This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.12 Resource MedicinalProductDeviceSpec - Content

Biomedical Research and Regulation

Work Group

Maturity 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.

11.12.1 Scope and Usage

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

This resource is referenced by medicinalproductpackaged

Structure

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

UML Diagram (Legend)

XML Template

<MedicinalProductDeviceSpec xmlns="http://hl7.org/fhir"> 
 <!-- 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

{
  "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/> .


[ 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.