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  • UNI EN ISO 10079-3 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE

    Available format(s): 

    Superseded date:  13-07-2022

    Language(s): 

    Published date:  26-08-2014

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Cleaning, disinfection and sterilization
    6 Design requirements
    7 Operational requirements
    8 Physical requirements for field and
       transport use suction equipment
    9 Performance requirements for vacuum
       level and flowrate
    10 Resistance to environment of suction equipment
       for field and/or transport use
    11 Marking
    12 Information to be supplied by the
       manufacturer
    Annex A (normative) - Test methods
    Annex B (informative) - Rationale statement
    Annex C (informative) - Lumen size and its effect
            on flowrate
    Annex D (informative) - Schematic of suction
            equipment
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction.

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

    Committee CT 44
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 8836:2014 Suction catheters for use in the respiratory tract
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    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
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 18082:2014 Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
    ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
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