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  • BS EN 592:2002

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Instructions for use for in vitro diagnostic instruments for self-testing

    Available format(s):  Hardcopy, PDF

    Superseded date:  28-02-2010

    Language(s):  English

    Published date:  03-05-2002

    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 Form and presentation of the instructions for use
    5 Requirements for the content of the instructions for
      use
    6 Requirements for supplementary information
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.

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

    Committee CH/212
    Development Note Supersedes 99/565689 DC (05/2002) Supersedes 91/57328 DC. (03/2006)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
    EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
    EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN 28601 : 1992 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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