Search FHIR

ANS IG document core
0.1.0 - ci-build France flag

ANS IG document core - version de développement local (v0.1.0) construite par les outils de publication FHIR (HL7® FHIR® Standard). Voir le répertoire des versions publiées

Resource Profile: FRDeviceAuteurDocument - Detailed Descriptions

Draft as of 2025-12-05

Definitions for the fr-device-auteur-document resource profile.

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. Device
Définition

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.

CourtItem used in healthcare
Contrôle0..*
Est modificateurfalse
Résuméfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.implicitRules
Définition

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.

CourtA set of rules under which this content was created
Commentaires

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.

Contrôle0..1
Typeuri
Est modificateurtrue parce que 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
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Device.modifierExtension
Définition

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).

CourtExtensions that cannot be ignored
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résuméfalse
Exigences

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.

Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Device.identifier
Définition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

CourtInstance identifier
Commentaires

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.

NoteCeci est un identifiant métier, pas un identifiant de ressource (voir discussion)
Contrôle10..*
TypeIdentifier
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Device.status
Définition

Status of the Device availability.

Courtactive | inactive | entered-in-error | unknown
Commentaires

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.

Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

The availability status of the device.

Typecode
Est modificateurtrue parce que This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.type
Définition

The kind or type of device.

CourtProfession / savoir-faire ou rôleThe kind or type of device
Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de Pour des exemples de codes, voir Jdv Type Systeme CISIShttp://hl7.org/fhir/ValueSet/device-type|4.0.1
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-type-systeme-cisis)
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.owner
Définition

An organization that is responsible for the provision and ongoing maintenance of the device.

CourtStructureOrganization responsible for device
Contrôle10..1
TypeReference(FR Organization Document, Organization)
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. Device
2. Device.identifier
NoteCeci est un identifiant métier, pas un identifiant de ressource (voir discussion)
Contrôle1..?
4. Device.deviceName
6. Device.deviceName.name
CourtNom du modèle du système
8. Device.deviceName.type
CourtNom du système
10. Device.type
CourtProfession / savoir-faire ou rôle
BindingLes codes DOIVENT (SHALL) être pris de Jdv Type Systeme CISIS
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-type-systeme-cisis)
12. Device.owner
CourtStructure
Contrôle1..?
TypeReference(FR Organization Document)

Des conseils sur linterprétation du contenu de ce tableau peuvent être trouvésici

0. Device
Définition

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.

CourtItem used in healthcare
Contrôle0..*
Est modificateurfalse
Résuméfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Device.id
Définition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

CourtLogical id of this artifact
Commentaires

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Contrôle0..1
Typeid
Est modificateurfalse
Résumétrue
4. Device.meta
Définition

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.

CourtMetadata about the resource
Contrôle0..1
TypeMeta
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Device.implicitRules
Définition

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.

CourtA set of rules under which this content was created
Commentaires

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.

Contrôle0..1
Typeuri
Est modificateurtrue parce que 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
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Device.language
Définition

The base language in which the resource is written.

CourtLanguage of the resource content
Commentaires

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).

Contrôle0..1
BindingLes codes DEVRAIENT (SHOULD) être pris de CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

A human language.

Bindings AdditionnelsBut
AllLanguagesBinding Max
Typecode
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Device.text
Définition

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.

CourtText summary of the resource, for human interpretation
Commentaires

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.

Contrôle0..1
TypeNarrative
Est modificateurfalse
Résuméfalse
Noms alternatifsnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Device.contained
Définition

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.

CourtContained, inline Resources
Commentaires

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.

Contrôle0..*
TypeResource
Est modificateurfalse
Résuméfalse
Noms alternatifsinline resources, anonymous resources, contained resources
14. Device.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. Device.modifierExtension
Définition

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).

CourtExtensions that cannot be ignored
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Résuméfalse
Exigences

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.

Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. Device.identifier
Définition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

CourtInstance identifier
Commentaires

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.

NoteCeci est un identifiant métier, pas un identifiant de ressource (voir discussion)
Contrôle1..*
TypeIdentifier
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Device.definition
Définition

The reference to the definition for the device.

CourtThe reference to the definition for the device
Contrôle0..1
TypeReference(DeviceDefinition)
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Device.udiCarrier
Définition

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.

CourtUnique Device Identifier (UDI) Barcode string
Commentaires

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.

Contrôle0..*
TypeBackboneElement
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Device.udiCarrier.id
Définition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
26. Device.udiCarrier.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
28. Device.udiCarrier.modifierExtension
Définition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

CourtExtensions that cannot be ignored even if unrecognized
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
Exigences

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.

Noms alternatifsextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
30. Device.udiCarrier.deviceIdentifier
Définition

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.

CourtMandatory fixed portion of UDI
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Noms alternatifsDI
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Device.udiCarrier.issuer
Définition

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.
CourtUDI Issuing Organization
Contrôle0..1
Typeuri
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Noms alternatifsBarcode System
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. Device.udiCarrier.jurisdiction
Définition

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.

CourtRegional UDI authority
Contrôle0..1
Typeuri
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Exigences

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

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. Device.udiCarrier.carrierAIDC
Définition

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.

CourtUDI Machine Readable Barcode String
Commentaires

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.

Contrôle0..1
Typebase64Binary
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Noms alternatifsAutomatic Identification and Data Capture
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Device.udiCarrier.carrierHRF
Définition

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

CourtUDI Human Readable Barcode String
Commentaires

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Noms alternatifsHuman Readable Form
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. Device.udiCarrier.entryType
Définition

A coded entry to indicate how the data was entered.

Courtbarcode | rfid | manual +
Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de UDIEntryType
(required to http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1)

Codes to identify how UDI data was entered.

Typecode
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Exigences

Supports a way to distinguish hand entered from machine read data.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Device.status
Définition

Status of the Device availability.

Courtactive | inactive | entered-in-error | unknown
Commentaires

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.

Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de FHIRDeviceStatus
(required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

The availability status of the device.

Typecode
Est modificateurtrue parce que This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Device.statusReason
Définition

Reason for the dtatus of the Device availability.

Courtonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Contrôle0..*
BindingSauf si inapproprié, ces codes DOIVENT (SHALL) être pris de FHIRDeviceStatusReason
(extensible to http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1)

The availability status reason of the device.

TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Device.distinctIdentifier
Définition

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

CourtThe distinct identification string
Commentaires

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Noms alternatifsDistinct Identification Code (DIC)
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Device.manufacturer
Définition

A name of the manufacturer.

CourtName of device manufacturer
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. Device.manufactureDate
Définition

The date and time when the device was manufactured.

CourtDate when the device was made
Contrôle0..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. Device.expirationDate
Définition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

CourtDate and time of expiry of this device (if applicable)
Contrôle0..1
TypedateTime
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Device.lotNumber
Définition

Lot number assigned by the manufacturer.

CourtLot number of manufacture
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Device.serialNumber
Définition

The serial number assigned by the organization when the device was manufactured.

CourtSerial number assigned by the manufacturer
Commentaires

Alphanumeric Maximum 20.

Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. Device.deviceName
Définition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

CourtThe name of the device as given by the manufacturer
Contrôle0..*
TypeBackboneElement
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Device.deviceName.id
Définition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
62. Device.deviceName.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
64. Device.deviceName.modifierExtension
Définition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

CourtExtensions that cannot be ignored even if unrecognized
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
Exigences

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.

Noms alternatifsextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
66. Device.deviceName.name
Définition

The name of the device.

CourtNom du modèle du système
Contrôle1..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Noms alternatifsΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Device.deviceName.type
Définition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

CourtNom du système
Contrôle1..1
BindingLes codes DOIVENT (SHALL) être pris de DeviceNameType
(required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

The type of name the device is referred by.

Typecode
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Device.modelNumber
Définition

The model number for the device.

CourtThe model number for the device
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Device.partNumber
Définition

The part number of the device.

CourtThe part number of the device
Commentaires

Alphanumeric Maximum 20.

Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Device.type
Définition

The kind or type of device.

CourtProfession / savoir-faire ou rôle
Contrôle0..1
BindingLes codes DOIVENT (SHALL) être pris de Jdv Type Systeme CISIS
(required to https://smt.esante.gouv.fr/fhir/ValueSet/jdv-type-systeme-cisis)
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Device.specialization
Définition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

CourtThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
Contrôle0..*
TypeBackboneElement
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. Device.specialization.id
Définition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
80. Device.specialization.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
82. Device.specialization.modifierExtension
Définition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

CourtExtensions that cannot be ignored even if unrecognized
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
Exigences

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.

Noms alternatifsextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
84. Device.specialization.systemType
Définition

The standard that is used to operate and communicate.

CourtThe standard that is used to operate and communicate
Contrôle1..1
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Noms alternatifsΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. Device.specialization.version
Définition

The version of the standard that is used to operate and communicate.

CourtThe version of the standard that is used to operate and communicate
NoteCeci est un ID de version métier, pas un ID de version de ressource (voir discussion)
Contrôle0..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. Device.version
Définition

The actual design of the device or software version running on the device.

CourtThe actual design of the device or software version running on the device
NoteCeci est un ID de version métier, pas un ID de version de ressource (voir discussion)
Contrôle0..*
TypeBackboneElement
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Device.version.id
Définition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
92. Device.version.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
94. Device.version.modifierExtension
Définition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

CourtExtensions that cannot be ignored even if unrecognized
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
Exigences

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.

Noms alternatifsextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
96. Device.version.type
Définition

The type of the device version.

CourtThe type of the device version
Contrôle0..1
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Noms alternatifsΣ
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. Device.version.component
Définition

A single component of the device version.

CourtA single component of the device version
Contrôle0..1
TypeIdentifier
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. Device.version.value
Définition

The version text.

CourtThe version text
Contrôle1..1
Typestring
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. Device.property
Définition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

CourtThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Contrôle0..*
TypeBackboneElement
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Device.property.id
Définition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

CourtUnique id for inter-element referencing
Contrôle0..1
Typestring
Est modificateurfalse
Format XMLDans le format XML, cette propriété est représentée comme attribut.
Résuméfalse
106. Device.property.extension
Définition

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.

CourtAdditional content defined by implementations
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurfalse
Résuméfalse
Noms alternatifsextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
108. Device.property.modifierExtension
Définition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

CourtExtensions that cannot be ignored even if unrecognized
Commentaires

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.

Contrôle0..*
TypeExtension
Est modificateurtrue parce que Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Résumétrue
Exigences

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.

Noms alternatifsextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
110. Device.property.type
Définition

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

CourtCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
Contrôle1..1
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. Device.property.valueQuantity
Définition

Property value as a quantity.

CourtProperty value as a quantity
Contrôle0..*
TypeQuantity
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Device.property.valueCode
Définition

Property value as a code, e.g., NTP4 (synced to NTP).

CourtProperty value as a code, e.g., NTP4 (synced to NTP)
Contrôle0..*
TypeCodeableConcept
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. Device.patient
Définition

Patient information, If the device is affixed to a person.

CourtPatient to whom Device is affixed
Contrôle0..1
TypeReference(Patient)
Est modificateurfalse
Résuméfalse
Exigences

If the device is implanted in a patient, then need to associate the device to the patient.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
118. Device.owner
Définition

An organization that is responsible for the provision and ongoing maintenance of the device.

CourtStructure
Contrôle1..1
TypeReference(FR Organization Document)
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. Device.contact
Définition

Contact details for an organization or a particular human that is responsible for the device.

CourtDetails for human/organization for support
Commentaires

used for troubleshooting etc.

Contrôle0..*
TypeContactPoint
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. Device.location
Définition

The place where the device can be found.

CourtWhere the device is found
Contrôle0..1
TypeReference(Location)
Est modificateurfalse
Résuméfalse
Exigences

Device.location can be used to track device location.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. Device.url
Définition

A network address on which the device may be contacted directly.

CourtNetwork address to contact device
Commentaires

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Contrôle0..1
Typeuri
Est modificateurfalse
Valeur primitiveCet élément primitif peut être présent, absent ou remplacé par une extension
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. Device.note
Définition

Descriptive information, usage information or implantation information that is not captured in an existing element.

CourtDevice notes and comments
Contrôle0..*
TypeAnnotation
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. Device.safety
Définition

Provides additional safety characteristics about a medical device. For example devices containing latex.

CourtSafety Characteristics of Device
Contrôle0..*
TypeCodeableConcept
Est modificateurfalse
Résumétrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. Device.parent
Définition

The parent device.

CourtThe parent device
Contrôle0..1
TypeReference(Device)
Est modificateurfalse
Résuméfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))