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  • DIN EN ISO 14408:2016-07

    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):  English, German

    Published date:  01-01-2016

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Marking and labelling
    5 Information to be supplied by the manufacturer
    Bibliography
    Annex ZA (informative) - Relationship between this European
              Standard and the Essential Requirements of EU
               Directive 93/42/EEC

    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)

    Development Note DIN EN ISO 14408 issue 08-2009 remains valid alongside this standard until 31-03-2019. (07/2016)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    DIN ISO 7000:2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
    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
    DIN EN ISO 15223-1:2015-08 (Draft) MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
    DIN EN ISO 11990-2:2016-02 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS (ISO 11990-2:2010)
    DIN EN ISO 5361:2014-05 (Draft) ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO 5361:2016)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    DIN EN ISO 11990-1:2016-02 LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 1: TRACHEAL TUBE SHAFT (ISO 11990-1:2011)
    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
    DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
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