• UNI EN 592 : 2002

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING

    Available format(s): 

    Superseded date:  23-08-2022

    Language(s): 

    Published date:  30-11-2002

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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 CT 37
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
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