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  • UNE-EN ISO 14408:2016

    Current The latest, up-to-date edition.

    Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  08-11-2016

    Publisher:  Asociacion Espanola de Normalizacion

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Marking and labelling
    5 Information to be supplied by the manufacturer
    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 marking, labelling and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser.

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

    Committee CTN 110
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

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

    ISO 11990-1:2011 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft
    ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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