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  • 06/30146522 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-02-2010

    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    Status Superseded
    Superseded By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 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
    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 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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