• UNI CEI EN 15986 : 2011

    Current The latest, up-to-date edition.

    SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

    Available format(s): 

    Language(s): 

    Published date:  04-05-2011

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Terms and definitions
    3 Requirements for usage
    4 Symbol labelling phthalates
    Annex A (informative) - Examples of uses of the symbol
            given in this European Standard
    Annex B (informative) - Use of the negation symbol
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph.

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

    Committee CT 44
    Document Type Standard
    Product Note Italian version of this standard is now available.
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current

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

    EN 80416-3:2002/A1:2011 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    IEC 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN 12264:2005 Health informatics - Categorial structures for systems of concepts
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