• 15/30273269 DC : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    BS EN ISO 5366 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART: TUBES AND CONNECTORS FOR USE IN ADULTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2016

    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 for
      TRACHEOSTOMY TUBES and connectors
    5 Materials
    6 Design requirements for TRACHEOSTOMY TUBES
      and connectors
    7 Requirements for TRACHEOSTOMY TUBES
      supplied sterile
    8 Marking and labelling
    Annex A (informative) - Rationale
    Annex B (normative) - Test method for the security
            of attachment of a fitted connector and
            PLATE to the TRACHEOSTOMY TUBE
    Annex C (normative) - Test method for determining
            the diameter of the CUFF
    Annex D (normative) - Test method for CUFF herniation
    Annex E (normative) - Test method for leakage past
            the CUFF
    Annex F (normative) - Test method for determining
            kink resistance
    Annex G (informative) - Guidance on materials and design
    Annex H (informative) - Hazard identification for risk assessment
    Bibliography
    Annex ZA (informative) - Relationship between this
            document and the Essential Requirements
            EU Directive 93/42/EEC

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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