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11.13 Resource MedicinalProductDeviceSpec - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Draft Compartments: Not linked to any defined compartments

A detailed description of a device, typically as part of a regulated medicinal product. It is not intended to relace the Device resource, which covers use of device instances.

MedicinalProductDeviceSpec is intended to be a datatype and not a resource.

This resource is referenced by medicinalproductpackaged

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDeviceSpec ΣDDomainResourceA detailed description of a device, typically as part of a regulated medicinal product. It is not intended to relace the Device resource, which covers use of device instances
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier
... type Σ1..1CodeableConceptThe type of device
... tradeName Σ0..1stringTrade name of the device, where applicable
... quantity Σ0..1QuantityThe quantity of the device present in the packaging of a medicinal product
... listingNumber Σ0..1stringDevice listing number
... modelNumber Σ0..1stringDevice model or reference number
... sterilityIndicator Σ0..1CodeableConceptWhether the device is supplied as sterile
... sterilisationRequirement Σ0..1CodeableConceptWhether the device must be sterilised before use
... usage Σ0..1CodeableConceptUsage pattern including the number of times that the device may be used
... nomenclature Σ0..*CodeableConceptA nomenclature term for the device
... shelfLife Σ0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics Σ0..1ProdCharacteristicDimensions, color etc.
... otherCharacteristics Σ0..*CodeableConceptOther codeable characteristics
... batchIdentifier Σ0..*IdentifierBatch number or expiry date of a device
... manufacturer Σ0..*Reference(Organization)Manufacturer of this Device
... material Σ0..*BackboneElementA substance used to create the material(s) of which the device is made
.... substance Σ1..1CodeableConceptThe substance
.... alternate Σ0..1booleanIndicates an alternative material of the device
.... allergenicIndicator Σ0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

XML Template

<MedicinalProductDeviceSpec xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier Business identifier --></identifier>
 <type><!-- 1..1 CodeableConcept The type of device --></type>
 <tradeName value="[string]"/><!-- 0..1 Trade name of the device, where applicable -->
 <quantity><!-- 0..1 Quantity The quantity of the device present in the packaging of a medicinal product --></quantity>
 <listingNumber value="[string]"/><!-- 0..1 Device listing number -->
 <modelNumber value="[string]"/><!-- 0..1 Device model or reference number -->
 <sterilityIndicator><!-- 0..1 CodeableConcept Whether the device is supplied as sterile --></sterilityIndicator>
 <sterilisationRequirement><!-- 0..1 CodeableConcept Whether the device must be sterilised before use --></sterilisationRequirement>
 <usage><!-- 0..1 CodeableConcept Usage pattern including the number of times that the device may be used --></usage>
 <nomenclature><!-- 0..* CodeableConcept A nomenclature term for the device --></nomenclature>
 <shelfLife><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLife>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
 <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
 <batchIdentifier><!-- 0..* Identifier Batch number or expiry date of a device --></batchIdentifier>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Device --></manufacturer>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept The substance --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
</MedicinalProductDeviceSpec>

JSON Template

{doco
  "resourceType" : "MedicinalProductDeviceSpec",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // Business identifier
  "type" : { CodeableConcept }, // R!  The type of device
  "tradeName" : "<string>", // Trade name of the device, where applicable
  "quantity" : { Quantity }, // The quantity of the device present in the packaging of a medicinal product
  "listingNumber" : "<string>", // Device listing number
  "modelNumber" : "<string>", // Device model or reference number
  "sterilityIndicator" : { CodeableConcept }, // Whether the device is supplied as sterile
  "sterilisationRequirement" : { CodeableConcept }, // Whether the device must be sterilised before use
  "usage" : { CodeableConcept }, // Usage pattern including the number of times that the device may be used
  "nomenclature" : [{ CodeableConcept }], // A nomenclature term for the device
  "shelfLife" : [{ ProductShelfLife }], // Shelf Life and storage information
  "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
  "otherCharacteristics" : [{ CodeableConcept }], // Other codeable characteristics
  "batchIdentifier" : [{ Identifier }], // Batch number or expiry date of a device
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Device
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  The substance
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductDeviceSpec;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDeviceSpec.identifier [ Identifier ]; # 0..1 Business identifier
  fhir:MedicinalProductDeviceSpec.type [ CodeableConcept ]; # 1..1 The type of device
  fhir:MedicinalProductDeviceSpec.tradeName [ string ]; # 0..1 Trade name of the device, where applicable
  fhir:MedicinalProductDeviceSpec.quantity [ Quantity ]; # 0..1 The quantity of the device present in the packaging of a medicinal product
  fhir:MedicinalProductDeviceSpec.listingNumber [ string ]; # 0..1 Device listing number
  fhir:MedicinalProductDeviceSpec.modelNumber [ string ]; # 0..1 Device model or reference number
  fhir:MedicinalProductDeviceSpec.sterilityIndicator [ CodeableConcept ]; # 0..1 Whether the device is supplied as sterile
  fhir:MedicinalProductDeviceSpec.sterilisationRequirement [ CodeableConcept ]; # 0..1 Whether the device must be sterilised before use
  fhir:MedicinalProductDeviceSpec.usage [ CodeableConcept ]; # 0..1 Usage pattern including the number of times that the device may be used
  fhir:MedicinalProductDeviceSpec.nomenclature [ CodeableConcept ], ... ; # 0..* A nomenclature term for the device
  fhir:MedicinalProductDeviceSpec.shelfLife [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
  fhir:MedicinalProductDeviceSpec.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc.
  fhir:MedicinalProductDeviceSpec.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
  fhir:MedicinalProductDeviceSpec.batchIdentifier [ Identifier ], ... ; # 0..* Batch number or expiry date of a device
  fhir:MedicinalProductDeviceSpec.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Device
  fhir:MedicinalProductDeviceSpec.material [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:MedicinalProductDeviceSpec.material.substance [ CodeableConcept ]; # 1..1 The substance
    fhir:MedicinalProductDeviceSpec.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device
    fhir:MedicinalProductDeviceSpec.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDeviceSpec ΣDDomainResourceA detailed description of a device, typically as part of a regulated medicinal product. It is not intended to relace the Device resource, which covers use of device instances
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier
... type Σ1..1CodeableConceptThe type of device
... tradeName Σ0..1stringTrade name of the device, where applicable
... quantity Σ0..1QuantityThe quantity of the device present in the packaging of a medicinal product
... listingNumber Σ0..1stringDevice listing number
... modelNumber Σ0..1stringDevice model or reference number
... sterilityIndicator Σ0..1CodeableConceptWhether the device is supplied as sterile
... sterilisationRequirement Σ0..1CodeableConceptWhether the device must be sterilised before use
... usage Σ0..1CodeableConceptUsage pattern including the number of times that the device may be used
... nomenclature Σ0..*CodeableConceptA nomenclature term for the device
... shelfLife Σ0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics Σ0..1ProdCharacteristicDimensions, color etc.
... otherCharacteristics Σ0..*CodeableConceptOther codeable characteristics
... batchIdentifier Σ0..*IdentifierBatch number or expiry date of a device
... manufacturer Σ0..*Reference(Organization)Manufacturer of this Device
... material Σ0..*BackboneElementA substance used to create the material(s) of which the device is made
.... substance Σ1..1CodeableConceptThe substance
.... alternate Σ0..1booleanIndicates an alternative material of the device
.... allergenicIndicator Σ0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

XML Template

<MedicinalProductDeviceSpec xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..1 Identifier Business identifier --></identifier>
 <type><!-- 1..1 CodeableConcept The type of device --></type>
 <tradeName value="[string]"/><!-- 0..1 Trade name of the device, where applicable -->
 <quantity><!-- 0..1 Quantity The quantity of the device present in the packaging of a medicinal product --></quantity>
 <listingNumber value="[string]"/><!-- 0..1 Device listing number -->
 <modelNumber value="[string]"/><!-- 0..1 Device model or reference number -->
 <sterilityIndicator><!-- 0..1 CodeableConcept Whether the device is supplied as sterile --></sterilityIndicator>
 <sterilisationRequirement><!-- 0..1 CodeableConcept Whether the device must be sterilised before use --></sterilisationRequirement>
 <usage><!-- 0..1 CodeableConcept Usage pattern including the number of times that the device may be used --></usage>
 <nomenclature><!-- 0..* CodeableConcept A nomenclature term for the device --></nomenclature>
 <shelfLife><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLife>
 <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
 <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
 <batchIdentifier><!-- 0..* Identifier Batch number or expiry date of a device --></batchIdentifier>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Device --></manufacturer>
 <material>  <!-- 0..* A substance used to create the material(s) of which the device is made -->
  <substance><!-- 1..1 CodeableConcept The substance --></substance>
  <alternate value="[boolean]"/><!-- 0..1 Indicates an alternative material of the device -->
  <allergenicIndicator value="[boolean]"/><!-- 0..1 Whether the substance is a known or suspected allergen -->
 </material>
</MedicinalProductDeviceSpec>

JSON Template

{doco
  "resourceType" : "MedicinalProductDeviceSpec",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // Business identifier
  "type" : { CodeableConcept }, // R!  The type of device
  "tradeName" : "<string>", // Trade name of the device, where applicable
  "quantity" : { Quantity }, // The quantity of the device present in the packaging of a medicinal product
  "listingNumber" : "<string>", // Device listing number
  "modelNumber" : "<string>", // Device model or reference number
  "sterilityIndicator" : { CodeableConcept }, // Whether the device is supplied as sterile
  "sterilisationRequirement" : { CodeableConcept }, // Whether the device must be sterilised before use
  "usage" : { CodeableConcept }, // Usage pattern including the number of times that the device may be used
  "nomenclature" : [{ CodeableConcept }], // A nomenclature term for the device
  "shelfLife" : [{ ProductShelfLife }], // Shelf Life and storage information
  "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
  "otherCharacteristics" : [{ CodeableConcept }], // Other codeable characteristics
  "batchIdentifier" : [{ Identifier }], // Batch number or expiry date of a device
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Device
  "material" : [{ // A substance used to create the material(s) of which the device is made
    "substance" : { CodeableConcept }, // R!  The substance
    "alternate" : <boolean>, // Indicates an alternative material of the device
    "allergenicIndicator" : <boolean> // Whether the substance is a known or suspected allergen
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:MedicinalProductDeviceSpec;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:MedicinalProductDeviceSpec.identifier [ Identifier ]; # 0..1 Business identifier
  fhir:MedicinalProductDeviceSpec.type [ CodeableConcept ]; # 1..1 The type of device
  fhir:MedicinalProductDeviceSpec.tradeName [ string ]; # 0..1 Trade name of the device, where applicable
  fhir:MedicinalProductDeviceSpec.quantity [ Quantity ]; # 0..1 The quantity of the device present in the packaging of a medicinal product
  fhir:MedicinalProductDeviceSpec.listingNumber [ string ]; # 0..1 Device listing number
  fhir:MedicinalProductDeviceSpec.modelNumber [ string ]; # 0..1 Device model or reference number
  fhir:MedicinalProductDeviceSpec.sterilityIndicator [ CodeableConcept ]; # 0..1 Whether the device is supplied as sterile
  fhir:MedicinalProductDeviceSpec.sterilisationRequirement [ CodeableConcept ]; # 0..1 Whether the device must be sterilised before use
  fhir:MedicinalProductDeviceSpec.usage [ CodeableConcept ]; # 0..1 Usage pattern including the number of times that the device may be used
  fhir:MedicinalProductDeviceSpec.nomenclature [ CodeableConcept ], ... ; # 0..* A nomenclature term for the device
  fhir:MedicinalProductDeviceSpec.shelfLife [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
  fhir:MedicinalProductDeviceSpec.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc.
  fhir:MedicinalProductDeviceSpec.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
  fhir:MedicinalProductDeviceSpec.batchIdentifier [ Identifier ], ... ; # 0..* Batch number or expiry date of a device
  fhir:MedicinalProductDeviceSpec.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Device
  fhir:MedicinalProductDeviceSpec.material [ # 0..* A substance used to create the material(s) of which the device is made
    fhir:MedicinalProductDeviceSpec.material.substance [ CodeableConcept ]; # 1..1 The substance
    fhir:MedicinalProductDeviceSpec.material.alternate [ boolean ]; # 0..1 Indicates an alternative material of the device
    fhir:MedicinalProductDeviceSpec.material.allergenicIndicator [ boolean ]; # 0..1 Whether the substance is a known or suspected allergen
  ], ...;
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

Alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis