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  • 07/30157023 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 15194 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-05-2009

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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    Comment Closes On
    Committee CH/212
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
    ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 18153:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    ISO Guide 31:2015 Reference materials — Contents of certificates, labels and accompanying documentation
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO Guide 34:2009 General requirements for the competence of reference material producers
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