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  • AAMI ISO 5367 : 2015

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

    Available format(s): 

    Withdrawn date:  17-04-2024

    Language(s): 

    Published date:  29-12-2015

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption
    of ISO 5367:2014
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Specific requirements
    6 Prevention of electrostatic charges
    7 Requirements for breathing sets and
      breathing tubes supplied sterile
    8 Marking
    Annex A (informative) - Rationale
    Annex B (informative) - Hazard
            identification for risk
            assessment
    Annex C (normative) - Test for security of
            attachment of plain end to conical
            connector
    Annex D (normative) - Test for security
            of attachment of adaptor to
            breathing tube
    Annex E (normative) - Test for leakage
    Annex F (normative) - Measurement of
            resistance to flow
    Annex G (normative) - Test for increase
            in flow resistance with bending
    Annex H (normative) - Test for compliance
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers.

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

    Committee ISO/TC 121/SC 2
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Withdrawn

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

    ISO 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    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 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    ISO 5362:2006 Anaesthetic reservoir bags
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    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
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    View more information

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