used for a production-level DeviceDefinition.

Allows filtering of DeviceDefinitions that are appropriate for use versus not. Experimental resources might include example instances in implementation guides, instances created solely for testing purposes, etc. If experimental is 'true' for any version of a resource, it should be true for all versions of the resource. (If experimental changes, then it is being misused or a resource that was never intended for real-world use has unexpectedly changed its purpose.). Experimental resources are not expected to be stable and may well have breaking changes without a corresponding change to the 'version' element.

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

The date (and optionally time) when the DeviceDefinition was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the DeviceDefinition changes.

The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the DeviceDefinition. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource. See guidance around (not) making local changes to elements here.

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

used for troubleshooting etc.

The name of the organization or individual responsible for the release and ongoing maintenance of the device definition.

The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate DeviceDefinitions.

Assist in searching for appropriate content.

When multiple useContexts are specified, there is no expectation that all or even any of the contexts apply.

A legal or geographic region in which the DeviceDefinition is intended to be used.

It may be possible for the DeviceDefinition to be used in jurisdictions other than those for which it was originally designed or intended. DEPRECATION NOTE: For consistency, implementations are encouraged to migrate to using the new 'jurisdiction' code in the useContext element. (I.e. useContext.code indicating http://terminology.hl7.org/CodeSystem/usage-context-type#jurisdiction and useContext.valueCodeableConcept indicating the jurisdiction.)

Explanation of why this DeviceDefinition is needed and why it has been designed as it has.

This element does not describe the usage of the DeviceDefinition. Instead, it provides traceability of "why" the resource is either needed or "why" it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this DeviceDefinition.

A copyright statement relating to the DeviceDefinition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the DeviceDefinition.

Consumers must be able to determine any legal restrictions on the use of the DeviceDefinition and/or its content.

The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.

A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').

Defines the content expected to be rendered in all representations of the artifact.

The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.

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 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.

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 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.