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    I.S. EN ISO 10079-2:2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)

    Available format(s):  Hardcopy, PDF

    Superseded date:  22-06-2022

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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)

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

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By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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