• UNI EN ISO 10079-2 : 2014

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT

    Available format(s): 

    Superseded date:  13-07-2022

    Language(s): 

    Published date:  31-12-2013

    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
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction.

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

    Committee U42.04
    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    Status Superseded
    Superseded By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 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
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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