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  • BS EN ISO 5361:2016

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Anaesthetic and respiratory equipment. Tracheal tubes and connectors

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-02-2023

    Language(s):  English

    Published date:  31-10-2016

    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 tracheal tubes and
      tracheal tube connectors
    5 Specific requirements for tracheal tubes and
      tracheal tube connectors
    6 Additional requirement for tracheal tubes
      with a Murphy eye
    7 Requirements for tracheal tubes with tracheal
      tube connectors supplied sterile
    8 Marking
    Annex A (informative) - Rationale
    Annex B (normative) - Determination of cuff
            diameter
    Annex C (normative) - Test method for cuffed
            tube collapse
    Annex D (normative) - Test method for cuff
            herniation
    Annex E (informative) - Guidance on design of
            tracheal tube connectors
    Annex F (informative) - Hazard identification
            for risk assessment
    Annex G (normative) - Test method for tracheal
            seal
    Annex H (normative) - Test method to determine
            kink resistance
    Bibliography
    Annex ZA (informative) - Relationship between this
            European Standard and the Essential
            Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Gives essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors.

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

    Committee CH/121/5
    Development Note Supersedes BS EN 1782. (04/2014) Supersedes 14/30281859 DC. (10/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    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 14408:2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11990-2:2010 Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ANSI Z79.16 : 1983 CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ASTM F 1242 : 1996 : EDT 1 Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)
    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 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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