• CEI UNI 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:  01-01-2011

    Publisher:  Comitato Elettrotecnico Italiano

    Add To Cart

    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)

    Describes the 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 62
    Development Note Classificazione CEI 62-231. (12/2011)
    Document Type Standard
    Publisher Comitato Elettrotecnico Italiano
    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
    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
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective