• CEN ISO/TS 19844:2017

    Current The latest, up-to-date edition.

    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 19844:2016)

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    Published date:  30-08-2017

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    1 Scope
    2 Normative references
    3 General background and history
    4 Substance (Mandatory)
    5 Substance definitions
    6 Specified substance (Optional)
    7 Description of the information modelling
      principles and practices
    Annex A (normative) - Choosing a Substance ID
    Annex B (normative) - Chemical substance
    Annex C (normative) - Protein substance
    Annex D (normative) - Nucleic acid substance
    Annex E (normative) - Structurally Diverse
            Substance - Herbal Substance/Herbal
            Specified Substance
    Annex F (normative) - Structurally Diverse
            Substance, Homeopathic substance
    Annex G (normative) - Structurally Diverse
            Substance - Plasma-derived substances
    Annex H (normative) - Polymer Substance
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO/TS 19844:2016 is used in the implementation of ISO 11238. This document 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 document 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 second edition of the document addresses substances, Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G and H. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 may be covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, may be essential to distinguishing substances. This document 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.ISO/TS 19844:2016 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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 251
    Document Type Technical Specification
    Publisher Comite Europeen de Normalisation
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    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 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
    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/TS 18062:2016 Health informatics — Categorial structure for representation of herbal medicaments in terminological systems
    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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