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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2011

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
      4.1 Requirements for usage
          4.1.1 If phthalates which are classified as carcinogenic,
                mutagenic or toxic to reproduction of category
                1 or 2 in accordance with table 3.2 of Annex VI of
                Regulation 1272/2008, are part of the formulation
                and the device is:
          4.1.2 The meaning of the symbol in Clause 5.2 shall
                be explained in the information supplied by the
                manufacturer
    5 Symbol labelling phthalates
      5.1 General
          5.1.1 This Clause contains a symbol that neither has
                been published in previous editions of the
                European Standard EN 980 nor ISO standard
                ISO 15223-1 and may be new or unfamiliar to
                users
      5.2 Symbol for "CONTAINS OR PRESENCE OF PHTHALATE"
    Annex A (normative) - Examples of uses of symbols given
            in this standard
      A.1 Examples of use of symbol for "contains or presence
          of phthalate": bis (2-ethylhexyl) phthalate (DEHP)
      A.2 Examples of use of symbol for "contains or presence
          of phthalate": dibutyl phthalate (DBP)
      A.3 Examples of use of symbol for "contains or presence
          of phthalate": benzyl butyl phthalate (BBP)
      A.4 Examples of use of symbol for "contains or presence
          of phthalate": combination of bis (2-ethylhexyl)
          phthalate (DEHP); benzyl butyl phthalate (BBP) and
          dibutyl phthalate (DBP)
    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

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

    Comment Closes On
    Committee CH/210/3
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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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