Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq | Version: 1.0.0 | |||
Active as of 2024-05-08 | Computable Name: DeviceDefinitionDrugPq | |||
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.24 |
This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from DeviceDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
deviceName | S | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
classification | S | 0..* | BackboneElement | What kind of device or device system this is |
type | S | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: Device Type (example) |
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) |
value[x] | S | 1..1 | Value of the property | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueAttachment | Attachment | |||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
name | Σ | 1..1 | string | A name that is used to refer to the device |
type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
classification | SΣ | 0..* | BackboneElement | What kind of device or device system this is |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: Device Type (example) |
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) |
value[x] | S | 1..1 | Value of the property | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueAttachment | Attachment | |||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|5.0.0 from the FHIR Standard | |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
description | 0..1 | markdown | Additional information to describe the device | |||||
identifier | Σ | 0..* | Identifier | Instance identifier | ||||
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | 1..1 | code | basic | master | license Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type. | |||||
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 | |||||
partNumber | 0..1 | string | The part number or catalog number of the device | |||||
manufacturer | Σ | 0..1 | Reference(Organization) | Name of device manufacturer | ||||
deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | Σ | 1..1 | string | A name that is used to refer to the device | ||||
type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. | ||||
modelNumber | Σ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer | ||||
classification | SΣ | 0..* | BackboneElement | What kind of device or device system this is | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
category | Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance Binding: DeviceSpecificationCategory (example) | ||||
specification | Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: DeviceSpecificationType (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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | 0..1 | string | Distributor's human-readable name | |||||
organizationReference | 0..* | Reference(Organization) | Distributor as an Organization resource | |||||
udiDeviceIdentifier | 0..* | See udiDeviceIdentifier (DeviceDefinition) | Unique Device Identifier (UDI) Barcode string on the packaging | |||||
packaging | 0..* | See packaging (DeviceDefinition) | Allows packages within packages | |||||
version | 0..* | BackboneElement | The version of the device or software | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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: DeviceSafety (example) | ||||
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |||||
languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |||||
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) | ||||
value[x] | S | 1..1 | Value of the property | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueAttachment | Attachment | |||||||
owner | 0..1 | Reference(Organization) | Organization responsible for device | |||||
contact | 0..* | ContactPoint | Details for human/organization for support | |||||
link | 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
relation | 1..1 | Coding | The type indicates the relationship of the related device to the device instance Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device. | |||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |||||
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..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |||||
guideline | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
recall | 1..1 | boolean | Whether the corrective action was a recall | |||||
scope | 0..1 | code | model | lot-numbers | serial-numbers Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action. | |||||
period | 1..1 | Period | Start and end dates of the corrective action | |||||
chargeItem | 0..* | BackboneElement | Billing code or reference associated with the device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
DeviceDefinition.regulatoryIdentifier.type | required | DeviceDefinitionRegulatoryIdentifierTypehttp://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0 from the FHIR Standard | |
DeviceDefinition.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|5.0.0 from the FHIR Standard | |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.conformsTo.category | example | DeviceSpecificationCategoryhttp://hl7.org/fhir/ValueSet/device-specification-category from the FHIR Standard | |
DeviceDefinition.conformsTo.specification | example | DeviceSpecificationTypehttp://hl7.org/fhir/ValueSet/device-specification-type from the FHIR Standard | |
DeviceDefinition.safety | example | DeviceSafetyhttp://hl7.org/fhir/ValueSet/device-safety from the FHIR Standard | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG | |
DeviceDefinition.link.relation | extensible | DeviceDefinitionRelationTypehttp://hl7.org/fhir/ValueSet/devicedefinition-relationtype from the FHIR Standard | |
DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDIhttp://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0 from the FHIR Standard | |
DeviceDefinition.correctiveAction.scope | required | DeviceCorrectiveActionScopehttp://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Differential View
This structure is derived from DeviceDefinition
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
deviceName | S | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
classification | S | 0..* | BackboneElement | What kind of device or device system this is |
type | S | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: Device Type (example) |
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) |
value[x] | S | 1..1 | Value of the property | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueAttachment | Attachment | |||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
contained | 0..* | Resource | Contained, inline Resources | |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
name | Σ | 1..1 | string | A name that is used to refer to the device |
type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. |
classification | SΣ | 0..* | BackboneElement | What kind of device or device system this is |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | SΣ | 1..1 | CodeableConcept | A classification or risk class of the device model Binding: Device Type (example) |
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc |
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) |
value[x] | S | 1..1 | Value of the property | |
valueQuantity | Quantity | |||
valueCodeableConcept | CodeableConcept | |||
valueString | string | |||
valueBoolean | boolean | |||
valueInteger | integer | |||
valueRange | Range | |||
valueAttachment | Attachment | |||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|5.0.0 from the FHIR Standard | |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
DeviceDefinition | 0..* | DeviceDefinition | An instance of a medical-related component of a medical device | |||||
id | Σ | 0..1 | id | Logical id of this artifact | ||||
meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
language | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
contained | 0..* | Resource | Contained, inline Resources | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
description | 0..1 | markdown | Additional information to describe the device | |||||
identifier | Σ | 0..* | Identifier | Instance identifier | ||||
udiDeviceIdentifier | 0..* | BackboneElement | Unique Device Identifier (UDI) Barcode string | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | 1..1 | code | basic | master | license Binding: DeviceDefinitionRegulatoryIdentifierType (required): Device regulatory identifier type. | |||||
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 | |||||
partNumber | 0..1 | string | The part number or catalog number of the device | |||||
manufacturer | Σ | 0..1 | Reference(Organization) | Name of device manufacturer | ||||
deviceName | SΣ | 0..* | BackboneElement | The name or names of the device as given by the manufacturer | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | Σ | 1..1 | string | A name that is used to refer to the device | ||||
type | Σ | 1..1 | code | registered-name | user-friendly-name | patient-reported-name Binding: DeviceNameType (required): The type of name the device is referred by. | ||||
modelNumber | Σ | 0..1 | string | The catalog or model number for the device for example as defined by the manufacturer | ||||
classification | SΣ | 0..* | BackboneElement | What kind of device or device system this is | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | SΣ | 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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
category | Σ | 0..1 | CodeableConcept | Describes the common type of the standard, specification, or formal guidance Binding: DeviceSpecificationCategory (example) | ||||
specification | Σ | 1..1 | CodeableConcept | Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type Binding: DeviceSpecificationType (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 | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
name | 0..1 | string | Distributor's human-readable name | |||||
organizationReference | 0..* | Reference(Organization) | Distributor as an Organization resource | |||||
udiDeviceIdentifier | 0..* | See udiDeviceIdentifier (DeviceDefinition) | Unique Device Identifier (UDI) Barcode string on the packaging | |||||
packaging | 0..* | See packaging (DeviceDefinition) | Allows packages within packages | |||||
version | 0..* | BackboneElement | The version of the device or software | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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: DeviceSafety (example) | ||||
shelfLifeStorage | 0..* | ProductShelfLife | Shelf Life and storage information | |||||
languageCode | 0..* | CodeableConcept | Language code for the human-readable text strings produced by the device (all supported) | |||||
property | S | 0..* | BackboneElement | Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc | ||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
type | S | 1..1 | CodeableConcept | Code that specifies the property being represented Binding: Device Properties (example) | ||||
value[x] | S | 1..1 | Value of the property | |||||
valueQuantity | Quantity | |||||||
valueCodeableConcept | CodeableConcept | |||||||
valueString | string | |||||||
valueBoolean | boolean | |||||||
valueInteger | integer | |||||||
valueRange | Range | |||||||
valueAttachment | Attachment | |||||||
owner | 0..1 | Reference(Organization) | Organization responsible for device | |||||
contact | 0..* | ContactPoint | Details for human/organization for support | |||||
link | 0..* | BackboneElement | An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
relation | 1..1 | Coding | The type indicates the relationship of the related device to the device instance Binding: DeviceDefinitionRelationType (extensible): The type of relation between this and the linked device. | |||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
substance | 1..1 | CodeableConcept | A relevant substance that the device contains, may contain, or is made of | |||||
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..* | code | lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version Binding: DeviceProductionIdentifierInUDI (required): The production identifier(s) that are expected to appear in the UDI carrier. | |||||
guideline | 0..1 | BackboneElement | Information aimed at providing directions for the usage of this model of device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
recall | 1..1 | boolean | Whether the corrective action was a recall | |||||
scope | 0..1 | code | model | lot-numbers | serial-numbers Binding: DeviceCorrectiveActionScope (required): The type or scope of the corrective action. | |||||
period | 1..1 | Period | Start and end dates of the corrective action | |||||
chargeItem | 0..* | BackboneElement | Billing code or reference associated with the device | |||||
id | 0..1 | string | Unique id for inter-element referencing | |||||
extension | 0..* | Extension | Additional content defined by implementations | |||||
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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 | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI |
DeviceDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard | |
DeviceDefinition.regulatoryIdentifier.type | required | DeviceDefinitionRegulatoryIdentifierTypehttp://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0 from the FHIR Standard | |
DeviceDefinition.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|5.0.0 from the FHIR Standard | |
DeviceDefinition.classification.type | example | VsDeviceTypePQ (a valid code from Device Type - example)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceType-pq from this IG | |
DeviceDefinition.conformsTo.category | example | DeviceSpecificationCategoryhttp://hl7.org/fhir/ValueSet/device-specification-category from the FHIR Standard | |
DeviceDefinition.conformsTo.specification | example | DeviceSpecificationTypehttp://hl7.org/fhir/ValueSet/device-specification-type from the FHIR Standard | |
DeviceDefinition.safety | example | DeviceSafetyhttp://hl7.org/fhir/ValueSet/device-safety from the FHIR Standard | |
DeviceDefinition.property.type | example | VsDevicePropertyPQ (a valid code from Device Property Codes)http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq from this IG | |
DeviceDefinition.link.relation | extensible | DeviceDefinitionRelationTypehttp://hl7.org/fhir/ValueSet/devicedefinition-relationtype from the FHIR Standard | |
DeviceDefinition.productionIdentifierInUDI | required | DeviceProductionIdentifierInUDIhttp://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0 from the FHIR Standard | |
DeviceDefinition.correctiveAction.scope | required | DeviceCorrectiveActionScopehttp://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0 from the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | DeviceDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
dom-4 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
dom-5 | error | DeviceDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | DeviceDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from DeviceDefinition
Other representations of profile: CSV, Excel, Schematron