AAMI 10079-1

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Medical Suction Equipment-Part I: Electrically Powered SuctionEquipment-Safety Requirements
1999 Edition, 1999

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Description

  • Revision:1999 Edition, 1999
  • Published Date:January 1999
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:42
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10079 specifies minimum safety and performancerequirements for medical and surgical suction equipment (see Figure1) for health care facilities such as hospitals, for domiciliarycare of patients and for field and transport use.

    Although such equipment may be driven by centrally powered pipedvacuum systems, compressed gases and electricity, or be manuallypowered for a variety of applications, this part of ISO 10079addresses only mains electricity- and battery-powered suctionequipment.

    NOTE See also annex M in this part of ISO 10079.

    ISO 10079-1 is one of a series of International Standards basedon IEC 60601-1:1988; in IEC 60601-1 (the "General Standard"), thistype of International Standard is referred to as a "ParticularStandard". As stated in 1.3 of IEC 60601-1:1988, the requirementsof this part of ISO 10079 take precedence over those of IEC60601-1.

    The scope and object given in clause 1 of IEC 60601-1:1988apply, except that 1.1 shall be replaced by the following:

    This part of ISO 10079 is not applicable to:

    a) central power supply (by vacuum/compressed air generation),piping systems of vehicles and buildings, and wall connectors;

    b) catheter tubes, drains, curettes and suction tips;

    c) syringes;

    d) dental suction equipment;

    e) waste gas scavenging systems;

    f) laboratory suction;

    g) autotransfusion systems;

    h) passive urinary drainage;

    ii) closed systems for wound drainage;

    j) gravity gastric drainage;

    k) orally operated mucous extractors;

    l) suction equipment where the collection container isdownstream of the vacuum pump;

    m) equipment marked as suction unit for permanenttracheostomy;

    n) ventouse (obstetric) equipment;

    o) neonatal mucous extractors;

    p) suction equipment marked for endoscopic use only.

    NOTE 1 This part of ISO 10079 applies to mains electricity- andbattery-powered suction equipment. Part 2 of ISO 10079 applies tomanually powered suction equipment. Part 3 of ISO 10079 applies tosuction equipment powered from a vacuum or pressure source.

    NOTE 2 Components illustrated are not necessarily required bythis part of ISO 10079.

    NOTE 3 Suction equipment shown is an example only, and actualsystems may consist of other arrangements and components notillustrated.