IKNL PZP STU3
0.1.3-beta3 - consultation
IKNL PZP STU3 - Local Development build (v0.1.3-beta3) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Draft as of 2025-08-28 |
Definitions for the ACP-MedicalDevice.Product-ICD resource profile.
Guidance on how to interpret the contents of this table can be foundhere
0. Device | |
Definitie | The medical aid used (internally or externally). This resource identifies an instance or 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. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc. |
Kort | ProductItem used in healthcare |
Control | 0..* |
Alternatieve namen | 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() )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 | |
Definitie | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. |
Kort | A set of rules under which this content was created |
Opmerkingen | 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 omdat No Modifier Reason provideed in previous versions of FHIR |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | true |
4. Device.modifierExtension | |
Definitie | 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. |
Kort | Extensions that cannot be ignored |
Opmerkingen | 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 omdat No Modifier Reason provideed in previous versions of FHIR |
Alternatieve namen | extensions, user content |
6. Device.identifier | |
Definitie | 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. |
Kort | ProductIDInstance identifier |
Opmerkingen | 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. |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
Control | 0..* |
Type | Identifier |
Alternatieve namen | Serial Number, ProductID |
Slicing | Dit element introduceert een set slices op Device.identifier De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: |
8. Device.identifier:serialNumber | |
Slicenaam | serialNumber |
Definitie | Unique instance identifiers assigned to a device by manufacturers other organizations or owners. |
Kort | serial number (21) part of the UDIInstance identifier |
Opmerkingen | 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. |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
Control | 0..1* |
Type | Identifier |
Alternatieve namen | Serial Number |
10. Device.identifier:serialNumber.use | |
Definitie | The purpose of this identifier. |
Kort | usual | official | temp | secondary (If known) |
Opmerkingen | 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 | De codes MOETEN komen uit IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use (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 omdat No Modifier Reason provideed in previous versions of FHIR |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | 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 | |
Definitie | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. |
Kort | Description of identifier |
Opmerkingen | 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 | Tenzij dat niet past, MOETEN deze codes worden gehaald uit Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type (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 |
Samenvatting | true |
Requirements | Allows users to make use of identifiers when the identifier system is not known. |
Patroonwaarde | { |
14. Device.identifier:serialNumber.type.coding | |
Definitie | A reference to a code defined by a terminology system. |
Kort | Code defined by a terminology system |
Opmerkingen | 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 |
Samenvatting | 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 | |
Definitie | The identification of the code system that defines the meaning of the symbol in the code. |
Kort | Identity of the terminology system |
Opmerkingen | 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 |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | true |
Requirements | Need to be unambiguous about the source of the definition of the symbol. |
Vast waarde | http://hl7.org/fhir/identifier-type |
18. Device.identifier:serialNumber.type.coding.code | |
Definitie | 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). |
Kort | Symbol in syntax defined by the system |
Control | 10..1 |
Type | code |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | true |
Requirements | Need to refer to a particular code in the system. |
Vast waarde | SNO |
20. Device.identifier:serialNumber.value | |
Definitie | The portion of the identifier typically relevant to the user and which is unique within the context of the system. |
Kort | The value that is unique |
Opmerkingen | 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 |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | true |
Voorbeeld | General: 123456 |
22. Device.identifier:gs1ProductID | |
Slicenaam | gs1ProductID |
Definitie | 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. |
Kort | ProductIDInstance identifier |
Opmerkingen | 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. |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
Control | 0..* |
Type | Identifier |
Alternatieve namen | Serial Number, ProductID |
24. Device.identifier:hibcProductID | |
Slicenaam | hibcProductID |
Definitie | 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. |
Kort | ProductIDInstance identifier |
Opmerkingen | 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. |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
Control | 0..* |
Type | Identifier |
Alternatieve namen | Serial Number, ProductID |
26. Device.status | |
Definitie | Status of the Device availability. |
Kort | active | inactive | entered-in-error | unknown |
Opmerkingen | 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 | De codes MOETEN komen uit FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status (required to http://hl7.org/fhir/ValueSet/device-status|3.0.2 )The availability status of the device. |
Type | code |
Is modifier | true omdat No Modifier Reason provideed in previous versions of FHIR |
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie |
Samenvatting | true |
28. Device.type | |
Definitie | The code of the type of product. Code or identifier to identify a kind of device. |
Kort | ProductTypeWhat kind of device this is |
Control | 0..1 |
Binding | De codes MOETEN komen uit Voor voorbeeldcodes, zie ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3)http://hl7.org/fhir/ValueSet/device-kind (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3 ) |
Type | CodeableConcept |
Alternatieve namen | ProductType |
Guidance on how to interpret the contents of this table can be foundhere
0. Device | |
2. Device.identifier:gs1ProductID | |
Slicenaam | gs1ProductID |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
4. Device.identifier:hibcProductID | |
Slicenaam | hibcProductID |
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) |
6. Device.udi | |
8. Device.udi.carrierHRF | |
10. Device.type | |
Binding | De codes MOETEN komen uit ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3) (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3 ) |
12. Device.note | |
14. Device.note.text |
Guidance on how to interpret the contents of this table can be foundhere
0. Device | |||||
Definitie | The medical aid used (internally or externally). | ||||
Kort | Product | ||||
Control | 0..* | ||||
Alternatieve namen | 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 | |||||
Definitie | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
Kort | Logical id of this artifact | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
4. Device.meta | |||||
Definitie | 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. | ||||
Kort | Metadata about the resource | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Samenvatting | true | ||||
6. Device.implicitRules | |||||
Definitie | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. | ||||
Kort | A set of rules under which this content was created | ||||
Opmerkingen | 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 omdat No Modifier Reason provideed in previous versions of FHIR | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
8. Device.language | |||||
Definitie | The base language in which the resource is written. | ||||
Kort | Language of the resource content | ||||
Opmerkingen | 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 | Tenzij dat niet past, MOETEN deze codes worden gehaald uit Common Languages (extensible to http://hl7.org/fhir/ValueSet/languages|3.0.2 )A human language.
| ||||
Type | code | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
10. Device.text | |||||
Definitie | 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. | ||||
Kort | Text summary of the resource, for human interpretation | ||||
Opmerkingen | 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 Dit element wordt geraakt door de volgende invariants: dom-1 | ||||
Type | Narrative | ||||
Alternatieve namen | narrative, html, xhtml, display | ||||
12. Device.contained | |||||
Definitie | 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. | ||||
Kort | Contained, inline Resources | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | inline resources, anonymous resources, contained resources | ||||
14. Device.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
16. Device.modifierExtension | |||||
Definitie | 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. | ||||
Kort | Extensions that cannot be ignored | ||||
Opmerkingen | 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 omdat No Modifier Reason provideed in previous versions of FHIR | ||||
Alternatieve namen | extensions, user content | ||||
18. Device.identifier | |||||
Definitie | 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). | ||||
Kort | ProductID | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Alternatieve namen | Serial Number, ProductID | ||||
Slicing | Dit element introduceert een set slices op Device.identifier De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
20. Device.identifier:serialNumber | |||||
Slicenaam | serialNumber | ||||
Definitie | Unique instance identifiers assigned to a device by manufacturers other organizations or owners. | ||||
Kort | serial number (21) part of the UDI | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) | ||||
Control | 0..1 | ||||
Type | Identifier | ||||
Alternatieve namen | Serial Number | ||||
22. Device.identifier:serialNumber.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
24. Device.identifier:serialNumber.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.identifier.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
26. Device.identifier:serialNumber.use | |||||
Definitie | The purpose of this identifier. | ||||
Kort | usual | official | temp | secondary (If known) | ||||
Opmerkingen | 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 | De codes MOETEN komen uit 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 omdat No Modifier Reason provideed in previous versions of FHIR | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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 | |||||
Definitie | A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. | ||||
Kort | Description of identifier | ||||
Opmerkingen | 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 | Tenzij dat niet past, MOETEN deze codes worden gehaald uit 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 | ||||
Samenvatting | true | ||||
Requirements | Allows users to make use of identifiers when the identifier system is not known. | ||||
Patroonwaarde | { | ||||
30. Device.identifier:serialNumber.type.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
32. Device.identifier:serialNumber.type.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.identifier.type.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
34. Device.identifier:serialNumber.type.coding | |||||
Definitie | A reference to a code defined by a terminology system. | ||||
Kort | Code defined by a terminology system | ||||
Opmerkingen | 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 | ||||
Samenvatting | 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 | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
38. Device.identifier:serialNumber.type.coding.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.identifier.type.coding.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
40. Device.identifier:serialNumber.type.coding.system | |||||
Definitie | The identification of the code system that defines the meaning of the symbol in the code. | ||||
Kort | Identity of the terminology system | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Requirements | Need to be unambiguous about the source of the definition of the symbol. | ||||
Vast waarde | http://hl7.org/fhir/identifier-type | ||||
42. Device.identifier:serialNumber.type.coding.version | |||||
Definitie | 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. | ||||
Kort | Version of the system - if relevant | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-versieidentifier, geen resource-versieidentifier (zie discussie) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
44. Device.identifier:serialNumber.type.coding.code | |||||
Definitie | 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). | ||||
Kort | Symbol in syntax defined by the system | ||||
Control | 1..1 | ||||
Type | code | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Requirements | Need to refer to a particular code in the system. | ||||
Vast waarde | SNO | ||||
46. Device.identifier:serialNumber.type.coding.display | |||||
Definitie | A representation of the meaning of the code in the system, following the rules of the system. | ||||
Kort | Representation defined by the system | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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 | |||||
Definitie | Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). | ||||
Kort | If this coding was chosen directly by the user | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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 | |||||
Definitie | 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. | ||||
Kort | Plain text representation of the concept | ||||
Opmerkingen | Very often the text is the same as a displayName of one of the codings. | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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 | |||||
Definitie | Establishes the namespace for the value - that is, a URL that describes a set values that are unique. | ||||
Kort | The namespace for the identifier value | ||||
Control | 0..1 | ||||
Type | uri | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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. | ||||
Voorbeeld | General: http://www.acme.com/identifiers/patient | ||||
54. Device.identifier:serialNumber.value | |||||
Definitie | The portion of the identifier typically relevant to the user and which is unique within the context of the system. | ||||
Kort | The value that is unique | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Voorbeeld | General: 123456 | ||||
56. Device.identifier:serialNumber.period | |||||
Definitie | Time period during which identifier is/was valid for use. | ||||
Kort | Time period when id is/was valid for use | ||||
Control | 0..1 | ||||
Type | Period | ||||
Samenvatting | true | ||||
58. Device.identifier:serialNumber.assigner | |||||
Definitie | Organization that issued/manages the identifier. | ||||
Kort | Organization that issued id (may be just text) | ||||
Opmerkingen | 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) | ||||
Samenvatting | true | ||||
60. Device.identifier:gs1ProductID | |||||
Slicenaam | gs1ProductID | ||||
Definitie | 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). | ||||
Kort | ProductID | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Alternatieve namen | Serial Number, ProductID | ||||
62. Device.identifier:hibcProductID | |||||
Slicenaam | hibcProductID | ||||
Definitie | 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). | ||||
Kort | ProductID | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-identifier, geen resource-identifier (zie discussie) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Alternatieve namen | Serial Number, ProductID | ||||
64. Device.udi | |||||
Definitie | Unique device identifier (UDI) assigned to device label or package. | ||||
Kort | Unique Device Identifier (UDI) Barcode string | ||||
Opmerkingen | 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 | ||||
Samenvatting | true | ||||
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() | (children().count() > id.count()) ) | ||||
66. Device.udi.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
68. Device.udi.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
70. Device.udi.modifierExtension | |||||
Definitie | 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. | ||||
Kort | Extensions that cannot be ignored | ||||
Opmerkingen | 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 omdat No Modifier Reason provideed in previous versions of FHIR | ||||
Samenvatting | true | ||||
Alternatieve namen | extensions, user content, modifiers | ||||
72. Device.udi.deviceIdentifier | |||||
Definitie | 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. | ||||
Kort | application identifier (AI) (01) part of the udi | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Alternatieve namen | DI | ||||
74. Device.udi.name | |||||
Definitie | Name of device as used in labeling or catalog. | ||||
Kort | Device Name as appears on UDI label | ||||
Opmerkingen | Use the | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Alternatieve namen | Brand Name | ||||
76. Device.udi.jurisdiction | |||||
Definitie | 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. | ||||
Kort | Regional UDI authority | ||||
Control | 0..1 | ||||
Type | uri | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Requirements | Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. | ||||
78. Device.udi.carrierHRF | |||||
Definitie | 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). | ||||
Kort | ProductID | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Alternatieve namen | Human Readable Form | ||||
80. Device.udi.carrierAIDC | |||||
Definitie | 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. | ||||
Kort | UDI Machine Readable Barcode String | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Alternatieve namen | Automatic Identification and Data Capture | ||||
82. Device.udi.issuer | |||||
Definitie | 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. | ||||
Kort | UDI Issuing Organization | ||||
Control | 0..1 | ||||
Type | uri | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Alternatieve namen | Barcode System | ||||
84. Device.udi.entryType | |||||
Definitie | A coded entry to indicate how the data was entered. | ||||
Kort | barcode | rfid | manual + | ||||
Control | 0..1 | ||||
Binding | De codes MOETEN komen uit UDIEntryType (required to http://hl7.org/fhir/ValueSet/udi-entry-type|3.0.2 )Codes to identify how UDI data was entered | ||||
Type | code | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Requirements | Supports a way to distinguish hand entered from machine read data. | ||||
86. Device.status | |||||
Definitie | Status of the Device availability. | ||||
Kort | active | inactive | entered-in-error | unknown | ||||
Opmerkingen | 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 | De codes MOETEN komen uit FHIRDeviceStatus (required to http://hl7.org/fhir/ValueSet/device-status|3.0.2 )The availability status of the device. | ||||
Type | code | ||||
Is modifier | true omdat No Modifier Reason provideed in previous versions of FHIR | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
88. Device.type | |||||
Definitie | The code of the type of product. | ||||
Kort | ProductType | ||||
Control | 0..1 | ||||
Binding | De codes MOETEN komen uit ACPMedicalDeviceProductTypeICDVS (0.1.3-beta3) (required to https://fhir.iknl.nl/fhir/ValueSet/ACP-MedicalDeviceProductType-ICD|0.1.3-beta3 ) | ||||
Type | CodeableConcept | ||||
Alternatieve namen | ProductType | ||||
90. Device.type.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
92. Device.type.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.type.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
94. Device.type.coding | |||||
Definitie | A reference to a code defined by a terminology system. | ||||
Kort | Code defined by a terminology system | ||||
Opmerkingen | 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 | ||||
Samenvatting | true | ||||
Requirements | Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. | ||||
96. Device.type.coding.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
98. Device.type.coding.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.type.coding.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
100. Device.type.coding.system | |||||
Definitie | The identification of the code system that defines the meaning of the symbol in the code. | ||||
Kort | Identity of the terminology system | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Requirements | Need to be unambiguous about the source of the definition of the symbol. | ||||
102. Device.type.coding.version | |||||
Definitie | 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. | ||||
Kort | Version of the system - if relevant | ||||
Opmerkingen | 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. | ||||
Notitie | Dit is een business-versieidentifier, geen resource-versieidentifier (zie discussie) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
104. Device.type.coding.code | |||||
Definitie | 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). | ||||
Kort | Symbol in syntax defined by the system | ||||
Control | 1..1 | ||||
Type | code | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Requirements | Need to refer to a particular code in the system. | ||||
106. Device.type.coding.display | |||||
Definitie | A representation of the meaning of the code in the system, following the rules of the system. | ||||
Kort | Representation defined by the system | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. | ||||
108. Device.type.coding.userSelected | |||||
Definitie | Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). | ||||
Kort | If this coding was chosen directly by the user | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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. | ||||
110. Device.type.text | |||||
Definitie | 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. | ||||
Kort | Plain text representation of the concept | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | 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. | ||||
112. Device.lotNumber | |||||
Definitie | Lot number assigned by the manufacturer. | ||||
Kort | batch or lot number (10) part of the UDI | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
114. Device.manufacturer | |||||
Definitie | A name of the manufacturer. | ||||
Kort | Name of device manufacturer | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
116. Device.manufactureDate | |||||
Definitie | The date and time when the device was manufactured. | ||||
Kort | Date when the device was made | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
118. Device.expirationDate | |||||
Definitie | The date and time beyond which this device is no longer valid or should not be used (if applicable). | ||||
Kort | expiration date (17) part of the UDI | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
120. Device.model | |||||
Definitie | 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. | ||||
Kort | Model id assigned by the manufacturer | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
122. Device.version | |||||
Definitie | The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware. | ||||
Kort | Version number (i.e. software) | ||||
Notitie | Dit is een business-versieidentifier, geen resource-versieidentifier (zie discussie) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
124. Device.patient | |||||
Definitie | Patient information, If the device is affixed to a person. | ||||
Kort | 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. | ||||
126. Device.owner | |||||
Definitie | An organization that is responsible for the provision and ongoing maintenance of the device. | ||||
Kort | Organization responsible for device | ||||
Control | 0..1 | ||||
Type | Reference(nl-core-organization) | ||||
128. Device.contact | |||||
Definitie | Contact details for an organization or a particular human that is responsible for the device. | ||||
Kort | Details for human/organization for support | ||||
Opmerkingen | used for troubleshooting etc. | ||||
Control | 0..* | ||||
Type | ContactPoint | ||||
130. Device.location | |||||
Definitie | The place where the device can be found. | ||||
Kort | Where the resource is found | ||||
Control | 0..1 | ||||
Type | Reference(nl-core-location) | ||||
Requirements | Device.location can be used to track device location. | ||||
132. Device.url | |||||
Definitie | A network address on which the device may be contacted directly. | ||||
Kort | Network address to contact device | ||||
Opmerkingen | 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 | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
134. Device.note | |||||
Definitie | Descriptive information, usage information or implantation information that is not captured in an existing element. | ||||
Kort | Device notes and comments | ||||
Control | 0..* | ||||
Type | Annotation | ||||
136. Device.note.id | |||||
Definitie | unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
Kort | xml:id (or equivalent in JSON) | ||||
Control | 0..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Xml-formaat | In xml wordt dit attribuut gerepresenteerd als attribuut. | ||||
138. Device.note.extension | |||||
Definitie | 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. | ||||
Kort | Additional Content defined by implementations | ||||
Opmerkingen | 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 | ||||
Alternatieve namen | extensions, user content | ||||
Slicing | Dit element introduceert een set slices op Device.note.extension De slices zijnZonder volgorde en Open, en kunnen worden gedifferentieerd met de volgende discriminators: | ||||
140. Device.note.author[x] | |||||
Definitie | The individual responsible for making the annotation. | ||||
Kort | Individual responsible for the annotation | ||||
Control | 0..1 | ||||
Type | Keuze uit: Reference(Practitioner, Patient, RelatedPerson), string | ||||
[x] Note | ZieKeuze uit datatypenvoor verdere informatie over hoe [x] te gebruiken | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
142. Device.note.time | |||||
Definitie | Indicates when this particular annotation was made. | ||||
Kort | When the annotation was made | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Samenvatting | true | ||||
144. Device.note.text | |||||
Definitie | Textual description of the product. | ||||
Kort | ProductDescription | ||||
Control | 1..1 | ||||
Type | string | ||||
Primitieve waarde | Dit primitieve element kan aanwezig zijn of niet, of worden vervangen door een extensie | ||||
Alternatieve namen | ProductOmschrijving | ||||
146. Device.safety | |||||
Definitie | Provides additional safety characteristics about a medical device. For example devices containing latex. | ||||
Kort | Safety Characteristics of Device | ||||
Control | 0..* | ||||
Binding | Voor voorbeeldcodes, zie 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 | ||||
Samenvatting | true |