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  • BS EN 375:2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-02-2010

    Language(s):  English

    Published date:  15-03-2001

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements for labels
       4.1 Outer container
       4.2 Immediate container
    5 Requirements for instructions for use
    Annex ZA (informative) Relationship of this document
             with EC Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents that includes reagent products, calibrators, control materials and kits for professional use, hereafter called IVD reagents. Also applicable to accessories.

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

    Committee CH/212
    Development Note Supersedes 98/564938 DC. (05/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    ISO 3864:1984 Safety colours and safety signs
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
    ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
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