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  • BS EN ISO 22870:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Point-of-care testing (POCT). Requirements for quality and competence

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-12-2022

    Language(s):  English

    Published date:  31-12-2016

    Publisher:  British Standards Institution

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    This document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.

    Patient self-testing in a home or community setting is excluded, but elements of this document can be applicable.

    NOTE Local, regional and national regulations are to be taken into consideration.

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    Committee CH/212
    Development Note Supersedes 04/30090846 DC. (04/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By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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