The characteristics, operational status and capabilities definition of a medical-related component kind of device or device component. Typically, this definition corresponds to a medical 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.

Unique instance identifiers assigned An absolute URI that is used to identify this DeviceDefinition when it is referenced in a device 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 software, manufacturers, 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 organizations formats, or owners. For example: handle ID. 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.

Unique device 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 (UDI) assigned for the resource by machine processing applications such as code generation.

Supports code generation.

The name is not expected to device label or package. Note 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 Device DeviceDefinition.

This name does not need to be machine-processing friendly and may include multiple udiCarriers 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 just 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 udiCarrier 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 jurisdiction '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 sold, 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 authority that maintains the resource is operating. In general, the jurisdiction is also found in the useContext. The useContext may reference additional jurisdictions because the defining jurisdiction does not necessarily limit the jurisdictions of use.

It may be possible for the DeviceDefinition to be used in jurisdictions other than those for which it could have 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 sold. 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 notices of intellectual property ownership and can include 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 without the copyright prefix (i.e., do not include '(c)' or the symbol).

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

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

The copyright symbol and the '(c)' textual representation 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.

The Device Identifier (DI) portion of the Unique Device Identifier (UDI) placed on a device label or package. Also known as UDI-DI. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.

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

A name Begin and end dates for the commercial distribution of the manufacturer. device.

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

Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the device identifier.

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 used in the associated regulatory context.

The organization that issued this identifier.

The applicable jurisdiction overseeing the enforcement of Data Types the Identifier.

Establishes the namespace for further information about how the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to use [x] create the identifier.

A The name given to or names of the device to identify it. as given by the manufacturer.

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

The type of deviceName. UDILabelName RegisteredName | UserFriendlyName | PatientReportedName 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.

The model number for 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. device model.

What kind 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 system this is. 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.

The capabilities supported on a device, Code that identifies the standards specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device conforms for a particular purpose, and used for the communication. 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.

The standard device that is used to operate and communicate. 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 version business identifier of the standard that is used to operate and communicate. 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 available versions version of the device, e.g., 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 resource version id (see discussion 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.

Dimensions, 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 etc. being represented.

Language code for The value of the human-readable text strings produced property specified by the device (all supported). 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.

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

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

Description of capability. A reference to the linked device.

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

The actual configuration settings A substance used to create the material(s) of a which the device as it actually operates, e.g., regulation status, time properties. is made.

Code A substance that specifies the property DeviceDefinitionPropetyCode (Extensible). 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.

Property value as a quantity. Indicates an alternative material of the device.

Property value as Whether the substance is a code, e.g., NTP4 (synced to NTP). known or suspected allergen.

An organization Indicates the production identifier(s) that is responsible for are expected to appear in the provision and ongoing maintenance of UDI carrier on the device. 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.

Contact details Information aimed at providing directions for an organization or the usage of this model of device.

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

The circumstances that form the setting for using the device.

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

A source of information or reference for this guideline.

A network address on clinical condition for which the device may was designed to be contacted directly. used.

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

A specific situation when a FHIR server, the network address device should not be the Base URL from which used because it may cause harm.

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

Access to on-line Specific hazard alert information about 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.

Descriptive information, usage information A description of the general purpose or implantation information that is not captured in an existing element. medical use of the device or its function.

The quantity Tracking of latest field safety corrective action.

Whether the last corrective action known for this device present 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 packaging (e.g. corrective action - whether the number action targeted all units of devices present in a pack, given device model, or the number only a specific set of batches identified by lot numbers, or individually identified devices in the same package of identified by the medicinal product). serial name.

The parent device it can be part of. Start and end dates of the corrective action.

A substance used to create Billing code or reference associated with the material(s) of which device.

The substance. code or reference for the charge item.

Indicates an alternative material of Coefficient applicable to the device. billing code.

A specific time period in which this charge item applies.

Whether the substance is a known or suspected allergen. The context to which this charge item applies.