| Draft as of 2026-06-11 |
Definitions for the KBV-PR-MIO-LAB-DeviceDefinition-Specimen-Container resource profile.
Guidance on how to interpret the contents of this table can be foundhere
| 0. DeviceDefinition | |||||
| Definition | Dieses Profil bildet das Modell eines Probenbehälters ab. The characteristics, operational status and capabilities of a medical-related component of a medical device. | ||||
| Short | An instance of a medical-related component of a medical device | ||||
| Comments | For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel. | ||||
| Control | 0..* | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) | ||||
| 2. DeviceDefinition.meta | |||||
| Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
| Short | Metadata about the resource | ||||
| Control | 0..1 | ||||
| Type | Meta | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 4. DeviceDefinition.meta.id | |||||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
| Short | Unique id for inter-element referencing | ||||
| Control | 0..01 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 6. DeviceDefinition.meta.versionId | |||||
| Definition | The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. | ||||
| Short | Version specific identifier | ||||
| Comments | The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. | ||||
| Control | 0..1 | ||||
| Type | id | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 8. DeviceDefinition.meta.lastUpdated | |||||
| Definition | When the resource last changed - e.g. when the version changed. | ||||
| Short | When the resource version last changed | ||||
| Comments | This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. | ||||
| Control | 0..1 | ||||
| Type | instant | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 10. DeviceDefinition.meta.source | |||||
| Definition | A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. | ||||
| Short | Identifies where the resource comes from | ||||
| Comments | In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. | ||||
| Control | 0..01 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 12. DeviceDefinition.implicitRules | |||||
| Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||||
| Short | A set of rules under which this content was created | ||||
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||||
| Control | 0..01 | ||||
| Type | uri | ||||
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 14. DeviceDefinition.language | |||||
| Definition | The base language in which the resource is written. | ||||
| Short | Language of the resource content | ||||
| Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). | ||||
| Control | 0..01 | ||||
| Binding | The codes SHOULD be taken from CommonLanguageshttp://hl7.org/fhir/ValueSet/languages|4.0.1 (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)A human language.
| ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 16. DeviceDefinition.contained | |||||
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. | ||||
| Short | Contained, inline Resources | ||||
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. | ||||
| Control | 0..0* | ||||
| Type | Resource | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | inline resources, anonymous resources, contained resources | ||||
| 18. DeviceDefinition.modifierExtension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
| Short | Extensions that cannot be ignored | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
| Summary | false | ||||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) | ||||
| 20. DeviceDefinition.identifier | |||||
| Definition | Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. | ||||
| Short | Instance identifier | ||||
| Note | This is a business identifier, not a resource identifier (see discussion) | ||||
| Control | 0..0* | ||||
| Type | Identifier | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 22. DeviceDefinition.udiDeviceIdentifier | |||||
| Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold. | ||||
| Short | Unique Device Identifier (UDI) Barcode string | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 28. DeviceDefinition.manufacturer[x] | |||||
| Definition | Hier wird der Hersteller des Probenbehälters referenziert. A name of the manufacturer. | ||||
| Short | Name of device manufacturer | ||||
| Control | 0..1 | ||||
| Type | Reference(KBV_PR_MIO_LAB_Organization, Organization), string | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 30. DeviceDefinition.deviceName | |||||
| Definition | A name given to the device to identify it. | ||||
| Short | A name given to the device to identify it | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 35. DeviceDefinition.modelNumber | |||||
| Definition | The model number for the device. | ||||
| Short | The model number for the device | ||||
| Control | 0..01 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 37. DeviceDefinition.type | |||||
| Definition | Kategorisierung des Probenbehälters What kind of device or device system this is. | ||||
| Short | KategorieWhat kind of device or device system this is | ||||
| Control | 10..1 | ||||
| Binding | For example codes, see FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kind|4.0.1 (example to http://hl7.org/fhir/ValueSet/device-kind|4.0.1)Type of device e.g. according to official classification. | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Pattern Value | { | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 39. DeviceDefinition.type.coding | |||||
| Definition | Fixcode für die Kategorie Probenbehälters. 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 | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Allows for alternative encodings within a code system, and translations to other code systems. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 41. DeviceDefinition.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 reference to some definition that establishes the system clearly and unambiguously. | ||||
| Control | 10..1 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to be unambiguous about the source of the definition of the symbol. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 43. DeviceDefinition.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 | 10..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 45. DeviceDefinition.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 | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to refer to a particular code in the system. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 47. DeviceDefinition.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 | 10..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 49. DeviceDefinition.type.coding.userSelected | |||||
| Definition | Indicates that this coding was chosen by a user directly - e.g. 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..01 | ||||
| Type | boolean | ||||
| Is Modifier | false | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 51. DeviceDefinition.type.text | |||||
| Definition | Hier wird ein Freitext eingetragen. 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..01 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 53. DeviceDefinition.specialization | |||||
| Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. | ||||
| Short | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 57. DeviceDefinition.version | |||||
| Definition | The available versions of the device, e.g., software versions. | ||||
| Short | Available versions | ||||
| Note | This is a business version Id, not a resource version Id (see discussion) | ||||
| Control | 0..0* | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 59. DeviceDefinition.safety | |||||
| Definition | Safety characteristics of the device. | ||||
| Short | Safety characteristics of the device | ||||
| Control | 0..0* | ||||
| Binding | For example codes, see DeviceSafetyhttp://hl7.org/fhir/ValueSet/device-safety|4.0.1 (example to http://hl7.org/fhir/ValueSet/device-safety|4.0.1) | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 61. DeviceDefinition.shelfLifeStorage | |||||
| Definition | Shelf Life and storage information. | ||||
| Short | Shelf Life and storage information | ||||
| Control | 0..0* | ||||
| Type | ProductShelfLife | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 63. DeviceDefinition.physicalCharacteristics | |||||
| Definition | Dimensions, color etc. | ||||
| Short | Dimensions, color etc. | ||||
| Control | 0..01 | ||||
| Type | ProdCharacteristic | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 65. DeviceDefinition.languageCode | |||||
| Definition | Language code for the human-readable text strings produced by the device (all supported). | ||||
| Short | Language code for the human-readable text strings produced by the device (all supported) | ||||
| Control | 0..0* | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 67. DeviceDefinition.capability | |||||
| Definition | Device capabilities. | ||||
| Short | Device capabilities | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 71. DeviceDefinition.property | |||||
| Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. | ||||
| Short | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 75. DeviceDefinition.owner | |||||
| Definition | An organization that is responsible for the provision and ongoing maintenance of the device. | ||||
| Short | Organization responsible for device | ||||
| Control | 0..01 | ||||
| Type | Reference(Organization) | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 77. DeviceDefinition.contact | |||||
| Definition | Contact details for an organization or a particular human that is responsible for the device. | ||||
| Short | Details for human/organization for support | ||||
| Comments | used for troubleshooting etc. | ||||
| Control | 0..0* | ||||
| Type | ContactPoint | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 79. DeviceDefinition.url | |||||
| Definition | A network address on which the device may be contacted directly. | ||||
| Short | Network address to contact device | ||||
| Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. | ||||
| Control | 0..01 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 81. DeviceDefinition.onlineInformation | |||||
| Definition | Access to on-line information about the device. | ||||
| Short | Access to on-line information | ||||
| Control | 0..01 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 83. DeviceDefinition.note | |||||
| Definition | Descriptive information, usage information or implantation information that is not captured in an existing element. | ||||
| Short | Device notes and comments | ||||
| Control | 0..0* | ||||
| Type | Annotation | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 85. DeviceDefinition.quantity | |||||
| Definition | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product). | ||||
| Short | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) | ||||
| Control | 0..01 | ||||
| Type | Quantity | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 87. DeviceDefinition.parentDevice | |||||
| Definition | The parent device it can be part of. | ||||
| Short | The parent device it can be part of | ||||
| Control | 0..01 | ||||
| Type | Reference(DeviceDefinition) | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 89. DeviceDefinition.material | |||||
| Definition | A substance used to create the material(s) of which the device is made. | ||||
| Short | A substance used to create the material(s) of which the device is made | ||||
| Control | 0..0* | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
Guidance on how to interpret the contents of this table can be foundhere
| 0. DeviceDefinition | |
| Definition | Dieses Profil bildet das Modell eines Probenbehälters ab. |
| 2. DeviceDefinition.meta | |
| Must Support | true |
| 4. DeviceDefinition.meta.id | |
| Control | 0..0 |
| 6. DeviceDefinition.meta.versionId | |
| Must Support | true |
| 8. DeviceDefinition.meta.lastUpdated | |
| Must Support | true |
| 10. DeviceDefinition.meta.source | |
| Control | 0..0 |
| 12. DeviceDefinition.implicitRules | |
| Control | 0..0 |
| 14. DeviceDefinition.language | |
| Control | 0..0 |
| 16. DeviceDefinition.text | |
| 18. DeviceDefinition.text.status | |
| Pattern Value | extensions |
| 20. DeviceDefinition.contained | |
| Control | 0..0 |
| 22. DeviceDefinition.identifier | |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 0..0 |
| 24. DeviceDefinition.udiDeviceIdentifier | |
| Control | 0..0 |
| 26. DeviceDefinition.manufacturer[x] | |
| Definition | Hier wird der Hersteller des Probenbehälters referenziert. |
| Type | Reference(KBV_PR_MIO_LAB_Organization), string |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Must Support | true |
| 28. DeviceDefinition.deviceName | |
| Control | 0..0 |
| 30. DeviceDefinition.modelNumber | |
| Control | 0..0 |
| 32. DeviceDefinition.type | |
| Definition | Kategorisierung des Probenbehälters |
| Short | Kategorie |
| Control | 1..? |
| Must Support | true |
| Pattern Value | { |
| 34. DeviceDefinition.type.coding | |
| Definition | Fixcode für die Kategorie Probenbehälters. |
| Control | 1..1 |
| Must Support | true |
| 36. DeviceDefinition.type.coding.system | |
| Control | 1..? |
| Must Support | true |
| 38. DeviceDefinition.type.coding.version | |
| Note | This is a business version Id, not a resource version Id (see discussion) |
| Control | 1..? |
| Must Support | true |
| 40. DeviceDefinition.type.coding.code | |
| Control | 1..? |
| Must Support | true |
| 42. DeviceDefinition.type.coding.display | |
| Control | 1..? |
| Must Support | true |
| 44. DeviceDefinition.type.coding.userSelected | |
| Control | 0..0 |
| 46. DeviceDefinition.type.text | |
| Definition | Hier wird ein Freitext eingetragen. |
| Control | 0..0 |
| 48. DeviceDefinition.specialization | |
| Control | 0..0 |
| 50. DeviceDefinition.version | |
| Note | This is a business version Id, not a resource version Id (see discussion) |
| Control | 0..0 |
| 52. DeviceDefinition.safety | |
| Control | 0..0 |
| 54. DeviceDefinition.shelfLifeStorage | |
| Control | 0..0 |
| 56. DeviceDefinition.physicalCharacteristics | |
| Control | 0..0 |
| 58. DeviceDefinition.languageCode | |
| Control | 0..0 |
| 60. DeviceDefinition.capability | |
| Control | 0..0 |
| 62. DeviceDefinition.property | |
| Control | 0..0 |
| 64. DeviceDefinition.owner | |
| Control | 0..0 |
| 66. DeviceDefinition.contact | |
| Control | 0..0 |
| 68. DeviceDefinition.url | |
| Control | 0..0 |
| 70. DeviceDefinition.onlineInformation | |
| Control | 0..0 |
| 72. DeviceDefinition.note | |
| Control | 0..0 |
| 74. DeviceDefinition.quantity | |
| Control | 0..0 |
| 76. DeviceDefinition.parentDevice | |
| Control | 0..0 |
| 78. DeviceDefinition.material | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be foundhere
| 0. DeviceDefinition | |||||
| Definition | Dieses Profil bildet das Modell eines Probenbehälters ab. | ||||
| Short | An instance of a medical-related component of a medical device | ||||
| Comments | For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel. | ||||
| Control | 0..* | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource ( contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty())dom-6: A resource should have narrative for robust management ( text.`div`.exists()) | ||||
| 2. DeviceDefinition.id | |||||
| Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
| Short | Logical id of this artifact | ||||
| Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||||
| Control | 0..1 | ||||
| Type | id | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| 4. DeviceDefinition.meta | |||||
| Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
| Short | Metadata about the resource | ||||
| Control | 0..1 | ||||
| Type | Meta | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 6. DeviceDefinition.meta.id | |||||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
| Short | Unique id for inter-element referencing | ||||
| Control | 0..0 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 8. DeviceDefinition.meta.extension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
| Short | Additional content defined by implementations | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| Slicing | This element introduces a set of slices on DeviceDefinition.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 10. DeviceDefinition.meta.versionId | |||||
| Definition | The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. | ||||
| Short | Version specific identifier | ||||
| Comments | The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. | ||||
| Control | 0..1 | ||||
| Type | id | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 12. DeviceDefinition.meta.lastUpdated | |||||
| Definition | When the resource last changed - e.g. when the version changed. | ||||
| Short | When the resource version last changed | ||||
| Comments | This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. | ||||
| Control | 0..1 | ||||
| Type | instant | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 14. DeviceDefinition.meta.source | |||||
| Definition | A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. | ||||
| Short | Identifies where the resource comes from | ||||
| Comments | In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. | ||||
| Control | 0..0 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 16. DeviceDefinition.meta.profile | |||||
| Definition | A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. | ||||
| Short | Profiles this resource claims to conform to | ||||
| Comments | It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. | ||||
| Control | 0..* | ||||
| Type | canonical(StructureDefinition) | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 18. DeviceDefinition.meta.security | |||||
| Definition | Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. | ||||
| Short | Security Labels applied to this resource | ||||
| Comments | The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. | ||||
| Control | 0..* | ||||
| Binding | Unless not suitable, these codes SHALL be taken from All Security Labels (extensible to http://hl7.org/fhir/ValueSet/security-labels|4.0.1)Security Labels from the Healthcare Privacy and Security Classification System. | ||||
| Type | Coding | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 20. DeviceDefinition.meta.tag | |||||
| Definition | Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. | ||||
| Short | Tags applied to this resource | ||||
| Comments | The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. | ||||
| Control | 0..* | ||||
| Binding | For example codes, see CommonTags (example to http://hl7.org/fhir/ValueSet/common-tags|4.0.1)Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". | ||||
| Type | Coding | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 22. DeviceDefinition.implicitRules | |||||
| Definition | A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. | ||||
| Short | A set of rules under which this content was created | ||||
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. | ||||
| Control | 0..0 | ||||
| Type | uri | ||||
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 24. DeviceDefinition.language | |||||
| Definition | The base language in which the resource is written. | ||||
| Short | Language of the resource content | ||||
| Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). | ||||
| Control | 0..0 | ||||
| Binding | The codes SHOULD be taken from CommonLanguages (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)A human language.
| ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 26. DeviceDefinition.text | |||||
| Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. | ||||
| Short | Text summary of the resource, for human interpretation | ||||
| Comments | Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. | ||||
| Control | 0..1 | ||||
| Type | Narrative | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | narrative, html, xhtml, display | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 28. DeviceDefinition.text.id | |||||
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | ||||
| Short | Unique id for inter-element referencing | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 30. DeviceDefinition.text.extension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
| Short | Additional content defined by implementations | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| Slicing | This element introduces a set of slices on DeviceDefinition.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 32. DeviceDefinition.text.status | |||||
| Definition | The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data. | ||||
| Short | generated | extensions | additional | empty | ||||
| Control | 1..1 | ||||
| Binding | The codes SHALL be taken from NarrativeStatus (required to http://hl7.org/fhir/ValueSet/narrative-status|4.0.1)The status of a resource narrative. | ||||
| Type | code | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Pattern Value | extensions | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 34. DeviceDefinition.text.div | |||||
| Definition | The actual narrative content, a stripped down version of XHTML. | ||||
| Short | Limited xhtml content | ||||
| Comments | The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects. | ||||
| Control | 1..1 | ||||
| Type | xhtml | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))txt-1: The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes ( htmlChecks())txt-2: The narrative SHALL have some non-whitespace content ( htmlChecks()) | ||||
| 36. DeviceDefinition.contained | |||||
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. | ||||
| Short | Contained, inline Resources | ||||
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. | ||||
| Control | 0..0 | ||||
| Type | Resource | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | inline resources, anonymous resources, contained resources | ||||
| 38. DeviceDefinition.extension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
| Short | Additional content defined by implementations | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| 40. DeviceDefinition.modifierExtension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | ||||
| Short | Extensions that cannot be ignored | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them | ||||
| Summary | false | ||||
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| 42. DeviceDefinition.identifier | |||||
| Definition | Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. | ||||
| Short | Instance identifier | ||||
| Note | This is a business identifier, not a resource identifier (see discussion) | ||||
| Control | 0..0 | ||||
| Type | Identifier | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 44. DeviceDefinition.udiDeviceIdentifier | |||||
| Definition | Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold. | ||||
| Short | Unique Device Identifier (UDI) Barcode string | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 52. DeviceDefinition.manufacturer[x] | |||||
| Definition | Hier wird der Hersteller des Probenbehälters referenziert. | ||||
| Short | Name of device manufacturer | ||||
| Control | 0..1 | ||||
| Type | Reference(KBV_PR_MIO_LAB_Organization) | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 54. DeviceDefinition.deviceName | |||||
| Definition | A name given to the device to identify it. | ||||
| Short | A name given to the device to identify it | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 61. DeviceDefinition.modelNumber | |||||
| Definition | The model number for the device. | ||||
| Short | The model number for the device | ||||
| Control | 0..0 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 63. DeviceDefinition.type | |||||
| Definition | Kategorisierung des Probenbehälters | ||||
| Short | Kategorie | ||||
| Control | 1..1 | ||||
| Binding | For example codes, see FHIRDeviceTypes (example to http://hl7.org/fhir/ValueSet/device-kind|4.0.1)Type of device e.g. according to official classification. | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | false | ||||
| Pattern Value | { | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 65. DeviceDefinition.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 | Unique id for inter-element referencing | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 67. DeviceDefinition.type.extension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
| Short | Additional content defined by implementations | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| Slicing | This element introduces a set of slices on DeviceDefinition.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 69. DeviceDefinition.type.coding | |||||
| Definition | Fixcode für die Kategorie Probenbehälters. | ||||
| 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 | ||||
| Is Modifier | false | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Allows for alternative encodings within a code system, and translations to other code systems. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 71. DeviceDefinition.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 | Unique id for inter-element referencing | ||||
| Control | 0..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| XML Format | In the XML format, this property is represented as an attribute. | ||||
| Summary | false | ||||
| 73. DeviceDefinition.type.coding.extension | |||||
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | ||||
| Short | Additional content defined by implementations | ||||
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
| Control | 0..* | ||||
| Type | Extension | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Alternate Names | extensions, user content | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) | ||||
| Slicing | This element introduces a set of slices on DeviceDefinition.type.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: | ||||
| 75. DeviceDefinition.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 reference to some definition that establishes the system clearly and unambiguously. | ||||
| Control | 1..1 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to be unambiguous about the source of the definition of the symbol. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 77. DeviceDefinition.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 | 1..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 79. DeviceDefinition.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 | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to refer to a particular code in the system. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 81. DeviceDefinition.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 | 1..1 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Must Support | true | ||||
| Summary | true | ||||
| Requirements | Need to be able to carry a human-readable meaning of the code for readers that do not know the system. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 83. DeviceDefinition.type.coding.userSelected | |||||
| Definition | Indicates that this coding was chosen by a user directly - e.g. 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..0 | ||||
| Type | boolean | ||||
| Is Modifier | false | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 85. DeviceDefinition.type.text | |||||
| Definition | Hier wird ein Freitext eingetragen. | ||||
| 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..0 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| 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. | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 87. DeviceDefinition.specialization | |||||
| Definition | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. | ||||
| Short | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 94. DeviceDefinition.version | |||||
| Definition | The available versions of the device, e.g., software versions. | ||||
| Short | Available versions | ||||
| Note | This is a business version Id, not a resource version Id (see discussion) | ||||
| Control | 0..0 | ||||
| Type | string | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 96. DeviceDefinition.safety | |||||
| Definition | Safety characteristics of the device. | ||||
| Short | Safety characteristics of the device | ||||
| Control | 0..0 | ||||
| Binding | For example codes, see DeviceSafety (example to http://hl7.org/fhir/ValueSet/device-safety|4.0.1) | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 98. DeviceDefinition.shelfLifeStorage | |||||
| Definition | Shelf Life and storage information. | ||||
| Short | Shelf Life and storage information | ||||
| Control | 0..0 | ||||
| Type | ProductShelfLife | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 100. DeviceDefinition.physicalCharacteristics | |||||
| Definition | Dimensions, color etc. | ||||
| Short | Dimensions, color etc. | ||||
| Control | 0..0 | ||||
| Type | ProdCharacteristic | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 102. DeviceDefinition.languageCode | |||||
| Definition | Language code for the human-readable text strings produced by the device (all supported). | ||||
| Short | Language code for the human-readable text strings produced by the device (all supported) | ||||
| Control | 0..0 | ||||
| Type | CodeableConcept | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 104. DeviceDefinition.capability | |||||
| Definition | Device capabilities. | ||||
| Short | Device capabilities | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 111. DeviceDefinition.property | |||||
| Definition | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. | ||||
| Short | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 119. DeviceDefinition.owner | |||||
| Definition | An organization that is responsible for the provision and ongoing maintenance of the device. | ||||
| Short | Organization responsible for device | ||||
| Control | 0..0 | ||||
| Type | Reference(Organization) | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 121. DeviceDefinition.contact | |||||
| Definition | Contact details for an organization or a particular human that is responsible for the device. | ||||
| Short | Details for human/organization for support | ||||
| Comments | used for troubleshooting etc. | ||||
| Control | 0..0 | ||||
| Type | ContactPoint | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 123. DeviceDefinition.url | |||||
| Definition | A network address on which the device may be contacted directly. | ||||
| Short | Network address to contact device | ||||
| Comments | If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. | ||||
| Control | 0..0 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 125. DeviceDefinition.onlineInformation | |||||
| Definition | Access to on-line information about the device. | ||||
| Short | Access to on-line information | ||||
| Control | 0..0 | ||||
| Type | uri | ||||
| Is Modifier | false | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 127. DeviceDefinition.note | |||||
| Definition | Descriptive information, usage information or implantation information that is not captured in an existing element. | ||||
| Short | Device notes and comments | ||||
| Control | 0..0 | ||||
| Type | Annotation | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 129. DeviceDefinition.quantity | |||||
| Definition | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product). | ||||
| Short | The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product) | ||||
| Control | 0..0 | ||||
| Type | Quantity | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 131. DeviceDefinition.parentDevice | |||||
| Definition | The parent device it can be part of. | ||||
| Short | The parent device it can be part of | ||||
| Control | 0..0 | ||||
| Type | Reference(DeviceDefinition) | ||||
| Is Modifier | false | ||||
| Summary | true | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||
| 133. DeviceDefinition.material | |||||
| Definition | A substance used to create the material(s) of which the device is made. | ||||
| Short | A substance used to create the material(s) of which the device is made | ||||
| Control | 0..0 | ||||
| Type | BackboneElement | ||||
| Is Modifier | false | ||||
| Summary | false | ||||
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) | ||||