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  • UNE-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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  21-12-2022

    Language(s):  Spanish, Castilian, English

    Published date:  19-11-2014

    Publisher:  Asociacion Espanola de Normalizacion

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

    1. Scope
    2. Normative references
    3. Terms and definitions
    4. Cleaning and sterilization
    5. Design requirements
    6. Operational requirements
    7. Physical requirements
    8. Performance requirements for vacuum and flowrate
    9. Resistance to environment
    10. Marking
    11. Information to be supplied by manufacturer
    Annexes
    A. (normative) Test methods
    B. (informative) Table of typical range of volumes for
        collection containers for specific uses
    C. (informative) Rationale statement

    Abstract - (Show below) - (Hide below)

    Defines safety and performance requirements for manually powered medical suction equipment for oro-pharyngeal suction for establishing and maintaining the patency of the airway. Describes hand or foot operated equipment. Also includes non-electrical suction equipment which may be integrated with electrical equipment.

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

    Committee CTN 110
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Superseded
    Superseded By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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