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  • UNI EN ISO 5361 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS

    Available format(s): 

    Superseded date:  12-09-2022

    Language(s): 

    Published date:  01-01-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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)

    Development Note Supersedes UNI EN 1782. (02/2013)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By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 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
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    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
    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 980:2008 Symbols for use in the labelling of medical devices
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
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