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PD CEN ISO/TS 19844:2015

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Health informatics. Identification of medicinal products. Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances
Available format(s)

Hardcopy , PDF

Withdrawn date

29-09-2018

Language(s)

English

Published date

31-01-2016

Foreword
Introduction
1 Scope
2 Normative references
3 General background and history
4 Substance (Mandatory)
5 Substance definitions
6 specified substance (Optional)
Annex A (normative) - Choosing a Substance ID
Annex B (normative) - Chemical Substance
Annex C (normative) - Protein Substance
Annex D (normative) - Nucleic Acid Substance
Bibliography

Specifies substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.

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-by-element 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.

This Technical Specification addresses the following:

  • Data elements necessary for defining substances and specified substances Groups 1 to 3;

  • The logical use of data elements as defined in ISO 11238;

  • Substances and specified substances Groups 1 to 3 business rules for

    • determining necessary data elements,

    • distinguishing and defining materials according to ISO 11238,

    • triggering the assignment of identifiers.

This Technical Specification does not address the following:

  • Business processes for data management;

  • Implementation of a specific data information system (e.g. a relational database schema);

  • Normative messaging standards for substances;

  • The maintenance of controlled vocabularies;

  • The specific global identifier system that should be used;

  • Nomenclature standards for substances.

Committee
IST/35
DocumentType
Standard
Pages
274
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy

Standards Relationship
CEN ISO/TS 19844:2015 Identical
ISO/TS 19844:2015 Identical
ISO/TS 19844:2016 Identical
CEN ISO/TS 19844:2017 Identical

ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
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 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
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 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
ISO 11239:2012 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

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