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  • BS 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):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2011

    Publisher:  British Standards Institution

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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)

    Defines requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates.

    Scope - (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 AnnexI of Directive 93/42/EEC Section7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN980 and EN1041.

    This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

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

    Committee CH/210/3
    Development Note Supersedes 09/30205582 DC. (03/2011)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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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