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

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.

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.

ShortLIVDDeviceDefinitionAn 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.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-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.

ShortA 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.

Control0..1
Typeuri
Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
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 Namesextensions, user content
Invariantsele-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.

ShortInstance identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..0*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-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.

ShortUnique 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.

Control0..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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).

ShortExtensions 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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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 Namesextensions, user content, modifiers
Invariantsele-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.

ShortThe 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Alternate NamesDI
Invariantsele-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 :

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.

The organization that assigns the identifier algorithm.

ShortUDI Issuing OrganizationThe organization that assigns the identifier algorithm
Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Requirements

This field is required when Device.udi.deviceIdentifier is valued.

Alternate NamesBarcode System
Invariantsele-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.

ShortRegional UDI authorityThe jurisdiction to which the deviceIdentifier applies
Control1..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Invariantsele-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.

ShortName of device manufacturer
Control10..1
Typestring, Reference(Organization)
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Invariantsele-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.

ShortA name given to the device to identify it
Control0..0*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-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.

ShortModel 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).

Control10..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summaryfalse
Invariantsele-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.

ShortWhat kind of device or device system this is
Control0..1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see IVD device types for LIVD device definitions VShttp://hl7.org/fhir/ValueSet/device-kind
(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.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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.

ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Control0..0*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-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.

ShortAvailable versions
NoteThis is a business version Id, not a resource version Id (see discussion)
Control0..0*
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-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.

ShortSafety characteristics of the device
Control0..0*
BindingFor example codes, see DeviceSafetyhttp://hl7.org/fhir/ValueSet/device-safety
(example to http://hl7.org/fhir/ValueSet/device-safety)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-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.

ShortShelf Life and storage information
Control0..0*
TypeProductShelfLife
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. DeviceDefinition.physicalCharacteristics
Definition

Dimensions, color etc.

ShortDimensions, color etc.
Control0..01
TypeProdCharacteristic
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-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).

ShortLanguage code for the human-readable text strings produced by the device (all supported)
Control0..0*
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. DeviceDefinition.capability
Definition

Device capabilities.

ShortDevice capabilities
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-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.

ShortExtensionAdditional 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.

Control10..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis 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 NameDeviceDefinitionExtensionAnalyte
    Definition

    Add a reference from DeviceDefinition.capability to one or more ObservationDefinition resources representing test analytes that may be measured.

    ShortLIVD Test Analyte
    Control1..*
    This element is affected by the following invariants: ele-1
    TypeExtension(LIVD Test Analyte) (Extension Type: Reference)
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-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).

    ShortExtensions 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.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    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 Namesextensions, user content, modifiers
    Invariantsele-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.

    ShortType of capability
    Comments

    removed "DeviceCapabilityType (ObservationDefinition)" from Value column.

    Control1..1
    TypeCodeableConcept
    Is Modifierfalse
    Must Supporttrue
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    54. DeviceDefinition.capability.description
    Definition

    Description of capability.

    ShortDescription of capability
    Control0..0*
    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
    Control0..0*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortOrganization responsible for device
    Control0..01
    TypeReference(Organization)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortDetails for human/organization for support
    Comments

    used for troubleshooting etc.

    Control0..0*
    TypeContactPoint
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortNetwork 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.

    Control0..01
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortAccess to on-line information
    Control0..01
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Invariantsele-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.

    ShortDevice notes and comments
    Control0..0*
    TypeAnnotation
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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).

    ShortThe 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)
    Control0..01
    TypeQuantity
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-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
    ShortLIVDDeviceDefinition
    Must Supportfalse
    2. DeviceDefinition.identifier
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..0
    Must Supportfalse
    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.

    Control0..1
    Must Supporttrue
    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 Supporttrue
    Alternate NamesDI
    8. DeviceDefinition.udiDeviceIdentifier.issuer
    Definition

    Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

    1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
    2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
    3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
    4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
    ShortUDI Issuing Organization
    Must Supporttrue
    Requirements

    This field is required when Device.udi.deviceIdentifier is valued.

    Alternate NamesBarcode 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.

    ShortRegional UDI authority
    Must Supporttrue
    Requirements

    Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

    12. DeviceDefinition.manufacturer[x]
    Control1..?
    Typestring, Reference(Organization)
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    14. DeviceDefinition.deviceName
    Control0..0
    Must Supportfalse
    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.

    ShortModel 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).

    Control1..?
    Must Supporttrue
    20. DeviceDefinition.type
    BindingUnless 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 Supporttrue
    22. DeviceDefinition.specialization
    Control0..0
    Must Supportfalse
    26. DeviceDefinition.version
    NoteThis is a business version Id, not a resource version Id (see discussion)
    Control0..0
    Must Supportfalse
    28. DeviceDefinition.safety
    Control0..0
    Must Supportfalse
    30. DeviceDefinition.shelfLifeStorage
    Control0..0
    Must Supportfalse
    32. DeviceDefinition.physicalCharacteristics
    Control0..0
    Must Supportfalse
    34. DeviceDefinition.languageCode
    Control0..0
    Must Supportfalse
    36. DeviceDefinition.capability
    Control1..?
    Must Supporttrue
    38. DeviceDefinition.capability.extension
    Control1..?
    SlicingThis 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 NameDeviceDefinitionExtensionAnalyte
      Control1..*
      TypeExtension(LIVD Test Analyte) (Extension Type: Reference)
      Must Supporttrue
      42. DeviceDefinition.capability.type
      Comments

      removed "DeviceCapabilityType (ObservationDefinition)" from Value column.

      Must Supporttrue
      44. DeviceDefinition.capability.description
      Control0..0
      Must Supportfalse
      46. DeviceDefinition.property
      Control0..0
      Must Supportfalse
      51. DeviceDefinition.owner
      Control0..0
      Must Supportfalse
      53. DeviceDefinition.contact
      Control0..0
      Must Supportfalse
      55. DeviceDefinition.url
      Control0..0
      Must Supportfalse
      57. DeviceDefinition.onlineInformation
      Control0..0
      Must Supportfalse
      59. DeviceDefinition.note
      Control0..0
      Must Supportfalse
      61. DeviceDefinition.quantity
      Control0..0
      Must Supportfalse

      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.

      ShortLIVDDeviceDefinition
      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.

      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsdom-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.

      ShortLogical 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.

      Control0..1
      Typeid
      Is Modifierfalse
      Summarytrue
      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.

      ShortMetadata about the resource
      Control0..1
      TypeMeta
      Is Modifierfalse
      Summarytrue
      Invariantsele-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.

      ShortA 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.

      Control0..1
      Typeuri
      Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-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.

      ShortLanguage 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).

      Control0..1
      BindingThe codes SHOULD be taken from CommonLanguages
      (preferred to http://hl7.org/fhir/ValueSet/languages)

      A human language.

      Additional BindingsPurpose
      AllLanguagesMax Binding
      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summaryfalse
      Invariantsele-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.

      ShortText 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.

      Control0..1
      TypeNarrative
      Is Modifierfalse
      Summaryfalse
      Alternate Namesnarrative, html, xhtml, display
      Invariantsele-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.

      ShortContained, 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.

      Control0..*
      TypeResource
      Is Modifierfalse
      Summaryfalse
      Alternate Namesinline 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.

      ShortAdditional 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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-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).

      ShortExtensions 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.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Summaryfalse
      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 Namesextensions, user content
      Invariantsele-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.

      ShortInstance identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..0
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-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.

      ShortUnique 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.

      Control0..1
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-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.

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      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.

      ShortAdditional 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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-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).

      ShortExtensions 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.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      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 Namesextensions, user content, modifiers
      Invariantsele-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.

      ShortThe 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.

      Control1..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Alternate NamesDI
      Invariantsele-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 :

      1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
      2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
      3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
      4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
      ShortUDI Issuing Organization
      Control1..1
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Requirements

      This field is required when Device.udi.deviceIdentifier is valued.

      Alternate NamesBarcode System
      Invariantsele-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.

      ShortRegional UDI authority
      Control1..1
      Typeuri
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Requirements

      Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

      Invariantsele-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.

      ShortName of device manufacturer
      Control1..1
      Typestring
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Invariantsele-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.

      ShortA name given to the device to identify it
      Control0..0
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-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.

      ShortModel 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).

      Control1..1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summaryfalse
      Invariantsele-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.

      ShortWhat kind of device or device system this is
      Control0..1
      BindingUnless 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).

      TypeCodeableConcept
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-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.

      ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
      Control0..0
      TypeBackboneElement
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-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.

      ShortAvailable versions
      NoteThis is a business version Id, not a resource version Id (see discussion)
      Control0..0
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-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.

      ShortSafety characteristics of the device
      Control0..0
      BindingFor example codes, see DeviceSafety
      (example to http://hl7.org/fhir/ValueSet/device-safety)
      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-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.

      ShortShelf Life and storage information
      Control0..0
      TypeProductShelfLife
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      60. DeviceDefinition.physicalCharacteristics
      Definition

      Dimensions, color etc.

      ShortDimensions, color etc.
      Control0..0
      TypeProdCharacteristic
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-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).

      ShortLanguage code for the human-readable text strings produced by the device (all supported)
      Control0..0
      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      64. DeviceDefinition.capability
      Definition

      Device capabilities.

      ShortDevice capabilities
      Control1..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Invariantsele-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.

      ShortUnique id for inter-element referencing
      Control0..1
      Typestring
      Is Modifierfalse
      XML FormatIn the XML format, this property is represented as an attribute.
      Summaryfalse
      68. DeviceDefinition.capability.extension
      Definition

      An Extension

      ShortExtension
      Control1..*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-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())
      SlicingThis 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 NameDeviceDefinitionExtensionAnalyte
        Definition

        Add a reference from DeviceDefinition.capability to one or more ObservationDefinition resources representing test analytes that may be measured.

        ShortLIVD Test Analyte
        Control1..*
        This element is affected by the following invariants: ele-1
        TypeExtension(LIVD Test Analyte) (Extension Type: Reference)
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-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).

        ShortExtensions 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.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        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 Namesextensions, user content, modifiers
        Invariantsele-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.

        ShortType of capability
        Comments

        removed "DeviceCapabilityType (ObservationDefinition)" from Value column.

        Control1..1
        TypeCodeableConcept
        Is Modifierfalse
        Must Supporttrue
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        76. DeviceDefinition.capability.description
        Definition

        Description of capability.

        ShortDescription of capability
        Control0..0
        TypeCodeableConcept
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
        Control0..0
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortOrganization responsible for device
        Control0..0
        TypeReference(Organization)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortDetails for human/organization for support
        Comments

        used for troubleshooting etc.

        Control0..0
        TypeContactPoint
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortNetwork 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.

        Control0..0
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortAccess to on-line information
        Control0..0
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortDevice notes and comments
        Control0..0
        TypeAnnotation
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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).

        ShortThe 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)
        Control0..0
        TypeQuantity
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-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.

        ShortThe parent device it can be part of
        Control0..1
        TypeReference(DeviceDefinition)
        Is Modifierfalse
        Summarytrue
        Invariantsele-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.

        ShortA substance used to create the material(s) of which the device is made
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Summaryfalse
        Invariantsele-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.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        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.

        ShortAdditional 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.

        Control0..*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-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).

        ShortExtensions 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.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
        Summarytrue
        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 Namesextensions, user content, modifiers
        Invariantsele-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.

        ShortThe substance
        Control1..1
        TypeCodeableConcept
        Is Modifierfalse
        Summaryfalse
        Invariantsele-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.

        ShortIndicates an alternative material of the device
        Control0..1
        Typeboolean
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-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.

        ShortWhether the substance is a known or suspected allergen
        Control0..1
        Typeboolean
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))