• BS EN ISO 11990-1:2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes Tracheal tube shaft

    Available format(s):  Hardcopy, PDF

    Superseded date:  24-10-2018

    Language(s):  English

    Published date:  30-11-2014

    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 Principle
    5 Significance and use of the test
    6 Apparatus
    7 Reagents and materials
    8 Preparation of test specimen
    9 Preparation of apparatus
    10 Test procedure
    11 Interpretation of results
    12 Test report
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             (Medical Devices)

    Abstract - (Show below) - (Hide below)

    Defines a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser.

    Scope - (Show below) - (Hide below)

    ISO 11990-1:2011 specifies a method of testing the continuous wave (cw) resistance of the shaft of a tracheal tube designed to resist ignition by a laser. It is not applicable to other components of the system, such as the inflation system and cuff, which are defined in ISO 11990-2:2010. ISO 11990-1:2011 can be used to measure and describe the properties of materials, products or assemblies in response to heat and flame under controlled laboratory conditions. It does not describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual clinical use conditions. However, the results of this test can be used as one element of a fire risk assessment which takes into account all factors pertinent to an assessment of the hazard of a particular end use.

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

    Committee CPW/172
    Development Note Supersedes BS EN ISO 11990. (11/2011)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
    ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
    ISO 11146-1:2005 Lasers and laser-related equipment Test methods for laser beam widths, divergence angles and beam propagation ratios Part 1: Stigmatic and simple astigmatic beams
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 11145:2016 Optics and photonics Lasers and laser-related equipment Vocabulary and symbols
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