Advance Care Planning (PZP)
1.0.0-rc1 - trial-use

Advance Care Planning (PZP) - Downloaded Version 1.0.0-rc1 See the Directory of published versions

## Resource Profile: ACPMedicalDeviceProductICD - Detailed Descriptions

Draft as of 2025-10-30

Definitions for the ACP-MedicalDevice.Product-ICD 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. Device
Definition | The medical device (internally or externally). A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
Short | ProductItem used in healthcare
Comments | Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device. In all cases the full identifier will be populated in `.identifier`. If the identifier is a UDI in particular, it should also be populated in `udiCarrier.carrierHRF`, and the element `udiCarrier.issuer` is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely `.udiCarrier.deviceIdentifier`, `.manufactureDate`, `.expirationDate`, `.lotNumber` and `.serialNumber`. For GTIN, guidance is given at the respective elements in this profile and is based on https://www.gs1.org/industries/healthcare/udi. For HIBC please consult the the Supplier Labeling Standard that can be found at https://www.hibcc.org/udi-labeling-standards/barcode-standards/, as conversion into the several parts is less straightforward.
Control | 0..*
Is Modifier | false
Alternate Names | Product, nl-core-MedicalDevice.Product
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.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-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-6: A resource should have narrative for robust management (`text.`div`.exists()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`) 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. Device.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 This element is affected by the following invariants: ele-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())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.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..* This element is affected by the following invariants: ele-1
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
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()`) 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 `Device.modifierExtension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
6. Device.identifier
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | Instance identifier
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1* This element is affected by the following invariants: ele-1
Type | Identifier
Is Modifier | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `Device.identifier`. The slices areUnordered and Open, and can be differentiated using the following discriminators: pattern @ $this
8. Device.identifier:gs1ProductID
Slice Name | gs1ProductID
Definition | Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource. Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | ProductIDInstance identifier
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1* This element is affected by the following invariants: ele-1
Type | Identifier
Is Modifier | false
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductID
Pattern Value | `{ "system" : "https://www.gs1.org/gtin" }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.identifier:hibcProductID
Slice Name | hibcProductID
Definition | Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource. Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | ProductIDInstance identifier
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1* This element is affected by the following invariants: ele-1
Type | Identifier
Is Modifier | false
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductID
Pattern Value | `{ "system" : "urn:oid:2.16.840.1.113883.6.40" }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.udiCarrier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC. 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 | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1* This element is affected by the following invariants: ele-1
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `Device.udiCarrier`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ issuer
14. Device.udiCarrier.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..* This element is affected by the following invariants: ele-1
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()`) 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. Device.udiCarrier:gs1UdiCarrier
Slice Name | gs1UdiCarrier
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 | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1* This element is affected by the following invariants: ele-1
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Device.udiCarrier:gs1UdiCarrier.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..* This element is affected by the following invariants: ele-1
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()`) 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())
20. Device.udiCarrier:gs1UdiCarrier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID. 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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
Pattern Value | `https://www.gs1.org/gtin`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.udiCarrier:gs1UdiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | ProductIDUDI Human Readable Barcode String
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | Human Readable Form, ProductID
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.udiCarrier:hibcUdiCarrier
Slice Name | hibcUdiCarrier
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 | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1* This element is affected by the following invariants: ele-1
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. Device.udiCarrier:hibcUdiCarrier.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..* This element is affected by the following invariants: ele-1
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()`) 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. Device.udiCarrier:hibcUdiCarrier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID. 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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
Pattern Value | `urn:oid:2.16.840.1.113883.6.40`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Device.udiCarrier:hibcUdiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | ProductIDUDI Human Readable Barcode String
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | Human Readable Form, ProductID
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Device.status
Definition | Status of the Device availability.
Short | active | inactive | entered-in-error | unknown
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|4.0.1 (required to `http://hl7.org/fhir/ValueSet/device-status|4.0.1` ) The availability status of the device.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
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())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Device.type
Definition | The code of the type of product. The kind or type of device.
Short | ProductTypeThe kind or type of device
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from For example codes, see ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1)http://hl7.org/fhir/ValueSet/device-type|4.0.1 (required to `https://api.iknl.nl/docs/pzp/r4/ValueSet/ACP-MedicalDeviceProductType-ICD|1.0.0-rc1` )
Type | CodeableConcept
Is Modifier | false
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductType
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Device.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Comments | For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
Control | 0..1* This element is affected by the following invariants: ele-1
Type | Annotation
Is Modifier | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Device.note.text
Definition | Textual description of the product. The text of the annotation in markdown format.
Short | ProductDescriptionThe annotation - text content (as markdown)
Comments | Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
Control | 1..1 This element is affected by the following invariants: ele-1
Type | markdown
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | ProductOmschrijving
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) 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. Device
2. Device.identifier:gs1ProductID
Slice Name | gs1ProductID
Note | This is a business identifier, not a resource identifier (see discussion)
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
4. Device.identifier:hibcProductID
Slice Name | hibcProductID
Note | This is a business identifier, not a resource identifier (see discussion)
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
6. Device.udiCarrier:gs1UdiCarrier
Slice Name | gs1UdiCarrier
8. Device.udiCarrier:gs1UdiCarrier.carrierHRF
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
10. Device.udiCarrier:hibcUdiCarrier
Slice Name | hibcUdiCarrier
12. Device.udiCarrier:hibcUdiCarrier.carrierHRF
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
14. Device.type
Binding | The codes SHALL be taken from ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required to `https://api.iknl.nl/docs/pzp/r4/ValueSet/ACP-MedicalDeviceProductType-ICD|1.0.0-rc1` )
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
16. Device.note
18. Device.note.text
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter

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

0. Device
Definition | The medical device (internally or externally).
Short | Product
Comments | Frequently used coding systems to identify devices are Health Industry Bar Code (HIBC) or GS1's Global Trade Item Number (GTIN). If one of these systems is used, the device identification happens on the basis of a UDI. Next to these two, other systems to identify devices are allowed by the zib, as long as such a system allows for unique identification of the device. In all cases the full identifier will be populated in `.identifier`. If the identifier is a UDI in particular, it should also be populated in `udiCarrier.carrierHRF`, and the element `udiCarrier.issuer` is used to indicate which 'coding system' is used. Moreover the identifier may be broken down into several parts in that case, namely `.udiCarrier.deviceIdentifier`, `.manufactureDate`, `.expirationDate`, `.lotNumber` and `.serialNumber`. For GTIN, guidance is given at the respective elements in this profile and is based on https://www.gs1.org/industries/healthcare/udi. For HIBC please consult the the Supplier Labeling Standard that can be found at https://www.hibcc.org/udi-labeling-standards/barcode-standards/, as conversion into the several parts is less straightforward.
Control | 0..*
Alternate Names | Product, nl-core-MedicalDevice.Product
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.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-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-6: A resource should have narrative for robust management (`text.`div`.exists()`) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (`contained.meta.security.empty()`)
2. Device.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
Summary | true
4. Device.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 This element is affected by the following invariants: ele-1
Type | Meta
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
6. Device.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 This element is affected by the following invariants: ele-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. Device.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 This element is affected by the following invariants: ele-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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
10. Device.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 This element is affected by the following invariants: ele-1
Type | Narrative
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. Device.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
Alternate Names | inline resources, anonymous resources, contained resources
14. Device.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
16. Device.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..* This element is affected by the following invariants: ele-1
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
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()`)
Slicing | This element introduces a set of slices on `Device.modifierExtension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
18. Device.identifier
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | Instance identifier
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Identifier
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `Device.identifier`. The slices areUnordered and Open, and can be differentiated using the following discriminators: pattern @ $this
20. Device.identifier:gs1ProductID
Slice Name | gs1ProductID
Definition | Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource.
Short | ProductID
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Identifier
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductID
Pattern Value | `{ "system" : "https://www.gs1.org/gtin" }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
22. Device.identifier:hibcProductID
Slice Name | hibcProductID
Definition | Unique identification of the product, such as the serial number. The `identifier` may only be used if it also identifies the resource.
Short | ProductID
Comments | The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Identifier
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductID
Pattern Value | `{ "system" : "urn:oid:2.16.840.1.113883.6.40" }`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
24. Device.definition
Definition | The reference to the definition for the device.
Short | The reference to the definition for the device
Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Reference(DeviceDefinition)
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ref-1: SHALL have a contained resource if a local reference is provided (`reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`)
26. Device.udiCarrier
Definition | Unique device identifier (UDI) assigned to device label or package. Note that a udiCarrier is only applicable if the zib concept ProductID actually contains a UDI, e.g. an ID according to GTIN or HIBC.
Short | Unique Device Identifier (UDI) Barcode string
Comments | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | BackboneElement
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `Device.udiCarrier`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ issuer
28. Device.udiCarrier.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
XML Format | In the XML format, this property is represented as an attribute.
30. Device.udiCarrier.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.udiCarrier.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
32. Device.udiCarrier.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..* This element is affected by the following invariants: ele-1
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()`)
34. Device.udiCarrier.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 | Mandatory fixed portion of UDI
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. Device.udiCarrier.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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. Device.udiCarrier.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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
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())`)
40. Device.udiCarrier.carrierAIDC
Definition | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.
Short | UDI Machine Readable Barcode String
Comments | The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | base64Binary
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Automatic Identification and Data Capture
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. Device.udiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | UDI Human Readable Barcode String
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Human Readable Form
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. Device.udiCarrier.entryType
Definition | A coded entry to indicate how the data was entered.
Short | barcode | rfid | manual +
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from UDIEntryType (required to `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` ) Codes to identify how UDI data was entered.
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Requirements | Supports a way to distinguish hand entered from machine read data.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. Device.udiCarrier:gs1UdiCarrier
Slice Name | gs1UdiCarrier
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 | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | BackboneElement
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. Device.udiCarrier:gs1UdiCarrier.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
XML Format | In the XML format, this property is represented as an attribute.
50. Device.udiCarrier:gs1UdiCarrier.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.udiCarrier.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
52. Device.udiCarrier:gs1UdiCarrier.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..* This element is affected by the following invariants: ele-1
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()`)
54. Device.udiCarrier:gs1UdiCarrier.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. In the GS1 standard this element represents the GTIN itself - e.g. 01234567891234 - as part of the Application Identifier (AI), namely AI(01).
Short | Mandatory fixed portion of UDI
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. Device.udiCarrier:gs1UdiCarrier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.
Short | UDI Issuing Organization
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
Pattern Value | `https://www.gs1.org/gtin`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. Device.udiCarrier:gs1UdiCarrier.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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
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())`)
60. Device.udiCarrier:gs1UdiCarrier.carrierAIDC
Definition | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.
Short | UDI Machine Readable Barcode String
Comments | The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | base64Binary
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Automatic Identification and Data Capture
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
62. Device.udiCarrier:gs1UdiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | ProductID
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | Human Readable Form, ProductID
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
64. Device.udiCarrier:gs1UdiCarrier.entryType
Definition | A coded entry to indicate how the data was entered.
Short | barcode | rfid | manual +
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from UDIEntryType (required to `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` ) Codes to identify how UDI data was entered.
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Requirements | Supports a way to distinguish hand entered from machine read data.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. Device.udiCarrier:hibcUdiCarrier
Slice Name | hibcUdiCarrier
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 | UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | BackboneElement
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. Device.udiCarrier:hibcUdiCarrier.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
XML Format | In the XML format, this property is represented as an attribute.
70. Device.udiCarrier:hibcUdiCarrier.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.udiCarrier.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
72. Device.udiCarrier:hibcUdiCarrier.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..* This element is affected by the following invariants: ele-1
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. Device.udiCarrier:hibcUdiCarrier.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 | Mandatory fixed portion of UDI
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. Device.udiCarrier:hibcUdiCarrier.issuer
Definition | Organization that is charged with issuing UDIs for devices. For the zib this would be GS1's Global Trade Item Number (GTIN) or Health Industry Bar Code (HIBC). Note that the issuer must match the issuer implicitly contained in the ProductID.
Short | UDI Issuing Organization
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
Pattern Value | `urn:oid:2.16.840.1.113883.6.40`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. Device.udiCarrier:hibcUdiCarrier.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
Comments | see http://en.wikipedia.org/wiki/Uniform_resource_identifier
Control | 0..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
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())`)
80. Device.udiCarrier:hibcUdiCarrier.carrierAIDC
Definition | The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.
Short | UDI Machine Readable Barcode String
Comments | The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | base64Binary
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Automatic Identification and Data Capture
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
82. Device.udiCarrier:hibcUdiCarrier.carrierHRF
Definition | The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Short | ProductID
Comments | If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | Human Readable Form, ProductID
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
84. Device.udiCarrier:hibcUdiCarrier.entryType
Definition | A coded entry to indicate how the data was entered.
Short | barcode | rfid | manual +
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from UDIEntryType (required to `http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1` ) Codes to identify how UDI data was entered.
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Requirements | Supports a way to distinguish hand entered from machine read data.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
86. Device.status
Definition | Status of the Device availability.
Short | active | inactive | entered-in-error | unknown
Comments | This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from FHIRDeviceStatus (required to `http://hl7.org/fhir/ValueSet/device-status|4.0.1` ) The availability status of the device.
Type | code
Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
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())`)
88. Device.statusReason
Definition | Reason for the dtatus of the Device availability.
Short | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..* This element is affected by the following invariants: ele-1
Binding | Unless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason (extensible to `http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1` ) The availability status reason of the device.
Type | CodeableConcept
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
90. Device.distinctIdentifier
Definition | The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.
Short | The distinct identification string
Comments | For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Distinct Identification Code (DIC)
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. Device.manufacturer
Definition | A name of the manufacturer.
Short | Name of device manufacturer
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. Device.manufactureDate
Definition | The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Manufacture date - e.g. 250717 - as part of the Application Identifier (AI), namely AI(11).
Short | Date when the device was made
Control | 0..1 This element is affected by the following invariants: ele-1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. Device.expirationDate
Definition | The expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Expiration date - e.g. 141120 - as part of the Application Identifier (AI), namely AI(17).
Short | Date and time of expiry of this device (if applicable)
Control | 0..1 This element is affected by the following invariants: ele-1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. Device.lotNumber
Definition | The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. In the GS1 standard this element represents the Lot/batch number - e.g. 1234AB - as part of the Application Identifier (AI), namely AI(10).
Short | Lot number of manufacture
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
100. Device.serialNumber
Definition | The serial number assigned by the organization when the device was manufactured. In the GS1 standard this element represents the Serial number - e.g. 12345XYZ - as part of the Application Identifier (AI), namely AI(21).
Short | Serial number assigned by the manufacturer
Comments | Alphanumeric Maximum 20.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
102. Device.deviceName
Definition | This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
Short | The name of the device as given by the manufacturer
Control | 0..* This element is affected by the following invariants: ele-1
Type | BackboneElement
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
104. Device.deviceName.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
XML Format | In the XML format, this property is represented as an attribute.
106. Device.deviceName.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.deviceName.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
108. Device.deviceName.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..* This element is affected by the following invariants: ele-1
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()`)
110. Device.deviceName.name
Definition | The name of the device.
Short | The name of the device
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 1..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. Device.deviceName.type
Definition | The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
Short | udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 1..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from DeviceNameType (required to `http://hl7.org/fhir/ValueSet/device-nametype|4.0.1` ) The type of name the device is referred by.
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. Device.modelNumber
Definition | The model number for the device.
Short | The model number for the device
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
116. Device.partNumber
Definition | The part number of the device.
Short | The part number of the device
Comments | Alphanumeric Maximum 20.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
118. Device.type
Definition | The code of the type of product.
Short | ProductType
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..1 This element is affected by the following invariants: ele-1
Binding | The codes SHALL be taken from ACPMedicalDeviceProductTypeICDVS (1.0.0-rc1) (required to `https://api.iknl.nl/docs/pzp/r4/ValueSet/ACP-MedicalDeviceProductType-ICD|1.0.0-rc1` )
Type | CodeableConcept
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Alternate Names | ProductType
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
120. Device.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..* This element is affected by the following invariants: ele-1
Type | BackboneElement
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
122. Device.specialization.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
XML Format | In the XML format, this property is represented as an attribute.
124. Device.specialization.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.specialization.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
126. Device.specialization.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..* This element is affected by the following invariants: ele-1
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()`)
128. Device.specialization.systemType
Definition | The standard that is used to operate and communicate.
Short | The standard that is used to operate and communicate
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 1..1 This element is affected by the following invariants: ele-1
Type | CodeableConcept
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
130. Device.specialization.version
Definition | The version of the standard that is used to operate and communicate.
Short | The version of the standard that is used to operate and communicate
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
132. Device.version
Definition | The actual design of the device or software version running on the device.
Short | The actual design of the device or software version running on the device
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..* This element is affected by the following invariants: ele-1
Type | BackboneElement
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
134. Device.version.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
XML Format | In the XML format, this property is represented as an attribute.
136. Device.version.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.version.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
138. Device.version.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..* This element is affected by the following invariants: ele-1
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()`)
140. Device.version.type
Definition | The type of the device version.
Short | The type of the device version
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | CodeableConcept
Alternate Names | Σ
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
142. Device.version.component
Definition | A single component of the device version.
Short | A single component of the device version
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Identifier
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
144. Device.version.value
Definition | The version text.
Short | The version text
Comments | Note that FHIR strings SHALL NOT exceed 1MB in size
Control | 1..1 This element is affected by the following invariants: ele-1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
146. Device.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..* This element is affected by the following invariants: ele-1
Type | BackboneElement
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
148. Device.property.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
XML Format | In the XML format, this property is represented as an attribute.
150. Device.property.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.property.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
152. Device.property.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..* This element is affected by the following invariants: ele-1
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()`)
154. Device.property.type
Definition | Code that specifies the property DeviceDefinitionPropetyCode (Extensible).
Short | Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 1..1 This element is affected by the following invariants: ele-1
Type | CodeableConcept
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
156. Device.property.valueQuantity
Definition | Property value as a quantity.
Short | Property value as a quantity
Comments | The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.
Control | 0..* This element is affected by the following invariants: ele-1
Type | Quantity
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) qty-3: If a code for the unit is present, the system SHALL also be present (`code.empty() or system.exists()`)
158. Device.property.valueCode
Definition | Property value as a code, e.g., NTP4 (synced to NTP).
Short | Property value as a code, e.g., NTP4 (synced to NTP)
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..* This element is affected by the following invariants: ele-1
Type | CodeableConcept
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
160. Device.patient
Definition | Patient information, If the device is affixed to a person.
Short | Patient to whom Device is affixed
Comments | According to https://www.hl7.org/fhir/r4/compartmentdefinition-patient.html, this reference may not be populated. Therefore, no reference to the nl-core-Patient profile is defined here.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Reference(Patient)
Requirements | If the device is implanted in a patient, then need to associate the device to the patient.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ref-1: SHALL have a contained resource if a local reference is provided (`reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`)
162. Device.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Short | Organization responsible for device
Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Reference(Organization)
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ref-1: SHALL have a contained resource if a local reference is provided (`reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`)
164. Device.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..* This element is affected by the following invariants: ele-1
Type | ContactPoint
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) cpt-2: A system is required if a value is provided. (`value.empty() or system.exists()`)
166. Device.location
Definition | The place where the device can be found.
Short | Where the device is found
Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Reference(Location)
Requirements | Device.location can be used to track device location.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ref-1: SHALL have a contained resource if a local reference is provided (`reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`)
168. Device.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..1 This element is affected by the following invariants: ele-1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
170. Device.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Comments | For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Annotation
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
172. Device.note.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
XML Format | In the XML format, this property is represented as an attribute.
174. Device.note.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..* This element is affected by the following invariants: ele-1
Type | Extension
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 `Device.note.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
176. Device.note.author[x]
Definition | The individual responsible for making the annotation.
Short | Individual responsible for the annotation
Comments | Organization is used when there's no need for specific attribution as to who made the comment.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Choice of: Reference(Practitioner, Patient, RelatedPerson, Organization), string
[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
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
178. Device.note.time
Definition | Indicates when this particular annotation was made.
Short | When the annotation was made
Control | 0..1 This element is affected by the following invariants: ele-1
Type | dateTime
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())`)
180. Device.note.text
Definition | Textual description of the product.
Short | ProductDescription
Comments | Systems are not required to have markdown support, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/
Control | 1..1 This element is affected by the following invariants: ele-1
Type | markdown
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHALL:populate-if-known | ACP Actor Provider
SHALL:no-error | ACP Actor Consulter
Summary | true
Alternate Names | ProductOmschrijving
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
182. Device.safety
Definition | Provides additional safety characteristics about a medical device. For example devices containing latex.
Short | Safety Characteristics of Device
Comments | Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Control | 0..* This element is affected by the following invariants: ele-1
Type | CodeableConcept
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
184. Device.parent
Definition | The parent device.
Short | The parent device
Comments | References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Control | 0..1 This element is affected by the following invariants: ele-1
Type | Reference(Device)
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`) ref-1: SHALL have a contained resource if a local reference is provided (`reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`)