profile-medicalproductofhumanorigin Definitions
<a id="BiologicallyDerivedProduct"></a>
BiologicallyDerivedProduct
Medical Product of Human Origin Profile
Definition: This profile is designed for biologically derived products that are derived from a human donor and intended for clinical application in a human recipient. Donor and recipient might, or might not, be the same individual. Products of this nature are referred to as medical products of human origin (MPHO) and have specific traceability requirements to ensure that the bi-directional link between donor and recipient is maintained. The profile specifies the essential identifiers for traceability as required elements.
Cardinality: 0..*
<a id="BiologicallyDerivedProduct.productCategory"></a>
BiologicallyDerivedProduct.productCategory
Cardinality: 1..*
<a id="BiologicallyDerivedProduct.productCategory"></a>
BiologicallyDerivedProduct.productCategory
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.productCode"></a>
BiologicallyDerivedProduct.productCode
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.productCode.coding"></a>
BiologicallyDerivedProduct.productCode.coding
Cardinality: 1..*
<a id="BiologicallyDerivedProduct.productCode.coding.system"></a>
BiologicallyDerivedProduct.productCode.coding.system
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.productCode.coding.code"></a>
BiologicallyDerivedProduct.productCode.coding.code
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.identifier"></a>
BiologicallyDerivedProduct.identifier
Under most circumstances an MPHO will be uniquely identified using a single identifier from production to point of use. In some cases, a second identifier may be required (for example, import from another country that uses a different identification coding system). In these cases, both the original and new identifier must be included.
Cardinality: 1..*
<a id="BiologicallyDerivedProduct.identifier.system"></a>
BiologicallyDerivedProduct.identifier.system
Identity of the Issuing Agency responsible for the allocation of unique identifiers
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.identifier.value"></a>
BiologicallyDerivedProduct.identifier.value
Unique identifier of the MPHO item
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.biologicalSourceEvent"></a>
BiologicallyDerivedProduct.biologicalSourceEvent
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.biologicalSourceEvent.system"></a>
BiologicallyDerivedProduct.biologicalSourceEvent.system
Identity of the Issuing Agency responsible for the allocation of unique identifiers
Cardinality: 1..1
<a id="BiologicallyDerivedProduct.biologicalSourceEvent.value"></a>
BiologicallyDerivedProduct.biologicalSourceEvent.value
Unique identifier of the donation, collection or pooling event from which the MPHO item was derived
Cardinality: 1..1