LOINC – IVD Test Code (LIVD) Mapping
1.0.0 - STU 1

LOINC – IVD Test Code (LIVD) Mapping, published by HL7 International / Orders and Observations. 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/livd/ and changes regularly. See the Directory of published versions

## Resource Profile: LIVDDeviceDefinition - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the devicedefinition-uv-livd resource profile.

- Key Elements Table
- Differential Elements Table
- Snapshot Elements Table

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceDefinition
Definition | The characteristics, operational status and capabilities of a medical-related component of a medical device.
Short | LIVDDeviceDefinitionAn instance of a medical-related component of a medical device
Comments | For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. DeviceDefinition.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. DeviceDefinition.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. DeviceDefinition.identifier
Definition | Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.
Short | Instance identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..0*
Type | Identifier
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. DeviceDefinition.udiDeviceIdentifier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Short | Unique Device Identifier (UDI) Barcode string
Comments | In this profile only a type of device can be represented where the UDI only identifies the type of the device.
Control | 0..1*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. DeviceDefinition.udiDeviceIdentifier.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier.
Short | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
Comments | While the device identifier is a mandatory part of the UDI definition, for this profile the deviceidentifier does not need to be communicated. If it is communicated, it is communicated here. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. DeviceDefinition.udiDeviceIdentifier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di. The organization that assigns the identifier algorithm.
Short | UDI Issuing OrganizationThe organization that assigns the identifier algorithm
Control | 1..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Requirements | This field is required when Device.udi.deviceIdentifier is valued.
Alternate Names | Barcode System
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. DeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. The jurisdiction to which the deviceIdentifier applies.
Short | Regional UDI authorityThe jurisdiction to which the deviceIdentifier applies
Control | 1..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. DeviceDefinition.manufacturer[x]
Definition | A name of the manufacturer.
Short | Name of device manufacturer
Control | 10..1
Type | string, Reference(Organization)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. DeviceDefinition.deviceName
Definition | A name given to the device to identify it.
Short | A name given to the device to identify it
Control | 0..0*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
25. DeviceDefinition.modelNumber
Definition | The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by all the devices sold as the same type. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab. The model number for the device.
Short | Model id assigned by the manufacturerThe model number for the device
Comments | The Device.model field is used to map the Device to the correct Concept Map (using ConceptMap.group.source) and IVD Test Code System (using CodeSystem.identifier).
Control | 10..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
27. DeviceDefinition.type
Definition | What kind of device or device system this is.
Short | What kind of device or device system this is
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from For example codes, see IVD device types for LIVD device definitions VS http://hl7.org/fhir/ValueSet/device-kind|4.0.1 (extensible to `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` ) IVD device types for LIVD device definitions (extensible). Type of device e.g. according to official classification.
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
29. DeviceDefinition.specialization
Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
Short | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Control | 0..0*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. DeviceDefinition.version
Definition | The available versions of the device, e.g., software versions.
Short | Available versions
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..0*
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. DeviceDefinition.safety
Definition | Safety characteristics of the device.
Short | Safety characteristics of the device
Control | 0..0*
Binding | For example codes, see DeviceSafety http://hl7.org/fhir/ValueSet/device-safety|4.0.1 (example to `http://hl7.org/fhir/ValueSet/device-safety|4.0.1` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. DeviceDefinition.shelfLifeStorage
Definition | Shelf Life and storage information.
Short | Shelf Life and storage information
Control | 0..0*
Type | ProductShelfLife
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. DeviceDefinition.physicalCharacteristics
Definition | Dimensions, color etc.
Short | Dimensions, color etc.
Control | 0..01
Type | ProdCharacteristic
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. DeviceDefinition.languageCode
Definition | Language code for the human-readable text strings produced by the device (all supported).
Short | Language code for the human-readable text strings produced by the device (all supported)
Control | 0..0*
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. DeviceDefinition.capability
Definition | Device capabilities.
Short | Device capabilities
Control | 10..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. DeviceDefinition.capability.extension
Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | ExtensionAdditional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 10..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
Slicing | This element introduces a set of slices on `DeviceDefinition.capability.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
48. DeviceDefinition.capability.extension:DeviceDefinitionExtensionAnalyte
Slice Name | DeviceDefinitionExtensionAnalyte
Definition | Add a reference from DeviceDefinition.capability to one or more ObservationDefinition resources representing test analytes that may be measured.
Short | LIVD Test Analyte
Control | 1..* This element is affected by the following invariants: ele-1
Type | Extension(LIVD Test Analyte) (Extension Type: Reference)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
50. DeviceDefinition.capability.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
52. DeviceDefinition.capability.type
Definition | Type of capability.
Short | Type of capability
Comments | removed "DeviceCapabilityType (ObservationDefinition)" from Value column.
Control | 1..1
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. DeviceDefinition.capability.description
Definition | Description of capability.
Short | Description of capability
Control | 0..0*
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. DeviceDefinition.property
Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Short | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Control | 0..0*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. DeviceDefinition.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Short | Organization responsible for device
Control | 0..01
Type | Reference(Organization)
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. DeviceDefinition.contact
Definition | Contact details for an organization or a particular human that is responsible for the device.
Short | Details for human/organization for support
Comments | used for troubleshooting etc.
Control | 0..0*
Type | ContactPoint
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. DeviceDefinition.url
Definition | A network address on which the device may be contacted directly.
Short | Network address to contact device
Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
Control | 0..01
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. DeviceDefinition.onlineInformation
Definition | Access to on-line information about the device.
Short | Access to on-line information
Control | 0..01
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. DeviceDefinition.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Control | 0..0*
Type | Annotation
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. DeviceDefinition.quantity
Definition | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).
Short | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
Control | 0..01
Type | Quantity
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceDefinition
Short | LIVDDeviceDefinition
Must Support | false
2. DeviceDefinition.identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..0
Must Support | false
4. DeviceDefinition.udiDeviceIdentifier
Comments | In this profile only a type of device can be represented where the UDI only identifies the type of the device.
Control | 0..1
Must Support | true
6. DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Comments | While the device identifier is a mandatory part of the UDI definition, for this profile the deviceidentifier does not need to be communicated. If it is communicated, it is communicated here. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
Must Support | true
Alternate Names | DI
8. DeviceDefinition.udiDeviceIdentifier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Short | UDI Issuing Organization
Must Support | true
Requirements | This field is required when Device.udi.deviceIdentifier is valued.
Alternate Names | Barcode System
10. DeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Short | Regional UDI authority
Must Support | true
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
12. DeviceDefinition.manufacturer[x]
Control | 1..?
Type | string, Reference(Organization)
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
14. DeviceDefinition.deviceName
Control | 0..0
Must Support | false
18. DeviceDefinition.modelNumber
Definition | The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by all the devices sold as the same type. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
Short | Model id assigned by the manufacturer
Comments | The Device.model field is used to map the Device to the correct Concept Map (using ConceptMap.group.source) and IVD Test Code System (using CodeSystem.identifier).
Control | 1..?
Must Support | true
20. DeviceDefinition.type
Binding | Unless not suitable, these codes SHALL be taken from IVD device types for LIVD device definitions VS (extensible to `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` ) IVD device types for LIVD device definitions (extensible).
Must Support | true
22. DeviceDefinition.specialization
Control | 0..0
Must Support | false
26. DeviceDefinition.version
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..0
Must Support | false
28. DeviceDefinition.safety
Control | 0..0
Must Support | false
30. DeviceDefinition.shelfLifeStorage
Control | 0..0
Must Support | false
32. DeviceDefinition.physicalCharacteristics
Control | 0..0
Must Support | false
34. DeviceDefinition.languageCode
Control | 0..0
Must Support | false
36. DeviceDefinition.capability
Control | 1..?
Must Support | true
38. DeviceDefinition.capability.extension
Control | 1..?
Slicing | This element introduces a set of slices on `DeviceDefinition.capability.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
40. DeviceDefinition.capability.extension:DeviceDefinitionExtensionAnalyte
Slice Name | DeviceDefinitionExtensionAnalyte
Control | 1..*
Type | Extension(LIVD Test Analyte) (Extension Type: Reference)
Must Support | true
42. DeviceDefinition.capability.type
Comments | removed "DeviceCapabilityType (ObservationDefinition)" from Value column.
Must Support | true
44. DeviceDefinition.capability.description
Control | 0..0
Must Support | false
46. DeviceDefinition.property
Control | 0..0
Must Support | false
51. DeviceDefinition.owner
Control | 0..0
Must Support | false
53. DeviceDefinition.contact
Control | 0..0
Must Support | false
55. DeviceDefinition.url
Control | 0..0
Must Support | false
57. DeviceDefinition.onlineInformation
Control | 0..0
Must Support | false
59. DeviceDefinition.note
Control | 0..0
Must Support | false
61. DeviceDefinition.quantity
Control | 0..0
Must Support | false

Guidance on how to interpret the contents of this table can be foundhere

0. DeviceDefinition
Definition | The characteristics, operational status and capabilities of a medical-related component of a medical device.
Short | LIVDDeviceDefinition
Comments | For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-3: 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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`) dom-4: 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: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) dom-6: A resource should have narrative for robust management (`text.`div`.exists()`)
2. DeviceDefinition.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Control | 0..1
Type | id
Is Modifier | false
Summary | true
4. DeviceDefinition.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. DeviceDefinition.implicitRules
Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Short | A set of rules under which this content was created
Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
8. DeviceDefinition.language
Definition | The base language in which the resource is written.
Short | Language of the resource content
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. DeviceDefinition.text
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Short | Text summary of the resource, for human interpretation
Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
Control | 0..1
Type | Narrative
Is Modifier | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
12. DeviceDefinition.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Short | Contained, inline Resources
Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
Control | 0..*
Type | Resource
Is Modifier | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. DeviceDefinition.extension
Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
16. DeviceDefinition.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
18. DeviceDefinition.identifier
Definition | Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID.
Short | Instance identifier
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..0
Type | Identifier
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. DeviceDefinition.udiDeviceIdentifier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Short | Unique Device Identifier (UDI) Barcode string
Comments | In this profile only a type of device can be represented where the UDI only identifies the type of the device.
Control | 0..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. DeviceDefinition.udiDeviceIdentifier.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
24. DeviceDefinition.udiDeviceIdentifier.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
26. DeviceDefinition.udiDeviceIdentifier.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
28. DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Definition | The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Short | The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
Comments | While the device identifier is a mandatory part of the UDI definition, for this profile the deviceidentifier does not need to be communicated. If it is communicated, it is communicated here. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. DeviceDefinition.udiDeviceIdentifier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : GS1: http://hl7.org/fhir/NamingSystem/gs1-di, HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Short | UDI Issuing Organization
Control | 1..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Requirements | This field is required when Device.udi.deviceIdentifier is valued.
Alternate Names | Barcode System
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. DeviceDefinition.udiDeviceIdentifier.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Short | Regional UDI authority
Control | 1..1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. DeviceDefinition.manufacturer[x]
Definition | A name of the manufacturer.
Short | Name of device manufacturer
Control | 1..1
Type | string
[x] Note | SeeChoice of Data Typesfor further information about how to use [x]
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. DeviceDefinition.deviceName
Definition | A name given to the device to identify it.
Short | A name given to the device to identify it
Control | 0..0
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
43. DeviceDefinition.modelNumber
Definition | The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by all the devices sold as the same type. This would represent the device model/type at the level of granularity that the manufacturer believes is most appropriate to enable the best guidance to assist in the mapping for a particular device used in the Lab.
Short | Model id assigned by the manufacturer
Comments | The Device.model field is used to map the Device to the correct Concept Map (using ConceptMap.group.source) and IVD Test Code System (using CodeSystem.identifier).
Control | 1..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
45. DeviceDefinition.type
Definition | What kind of device or device system this is.
Short | What kind of device or device system this is
Control | 0..1
Binding | Unless not suitable, these codes SHALL be taken from IVD device types for LIVD device definitions VS (extensible to `http://hl7.org/fhir/uv/livd/ValueSet/livd-device-type` ) IVD device types for LIVD device definitions (extensible).
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
47. DeviceDefinition.specialization
Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
Short | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Control | 0..0
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. DeviceDefinition.version
Definition | The available versions of the device, e.g., software versions.
Short | Available versions
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..0
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. DeviceDefinition.safety
Definition | Safety characteristics of the device.
Short | Safety characteristics of the device
Control | 0..0
Binding | For example codes, see DeviceSafety (example to `http://hl7.org/fhir/ValueSet/device-safety|4.0.1` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. DeviceDefinition.shelfLifeStorage
Definition | Shelf Life and storage information.
Short | Shelf Life and storage information
Control | 0..0
Type | ProductShelfLife
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
60. DeviceDefinition.physicalCharacteristics
Definition | Dimensions, color etc.
Short | Dimensions, color etc.
Control | 0..0
Type | ProdCharacteristic
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. DeviceDefinition.languageCode
Definition | Language code for the human-readable text strings produced by the device (all supported).
Short | Language code for the human-readable text strings produced by the device (all supported)
Control | 0..0
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. DeviceDefinition.capability
Definition | Device capabilities.
Short | Device capabilities
Control | 1..*
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. DeviceDefinition.capability.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
68. DeviceDefinition.capability.extension
Definition | An Extension
Short | Extension
Control | 1..*
Type | Extension
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
Slicing | This element introduces a set of slices on `DeviceDefinition.capability.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
70. DeviceDefinition.capability.extension:DeviceDefinitionExtensionAnalyte
Slice Name | DeviceDefinitionExtensionAnalyte
Definition | Add a reference from DeviceDefinition.capability to one or more ObservationDefinition resources representing test analytes that may be measured.
Short | LIVD Test Analyte
Control | 1..* This element is affected by the following invariants: ele-1
Type | Extension(LIVD Test Analyte) (Extension Type: Reference)
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
72. DeviceDefinition.capability.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
74. DeviceDefinition.capability.type
Definition | Type of capability.
Short | Type of capability
Comments | removed "DeviceCapabilityType (ObservationDefinition)" from Value column.
Control | 1..1
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. DeviceDefinition.capability.description
Definition | Description of capability.
Short | Description of capability
Control | 0..0
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. DeviceDefinition.property
Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Short | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Control | 0..0
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. DeviceDefinition.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Short | Organization responsible for device
Control | 0..0
Type | Reference(Organization)
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
88. DeviceDefinition.contact
Definition | Contact details for an organization or a particular human that is responsible for the device.
Short | Details for human/organization for support
Comments | used for troubleshooting etc.
Control | 0..0
Type | ContactPoint
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. DeviceDefinition.url
Definition | A network address on which the device may be contacted directly.
Short | Network address to contact device
Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
Control | 0..0
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. DeviceDefinition.onlineInformation
Definition | Access to on-line information about the device.
Short | Access to on-line information
Control | 0..0
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. DeviceDefinition.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Control | 0..0
Type | Annotation
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. DeviceDefinition.quantity
Definition | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product).
Short | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
Control | 0..0
Type | Quantity
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. DeviceDefinition.parentDevice
Definition | The parent device it can be part of.
Short | The parent device it can be part of
Control | 0..1
Type | Reference(DeviceDefinition)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
100. DeviceDefinition.material
Definition | A substance used to create the material(s) of which the device is made.
Short | A substance used to create the material(s) of which the device is made
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
102. DeviceDefinition.material.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
104. DeviceDefinition.material.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Short | Additional content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
106. DeviceDefinition.material.modifierExtension
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Short | Extensions that cannot be ignored even if unrecognized
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Alternate Names | extensions, user content, modifiers
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ext-1: Must have either extensions or value[x], not both (`extension.exists() != value.exists()`)
108. DeviceDefinition.material.substance
Definition | The substance.
Short | The substance
Control | 1..1
Type | CodeableConcept
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
110. DeviceDefinition.material.alternate
Definition | Indicates an alternative material of the device.
Short | Indicates an alternative material of the device
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. DeviceDefinition.material.allergenicIndicator
Definition | Whether the substance is a known or suspected allergen.
Short | Whether the substance is a known or suspected allergen
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)