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    I.S. EN ISO 22870:2016

    Current The latest, up-to-date edition.

    POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016)

    Available format(s):  Hardcopy, PDF

    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 Management requirements
    5 Technical requirements
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Superseded By
    Supersedes

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

    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
    EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    CLSI POCT7 A : 1ED 2010 QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE
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