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    I.S. EN ISO 15225:2016

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE (ISO 15225:2016)

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  13-05-2021

    Language(s):  English

    Published date:  01-01-2016

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principle of structure
    5 Data file dictionary
    Annex A (informative) - Examples for generation of
            generic device group terms and synonyms
    Annex B (informative) - Example of term record
    Annex C (informative) - Examples of collective terms
    Annex D (informative) - Examples of top-level collective
            term nodes
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, healthcare providers and end users.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    Supersedes

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

    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    ISO/IEC 8859-1:1998 Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1
    ENV 12611 : DRAFT 1997 MEDICAL INFORMATICS - CATEGORICAL STRUCTURE OF SYSTEMS OF CONCEPTS - MEDICAL DEVICES
    ISO 25964-1:2011 Information and documentation — Thesauri and interoperability with other vocabularies — Part 1: Thesauri for information retrieval
    ISO 1942:2009 Dentistry Vocabulary
    ISO 25964-2:2013 Information and documentation — Thesauri and interoperability with other vocabularies — Part 2: Interoperability with other vocabularies
    ISO/IEC 2382:2015 Information technology — Vocabulary
    ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
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