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  • 16/30344636 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-01-2018

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Message exchange format
    4 Conformance terminology and context
       as it relates to the ISO IDMP standards and
       corresponding IDMP technical specifications
    5 Terms, definitions and abbreviations
    6 Requirements
    7 Description of the information modelling
       principles and practices
    8 Identifying characteristics for authorised
       Medicinal Products
    9 Information for an authorised Medicinal
       Product
    10 Identifying characteristics for Investigational
       Medicinal Products
    11 Information for an Investigational
       Medicinal Product
    Annex A (informative) - Full model - Authorised Medicinal
            Products detailed diagram
    Annex B (informative) - Full model - Investigational Medicinal
            Products detailed diagram
    Bibliography

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

    Comment Closes On
    Committee ²IST/35
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    ISO/TS 19844:2016 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/IEC 15416:2016 Automatic identification and data capture techniques — Bar code print quality test specification — Linear symbols
    ISO/IEC TR 24720:2008 Information technology Automatic identification and data capture techniques Guidelines for direct part marking (DPM)
    ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO/IEC 2382-4:1999 Information technology Vocabulary Part 4: Organization of data
    ENV 12610 : DRAFT 1997 MEDICAL INFORMATICS - MEDICINAL PRODUCT IDENTIFICATION
    ISO 639-2:1998 Codes for the representation of names of languages — Part 2: Alpha-3 code
    ISO/IEC TR 29158:2011 Information technology Automatic identification and data capture techniques Direct Part Mark (DPM) Quality Guideline
    ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
    ISO/HL7 27953-1:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting
    ISO/IEC 15415:2011 Information technology Automatic identification and data capture techniques Bar code symbol print quality test specification Two-dimensional symbols
    ISO 1087-2:2000 Terminology work Vocabulary Part 2: Computer applications
    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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