AAMI 10079-2

Description / Abstract: This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the scope of this part of ISO 10079.

This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity- or battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure source which is dealt with in ISO 10079-3, nor to the following:

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

b) cathether 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;

i) 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) breast pumps;

q) liposuction;

r) uterine aspiration;

s) thoracic drainage.