Advance Care Planning (PZP) STU3
1.0.0 - release

Advance Care Planning (PZP) STU3 - Downloaded Version 1.0.0 See the Directory of published versions

## Resource Profile: ACP MedicalDevice Product ICD - Detailed Descriptions

Draft as of 2026-08-11

Definitions for the ACP-MedicalDevice.Product-ICD resource profile

- Key Elements Table
- Differential Table
- Snapshot Table

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

0. Device
Definition | The medical aid used (internally or externally). This is the base resource type for everything.
Short | ProductBase Resource
Control | 0..*
Alternate Names | Product
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (`contained.text.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 (`contained.where(('#'+id in %resource.descendants().reference).not()).empty()`)
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.
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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
Control | 0..1
Type | uri
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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. Usually modifier elements provide negation or qualification. In order 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.
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Alternate Names | extensions, user content
6. Device.identifier
Definition | Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information. The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10). 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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device. 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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Alternate Names | Serial Number, ProductID
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 @ type
8. Device.identifier:serialNumber
Slice Name | serialNumber
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | serial number (21) part of the UDIInstance 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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device. 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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1*
Type | Identifier
Alternate Names | Serial Number
10. Device.identifier:serialNumber.use
Definition | The purpose of this identifier.
Short | usual | official | temp | secondary (If known)
Comments | This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Control | 0..1
Binding | The codes SHALL be taken from IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|3.0.2 (required to `http://hl7.org/fhir/ValueSet/identifier-use|3.0.2` ) Identifies the purpose for this identifier, if known .
Type | code
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
12. Device.identifier:serialNumber.type
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Short | Description of identifier
Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Control | 10..1
Binding | Unless not suitable, these codes SHALL be taken from Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type|3.0.2 (extensible to `http://hl7.org/fhir/ValueSet/identifier-type|3.0.2` ) A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Type | CodeableConcept
Summary | true
Requirements | Allows users to make use of identifiers when the identifier system is not known.
Pattern Value | `{ "coding" : [{ "system" : "http://hl7.org/fhir/identifier-type", "code" : "SNO" }] }`
14. Device.identifier:serialNumber.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Control | 10..1*
Type | Coding
Summary | true
Requirements | Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
16. Device.identifier:serialNumber.type.coding.system
Definition | The identification of the code system that defines the meaning of the symbol in the code.
Short | Identity of the terminology system
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.
Control | 10..1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be unambiguous about the source of the definition of the symbol.
Fixed Value | `http://hl7.org/fhir/identifier-type`
18. Device.identifier:serialNumber.type.coding.code
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Short | Symbol in syntax defined by the system
Control | 10..1
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to refer to a particular code in the system.
Fixed Value | `SNO`
20. Device.identifier:serialNumber.value
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Short | The value that is unique
Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.
Control | 10..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Example | General: 123456
22. 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
Binding | The codes SHALL be taken from FHIRDeviceStatus http://hl7.org/fhir/ValueSet/device-status|3.0.2 (required to `http://hl7.org/fhir/ValueSet/device-status|3.0.2` ) The availability status of the device.
Type | code
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
24. Device.type
Definition | The code of the type of product. Code or identifier to identify a kind of device.
Short | ProductTypeWhat kind of device this is
Control | 0..1
Binding | The codes SHALL be taken from For example codes, see ACPMedicalDeviceProductTypeICDVS (1.0.0)http://hl7.org/fhir/ValueSet/device-kind|3.0.2 (required to `https://api.iknl.nl/docs/pzp/stu3/ValueSet/ACP-MedicalDeviceProductType-ICDVS|1.0.0` )
Type | CodeableConcept
Alternate Names | ProductType

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

0. Device
2. Device.identifier:serialNumber
Slice Name | serialNumber
Note | This is a business identifier, not a resource identifier (see discussion)
4. Device.udi
6. Device.udi.carrierHRF
8. Device.type
Binding | The codes SHALL be taken from ACPMedicalDeviceProductTypeICDVS (1.0.0) (required to `https://api.iknl.nl/docs/pzp/stu3/ValueSet/ACP-MedicalDeviceProductType-ICDVS|1.0.0` )
10. Device.note
12. Device.note.text

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

0. Device
Definition | The medical aid used (internally or externally).
Short | Product
Control | 0..*
Alternate Names | Product
Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (`contained.contained.empty()`) dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (`contained.text.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 (`contained.where(('#'+id in %resource.descendants().reference).not()).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
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
4. Device.meta
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Summary | true
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.
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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.
Control | 0..1
Type | uri
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
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
Binding | Unless not suitable, these codes SHALL be taken from Common Languages (extensible to `http://hl7.org/fhir/ValueSet/languages|3.0.2` ) A human language.
Additional Bindings | Purpose
All Languages | Max Binding
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
10. Device.text
Definition | A human-readable narrative that contains a summary of the resource, and may 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 in formation is added later.
Control | 0..1 This element is affected by the following invariants: dom-1
Type | Narrative
Alternate Names | narrative, html, xhtml, display
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.
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. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
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. Usually modifier elements provide negation or qualification. In order 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.
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Alternate Names | extensions, user content
18. Device.identifier
Definition | Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information. The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).
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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Alternate Names | Serial Number, ProductID
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 @ type
20. Device.identifier:serialNumber
Slice Name | serialNumber
Definition | Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
Short | serial number (21) part of the UDI
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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Alternate Names | Serial Number
22. Device.identifier:serialNumber.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
24. Device.identifier:serialNumber.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Slicing | This element introduces a set of slices on `Device.identifier.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
26. Device.identifier:serialNumber.use
Definition | The purpose of this identifier.
Short | usual | official | temp | secondary (If known)
Comments | This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Control | 0..1
Binding | The codes SHALL be taken from IdentifierUse (required to `http://hl7.org/fhir/ValueSet/identifier-use|3.0.2` ) Identifies the purpose for this identifier, if known .
Type | code
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
28. Device.identifier:serialNumber.type
Definition | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Short | Description of identifier
Comments | This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Control | 1..1
Binding | Unless not suitable, these codes SHALL be taken from Identifier Type Codes (extensible to `http://hl7.org/fhir/ValueSet/identifier-type|3.0.2` ) A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Type | CodeableConcept
Summary | true
Requirements | Allows users to make use of identifiers when the identifier system is not known.
Pattern Value | `{ "coding" : [{ "system" : "http://hl7.org/fhir/identifier-type", "code" : "SNO" }] }`
30. Device.identifier:serialNumber.type.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
32. Device.identifier:serialNumber.type.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Slicing | This element introduces a set of slices on `Device.identifier.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
34. Device.identifier:serialNumber.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Control | 1..1
Type | Coding
Summary | true
Requirements | Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
36. Device.identifier:serialNumber.type.coding.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
38. Device.identifier:serialNumber.type.coding.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Slicing | This element introduces a set of slices on `Device.identifier.type.coding.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
40. Device.identifier:serialNumber.type.coding.system
Definition | The identification of the code system that defines the meaning of the symbol in the code.
Short | Identity of the terminology system
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.
Control | 1..1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be unambiguous about the source of the definition of the symbol.
Fixed Value | `http://hl7.org/fhir/identifier-type`
42. Device.identifier:serialNumber.type.coding.version
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Short | Version of the system - if relevant
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
44. Device.identifier:serialNumber.type.coding.code
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Short | Symbol in syntax defined by the system
Control | 1..1
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to refer to a particular code in the system.
Fixed Value | `SNO`
46. Device.identifier:serialNumber.type.coding.display
Definition | A representation of the meaning of the code in the system, following the rules of the system.
Short | Representation defined by the system
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
48. Device.identifier:serialNumber.type.coding.userSelected
Definition | Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).
Short | If this coding was chosen directly by the user
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Control | 0..1
Type | boolean
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
50. Device.identifier:serialNumber.type.text
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Short | Plain text representation of the concept
Comments | Very often the text is the same as a displayName of one of the codings.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
52. Device.identifier:serialNumber.system
Definition | Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Short | The namespace for the identifier value
Control | 0..1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
Example | General: http://www.acme.com/identifiers/patient
54. Device.identifier:serialNumber.value
Definition | The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Short | The value that is unique
Comments | If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.
Control | 1..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Example | General: 123456
56. Device.identifier:serialNumber.period
Definition | Time period during which identifier is/was valid for use.
Short | Time period when id is/was valid for use
Control | 0..1
Type | Period
Summary | true
58. Device.identifier:serialNumber.assigner
Definition | Organization that issued/manages the identifier.
Short | Organization that issued id (may be just text)
Comments | The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
Control | 0..1
Type | Reference(Organization)
Summary | true
60. Device.udi
Definition | Unique device identifier (UDI) assigned to device label or package.
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
Type | BackboneElement
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() | (children().count() > id.count())`)
62. Device.udi.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
64. Device.udi.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
66. Device.udi.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 that contains it. Usually modifier elements provide negation or qualification. In order 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.
Short | Extensions that cannot be ignored
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Summary | true
Alternate Names | extensions, user content, modifiers
68. Device.udi.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 | application identifier (AI) (01) part of the udi
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | DI
70. Device.udi.name
Definition | Name of device as used in labeling or catalog.
Short | Device Name as appears on UDI label
Comments | Use the `Device.type` for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Brand Name
72. Device.udi.jurisdiction
Definition | The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.
Short | Regional UDI authority
Control | 0..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.
74. Device.udi.carrierHRF
Definition | Unique identification of the product, such as the serial number. Frequently used coding systems are HIBC and GTIN. If the law requires this to be registered on the basis of a UDI (Unique Device Identifier), the unique identification must consist of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). See http://www.gs1.org/healthcare/udi for more information. The UDI-DI must be recorded in reference to GS1 GTIN (01) encryptions, with which for example a firm is linked to the product type. The UDI-PI must consist of the following: application identifier (AI); expiration date (17) and serial number (21) and/or batch or lot number (10).
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
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Alternate Names | Human Readable Form
76. Device.udi.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
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
78. Device.udi.issuer
Definition | Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Short | UDI Issuing Organization
Control | 0..1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | Barcode System
80. Device.udi.entryType
Definition | A coded entry to indicate how the data was entered.
Short | barcode | rfid | manual +
Control | 0..1
Binding | The codes SHALL be taken from UDIEntryType (required to `http://hl7.org/fhir/ValueSet/udi-entry-type|3.0.2` ) 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.
82. 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
Binding | The codes SHALL be taken from FHIRDeviceStatus (required to `http://hl7.org/fhir/ValueSet/device-status|3.0.2` ) The availability status of the device.
Type | code
Is Modifier | true because No Modifier Reason provideed in previous versions of FHIR
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
84. Device.type
Definition | The code of the type of product.
Short | ProductType
Control | 0..1
Binding | The codes SHALL be taken from ACPMedicalDeviceProductTypeICDVS (1.0.0) (required to `https://api.iknl.nl/docs/pzp/stu3/ValueSet/ACP-MedicalDeviceProductType-ICDVS|1.0.0` )
Type | CodeableConcept
Alternate Names | ProductType
86. Device.type.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
88. Device.type.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Slicing | This element introduces a set of slices on `Device.type.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
90. Device.type.coding
Definition | A reference to a code defined by a terminology system.
Short | Code defined by a terminology system
Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Control | 0..*
Type | Coding
Summary | true
Requirements | Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.
92. Device.type.coding.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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
94. Device.type.coding.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
Slicing | This element introduces a set of slices on `Device.type.coding.extension`. The slices areUnordered and Open, and can be differentiated using the following discriminators: value @ url
96. Device.type.coding.system
Definition | The identification of the code system that defines the meaning of the symbol in the code.
Short | Identity of the terminology system
Comments | The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.
Control | 1..1
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be unambiguous about the source of the definition of the symbol.
98. Device.type.coding.version
Definition | The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Short | Version of the system - if relevant
Comments | Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
100. Device.type.coding.code
Definition | A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Short | Symbol in syntax defined by the system
Control | 1..1
Type | code
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to refer to a particular code in the system.
102. Device.type.coding.display
Definition | A representation of the meaning of the code in the system, following the rules of the system.
Short | Representation defined by the system
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
104. Device.type.coding.userSelected
Definition | Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).
Short | If this coding was chosen directly by the user
Comments | Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
Control | 0..1
Type | boolean
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
106. Device.type.text
Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Short | Plain text representation of the concept
Comments | For LaboratoryTestResult.Specimen.SpecimenSource a device may be recorded as a subject of the Specimen. For example if the material is not collected directly from the patient but comes from a patient-related object, e.g. a catheter tip. This source of material can be recorded here.
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
108. Device.lotNumber
Definition | Lot number assigned by the manufacturer.
Short | batch or lot number (10) part of the UDI
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
110. Device.manufacturer
Definition | A name of the manufacturer.
Short | Name of device manufacturer
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
112. Device.manufactureDate
Definition | The date and time when the device was manufactured.
Short | Date when the device was made
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
114. Device.expirationDate
Definition | The date and time beyond which this device is no longer valid or should not be used (if applicable).
Short | expiration date (17) part of the UDI
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
116. Device.model
Definition | The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.
Short | Model id assigned by the manufacturer
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
118. Device.version
Definition | The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.
Short | Version number (i.e. software)
Note | This is a business version Id, not a resource version Id (see discussion)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
120. Device.patient
Definition | Patient information, If the device is affixed to a person.
Short | Patient to whom Device is affixed
Control | 0..1
Type | Reference(nl-core-patient)
Requirements | If the device is implanted in a patient, then need to associate the device to the patient.
122. Device.owner
Definition | An organization that is responsible for the provision and ongoing maintenance of the device.
Short | Organization responsible for device
Control | 0..1
Type | Reference(nl-core-organization)
124. 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..*
Type | ContactPoint
126. Device.location
Definition | The place where the device can be found.
Short | Where the resource is found
Control | 0..1
Type | Reference(nl-core-location)
Requirements | Device.location can be used to track device location.
128. 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
Type | uri
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
130. Device.note
Definition | Descriptive information, usage information or implantation information that is not captured in an existing element.
Short | Device notes and comments
Control | 0..*
Type | Annotation
132. 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 | xml:id (or equivalent in JSON)
Control | 0..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
XML Format | In the XML format, this property is represented as an attribute.
134. Device.note.extension
Definition | May be used to represent additional information that is not part of the basic definition of the element. In order 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.
Short | Additional Content defined by implementations
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Control | 0..*
Type | Extension
Alternate Names | extensions, user content
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
136. Device.note.author[x]
Definition | The individual responsible for making the annotation.
Short | Individual responsible for the annotation
Control | 0..1
Type | Choice of: Reference(Practitioner, Patient, RelatedPerson), 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
138. Device.note.time
Definition | Indicates when this particular annotation was made.
Short | When the annotation was made
Control | 0..1
Type | dateTime
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
140. Device.note.text
Definition | Textual description of the product.
Short | ProductDescription
Control | 1..1
Type | string
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Alternate Names | ProductOmschrijving
142. Device.safety
Definition | Provides additional safety characteristics about a medical device. For example devices containing latex.
Short | Safety Characteristics of Device
Control | 0..*
Binding | For example codes, see DeviceSafety (example to `http://hl7.org/fhir/ValueSet/device-safety|3.0.2` ) Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations and are provided here as a suggestive example.
Type | CodeableConcept
Summary | true