---
type: "resource-definitions"
title: "DeviceDefinition Definitions"
resource: "DeviceDefinition"
---

# DeviceDefinition Definitions

<a id="DeviceDefinition"></a>

## DeviceDefinition
The definition of a kind of device or device component

**Definition:** 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.

**Comments:** 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.

**Cardinality:** 0..*

**Mappings:** w5=administrative.device; workflow=Definition


<a id="DeviceDefinition.url"></a>

## DeviceDefinition.url
Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)

**Definition:** 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.

**Comments:** 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](resource.html#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](resource.html#meta) element to indicate where the current master source of the resource can be found.

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

**Cardinality:** 0..1

**Type:** [uri](/uri)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Constraints:** cnl-1 | warning | URL should not contain | or # - these characters make processing canonical references
         problematic | exists() implies matches('^[^|# ]+$')

**Mappings:** w5=FiveWs.identifier; workflow=Definition


<a id="DeviceDefinition.identifier"></a>

## DeviceDefinition.identifier
Additional identifier for the DeviceDefinition

**Definition:** 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.

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

**Cardinality:** 0..*

**Type:** [Identifier](/Identifier)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Mappings:** w5=FiveWs.identifier


<a id="DeviceDefinition.version"></a>

## DeviceDefinition.version
Business version of the DeviceDefinition

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

**Comments:** 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](resource.html#bv-format).

**Cardinality:** 0..1

**Type:** [string](/string)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Mappings:** w5=FiveWs.version


<a id="DeviceDefinition.versionAlgorithm[x]"></a>

## DeviceDefinition.versionAlgorithm[x]
How to compare versions

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

**Comments:** 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.

**Cardinality:** 0..1

**Type:** [string](/string), [Coding](/Coding)

**Binding:** extensible:[version-algorithm](/valueset-version-algorithm)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.name"></a>

## DeviceDefinition.name
Name for this DeviceDefinition (computer friendly)

**Definition:** 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.

**Comments:** 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.

**Requirements:** Supports code generation.

**Conditions:** cnl-0

**Cardinality:** 0..1

**Type:** [string](/string)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.title"></a>

## DeviceDefinition.title
Name for this DeviceDefinition (human friendly)

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

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

**Cardinality:** 0..1

**Type:** [string](/string)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.status"></a>

## DeviceDefinition.status
draft | active | retired | unknown

**Definition:** The current state of this DeviceDefinition.

**Comments:** A nominal state-transition diagram can be found in the [Definition pattern](definition.html#statemachine) 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](canonicalresource.html#localization).  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.)

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

**Cardinality:** 1..1

**Type:** [code](/code)

**Binding:** required:[publication-status|6.0.0-ballot4](/valueset-publication-status|6.0.0-ballot4)

**Must Support:** false

**Summary:** true

**Is Modifier:** true (Reason: This is labeled as "Is Modifier" because applications should not use
       a retired DeviceDefinition without due consideration)

**Mappings:** w5=FiveWs.status


<a id="DeviceDefinition.experimental"></a>

## DeviceDefinition.experimental
For testing only - never for real usage

**Definition:** 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.

**Comments:** 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.

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

**Meaning if Missing:** If absent, this resource is treated as though it is not experimental.

**Cardinality:** 0..1

**Type:** [boolean](/boolean)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Mappings:** w5=FiveWs.class


<a id="DeviceDefinition.date"></a>

## DeviceDefinition.date
Date last changed

**Definition:** 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.

**Comments:** 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](canonicalresource.html#localization).

**Aliases:** Revision Date

**Cardinality:** 0..1

**Type:** [dateTime](/dateTime)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Mappings:** w5=FiveWs.recorded


<a id="DeviceDefinition.publisher"></a>

## DeviceDefinition.publisher
Name of the publisher/steward (organization or individual)

**Definition:** The name of the organization or individual responsible for the release and ongoing maintenance of the DeviceDefinition.

**Comments:** Usually an organization but may be an individual. The publisher (or steward) of the DeviceDefinition is the organization or individual primarily responsible for the maintenance and upkeep of the DeviceDefinition. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the DeviceDefinition. This item SHOULD be populated unless the information is available from context.

**Requirements:** Helps establish the "authority/credibility" of the DeviceDefinition.  May also
       allow for contact.

**Cardinality:** 0..1

**Type:** [string](/string)

**Must Support:** false

**Summary:** true

**Is Modifier:** false

**Mappings:** w5=FiveWs.witness


<a id="DeviceDefinition.contact"></a>

## DeviceDefinition.contact
Contact details for the publisher

**Definition:** Contact details to assist a user in finding and communicating with the publisher.

**Comments:** May be a web site, an email address, a telephone number, etc.  See guidance around (not) making local changes to elements [here](canonicalresource.html#localization).

**Cardinality:** 0..*

**Type:** [ContactDetail](/ContactDetail)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.description"></a>

## DeviceDefinition.description
Natural language description of the DeviceDefinition

**Definition:** A free text natural language description of the DeviceDefinition from a consumer's perspective.

**Comments:** This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the DeviceDefinition as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)

**Must Support:** false

**Summary:** false

**Is Modifier:** false


<a id="DeviceDefinition.useContext"></a>

## DeviceDefinition.useContext
The context that the content is intended to support

**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.

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

**Requirements:** Assist in searching for appropriate content.

**Cardinality:** 0..*

**Type:** [UsageContext](/UsageContext)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.jurisdiction"></a>

## DeviceDefinition.jurisdiction
Jurisdiction of the authority that maintains the DeviceDefinition (if applicable)

**Definition:** 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.

**Comments:** 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.)

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** extensible:[jurisdiction](/valueset-jurisdiction)

**Must Support:** false

**Summary:** true

**Is Modifier:** false


<a id="DeviceDefinition.purpose"></a>

## DeviceDefinition.purpose
Why this DeviceDefinition is defined

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

**Comments:** 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.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)

**Must Support:** false

**Summary:** false

**Is Modifier:** false

**Mappings:** w5=FiveWs.why[x]


<a id="DeviceDefinition.copyright"></a>

## DeviceDefinition.copyright
Notice about intellectual property ownership, can include restrictions on use

**Definition:** 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.

**Comments:** 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).

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

**Aliases:** License, Restrictions

**Cardinality:** 0..1

**Type:** [markdown](/markdown)

**Must Support:** false

**Summary:** false

**Is Modifier:** false


<a id="DeviceDefinition.copyrightLabel"></a>

## DeviceDefinition.copyrightLabel
Copyright holder and year(s)

**Definition:** 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').

**Comments:** 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.

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

**Cardinality:** 0..1

**Type:** [string](/string)

**Must Support:** false

**Summary:** false

**Is Modifier:** false


<a id="DeviceDefinition.approvalDate"></a>

## DeviceDefinition.approvalDate
When DeviceDefinition was approved by publisher

**Definition:** The date on which the asset content was approved by the publisher. Approval happens once when the content is officially approved for usage.

**Comments:** The date may be more recent than the approval date because of minor changes / editorial corrections.

See guidance around (not) making local changes to elements [here](canonicalresource.html#localization).

**Cardinality:** 0..1

**Type:** [date](/date)

**Mappings:** w5=FiveWs.recorded


<a id="DeviceDefinition.lastReviewDate"></a>

## DeviceDefinition.lastReviewDate
Date on which the asset content was last reviewed by the publisher

**Definition:** The date on which the asset content was last reviewed. Review happens periodically after that, but doesn't change the original approval date.

**Comments:** If specified, this is usually after the approval date.

See guidance around (not) making local changes to elements [here](canonicalresource.html#localization).

**Cardinality:** 0..1

**Type:** [date](/date)

**Mappings:** w5=FiveWs.recorded


<a id="DeviceDefinition.effectivePeriod"></a>

## DeviceDefinition.effectivePeriod
The effective date range for the DeviceDefinition

**Definition:** The period during which the DeviceDefinition content was or is planned to be effective.

**Comments:** The effective period for a DeviceDefinition determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2021 might be published in 2020.

See guidance around (not) making local changes to elements [here](canonicalresource.html#localization).

**Cardinality:** 0..1

**Type:** [Period](/Period)

**Summary:** true

**Mappings:** w5=FiveWs.done[x]


<a id="DeviceDefinition.partNumber"></a>

## DeviceDefinition.partNumber
The part number or catalog number of the device

**Definition:** The part number or catalog number of the device.

**Comments:** Alphanumeric Maximum 20.

**Cardinality:** 0..1

**Type:** [string](/string)

**Mappings:** w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].id


<a id="DeviceDefinition.manufacturer"></a>

## DeviceDefinition.manufacturer
Name of device manufacturer

**Definition:** 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.

**Cardinality:** 0..1

**Type:** Reference([Organization](/Organization))

**Summary:** true

**Mappings:** w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].scoper.name


<a id="DeviceDefinition.modelNumber"></a>

## DeviceDefinition.modelNumber
The catalog or model number for the device for example as defined by the manufacturer

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

**Cardinality:** 0..1

**Type:** [string](/string)

**Summary:** true

**Mappings:** w5=FiveWs.what[x]; rim=.softwareName (included as part)


<a id="DeviceDefinition.udiDeviceIdentifier"></a>

## DeviceDefinition.udiDeviceIdentifier
Unique Device Identifier (UDI) Barcode string

**Definition:** 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.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.udiDeviceIdentifier.deviceIdentifier"></a>

## DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier

**Definition:** The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.

**Cardinality:** 1..1

**Type:** [string](/string)


<a id="DeviceDefinition.udiDeviceIdentifier.issuer"></a>

## DeviceDefinition.udiDeviceIdentifier.issuer
The organization that assigns the identifier algorithm

**Definition:** The organization that assigns the identifier algorithm.

**Cardinality:** 1..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.udiDeviceIdentifier.jurisdiction"></a>

## DeviceDefinition.udiDeviceIdentifier.jurisdiction
The jurisdiction to which the deviceIdentifier applies

**Definition:** The jurisdiction to which the deviceIdentifier applies.

**Cardinality:** 1..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.udiDeviceIdentifier.marketDistribution"></a>

## DeviceDefinition.udiDeviceIdentifier.marketDistribution
Indicates whether and when the device is available on the market

**Definition:** Indicates where and when the device is available on the market.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod"></a>

## DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
Begin and end dates for the commercial distribution of the device

**Definition:** Begin and end dates for the commercial distribution of the device.

**Cardinality:** 1..1

**Type:** [Period](/Period)


<a id="DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction"></a>

## DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
National state or territory where the device is commercialized

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

**Cardinality:** 1..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem"></a>

## DeviceDefinition.udiDeviceIdentifier.deviceIdentifierSystem
The namespace for the device identifier value

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

**Cardinality:** 0..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.regulatoryIdentifier"></a>

## DeviceDefinition.regulatoryIdentifier
Regulatory identifier(s) associated with this device

**Definition:** 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.

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.regulatoryIdentifier.type"></a>

## DeviceDefinition.regulatoryIdentifier.type
basic | master | license

**Definition:** The type of identifier itself.

**Cardinality:** 1..1

**Type:** [code](/code)

**Binding:** required:[devicedefinition-regulatory-identifier-type](/valueset-devicedefinition-regulatory-identifier-type)


<a id="DeviceDefinition.regulatoryIdentifier.identifier"></a>

## DeviceDefinition.regulatoryIdentifier.identifier
The identifier itself

**Definition:** The identifier used in the associated regulatory context.

**Cardinality:** 1..1

**Type:** [string](/string)


<a id="DeviceDefinition.regulatoryIdentifier.issuer"></a>

## DeviceDefinition.regulatoryIdentifier.issuer
The organization that issued this identifier

**Definition:** The organization that issued this identifier.

**Cardinality:** 1..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.regulatoryIdentifier.jurisdiction"></a>

## DeviceDefinition.regulatoryIdentifier.jurisdiction
Relevant jurisdiction governing the identifier

**Definition:** The applicable jurisdiction overseeing the enforcement of the Identifier.

**Cardinality:** 1..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.regulatoryIdentifier.identifierSystem"></a>

## DeviceDefinition.regulatoryIdentifier.identifierSystem
The namespace for the device identifier value

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

**Cardinality:** 0..1

**Type:** [uri](/uri)


<a id="DeviceDefinition.deviceName"></a>

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

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Summary:** true


<a id="DeviceDefinition.deviceName.name"></a>

## DeviceDefinition.deviceName.name
A name that is used to refer to the device

**Definition:** 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.

**Aliases:** Σ

**Cardinality:** 1..1

**Type:** [string](/string)

**Summary:** true


<a id="DeviceDefinition.deviceName.type"></a>

## DeviceDefinition.deviceName.type
registered-name | user-friendly-name | patient-reported-name

**Definition:** The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName.

**Comments:** 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.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** extensible:[device-nametype](/valueset-device-nametype)

**Summary:** true

**Mappings:** w5=FiveWs.what[x]; rim=.playedRole[typeCode=MANU].code


<a id="DeviceDefinition.classification"></a>

## DeviceDefinition.classification
What kind of device or device system this is

**Definition:** What kind of device or device system this is.

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Summary:** true


<a id="DeviceDefinition.classification.type"></a>

## DeviceDefinition.classification.type
A classification or risk class of the device model

**Definition:** A classification or risk class of the device model.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-type](/valueset-device-type)

**Summary:** true


<a id="DeviceDefinition.classification.justification"></a>

## DeviceDefinition.classification.justification
Further information qualifying this classification of the device model

**Definition:** Further information qualifying this classification of the device model.

**Cardinality:** 0..*

**Type:** [RelatedArtifact](/RelatedArtifact)


<a id="DeviceDefinition.conformsTo"></a>

## DeviceDefinition.conformsTo
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device

**Definition:** 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.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Summary:** true


<a id="DeviceDefinition.conformsTo.category"></a>

## DeviceDefinition.conformsTo.category
Describes the common type of the standard, specification, or formal guidance

**Definition:** Describes the type of the standard, specification, or formal guidance.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-specification-category](/valueset-device-specification-category)

**Summary:** true


<a id="DeviceDefinition.conformsTo.specification"></a>

## DeviceDefinition.conformsTo.specification
Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type

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

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-specification-type](/valueset-device-specification-type)

**Summary:** true


<a id="DeviceDefinition.conformsTo.version"></a>

## DeviceDefinition.conformsTo.version
The specific form or variant of the standard, specification or formal guidance

**Definition:** 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.

**Cardinality:** 0..*

**Type:** [string](/string)

**Summary:** true


<a id="DeviceDefinition.conformsTo.source"></a>

## DeviceDefinition.conformsTo.source
Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

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

**Cardinality:** 0..*

**Type:** [RelatedArtifact](/RelatedArtifact)


<a id="DeviceDefinition.hasPart"></a>

## DeviceDefinition.hasPart
A device, part of the current one

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Summary:** true


<a id="DeviceDefinition.hasPart.definition[x]"></a>

## DeviceDefinition.hasPart.definition[x]
Reference to the part

**Definition:** The device that is part of the current device.

**Cardinality:** 1..1

**Type:** [canonical](/canonical), [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-type](/valueset-device-type)

**Summary:** true


<a id="DeviceDefinition.hasPart.count"></a>

## DeviceDefinition.hasPart.count
Number of occurrences of the part

**Definition:** Number of instances of the component device in the current device.

**Cardinality:** 0..1

**Type:** [integer](/integer)


<a id="DeviceDefinition.packaging"></a>

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

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.packaging.identifier"></a>

## DeviceDefinition.packaging.identifier
Business identifier of the packaged medication

**Definition:** The business identifier of the packaged medication.

**Cardinality:** 0..1

**Type:** [Identifier](/Identifier)


<a id="DeviceDefinition.packaging.type"></a>

## DeviceDefinition.packaging.type
A code that defines the specific type of packaging

**Definition:** A code that defines the specific type of packaging.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)


<a id="DeviceDefinition.packaging.count"></a>

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

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

**Cardinality:** 0..1

**Type:** [integer](/integer)


<a id="DeviceDefinition.packaging.distributor"></a>

## DeviceDefinition.packaging.distributor
An organization that distributes the packaged device

**Definition:** An organization that distributes the packaged device.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.packaging.distributor.name"></a>

## DeviceDefinition.packaging.distributor.name
Distributor's human-readable name

**Definition:** Distributor's human-readable name.

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="DeviceDefinition.packaging.distributor.organizationReference"></a>

## DeviceDefinition.packaging.distributor.organizationReference
Distributor as an Organization resource

**Definition:** Distributor as an Organization resource.

**Cardinality:** 0..*

**Type:** Reference([Organization](/Organization))


<a id="DeviceDefinition.packaging.udiDeviceIdentifier"></a>

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

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

**Cardinality:** 0..*


<a id="DeviceDefinition.packaging.packaging"></a>

## DeviceDefinition.packaging.packaging
Allows packages within packages

**Definition:** Allows packages within packages.

**Cardinality:** 0..*


<a id="DeviceDefinition.deviceVersion"></a>

## DeviceDefinition.deviceVersion
The version of the device or software

**Definition:** The version of the device or software.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.deviceVersion.type"></a>

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

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

**Aliases:** Σ

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)


<a id="DeviceDefinition.deviceVersion.component"></a>

## DeviceDefinition.deviceVersion.component
The hardware or software module of the device to which the version applies

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

**Comments:** 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.

**Cardinality:** 0..1

**Type:** [Identifier](/Identifier)

**Mappings:** w5=FiveWs.what[x]


<a id="DeviceDefinition.deviceVersion.value"></a>

## DeviceDefinition.deviceVersion.value
The version text

**Definition:** The version text.

**Cardinality:** 1..1

**Type:** [string](/string)


<a id="DeviceDefinition.safety"></a>

## DeviceDefinition.safety
Safety characteristics of the device

**Definition:** Safety characteristics of the device.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-safety](/valueset-device-safety)

**Summary:** true


<a id="DeviceDefinition.shelfLifeStorage"></a>

## DeviceDefinition.shelfLifeStorage
Shelf Life and storage information

**Definition:** Shelf Life and storage information.

**Cardinality:** 0..*

**Type:** [ProductShelfLife](/ProductShelfLife)


<a id="DeviceDefinition.outputLanguage"></a>

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

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

**Cardinality:** 0..*

**Type:** [code](/code)

**Binding:** required:[all-languages](/valueset-all-languages)


<a id="DeviceDefinition.property"></a>

## DeviceDefinition.property
Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

**Definition:** 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.

**Comments:** 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.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.property.type"></a>

## DeviceDefinition.property.type
Code that specifies the property being represented

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

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-property-type](/valueset-device-property-type)


<a id="DeviceDefinition.property.value[x]"></a>

## DeviceDefinition.property.value[x]
Value of the property

**Definition:** The value of the property specified by the associated property.type code.

**Comments:** 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.

**Cardinality:** 1..1

**Type:** [Quantity](/Quantity), [CodeableConcept](/CodeableConcept), [string](/string), [boolean](/boolean), [integer](/integer), [Range](/Range), [Attachment](/Attachment)


<a id="DeviceDefinition.link"></a>

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

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.link.relation"></a>

## DeviceDefinition.link.relation
The type indicates the relationship of the related device to the device instance

**Definition:** The type indicates the relationship of the related device to the device instance.

**Cardinality:** 1..1

**Type:** [Coding](/Coding)

**Binding:** extensible:[devicedefinition-relationtype](/valueset-devicedefinition-relationtype)


<a id="DeviceDefinition.link.relatedDevice[x]"></a>

## DeviceDefinition.link.relatedDevice[x]
A reference to the linked device

**Definition:** A reference to the linked device.

**Cardinality:** 1..1

**Type:** [canonical](/canonical), [CodeableConcept](/CodeableConcept)

**Binding:** example:[device-type](/valueset-device-type)


<a id="DeviceDefinition.note"></a>

## DeviceDefinition.note
Device notes and comments

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

**Cardinality:** 0..*

**Type:** [Annotation](/Annotation)

**Mappings:** rim=.text


<a id="DeviceDefinition.material"></a>

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

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

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.material.substance"></a>

## DeviceDefinition.material.substance
A relevant substance that the device contains, may contain, or is made of

**Definition:** 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.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[substance-code](/valueset-substance-code)


<a id="DeviceDefinition.material.alternate"></a>

## DeviceDefinition.material.alternate
Indicates an alternative material of the device

**Definition:** Indicates an alternative material of the device.

**Cardinality:** 0..1

**Type:** [boolean](/boolean)


<a id="DeviceDefinition.material.allergenicIndicator"></a>

## DeviceDefinition.material.allergenicIndicator
Whether the substance is a known or suspected allergen

**Definition:** Whether the substance is a known or suspected allergen.

**Cardinality:** 0..1

**Type:** [boolean](/boolean)


<a id="DeviceDefinition.productionIdentifierInUDI"></a>

## DeviceDefinition.productionIdentifierInUDI
lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version

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

**Comments:** 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.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** extensible:[device-productidentifierinudi](/valueset-device-productidentifierinudi)


<a id="DeviceDefinition.guideline"></a>

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

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

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

**Cardinality:** 0..1

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.guideline.useContext"></a>

## DeviceDefinition.guideline.useContext
The circumstances that form the setting for using the device

**Definition:** The circumstances that form the setting for using the device.

**Cardinality:** 0..*

**Type:** [UsageContext](/UsageContext)


<a id="DeviceDefinition.guideline.usageInstruction"></a>

## DeviceDefinition.guideline.usageInstruction
Detailed written and visual directions for the user on how to use the device

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

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="DeviceDefinition.guideline.relatedArtifact"></a>

## DeviceDefinition.guideline.relatedArtifact
A source of information or reference for this guideline

**Definition:** A source of information or reference for this guideline.

**Cardinality:** 0..*

**Type:** [RelatedArtifact](/RelatedArtifact)


<a id="DeviceDefinition.guideline.indication"></a>

## DeviceDefinition.guideline.indication
A clinical condition for which the device was designed to be used

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

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

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)


<a id="DeviceDefinition.guideline.contraindication"></a>

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

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

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

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)


<a id="DeviceDefinition.guideline.warning"></a>

## DeviceDefinition.guideline.warning
Specific hazard alert information that a user needs to know before using the device

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

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

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)


<a id="DeviceDefinition.guideline.intendedUse"></a>

## DeviceDefinition.guideline.intendedUse
A description of the general purpose or medical use of the device or its function

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

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="DeviceDefinition.correctiveAction"></a>

## DeviceDefinition.correctiveAction
Tracking of latest field safety corrective action

**Definition:** Tracking of latest field safety corrective action.

**Cardinality:** 0..1

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.correctiveAction.recall"></a>

## DeviceDefinition.correctiveAction.recall
Whether the corrective action was a recall

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

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

**Cardinality:** 1..1

**Type:** [boolean](/boolean)


<a id="DeviceDefinition.correctiveAction.scope"></a>

## DeviceDefinition.correctiveAction.scope
model | lot-numbers | serial-numbers

**Definition:** 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.

**Cardinality:** 0..1

**Type:** [code](/code)

**Binding:** required:[device-correctiveactionscope](/valueset-device-correctiveactionscope)


<a id="DeviceDefinition.correctiveAction.period"></a>

## DeviceDefinition.correctiveAction.period
Start and end dates of the  corrective action

**Definition:** Start and end dates of the  corrective action.

**Cardinality:** 1..1

**Type:** [Period](/Period)


<a id="DeviceDefinition.chargeItem"></a>

## DeviceDefinition.chargeItem
Billing code or reference associated with the device

**Definition:** Billing code or reference associated with the device.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="DeviceDefinition.chargeItem.chargeItemCode"></a>

## DeviceDefinition.chargeItem.chargeItemCode
The code or reference for the charge item

**Definition:** The code or reference for the charge item.

**Cardinality:** 1..1

**Type:** [CodeableReference](/CodeableReference)

**Binding:** example:[service-uscls](/valueset-service-uscls)


<a id="DeviceDefinition.chargeItem.count"></a>

## DeviceDefinition.chargeItem.count
Coefficient applicable to the billing code

**Definition:** Coefficient applicable to the billing code.

**Cardinality:** 1..1

**Type:** [Quantity](/Quantity)


<a id="DeviceDefinition.chargeItem.effectivePeriod"></a>

## DeviceDefinition.chargeItem.effectivePeriod
A specific time period in which this charge item applies

**Definition:** A specific time period in which this charge item applies.

**Cardinality:** 0..1

**Type:** [Period](/Period)


<a id="DeviceDefinition.chargeItem.useContext"></a>

## DeviceDefinition.chargeItem.useContext
The context to which this charge item applies

**Definition:** The context to which this charge item applies.

**Cardinality:** 0..*

**Type:** [UsageContext](/UsageContext)