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AAMI 10079-1

1999 Edition, January 1, 1999

Complete Document

Medical Suction Equipment-Part I: Electrically Powered Suction Equipment-Safety Requirements

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Description / Abstract:

This part of ISO 10079 specifies minimum safety and performance requirements for medical and surgical suction equipment (see Figure 1) for health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.

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

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

ISO 10079-1 is one of a series of International Standards based on IEC 60601-1:1988; in IEC 60601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 60601-1:1988, the requirements of this part of ISO 10079 take precedence over those of IEC 60601-1.

The scope and object given in clause 1 of IEC 60601-1:1988 apply, 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 is downstream of the vacuum pump;

m) equipment marked as suction unit for permanent tracheostomy;

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- and battery-powered suction equipment. Part 2 of ISO 10079 applies to manually powered suction equipment. Part 3 of ISO 10079 applies to suction equipment powered from a vacuum or pressure source.

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

NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements and components not illustrated.