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:33

ANSI Approved:Yes

DoD Adopted:No

This part of ISO 10079 specifies safety and performancerequirements for medical suction equipment powered from a vacuum orpressure source (see Figure 1). In particular it applies toconnections for pipelines and Venturi attachments.

Suction equipment with components controlled by electricalmeans, e.g. electronic timing, may also need to comply with IEC60601-1.

This part of ISO 10079 does not apply to electrically poweredsuction equipment, whether mains electricity or battery-powered,which is dealt with in ISO 10079-1, nor to manually powered suctionequipment which is dealt with in ISO 10079-2, nor to thefollowing:

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;

i) 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) breast pumps;

q) liposuction;

r) uterine aspiration.