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CEN ISO/TS 19844:2015

Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)

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Kehtetu alates 18.09.2017
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CEN ISO/TS 19844:2015; ISO/TS 19844:2015
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
18.09.2017
Põhitekst
05.01.2016
Põhitekst
This Technical Specification is used in the implementation of ISO 11238. This Technical Specification defines
substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.
ISO 11238 provides the conceptual framework for defining substances and specified substances and for assigning
unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high level model for the structuring of information for substances. This Technical Specification provides detailed explanations of each type or grouping of substance information, an element-byelement description for implementation of ISO 11238, and examples for a variety of substances and specified
substances.
This first edition of the Technical Specification will only address substances, and Groups 1 to 3 of the specified substances as defined in ISO 11238 and Annexes A, B, C, and D. It is anticipated that specified substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this Technical Specification. Some
information that would typically fall under specified substances Group 4 may be covered in the Annexes of this
Technical Specification. This information, although not defining of either a substance or a specified substance
Group 1, may be essential to distinguishing substances.
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