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BS EN ISO 11239:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

Available format(s)

Hardcopy , PDF

Superseded date

06-16-2023

Superseded by

BS EN ISO 11239:2023

Language(s)

English

Published date

11-30-2012

US$283.91
Excluding Tax where applicable

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 Requirements
5 Schema
Annex A (informative) - Examples of controlled
        vocabularies
Annex B (informative) - Examples of controlled
        vocabularies to describe medicinal products
Bibliography

Describes: - the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products; - a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange; - a mechanism for the versioning of the concepts in order to track their evolution; - rules to allow regional authorities to map existing regional terms to the terms created using this International Standard, in a harmonized and meaningful way.

Committee
IST/35
DevelopmentNote
Supersedes 10/30229861 DC. (11/2012)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

This International Standard specifies:

  • the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;

  • a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;

  • a mechanism for the versioning of the concepts in order to track their evolution;

  • rules to allow regional authorities to map existing regional terms to the terms created using this International Standard, in a harmonized and meaningful way.

In addition, to support the successful application of this International Standard, references to standards concerned with identification of medicinal products (IDMP) and messaging for medicinal product information are provided as required.

Standards Relationship
ISO 11239:2012 Identical
EN ISO 11239:2012 Identical

ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
ISO 21090:2011 Health informatics — Harmonized data types for information interchange
ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
ENV 13607:2000 Health informatics - Messages for the exchange of information on medicine prescriptions
ISO 11238:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
ENV 12610:1997 Medical informatics - Medicinal product identification

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