R6 Ballot (3rd Draft)

This page is part of the FHIR Specification v6.0.0-ballot3: Release 6 Ballot (3rd Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

8.18 Resource DeviceDefinition - Content

Orders and Observations icon Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: No defined compartments

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.

8.18.1 Scope and Usage

Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health, as well as devices such as a machine, cellphone, computer, software, application, etc. The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn.

Devices can also be subdivided into the following categories:

'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. MDR (EU) 2017/745 icon

Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.

This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.

To support the use and evaluate the reliability of the patient data, it is important to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.

Equipment and supplies that provide therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.

Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.

A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility (although that does not preclude such devices being used in a professional healthcare facility).

  • A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
  • A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health. 21CFR Part 860.3 icon Accessed 12 May 2022

'Implantable device' means any device, including those that are partially or wholly absorbed by the body, which is intended:

  • to be totally introduced into the human body, or
  • to replace an epithelial surface or the surface of the eye,

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; MDR (EU) 2017/745 icon Accessed 12 May 2022

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. iconUS Food and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics icon and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics icon Accessed 12 May 2022

Patient-use (also known as personal health device), or home use devices, intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes US Food and Drug Administration Center for Devices and Radiological Health. Home Use Devices. icon Accessed 13 March 2020. PHDs are the subset of patient-use devices that report their information to a peer via a protocol.

One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.

PHDs include the popular fitness trackers often combined with heart rate monitors, but also blood pressure monitors, weight scales, pulse oximeters, thermometers, and, for those that require them, glucose meters. Over time more sophisticated devices such as continuous glucose monitors, insulin pumps, vital signs monitors including ECGs, and even spirometers are entering the PHD consumer market. These devices communicate measurement data and data about themselves via a digital transport protocol to some peer entity, often a mobile phone or tablet. The protocol may follow a standard but most protocols are proprietary. In either case, it is common practice for manufacturers to provide free applications that run on these mobile platforms for the purpose of communicating with their devices.

The fields populated in the Device resource by PHDs, typically via a gateway, is the information a PHD reports about itself electronically. There is no input by the patient except for information the patient may enter on the device through some UI. This device reporting capability distinguishes communicating PHDs from the general set of patient-use devices.

Point-of-care medical devices (PoCD) are intended for use by qualified professionals. PoCDs are typically found at the patient's bedside and convey measurements and supporting data to receiving systems for use in electronic medical records, clinical decision support, and medical data archiving for aggregate quality measurement and research purposes.

PoCDs are of another level of complexity compared to PHDs: they include devices like multi-parameter physiological patient monitors, anesthesia workstations, infusion pumps and numerous other kinds of devices that provide near-real-time information about patient condition or therapy, potentially including dozens or hundreds of variables coming from a single device system. They may be structurally complex, involving multiple subsystems that are themselves complex, such as a ventilator or gas analyzer functioning within an anesthesia workstation, or pluggable modules in a patient monitor controlling invasive blood pressure or gathering EEG data.

Information systems using such data need to be able to understand the structure and dynamic state of the devices originating them. This requires more than a single Device resource - a hierarchy of Device resources is constructed carrying data about the top-level containing device (for example a monitor), and a hierarchy of contained Device resources representing subsystems (in the monitor, builtin and attached modular measurement capabilities), channels, and DeviceMetric resources representing individual measurements or computations.

A device that is intended to be used on one individual during a single procedure; MDR (EU) 2017/745 icon Accessed 12 May 2022

Reusable medical devices are devices that health care providers can reuse to diagnose and treat one or multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and laryngoscopes. US Food and Drug Administration Center for Devices and Radiological Health Reusable Medical Devices icon

The Device resource can represent an instance of a software component or application. A software item like a data transformer or converter, or a clinical support algorithm, may be an independently deployed, managed and configured entity that contributes to patient care and needs to be documented just a surely as, say, a physical cardiac monitor. The FHIR Device resource can contain instance data such as version information and operational attributes. It can also represent the relationship of the software item to other device and information system components through reference linkages. This category includes software regardless of whether or not is regulated. Device resource instances documenting software items are important to traceability of data and analyzing adverse events, and so have important patient safety roles.

8.18.2 Boundaries and Relationships

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).

The DeviceDefinition may vary by jurisdiction and the product may be considered a medication or biologically derived product.

Device vs deviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location, operational status which the DeviceDefinition resource does not have.

8.18.3 References to this Resource

8.18.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TU DomainResource The definition of a kind of device or device component

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: CanonicalResource
... url ΣC 0..1 uri Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic
... identifier Σ 0..* Identifier Additional identifier for the DeviceDefinition

... version Σ 0..1 string Business version of the DeviceDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: Version Algorithm (Extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name Σ 0..1 string Name for this DeviceDefinition (computer friendly)
... title Σ 0..1 string Name for this DeviceDefinition (human friendly)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... experimental Σ 0..1 boolean For testing only - never for real usage
... partNumber 0..1 string The part number or catalog number of the device
... manufacturer Σ 0..1 Reference(Organization) Name of device manufacturer
... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... date Σ 0..1 dateTime Date last changed
... contact Σ 0..* ContactDetail Contact details for the publisher

... publisher Σ 0..1 string The name of the organization responsible for publishing the definition
... useContext Σ 0..* UsageContext The context that the content is intended to support

... jurisdiction ΣXD 0..* CodeableConcept Intended jurisdiction for DeviceDefinition (if applicable)
Binding: Jurisdiction ValueSet (Extensible)

... purpose 0..1 markdown Why this DeviceDefinition is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel T 0..1 string Copyright holder and year(s)
... udiDeviceIdentifier 0..* BackboneElement Unique Device Identifier (UDI) Barcode string

.... deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1 uri The organization that assigns the identifier algorithm
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
.... marketDistribution 0..* BackboneElement Indicates whether and when the device is available on the market

..... marketPeriod 1..1 Period Begin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1 uri National state or territory where the device is commercialized
... regulatoryIdentifier 0..* BackboneElement Regulatory identifier(s) associated with this device

.... type 1..1 code basic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... deviceIdentifier 1..1 string The identifier itself
.... issuer 1..1 uri The organization that issued this identifier
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
... deviceName Σ 0..* BackboneElement The name or names of the device as given by the manufacturer

.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Extensible)
... classification Σ 0..* BackboneElement What kind of device or device system this is

.... type Σ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (Example)
.... justification 0..* RelatedArtifact Further information qualifying this classification of the device model

... conformsTo Σ 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device

.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (Example)
.... version Σ 0..* string The specific form or variant of the standard, specification or formal guidance

.... source 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

... hasPart Σ 0..* BackboneElement A device, part of the current one

.... reference Σ 1..1 Reference(DeviceDefinition) Reference to the part
.... count 0..1 integer Number of occurrences of the part
... packaging 0..* BackboneElement Information about the packaging of the device, i.e. how the device is packaged

.... identifier 0..1 Identifier Business identifier of the packaged medication
.... type 0..1 CodeableConcept A code that defines the specific type of packaging
.... count 0..1 integer The number of items contained in the package (devices or sub-packages)
.... distributor 0..* BackboneElement An organization that distributes the packaged device

..... name 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource

.... udiDeviceIdentifier 0..* see udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..* see packaging Allows packages within packages

... deviceVersion 0..* BackboneElement The version of the device or software

.... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... value 1..1 string The version text
... safety Σ 0..* CodeableConcept Safety characteristics of the device
Binding: Device Safety (Example)

... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information

... outputLanguage 0..* code Language code for the human-readable text strings produced by the device (all supported)
Binding: All Languages (Required)
Additional BindingsPurpose
Common Languages Starter


... property 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment
... link 0..* BackboneElement An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device

.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... relatedDevice 1..1 CodeableReference(DeviceDefinition) A reference to the linked device
... note 0..* Annotation Device notes and comments

... material 0..* BackboneElement A substance used to create the material(s) of which the device is made

.... substance 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of
Binding: Substance Code (Example)
.... alternate 0..1 boolean Indicates an alternative material of the device
.... allergenicIndicator 0..1 boolean Whether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Extensible)

... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... useContext 0..* UsageContext The circumstances that form the setting for using the device

.... usageInstruction 0..1 markdown Detailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..* RelatedArtifact A source of information or reference for this guideline

.... indication 0..* CodeableConcept A clinical condition for which the device was designed to be used

.... contraindication 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm

.... warning 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device

.... intendedUse 0..1 string A description of the general purpose or medical use of the device or its function
... correctiveAction 0..1 BackboneElement Tracking of latest field safety corrective action
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device

.... chargeItemCode 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item
.... count 1..1 Quantity Coefficient applicable to the billing code
.... effectivePeriod 0..1 Period A specific time period in which this charge item applies
.... useContext 0..* UsageContext The context to which this charge item applies


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceDefinition (DomainResource) +CanonicalResourceAn 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 serversurl : uri [0..1]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 instanceidentifier : Identifier [0..*]The identifier that is used to identify this version of the DeviceDefinition when it is referenced in a specificationversion : string [0..1]Indicates the mechanism used to compare versions to determine which is more currentversionAlgorithm[x] : DataType [0..1] « string|Coding; null (Strength=Extensible) VersionAlgorithm+ »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 generationname : string [0..1]A short, descriptive, user-friendly title for the DeviceDefinitiontitle : string [0..1]The current state of this DeviceDefinition (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »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 usageexperimental : boolean [0..1]The part number or catalog number of the devicepartNumber : string [0..1]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 jurisdictionmanufacturer : Reference [0..1] « Organization »The model number for the device for example as defined by the manufacturer or labeler, or other agencymodelNumber : string [0..1]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 changesdate : dateTime [0..1]Contact details for an organization or a particular human that is responsible for the devicecontact : ContactDetail [0..*]The name of the organization or individual responsible for the release and ongoing maintenance of the device definitionpublisher : string [0..1]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 DeviceDefinitionsuseContext : UsageContext [0..*]A legal or geographic region in which the DeviceDefinition is intended to be usedjurisdiction : CodeableConcept [0..*] « null (Strength=Extensible)JurisdictionValueSet+ »Explanation of why this DeviceDefinition is needed and why it has been designed as it haspurpose : markdown [0..1]A copyright statement relating to the DeviceDefinition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the DeviceDefinitioncopyright : markdown [0..1]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')copyrightLabel : string [0..1]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)DeviceSafety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Language code for the human-readable text strings produced by the device (all supported)outputLanguage : code [0..*] « null (Strength=Required)AllLanguages! »Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device labelproductionIdentifierInUDI : CodeableConcept [0..*] « null (Strength=Extensible) DeviceProductionIdentifierInU...+ »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifierdeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]UdiDeviceIdentifierMarketDistributionBegin and end dates for the commercial distribution of the devicemarketPeriod : Period [1..1]National state or territory to which the marketDistribution recers, typically where the device is commercializedsubJurisdiction : uri [1..1]RegulatoryIdentifierThe type of identifier itselftype : code [1..1] « null (Strength=Required)DeviceDefinitionRegulatoryIde...! »The identifier itselfdeviceIdentifier : string [1..1]The organization that issued this identifierissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]DeviceNameA 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 othername : string [1..1]The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedNametype : CodeableConcept [1..1] « null (Strength=Extensible)DeviceNameType+ »ClassificationA classification or risk class of the device modeltype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »Further information qualifying this classification of the device modeljustification : RelatedArtifact [0..*]ConformsToDescribes the type of the standard, specification, or formal guidancecategory : CodeableConcept [0..1] « null (Strength=Example)DeviceSpecificationCategory?? »Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheresspecification : CodeableConcept [1..1] « null (Strength=Example)DeviceSpecificationType?? »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 labelversion : string [0..*]Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformancesource : RelatedArtifact [0..*]HasPartReference to the device that is part of the current devicereference : Reference [1..1] « DeviceDefinition »Number of instances of the component device in the current devicecount : integer [0..1]PackagingThe business identifier of the packaged medicationidentifier : Identifier [0..1]A code that defines the specific type of packagingtype : CodeableConcept [0..1]The number of items contained in the package (devices or sub-packages)count : integer [0..1]PackagingDistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « Organization »DeviceVersionThe type of the device version, e.g. manufacturer, approved, internaltype : CodeableConcept [0..1]The hardware or software module of the device to which the version appliescomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property such as a resolution or color being representedtype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »The value of the property specified by the associated property.type codevalue[x] : DataType [1..1] « Quantity|CodeableConcept|string|boolean| integer|Range|Attachment »LinkThe type indicates the relationship of the related device to the device instancerelation : Coding [1..1] « null (Strength=Extensible)DeviceDefinitionRelationType+ »A reference to the linked devicerelatedDevice : CodeableReference [1..1] « DeviceDefinition »MaterialA 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 materialssubstance : CodeableConcept [1..1] « null (Strength=Example)SubstanceCode?? »Indicates an alternative material of the devicealternate : boolean [0..1]Whether the substance is a known or suspected allergenallergenicIndicator : boolean [0..1]GuidelineThe circumstances that form the setting for using the deviceuseContext : UsageContext [0..*]Detailed written and visual directions for the user on how to use the deviceusageInstruction : markdown [0..1]A source of information or reference for this guidelinerelatedArtifact : RelatedArtifact [0..*]A clinical condition for which the device was designed to be usedindication : CodeableConcept [0..*]A specific situation when a device should not be used because it may cause harmcontraindication : CodeableConcept [0..*]Specific hazard alert information that a user needs to know before using the devicewarning : CodeableConcept [0..*]A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]CorrectiveActionWhether the last corrective action known for this device was a recallrecall : boolean [1..1]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 namescope : code [0..1] « null (Strength=Required)DeviceCorrectiveActionScope! »Start and end dates of the corrective actionperiod : Period [1..1]ChargeItemThe code or reference for the charge itemchargeItemCode : CodeableReference [1..1] « ChargeItemDefinition »Coefficient applicable to the billing codecount : Quantity [1..1]A specific time period in which this charge item applieseffectivePeriod : Period [0..1]The context to which this charge item appliesuseContext : UsageContext [0..*]Indicates where and when the device is available on the marketmarketDistribution[0..*]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 soldudiDeviceIdentifier[0..*]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 EuroperegulatoryIdentifier[0..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]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 standardsconformsTo[0..*]A device that is part (for example a component) of the present devicehasPart[0..*]An organization that distributes the packaged devicedistributor[0..*]Unique Device Identifier (UDI) Barcode string on the packagingudiDeviceIdentifier[0..*]Allows packages within packagespackaging[0..*]Information about the packaging of the device, i.e. how the device is packagedpackaging[0..*]The version of the device or softwaredeviceVersion[0..*]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 attributesproperty[0..*]An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal devicelink[0..*]Information aimed at providing directions for the usage of this model of deviceguideline[0..1]Tracking of latest field safety corrective actioncorrectiveAction[0..1]Billing code or reference associated with the devicechargeItem[0..*]

XML Template

<DeviceDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) -->
 <identifier><!-- 0..* Identifier Additional identifier for the DeviceDefinition --></identifier>
 <version value="[string]"/><!-- 0..1 Business version of the DeviceDefinition -->
 <versionAlgorithm[x]><!-- 0..1 string|Coding How to compare versions --></versionAlgorithm[x]>
 <name value="[string]"/><!-- 0..1 Name for this DeviceDefinition (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this DeviceDefinition (human friendly) -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown  -->
 <experimental value="[boolean]"/><!-- 0..1 For testing only - never for real usage -->
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <date value="[dateTime]"/><!-- 0..1 Date last changed -->
 <contact><!-- 0..* ContactDetail Contact details for the publisher --></contact>
 <publisher value="[string]"/><!-- 0..1 The name of the organization responsible for publishing the definition -->
 <useContext><!-- 0..* UsageContext The context that the content is intended to support --></useContext>
 <jurisdiction><!-- 0..* CodeableConcept Intended jurisdiction for DeviceDefinition (if applicable) --></jurisdiction>
 <purpose value="[markdown]"/><!-- 0..1 Why this DeviceDefinition is defined -->
 <copyright value="[markdown]"/><!-- 0..1 Use and/or publishing restrictions -->
 <copyrightLabel value="[string]"/><!-- 0..1 Copyright holder and year(s) -->
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier -->
  <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance -->
  <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <outputLanguage value="[code]"/><!-- 0..* Language code for the human-readable text strings produced by the device (all supported) -->
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device -->
  <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

JSON Template

{doco
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
  "identifier" : [{ Identifier }], // Additional identifier for the DeviceDefinition
  "version" : "<string>", // Business version of the DeviceDefinition
  // versionAlgorithm[x]: How to compare versions. One of these 2:
  "versionAlgorithmString" : "<string>",
  "versionAlgorithmCoding" : { Coding },
  "name" : "<string>", // Name for this DeviceDefinition (computer friendly)
  "title" : "<string>", // Name for this DeviceDefinition (human friendly)
  "status" : "<code>", // R!  draft | active | retired | unknown 
  "experimental" : <boolean>, // For testing only - never for real usage
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "date" : "<dateTime>", // Date last changed
  "contact" : [{ ContactDetail }], // Contact details for the publisher
  "publisher" : "<string>", // The name of the organization responsible for publishing the definition
  "useContext" : [{ UsageContext }], // The context that the content is intended to support
  "jurisdiction" : [{ CodeableConcept }], // Intended jurisdiction for DeviceDefinition (if applicable)
  "purpose" : "<markdown>", // Why this DeviceDefinition is defined
  "copyright" : "<markdown>", // Use and/or publishing restrictions
  "copyrightLabel" : "<string>", // Copyright holder and year(s)
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "outputLanguage" : ["<code>"], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:url [ uri ] ; # 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Additional identifier for the DeviceDefinition
  fhir:version [ string ] ; # 0..1 Business version of the DeviceDefinition
  # versionAlgorithm[x] : 0..1 How to compare versions. One of these 2
    fhir:versionAlgorithm [  a fhir:string ; string ]
    fhir:versionAlgorithm [  a fhir:Coding ; Coding ]
  fhir:name [ string ] ; # 0..1 Name for this DeviceDefinition (computer friendly)
  fhir:title [ string ] ; # 0..1 Name for this DeviceDefinition (human friendly)
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown 
  fhir:experimental [ boolean ] ; # 0..1 For testing only - never for real usage
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:date [ dateTime ] ; # 0..1 Date last changed
  fhir:contact  ( [ ContactDetail ] ... ) ; # 0..* Contact details for the publisher
  fhir:publisher [ string ] ; # 0..1 The name of the organization responsible for publishing the definition
  fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context that the content is intended to support
  fhir:jurisdiction  ( [ CodeableConcept ] ... ) ; # 0..* Intended jurisdiction for DeviceDefinition (if applicable)
  fhir:purpose [ markdown ] ; # 0..1 Why this DeviceDefinition is defined
  fhir:copyright [ markdown ] ; # 0..1 Use and/or publishing restrictions
  fhir:copyrightLabel [ string ] ; # 0..1 Copyright holder and year(s)
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:outputLanguage  ( [ code ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

DeviceDefinition
DeviceDefinition.version
  • Max Cardinality changed from * to 1
DeviceDefinition.versionAlgorithm[x]
  • Added Element
DeviceDefinition.name
  • Added Element
DeviceDefinition.title
  • Added Element
DeviceDefinition.status
  • Added Mandatory Element
DeviceDefinition.experimental
  • Added Element
DeviceDefinition.partNumber
  • Added Element
DeviceDefinition.manufacturer
  • Renamed from manufacturer[x] to manufacturer
  • Remove Type string
DeviceDefinition.date
  • Added Element
DeviceDefinition.contact
  • Type changed from ContactPoint to ContactDetail
DeviceDefinition.publisher
  • Added Element
DeviceDefinition.useContext
  • Added Element
DeviceDefinition.jurisdiction
  • Added Element
DeviceDefinition.purpose
  • Added Element
DeviceDefinition.copyright
  • Added Element
DeviceDefinition.copyrightLabel
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  • Added Mandatory Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier
  • Added Element
DeviceDefinition.regulatoryIdentifier.type
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.deviceName.type
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Moved from DeviceDefinition to DeviceDefinition.classification
  • Min Cardinality changed from 0 to 1
DeviceDefinition.classification.justification
  • Added Element
DeviceDefinition.conformsTo
  • Renamed from specialization to conformsTo
DeviceDefinition.conformsTo.category
  • Added Element
DeviceDefinition.conformsTo.specification
  • Added Mandatory Element
DeviceDefinition.conformsTo.version
  • Moved from DeviceDefinition.specialization to DeviceDefinition.conformsTo
  • Max Cardinality changed from 1 to *
DeviceDefinition.conformsTo.source
  • Added Element
DeviceDefinition.hasPart
  • Added Element
DeviceDefinition.hasPart.reference
  • Added Mandatory Element
DeviceDefinition.hasPart.count
  • Added Element
DeviceDefinition.packaging
  • Added Element
DeviceDefinition.packaging.identifier
  • Added Element
DeviceDefinition.packaging.type
  • Added Element
DeviceDefinition.packaging.count
  • Added Element
DeviceDefinition.packaging.distributor
  • Added Element
DeviceDefinition.packaging.distributor.name
  • Added Element
DeviceDefinition.packaging.distributor.organizationReference
  • Added Element
DeviceDefinition.packaging.udiDeviceIdentifier
  • Added Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.deviceVersion
  • Added Element
DeviceDefinition.deviceVersion.type
  • Added Element
DeviceDefinition.deviceVersion.component
  • Added Element
DeviceDefinition.deviceVersion.value
  • Added Mandatory Element
DeviceDefinition.outputLanguage
  • Added Element
DeviceDefinition.property.value[x]
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.productionIdentifierInUDI
  • Added Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Moved from DeviceDefinition.onlineInformation to relatedArtifact
  • Max Cardinality changed from 1 to *
  • Type changed from uri to RelatedArtifact
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added Element
DeviceDefinition.correctiveAction
  • Added Element
DeviceDefinition.correctiveAction.recall
  • Added Mandatory Element
DeviceDefinition.correctiveAction.scope
  • Added Element
DeviceDefinition.correctiveAction.period
  • Added Mandatory Element
DeviceDefinition.chargeItem
  • Added Element
DeviceDefinition.chargeItem.chargeItemCode
  • Added Mandatory Element
DeviceDefinition.chargeItem.count
  • Added Mandatory Element
DeviceDefinition.chargeItem.effectivePeriod
  • Added Element
DeviceDefinition.chargeItem.useContext
  • Added Element
DeviceDefinition.specialization.systemType
  • Deleted
DeviceDefinition.physicalCharacteristics
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.languageCode
  • Deleted
DeviceDefinition.capability
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.property.valueQuantity
  • Deleted
DeviceDefinition.property.valueCode
  • Deleted
DeviceDefinition.owner
  • Deleted
DeviceDefinition.quantity
  • Deleted (-> DeviceDefinition.packaging.count or DeviceDefinition.hasPart.count)
DeviceDefinition.parentDevice
  • Deleted (Removed - to establish relations, use hasPArt)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition TU DomainResource The definition of a kind of device or device component

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
Interfaces Implemented: CanonicalResource
... url ΣC 0..1 uri Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
+ Warning: URL should not contain | or # - these characters make processing canonical references problematic
... identifier Σ 0..* Identifier Additional identifier for the DeviceDefinition

... version Σ 0..1 string Business version of the DeviceDefinition
... versionAlgorithm[x] Σ 0..1 How to compare versions
Binding: Version Algorithm (Extensible)
.... versionAlgorithmString string
.... versionAlgorithmCoding Coding
... name Σ 0..1 string Name for this DeviceDefinition (computer friendly)
... title Σ 0..1 string Name for this DeviceDefinition (human friendly)
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... experimental Σ 0..1 boolean For testing only - never for real usage
... partNumber 0..1 string The part number or catalog number of the device
... manufacturer Σ 0..1 Reference(Organization) Name of device manufacturer
... modelNumber Σ 0..1 string The catalog or model number for the device for example as defined by the manufacturer
... date Σ 0..1 dateTime Date last changed
... contact Σ 0..* ContactDetail Contact details for the publisher

... publisher Σ 0..1 string The name of the organization responsible for publishing the definition
... useContext Σ 0..* UsageContext The context that the content is intended to support

... jurisdiction ΣXD 0..* CodeableConcept Intended jurisdiction for DeviceDefinition (if applicable)
Binding: Jurisdiction ValueSet (Extensible)

... purpose 0..1 markdown Why this DeviceDefinition is defined
... copyright 0..1 markdown Use and/or publishing restrictions
... copyrightLabel T 0..1 string Copyright holder and year(s)
... udiDeviceIdentifier 0..* BackboneElement Unique Device Identifier (UDI) Barcode string

.... deviceIdentifier 1..1 string The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
.... issuer 1..1 uri The organization that assigns the identifier algorithm
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
.... marketDistribution 0..* BackboneElement Indicates whether and when the device is available on the market

..... marketPeriod 1..1 Period Begin and end dates for the commercial distribution of the device
..... subJurisdiction 1..1 uri National state or territory where the device is commercialized
... regulatoryIdentifier 0..* BackboneElement Regulatory identifier(s) associated with this device

.... type 1..1 code basic | master | license
Binding: Device Definition Regulatory Identifier Type (Required)
.... deviceIdentifier 1..1 string The identifier itself
.... issuer 1..1 uri The organization that issued this identifier
.... jurisdiction 1..1 uri The jurisdiction to which the deviceIdentifier applies
... deviceName Σ 0..* BackboneElement The name or names of the device as given by the manufacturer

.... name Σ 1..1 string A name that is used to refer to the device
.... type Σ 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name
Binding: Device Name Type (Extensible)
... classification Σ 0..* BackboneElement What kind of device or device system this is

.... type Σ 1..1 CodeableConcept A classification or risk class of the device model
Binding: Device Type (Example)
.... justification 0..* RelatedArtifact Further information qualifying this classification of the device model

... conformsTo Σ 0..* BackboneElement Identifies the standards, specifications, or formal guidances for the capabilities supported by the device

.... category Σ 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance
Binding: Device Specification Category (Example)
.... specification Σ 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Binding: Device Specification Type (Example)
.... version Σ 0..* string The specific form or variant of the standard, specification or formal guidance

.... source 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance

... hasPart Σ 0..* BackboneElement A device, part of the current one

.... reference Σ 1..1 Reference(DeviceDefinition) Reference to the part
.... count 0..1 integer Number of occurrences of the part
... packaging 0..* BackboneElement Information about the packaging of the device, i.e. how the device is packaged

.... identifier 0..1 Identifier Business identifier of the packaged medication
.... type 0..1 CodeableConcept A code that defines the specific type of packaging
.... count 0..1 integer The number of items contained in the package (devices or sub-packages)
.... distributor 0..* BackboneElement An organization that distributes the packaged device

..... name 0..1 string Distributor's human-readable name
..... organizationReference 0..* Reference(Organization) Distributor as an Organization resource

.... udiDeviceIdentifier 0..* see udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging

.... packaging 0..* see packaging Allows packages within packages

... deviceVersion 0..* BackboneElement The version of the device or software

.... type 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal
.... component 0..1 Identifier The hardware or software module of the device to which the version applies
.... value 1..1 string The version text
... safety Σ 0..* CodeableConcept Safety characteristics of the device
Binding: Device Safety (Example)

... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information

... outputLanguage 0..* code Language code for the human-readable text strings produced by the device (all supported)
Binding: All Languages (Required)
Additional BindingsPurpose
Common Languages Starter


... property 0..* BackboneElement Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc

.... type 1..1 CodeableConcept Code that specifies the property being represented
Binding: Device Property Type (Example)
.... value[x] 1..1 Value of the property
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueAttachment Attachment
... link 0..* BackboneElement An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device

.... relation 1..1 Coding The type indicates the relationship of the related device to the device instance
Binding: Device Definition Relation Type (Extensible)
.... relatedDevice 1..1 CodeableReference(DeviceDefinition) A reference to the linked device
... note 0..* Annotation Device notes and comments

... material 0..* BackboneElement A substance used to create the material(s) of which the device is made

.... substance 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of
Binding: Substance Code (Example)
.... alternate 0..1 boolean Indicates an alternative material of the device
.... allergenicIndicator 0..1 boolean Whether the substance is a known or suspected allergen
... productionIdentifierInUDI 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Binding: Device Production Identifier In UDI (Extensible)

... guideline 0..1 BackboneElement Information aimed at providing directions for the usage of this model of device
.... useContext 0..* UsageContext The circumstances that form the setting for using the device

.... usageInstruction 0..1 markdown Detailed written and visual directions for the user on how to use the device
.... relatedArtifact 0..* RelatedArtifact A source of information or reference for this guideline

.... indication 0..* CodeableConcept A clinical condition for which the device was designed to be used

.... contraindication 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm

.... warning 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device

.... intendedUse 0..1 string A description of the general purpose or medical use of the device or its function
... correctiveAction 0..1 BackboneElement Tracking of latest field safety corrective action
.... recall 1..1 boolean Whether the corrective action was a recall
.... scope 0..1 code model | lot-numbers | serial-numbers
Binding: Device Corrective Action Scope (Required)
.... period 1..1 Period Start and end dates of the corrective action
... chargeItem 0..* BackboneElement Billing code or reference associated with the device

.... chargeItemCode 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item
.... count 1..1 Quantity Coefficient applicable to the billing code
.... effectivePeriod 0..1 Period A specific time period in which this charge item applies
.... useContext 0..* UsageContext The context to which this charge item applies


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

DeviceDefinition (DomainResource) +CanonicalResourceAn 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 serversurl : uri [0..1]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 instanceidentifier : Identifier [0..*]The identifier that is used to identify this version of the DeviceDefinition when it is referenced in a specificationversion : string [0..1]Indicates the mechanism used to compare versions to determine which is more currentversionAlgorithm[x] : DataType [0..1] « string|Coding; null (Strength=Extensible) VersionAlgorithm+ »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 generationname : string [0..1]A short, descriptive, user-friendly title for the DeviceDefinitiontitle : string [0..1]The current state of this DeviceDefinition (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »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 usageexperimental : boolean [0..1]The part number or catalog number of the devicepartNumber : string [0..1]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 jurisdictionmanufacturer : Reference [0..1] « Organization »The model number for the device for example as defined by the manufacturer or labeler, or other agencymodelNumber : string [0..1]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 changesdate : dateTime [0..1]Contact details for an organization or a particular human that is responsible for the devicecontact : ContactDetail [0..*]The name of the organization or individual responsible for the release and ongoing maintenance of the device definitionpublisher : string [0..1]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 DeviceDefinitionsuseContext : UsageContext [0..*]A legal or geographic region in which the DeviceDefinition is intended to be usedjurisdiction : CodeableConcept [0..*] « null (Strength=Extensible)JurisdictionValueSet+ »Explanation of why this DeviceDefinition is needed and why it has been designed as it haspurpose : markdown [0..1]A copyright statement relating to the DeviceDefinition and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the DeviceDefinitioncopyright : markdown [0..1]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')copyrightLabel : string [0..1]Safety characteristics of the devicesafety : CodeableConcept [0..*] « null (Strength=Example)DeviceSafety?? »Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Language code for the human-readable text strings produced by the device (all supported)outputLanguage : code [0..*] « null (Strength=Required)AllLanguages! »Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device labelproductionIdentifierInUDI : CodeableConcept [0..*] « null (Strength=Extensible) DeviceProductionIdentifierInU...+ »UdiDeviceIdentifierThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifierdeviceIdentifier : string [1..1]The organization that assigns the identifier algorithmissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]UdiDeviceIdentifierMarketDistributionBegin and end dates for the commercial distribution of the devicemarketPeriod : Period [1..1]National state or territory to which the marketDistribution recers, typically where the device is commercializedsubJurisdiction : uri [1..1]RegulatoryIdentifierThe type of identifier itselftype : code [1..1] « null (Strength=Required)DeviceDefinitionRegulatoryIde...! »The identifier itselfdeviceIdentifier : string [1..1]The organization that issued this identifierissuer : uri [1..1]The jurisdiction to which the deviceIdentifier appliesjurisdiction : uri [1..1]DeviceNameA 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 othername : string [1..1]The type of deviceName. RegisteredName | UserFriendlyName | PatientReportedNametype : CodeableConcept [1..1] « null (Strength=Extensible)DeviceNameType+ »ClassificationA classification or risk class of the device modeltype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »Further information qualifying this classification of the device modeljustification : RelatedArtifact [0..*]ConformsToDescribes the type of the standard, specification, or formal guidancecategory : CodeableConcept [0..1] « null (Strength=Example)DeviceSpecificationCategory?? »Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheresspecification : CodeableConcept [1..1] « null (Strength=Example)DeviceSpecificationType?? »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 labelversion : string [0..*]Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformancesource : RelatedArtifact [0..*]HasPartReference to the device that is part of the current devicereference : Reference [1..1] « DeviceDefinition »Number of instances of the component device in the current devicecount : integer [0..1]PackagingThe business identifier of the packaged medicationidentifier : Identifier [0..1]A code that defines the specific type of packagingtype : CodeableConcept [0..1]The number of items contained in the package (devices or sub-packages)count : integer [0..1]PackagingDistributorDistributor's human-readable namename : string [0..1]Distributor as an Organization resourceorganizationReference : Reference [0..*] « Organization »DeviceVersionThe type of the device version, e.g. manufacturer, approved, internaltype : CodeableConcept [0..1]The hardware or software module of the device to which the version appliescomponent : Identifier [0..1]The version textvalue : string [1..1]PropertyCode that specifies the property such as a resolution or color being representedtype : CodeableConcept [1..1] « null (Strength=Example)DeviceType?? »The value of the property specified by the associated property.type codevalue[x] : DataType [1..1] « Quantity|CodeableConcept|string|boolean| integer|Range|Attachment »LinkThe type indicates the relationship of the related device to the device instancerelation : Coding [1..1] « null (Strength=Extensible)DeviceDefinitionRelationType+ »A reference to the linked devicerelatedDevice : CodeableReference [1..1] « DeviceDefinition »MaterialA 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 materialssubstance : CodeableConcept [1..1] « null (Strength=Example)SubstanceCode?? »Indicates an alternative material of the devicealternate : boolean [0..1]Whether the substance is a known or suspected allergenallergenicIndicator : boolean [0..1]GuidelineThe circumstances that form the setting for using the deviceuseContext : UsageContext [0..*]Detailed written and visual directions for the user on how to use the deviceusageInstruction : markdown [0..1]A source of information or reference for this guidelinerelatedArtifact : RelatedArtifact [0..*]A clinical condition for which the device was designed to be usedindication : CodeableConcept [0..*]A specific situation when a device should not be used because it may cause harmcontraindication : CodeableConcept [0..*]Specific hazard alert information that a user needs to know before using the devicewarning : CodeableConcept [0..*]A description of the general purpose or medical use of the device or its functionintendedUse : string [0..1]CorrectiveActionWhether the last corrective action known for this device was a recallrecall : boolean [1..1]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 namescope : code [0..1] « null (Strength=Required)DeviceCorrectiveActionScope! »Start and end dates of the corrective actionperiod : Period [1..1]ChargeItemThe code or reference for the charge itemchargeItemCode : CodeableReference [1..1] « ChargeItemDefinition »Coefficient applicable to the billing codecount : Quantity [1..1]A specific time period in which this charge item applieseffectivePeriod : Period [0..1]The context to which this charge item appliesuseContext : UsageContext [0..*]Indicates where and when the device is available on the marketmarketDistribution[0..*]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 soldudiDeviceIdentifier[0..*]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 EuroperegulatoryIdentifier[0..*]The name or names of the device as given by the manufacturerdeviceName[0..*]What kind of device or device system this isclassification[0..*]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 standardsconformsTo[0..*]A device that is part (for example a component) of the present devicehasPart[0..*]An organization that distributes the packaged devicedistributor[0..*]Unique Device Identifier (UDI) Barcode string on the packagingudiDeviceIdentifier[0..*]Allows packages within packagespackaging[0..*]Information about the packaging of the device, i.e. how the device is packagedpackaging[0..*]The version of the device or softwaredeviceVersion[0..*]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 attributesproperty[0..*]An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal devicelink[0..*]Information aimed at providing directions for the usage of this model of deviceguideline[0..1]Tracking of latest field safety corrective actioncorrectiveAction[0..1]Billing code or reference associated with the devicechargeItem[0..*]

XML Template

<DeviceDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique) -->
 <identifier><!-- 0..* Identifier Additional identifier for the DeviceDefinition --></identifier>
 <version value="[string]"/><!-- 0..1 Business version of the DeviceDefinition -->
 <versionAlgorithm[x]><!-- 0..1 string|Coding How to compare versions --></versionAlgorithm[x]>
 <name value="[string]"/><!-- 0..1 Name for this DeviceDefinition (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this DeviceDefinition (human friendly) -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown  -->
 <experimental value="[boolean]"/><!-- 0..1 For testing only - never for real usage -->
 <partNumber value="[string]"/><!-- 0..1 The part number or catalog number of the device -->
 <manufacturer><!-- 0..1 Reference(Organization) Name of device manufacturer --></manufacturer>
 <modelNumber value="[string]"/><!-- 0..1 The catalog or model number for the device for example as defined by the manufacturer -->
 <date value="[dateTime]"/><!-- 0..1 Date last changed -->
 <contact><!-- 0..* ContactDetail Contact details for the publisher --></contact>
 <publisher value="[string]"/><!-- 0..1 The name of the organization responsible for publishing the definition -->
 <useContext><!-- 0..* UsageContext The context that the content is intended to support --></useContext>
 <jurisdiction><!-- 0..* CodeableConcept Intended jurisdiction for DeviceDefinition (if applicable) --></jurisdiction>
 <purpose value="[markdown]"/><!-- 0..1 Why this DeviceDefinition is defined -->
 <copyright value="[markdown]"/><!-- 0..1 Use and/or publishing restrictions -->
 <copyrightLabel value="[string]"/><!-- 0..1 Copyright holder and year(s) -->
 <udiDeviceIdentifier>  <!-- 0..* Unique Device Identifier (UDI) Barcode string -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier -->
  <issuer value="[uri]"/><!-- 1..1 The organization that assigns the identifier algorithm -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
  <marketDistribution>  <!-- 0..* Indicates whether and when the device is available on the market -->
   <marketPeriod><!-- 1..1 Period Begin and end dates for the commercial distribution of the device --></marketPeriod>
   <subJurisdiction value="[uri]"/><!-- 1..1 National state or territory where the device is commercialized -->
  </marketDistribution>
 </udiDeviceIdentifier>
 <regulatoryIdentifier>  <!-- 0..* Regulatory identifier(s) associated with this device -->
  <type value="[code]"/><!-- 1..1 basic | master | license -->
  <deviceIdentifier value="[string]"/><!-- 1..1 The identifier itself -->
  <issuer value="[uri]"/><!-- 1..1 The organization that issued this identifier -->
  <jurisdiction value="[uri]"/><!-- 1..1 The jurisdiction to which the deviceIdentifier applies -->
 </regulatoryIdentifier>
 <deviceName>  <!-- 0..* The name or names of the device as given by the manufacturer -->
  <name value="[string]"/><!-- 1..1 A name that is used to refer to the device -->
  <type><!-- 1..1 CodeableConcept registered-name | user-friendly-name | patient-reported-name --></type>
 </deviceName>
 <classification>  <!-- 0..* What kind of device or device system this is -->
  <type><!-- 1..1 CodeableConcept A classification or risk class of the device model --></type>
  <justification><!-- 0..* RelatedArtifact Further information qualifying this classification of the device model --></justification>
 </classification>
 <conformsTo>  <!-- 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device -->
  <category><!-- 0..1 CodeableConcept Describes the common type of the standard, specification, or formal guidance --></category>
  <specification><!-- 1..1 CodeableConcept Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type --></specification>
  <version value="[string]"/><!-- 0..* The specific form or variant of the standard, specification or formal guidance -->
  <source><!-- 0..* RelatedArtifact Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance --></source>
 </conformsTo>
 <hasPart>  <!-- 0..* A device, part of the current one -->
  <reference><!-- 1..1 Reference(DeviceDefinition) Reference to the part --></reference>
  <count value="[integer]"/><!-- 0..1 Number of occurrences of the part -->
 </hasPart>
 <packaging>  <!-- 0..* Information about the packaging of the device, i.e. how the device is packaged -->
  <identifier><!-- 0..1 Identifier Business identifier of the packaged medication --></identifier>
  <type><!-- 0..1 CodeableConcept A code that defines the specific type of packaging --></type>
  <count value="[integer]"/><!-- 0..1 The number of items contained in the package (devices or sub-packages) -->
  <distributor>  <!-- 0..* An organization that distributes the packaged device -->
   <name value="[string]"/><!-- 0..1 Distributor's human-readable name -->
   <organizationReference><!-- 0..* Reference(Organization) Distributor as an Organization resource --></organizationReference>
  </distributor>
  <udiDeviceIdentifier><!-- 0..* Content as for DeviceDefinition.udiDeviceIdentifier Unique Device Identifier (UDI) Barcode string on the packaging --></udiDeviceIdentifier>
  <packaging><!-- 0..* Content as for DeviceDefinition.packaging Allows packages within packages --></packaging>
 </packaging>
 <deviceVersion>  <!-- 0..* The version of the device or software -->
  <type><!-- 0..1 CodeableConcept The type of the device version, e.g. manufacturer, approved, internal --></type>
  <component><!-- 0..1 Identifier The hardware or software module of the device to which the version applies --></component>
  <value value="[string]"/><!-- 1..1 The version text -->
 </deviceVersion>
 <safety><!-- 0..* CodeableConcept Safety characteristics of the device --></safety>
 <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 <outputLanguage value="[code]"/><!-- 0..* Language code for the human-readable text strings produced by the device (all supported) -->
 <property>  <!-- 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc -->
  <type><!-- 1..1 CodeableConcept Code that specifies the property being represented --></type>
  <value[x]><!-- 1..1 Quantity|CodeableConcept|string|boolean|integer|Range|
    Attachment Value of the property --></value[x]>
 </property>
 <link>  <!-- 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device -->
  <relation><!-- 1..1 Coding The type indicates the relationship of the related device to the device instance --></relation>
  <relatedDevice><!-- 1..1 CodeableReference(DeviceDefinition) A reference to the linked device --></relatedDevice>
 </link>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept A relevant substance that the device contains, may contain, or is made of --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
 <productionIdentifierInUDI><!-- 0..* CodeableConcept lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version --></productionIdentifierInUDI>
 <guideline>  <!-- 0..1 Information aimed at providing directions for the usage of this model of device -->
  <useContext><!-- 0..* UsageContext The circumstances that form the setting for using the device --></useContext>
  <usageInstruction value="[markdown]"/><!-- 0..1 Detailed written and visual directions for the user on how to use the device -->
  <relatedArtifact><!-- 0..* RelatedArtifact A source of information or reference for this guideline --></relatedArtifact>
  <indication><!-- 0..* CodeableConcept A clinical condition for which the device was designed to be used --></indication>
  <contraindication><!-- 0..* CodeableConcept A specific situation when a device should not be used because it may cause harm --></contraindication>
  <warning><!-- 0..* CodeableConcept Specific hazard alert information that a user needs to know before using the device --></warning>
  <intendedUse value="[string]"/><!-- 0..1 A description of the general purpose or medical use of the device or its function -->
 </guideline>
 <correctiveAction>  <!-- 0..1 Tracking of latest field safety corrective action -->
  <recall value="[boolean]"/><!-- 1..1 Whether the corrective action was a recall -->
  <scope value="[code]"/><!-- 0..1 model | lot-numbers | serial-numbers -->
  <period><!-- 1..1 Period Start and end dates of the  corrective action --></period>
 </correctiveAction>
 <chargeItem>  <!-- 0..* Billing code or reference associated with the device -->
  <chargeItemCode><!-- 1..1 CodeableReference(ChargeItemDefinition) The code or reference for the charge item --></chargeItemCode>
  <count><!-- 1..1 Quantity Coefficient applicable to the billing code --></count>
  <effectivePeriod><!-- 0..1 Period A specific time period in which this charge item applies --></effectivePeriod>
  <useContext><!-- 0..* UsageContext The context to which this charge item applies --></useContext>
 </chargeItem>
</DeviceDefinition>

JSON Template

{doco
  "resourceType" : "DeviceDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
  "identifier" : [{ Identifier }], // Additional identifier for the DeviceDefinition
  "version" : "<string>", // Business version of the DeviceDefinition
  // versionAlgorithm[x]: How to compare versions. One of these 2:
  "versionAlgorithmString" : "<string>",
  "versionAlgorithmCoding" : { Coding },
  "name" : "<string>", // Name for this DeviceDefinition (computer friendly)
  "title" : "<string>", // Name for this DeviceDefinition (human friendly)
  "status" : "<code>", // R!  draft | active | retired | unknown 
  "experimental" : <boolean>, // For testing only - never for real usage
  "partNumber" : "<string>", // The part number or catalog number of the device
  "manufacturer" : { Reference(Organization) }, // Name of device manufacturer
  "modelNumber" : "<string>", // The catalog or model number for the device for example as defined by the manufacturer
  "date" : "<dateTime>", // Date last changed
  "contact" : [{ ContactDetail }], // Contact details for the publisher
  "publisher" : "<string>", // The name of the organization responsible for publishing the definition
  "useContext" : [{ UsageContext }], // The context that the content is intended to support
  "jurisdiction" : [{ CodeableConcept }], // Intended jurisdiction for DeviceDefinition (if applicable)
  "purpose" : "<markdown>", // Why this DeviceDefinition is defined
  "copyright" : "<markdown>", // Use and/or publishing restrictions
  "copyrightLabel" : "<string>", // Copyright holder and year(s)
  "udiDeviceIdentifier" : [{ // Unique Device Identifier (UDI) Barcode string
    "deviceIdentifier" : "<string>", // R!  The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    "issuer" : "<uri>", // R!  The organization that assigns the identifier algorithm
    "jurisdiction" : "<uri>", // R!  The jurisdiction to which the deviceIdentifier applies
    "marketDistribution" : [{ // Indicates whether and when the device is available on the market
      "marketPeriod" : { Period }, // R!  Begin and end dates for the commercial distribution of the device
      "subJurisdiction" : "<uri>" // R!  National state or territory where the device is commercialized
    }]
  }],
  "regulatoryIdentifier" : [{ // Regulatory identifier(s) associated with this device
    "type" : "<code>", // R!  basic | master | license
    "deviceIdentifier" : "<string>", // R!  The identifier itself
    "issuer" : "<uri>", // R!  The organization that issued this identifier
    "jurisdiction" : "<uri>" // R!  The jurisdiction to which the deviceIdentifier applies
  }],
  "deviceName" : [{ // The name or names of the device as given by the manufacturer
    "name" : "<string>", // R!  A name that is used to refer to the device
    "type" : { CodeableConcept } // R!  registered-name | user-friendly-name | patient-reported-name
  }],
  "classification" : [{ // What kind of device or device system this is
    "type" : { CodeableConcept }, // R!  A classification or risk class of the device model
    "justification" : [{ RelatedArtifact }] // Further information qualifying this classification of the device model
  }],
  "conformsTo" : [{ // Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    "category" : { CodeableConcept }, // Describes the common type of the standard, specification, or formal guidance
    "specification" : { CodeableConcept }, // R!  Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    "version" : ["<string>"], // The specific form or variant of the standard, specification or formal guidance
    "source" : [{ RelatedArtifact }] // Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  }],
  "hasPart" : [{ // A device, part of the current one
    "reference" : { Reference(DeviceDefinition) }, // R!  Reference to the part
    "count" : <integer> // Number of occurrences of the part
  }],
  "packaging" : [{ // Information about the packaging of the device, i.e. how the device is packaged
    "identifier" : { Identifier }, // Business identifier of the packaged medication
    "type" : { CodeableConcept }, // A code that defines the specific type of packaging
    "count" : <integer>, // The number of items contained in the package (devices or sub-packages)
    "distributor" : [{ // An organization that distributes the packaged device
      "name" : "<string>", // Distributor's human-readable name
      "organizationReference" : [{ Reference(Organization) }] // Distributor as an Organization resource
    }],
    "udiDeviceIdentifier" : [{ Content as for DeviceDefinition.udiDeviceIdentifier }], // Unique Device Identifier (UDI) Barcode string on the packaging
    "packaging" : [{ Content as for DeviceDefinition.packaging }] // Allows packages within packages
  }],
  "deviceVersion" : [{ // The version of the device or software
    "type" : { CodeableConcept }, // The type of the device version, e.g. manufacturer, approved, internal
    "component" : { Identifier }, // The hardware or software module of the device to which the version applies
    "value" : "<string>" // R!  The version text
  }],
  "safety" : [{ CodeableConcept }], // Safety characteristics of the device
  "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
  "outputLanguage" : ["<code>"], // Language code for the human-readable text strings produced by the device (all supported)
  "property" : [{ // Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    "type" : { CodeableConcept }, // R!  Code that specifies the property being represented
    // value[x]: Value of the property. One of these 7:
    "valueQuantity" : { Quantity },
    "valueCodeableConcept" : { CodeableConcept },
    "valueString" : "<string>",
    "valueBoolean" : <boolean>,
    "valueInteger" : <integer>,
    "valueRange" : { Range },
    "valueAttachment" : { Attachment }
  }],
  "link" : [{ // An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    "relation" : { Coding }, // R!  The type indicates the relationship of the related device to the device instance
    "relatedDevice" : { CodeableReference(DeviceDefinition) } // R!  A reference to the linked device
  }],
  "note" : [{ Annotation }], // Device notes and comments
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  A relevant substance that the device contains, may contain, or is made of
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }],
  "productionIdentifierInUDI" : [{ CodeableConcept }], // lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  "guideline" : { // Information aimed at providing directions for the usage of this model of device
    "useContext" : [{ UsageContext }], // The circumstances that form the setting for using the device
    "usageInstruction" : "<markdown>", // Detailed written and visual directions for the user on how to use the device
    "relatedArtifact" : [{ RelatedArtifact }], // A source of information or reference for this guideline
    "indication" : [{ CodeableConcept }], // A clinical condition for which the device was designed to be used
    "contraindication" : [{ CodeableConcept }], // A specific situation when a device should not be used because it may cause harm
    "warning" : [{ CodeableConcept }], // Specific hazard alert information that a user needs to know before using the device
    "intendedUse" : "<string>" // A description of the general purpose or medical use of the device or its function
  },
  "correctiveAction" : { // Tracking of latest field safety corrective action
    "recall" : <boolean>, // R!  Whether the corrective action was a recall
    "scope" : "<code>", // model | lot-numbers | serial-numbers
    "period" : { Period } // R!  Start and end dates of the  corrective action
  },
  "chargeItem" : [{ // Billing code or reference associated with the device
    "chargeItemCode" : { CodeableReference(ChargeItemDefinition) }, // R!  The code or reference for the charge item
    "count" : { Quantity }, // R!  Coefficient applicable to the billing code
    "effectivePeriod" : { Period }, // A specific time period in which this charge item applies
    "useContext" : [{ UsageContext }] // The context to which this charge item applies
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:DeviceDefinition;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:url [ uri ] ; # 0..1 Canonical identifier for this DeviceDefinition, represented as an absolute URI (globally unique)
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Additional identifier for the DeviceDefinition
  fhir:version [ string ] ; # 0..1 Business version of the DeviceDefinition
  # versionAlgorithm[x] : 0..1 How to compare versions. One of these 2
    fhir:versionAlgorithm [  a fhir:string ; string ]
    fhir:versionAlgorithm [  a fhir:Coding ; Coding ]
  fhir:name [ string ] ; # 0..1 Name for this DeviceDefinition (computer friendly)
  fhir:title [ string ] ; # 0..1 Name for this DeviceDefinition (human friendly)
  fhir:status [ code ] ; # 1..1 draft | active | retired | unknown 
  fhir:experimental [ boolean ] ; # 0..1 For testing only - never for real usage
  fhir:partNumber [ string ] ; # 0..1 The part number or catalog number of the device
  fhir:manufacturer [ Reference(Organization) ] ; # 0..1 Name of device manufacturer
  fhir:modelNumber [ string ] ; # 0..1 The catalog or model number for the device for example as defined by the manufacturer
  fhir:date [ dateTime ] ; # 0..1 Date last changed
  fhir:contact  ( [ ContactDetail ] ... ) ; # 0..* Contact details for the publisher
  fhir:publisher [ string ] ; # 0..1 The name of the organization responsible for publishing the definition
  fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context that the content is intended to support
  fhir:jurisdiction  ( [ CodeableConcept ] ... ) ; # 0..* Intended jurisdiction for DeviceDefinition (if applicable)
  fhir:purpose [ markdown ] ; # 0..1 Why this DeviceDefinition is defined
  fhir:copyright [ markdown ] ; # 0..1 Use and/or publishing restrictions
  fhir:copyrightLabel [ string ] ; # 0..1 Copyright holder and year(s)
  fhir:udiDeviceIdentifier ( [ # 0..* Unique Device Identifier (UDI) Barcode string
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
    fhir:issuer [ uri ] ; # 1..1 The organization that assigns the identifier algorithm
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
    fhir:marketDistribution ( [ # 0..* Indicates whether and when the device is available on the market
      fhir:marketPeriod [ Period ] ; # 1..1 Begin and end dates for the commercial distribution of the device
      fhir:subJurisdiction [ uri ] ; # 1..1 National state or territory where the device is commercialized
    ] ... ) ;
  ] ... ) ;
  fhir:regulatoryIdentifier ( [ # 0..* Regulatory identifier(s) associated with this device
    fhir:type [ code ] ; # 1..1 basic | master | license
    fhir:deviceIdentifier [ string ] ; # 1..1 The identifier itself
    fhir:issuer [ uri ] ; # 1..1 The organization that issued this identifier
    fhir:jurisdiction [ uri ] ; # 1..1 The jurisdiction to which the deviceIdentifier applies
  ] ... ) ;
  fhir:deviceName ( [ # 0..* The name or names of the device as given by the manufacturer
    fhir:name [ string ] ; # 1..1 A name that is used to refer to the device
    fhir:type [ CodeableConcept ] ; # 1..1 registered-name | user-friendly-name | patient-reported-name
  ] ... ) ;
  fhir:classification ( [ # 0..* What kind of device or device system this is
    fhir:type [ CodeableConcept ] ; # 1..1 A classification or risk class of the device model
    fhir:justification  ( [ RelatedArtifact ] ... ) ; # 0..* Further information qualifying this classification of the device model
  ] ... ) ;
  fhir:conformsTo ( [ # 0..* Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
    fhir:category [ CodeableConcept ] ; # 0..1 Describes the common type of the standard, specification, or formal guidance
    fhir:specification [ CodeableConcept ] ; # 1..1 Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
    fhir:version  ( [ string ] ... ) ; # 0..* The specific form or variant of the standard, specification or formal guidance
    fhir:source  ( [ RelatedArtifact ] ... ) ; # 0..* Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
  ] ... ) ;
  fhir:hasPart ( [ # 0..* A device, part of the current one
    fhir:reference [ Reference(DeviceDefinition) ] ; # 1..1 Reference to the part
    fhir:count [ integer ] ; # 0..1 Number of occurrences of the part
  ] ... ) ;
  fhir:packaging ( [ # 0..* Information about the packaging of the device, i.e. how the device is packaged
    fhir:identifier [ Identifier ] ; # 0..1 Business identifier of the packaged medication
    fhir:type [ CodeableConcept ] ; # 0..1 A code that defines the specific type of packaging
    fhir:count [ integer ] ; # 0..1 The number of items contained in the package (devices or sub-packages)
    fhir:distributor ( [ # 0..* An organization that distributes the packaged device
      fhir:name [ string ] ; # 0..1 Distributor's human-readable name
      fhir:organizationReference  ( [ Reference(Organization) ] ... ) ; # 0..* Distributor as an Organization resource
    ] ... ) ;
    fhir:udiDeviceIdentifier  ( [ See DeviceDefinition.udiDeviceIdentifier ] ... ) ; # 0..* Unique Device Identifier (UDI) Barcode string on the packaging
    fhir:packaging  ( [ See DeviceDefinition.packaging ] ... ) ; # 0..* Allows packages within packages
  ] ... ) ;
  fhir:deviceVersion ( [ # 0..* The version of the device or software
    fhir:type [ CodeableConcept ] ; # 0..1 The type of the device version, e.g. manufacturer, approved, internal
    fhir:component [ Identifier ] ; # 0..1 The hardware or software module of the device to which the version applies
    fhir:value [ string ] ; # 1..1 The version text
  ] ... ) ;
  fhir:safety  ( [ CodeableConcept ] ... ) ; # 0..* Safety characteristics of the device
  fhir:shelfLifeStorage  ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information
  fhir:outputLanguage  ( [ code ] ... ) ; # 0..* Language code for the human-readable text strings produced by the device (all supported)
  fhir:property ( [ # 0..* Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
    fhir:type [ CodeableConcept ] ; # 1..1 Code that specifies the property being represented
    # value[x] : 1..1 Value of the property. One of these 7
      fhir:value [  a fhir:Quantity ; Quantity ]
      fhir:value [  a fhir:CodeableConcept ; CodeableConcept ]
      fhir:value [  a fhir:string ; string ]
      fhir:value [  a fhir:boolean ; boolean ]
      fhir:value [  a fhir:integer ; integer ]
      fhir:value [  a fhir:Range ; Range ]
      fhir:value [  a fhir:Attachment ; Attachment ]
  ] ... ) ;
  fhir:link ( [ # 0..* An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
    fhir:relation [ Coding ] ; # 1..1 The type indicates the relationship of the related device to the device instance
    fhir:relatedDevice [ CodeableReference(DeviceDefinition) ] ; # 1..1 A reference to the linked device
  ] ... ) ;
  fhir:note  ( [ Annotation ] ... ) ; # 0..* Device notes and comments
  fhir:material ( [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:substance [ CodeableConcept ] ; # 1..1 A relevant substance that the device contains, may contain, or is made of
    fhir:alternate [ boolean ] ; # 0..1 Indicates an alternative material of the device
    fhir:allergenicIndicator [ boolean ] ; # 0..1 Whether the substance is a known or suspected allergen
  ] ... ) ;
  fhir:productionIdentifierInUDI  ( [ CodeableConcept ] ... ) ; # 0..* lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
  fhir:guideline [ # 0..1 Information aimed at providing directions for the usage of this model of device
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The circumstances that form the setting for using the device
    fhir:usageInstruction [ markdown ] ; # 0..1 Detailed written and visual directions for the user on how to use the device
    fhir:relatedArtifact  ( [ RelatedArtifact ] ... ) ; # 0..* A source of information or reference for this guideline
    fhir:indication  ( [ CodeableConcept ] ... ) ; # 0..* A clinical condition for which the device was designed to be used
    fhir:contraindication  ( [ CodeableConcept ] ... ) ; # 0..* A specific situation when a device should not be used because it may cause harm
    fhir:warning  ( [ CodeableConcept ] ... ) ; # 0..* Specific hazard alert information that a user needs to know before using the device
    fhir:intendedUse [ string ] ; # 0..1 A description of the general purpose or medical use of the device or its function
  ] ;
  fhir:correctiveAction [ # 0..1 Tracking of latest field safety corrective action
    fhir:recall [ boolean ] ; # 1..1 Whether the corrective action was a recall
    fhir:scope [ code ] ; # 0..1 model | lot-numbers | serial-numbers
    fhir:period [ Period ] ; # 1..1 Start and end dates of the  corrective action
  ] ;
  fhir:chargeItem ( [ # 0..* Billing code or reference associated with the device
    fhir:chargeItemCode [ CodeableReference(ChargeItemDefinition) ] ; # 1..1 The code or reference for the charge item
    fhir:count [ Quantity ] ; # 1..1 Coefficient applicable to the billing code
    fhir:effectivePeriod [ Period ] ; # 0..1 A specific time period in which this charge item applies
    fhir:useContext  ( [ UsageContext ] ... ) ; # 0..* The context to which this charge item applies
  ] ... ) ;
]

Changes from both R4 and R4B

DeviceDefinition
DeviceDefinition.version
  • Max Cardinality changed from * to 1
DeviceDefinition.versionAlgorithm[x]
  • Added Element
DeviceDefinition.name
  • Added Element
DeviceDefinition.title
  • Added Element
DeviceDefinition.status
  • Added Mandatory Element
DeviceDefinition.experimental
  • Added Element
DeviceDefinition.partNumber
  • Added Element
DeviceDefinition.manufacturer
  • Renamed from manufacturer[x] to manufacturer
  • Remove Type string
DeviceDefinition.date
  • Added Element
DeviceDefinition.contact
  • Type changed from ContactPoint to ContactDetail
DeviceDefinition.publisher
  • Added Element
DeviceDefinition.useContext
  • Added Element
DeviceDefinition.jurisdiction
  • Added Element
DeviceDefinition.purpose
  • Added Element
DeviceDefinition.copyright
  • Added Element
DeviceDefinition.copyrightLabel
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution
  • Added Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
  • Added Mandatory Element
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier
  • Added Element
DeviceDefinition.regulatoryIdentifier.type
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.issuer
  • Added Mandatory Element
DeviceDefinition.regulatoryIdentifier.jurisdiction
  • Added Mandatory Element
DeviceDefinition.deviceName.type
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
DeviceDefinition.classification
  • Added Element
DeviceDefinition.classification.type
  • Moved from DeviceDefinition to DeviceDefinition.classification
  • Min Cardinality changed from 0 to 1
DeviceDefinition.classification.justification
  • Added Element
DeviceDefinition.conformsTo
  • Renamed from specialization to conformsTo
DeviceDefinition.conformsTo.category
  • Added Element
DeviceDefinition.conformsTo.specification
  • Added Mandatory Element
DeviceDefinition.conformsTo.version
  • Moved from DeviceDefinition.specialization to DeviceDefinition.conformsTo
  • Max Cardinality changed from 1 to *
DeviceDefinition.conformsTo.source
  • Added Element
DeviceDefinition.hasPart
  • Added Element
DeviceDefinition.hasPart.reference
  • Added Mandatory Element
DeviceDefinition.hasPart.count
  • Added Element
DeviceDefinition.packaging
  • Added Element
DeviceDefinition.packaging.identifier
  • Added Element
DeviceDefinition.packaging.type
  • Added Element
DeviceDefinition.packaging.count
  • Added Element
DeviceDefinition.packaging.distributor
  • Added Element
DeviceDefinition.packaging.distributor.name
  • Added Element
DeviceDefinition.packaging.distributor.organizationReference
  • Added Element
DeviceDefinition.packaging.udiDeviceIdentifier
  • Added Element
DeviceDefinition.packaging.packaging
  • Added Element
DeviceDefinition.deviceVersion
  • Added Element
DeviceDefinition.deviceVersion.type
  • Added Element
DeviceDefinition.deviceVersion.component
  • Added Element
DeviceDefinition.deviceVersion.value
  • Added Mandatory Element
DeviceDefinition.outputLanguage
  • Added Element
DeviceDefinition.property.value[x]
  • Added Mandatory Element
DeviceDefinition.link
  • Added Element
DeviceDefinition.link.relation
  • Added Mandatory Element
DeviceDefinition.link.relatedDevice
  • Added Mandatory Element
DeviceDefinition.productionIdentifierInUDI
  • Added Element
DeviceDefinition.guideline
  • Added Element
DeviceDefinition.guideline.useContext
  • Added Element
DeviceDefinition.guideline.usageInstruction
  • Added Element
DeviceDefinition.guideline.relatedArtifact
  • Moved from DeviceDefinition.onlineInformation to relatedArtifact
  • Max Cardinality changed from 1 to *
  • Type changed from uri to RelatedArtifact
DeviceDefinition.guideline.indication
  • Added Element
DeviceDefinition.guideline.contraindication
  • Added Element
DeviceDefinition.guideline.warning
  • Added Element
DeviceDefinition.guideline.intendedUse
  • Added Element
DeviceDefinition.correctiveAction
  • Added Element
DeviceDefinition.correctiveAction.recall
  • Added Mandatory Element
DeviceDefinition.correctiveAction.scope
  • Added Element
DeviceDefinition.correctiveAction.period
  • Added Mandatory Element
DeviceDefinition.chargeItem
  • Added Element
DeviceDefinition.chargeItem.chargeItemCode
  • Added Mandatory Element
DeviceDefinition.chargeItem.count
  • Added Mandatory Element
DeviceDefinition.chargeItem.effectivePeriod
  • Added Element
DeviceDefinition.chargeItem.useContext
  • Added Element
DeviceDefinition.specialization.systemType
  • Deleted
DeviceDefinition.physicalCharacteristics
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.languageCode
  • Deleted
DeviceDefinition.capability
  • Deleted (-> DeviceDefinition.property)
DeviceDefinition.property.valueQuantity
  • Deleted
DeviceDefinition.property.valueCode
  • Deleted
DeviceDefinition.owner
  • Deleted
DeviceDefinition.quantity
  • Deleted (-> DeviceDefinition.packaging.count or DeviceDefinition.hasPart.count)
DeviceDefinition.parentDevice
  • Deleted (Removed - to establish relations, use hasPArt)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) , the spreadsheet version & the dependency analysis

8.18.4.1 Terminology Bindings

Path ValueSet Type Documentation
DeviceDefinition.versionAlgorithm[x] VersionAlgorithm Extensible

Indicates the mechanism used to compare versions to determine which is more current.
DeviceDefinition.status PublicationStatus Required

The lifecycle status of an artifact.
DeviceDefinition.jurisdiction JurisdictionValueSet Extensible

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.
DeviceDefinition.regulatoryIdentifier.type DeviceDefinitionRegulatoryIdentifierType (a valid code from Device Regulatory Identifier Type) Required

Regulatory Identifier type
DeviceDefinition.deviceName.type DeviceNameType Extensible

The type of name the device is referred by.
DeviceDefinition.classification.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.conformsTo.category DeviceSpecificationCategory (a valid code from FHIR Device Specialization Category) Example

The kind of standards used by the device.
DeviceDefinition.conformsTo.specification DeviceSpecificationType Example

The type or specification of a standard that devices can adhere to
DeviceDefinition.safety DeviceSafety Example

Codes used to identify medical devices safety characteristics. These codes are taken from the NCI Thesaurus icon and are provided here as a suggestive example.
DeviceDefinition.outputLanguage AllLanguages (a valid code from Tags for the Identification of Languages icon) Required

This value set includes all possible codes from BCP-47 (see http://tools.ietf.org/html/bcp47)
  Common Languages starter
DeviceDefinition.property.type DeviceType Example

Codes used to identify medical devices. Includes concepts from SNOMED CT (http://www.snomed.org/) where concept is-a 49062001 (Device) and is provided as a suggestive example.
DeviceDefinition.link.relation DeviceDefinitionRelationType Extensible

Description Needed Here
DeviceDefinition.material.substance SubstanceCode Example

This value set contains concept codes for specific substances. It includes codes from SNOMED icon where concept is-a 105590001 (Substance (substance))
DeviceDefinition.productionIdentifierInUDI DeviceProductionIdentifierInUDI Extensible

Device Production Identifier in UDI
DeviceDefinition.correctiveAction.scope DeviceCorrectiveActionScope Required

Device - Corrective action scope

8.18.4.2 Constraints

UniqueKeyLevelLocationDescriptionExpression
img cnl-1Warning DeviceDefinition.urlURL should not contain | or # - these characters make processing canonical references problematicexists() implies matches('^[^|# ]+$')

8.18.5 Notes:

8.18.6 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
device-name string A server defined search that may match any of the string fields in DeviceDefinition.name or DeviceDefinition.classification.type - the latter to search for 'generic' devices. DeviceDefinition.deviceName.name | DeviceDefinition.classification.type.coding.display | DeviceDefinition.classification.type.text
has-part reference The manufacturer of the device DeviceDefinition.hasPart.reference
(DeviceDefinition)
identifier token The identifier of the component DeviceDefinition.identifier | DeviceDefinition.udiDeviceIdentifier 35 Resources
manufacturer reference The manufacturer of the device DeviceDefinition.manufacturer
(Organization)
model-number token The model of the device DeviceDefinition.modelNumber
part-number string The part number or catalog number of the device. DeviceDefinition.partNumber
publisher string The contact for the publisher of the device definition DeviceDefinition.contact.name | DeviceDefinition.publisher 31 Resources
specification token The specification that the device conforms to DeviceDefinition.conformsTo.specification
specification-version composite A composite of both specification and version On DeviceDefinition.conformsTo:
  specification: specification
  version: version
type token The device type DeviceDefinition.conformsTo.category
url N uri The uri that identifies the code system DeviceDefinition.url 35 Resources
version token The specific version of the device DeviceDefinition.deviceVersion.value 32 Resources
version-type composite Value and type of version On DeviceDefinition.deviceVersion:
  type: type
  value: value