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;
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) suction equipment marked for endoscopic use only.
BS EN ISO 10079-1:2009 Referenced Document
IEC 60079-4:1975 Electrical apparatus for explosive gas atmospheres. Part 4 : Method of test for ignition temperature
IEC 60529:1976 Classification of degrees of protection provided by enclosures (Edition 1.0; Amendment 1: 1978; Corrigendum 1: 1978; Amendment 2: 07/1983)
IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
IEC 60695-2-2:1980 Fire hazard testing - Part 2: Test methods - Needle-flame test
ISO 3744:1994 Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane
ISO 5356-1:1996 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 8836:1997 Suction catheters for use in the respiratory tract
BS EN ISO 10079-1:2009 history
2022BS EN ISO 10079-1:2022 Medical suction equipment. Electrically powered suction equipment