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  • EN ISO 5361:2016

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)

    Available format(s): 

    Withdrawn date:  30-09-2019

    Language(s): 

    Published date:  28-09-2016

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    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)

    ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.

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

    Committee CEN/TC 215
    Development Note Supersedes EN 1782. (05/2013)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Withdrawn
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
    I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES

    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)
    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
    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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