BS EN ISO 10079-1-2000 Medical suction equipment – Part 1: Electrically powered suction equipment一Safety requirements.
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 electricityand 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;
d) dental suction equipment;
e) waste gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
n) 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.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of IsO 10079. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of IsO and IEC maintain registers of currently valid International Standards.
ISO 3744:1994, Acoustics 一Determination of sound power levels of noise sources一Engineering methods for free-field conditions over a reflecting plane.
ISO 5356-1:1996, Anaesthetic and respiratory equipment一Conical connectors一Part 1: Cones and sockets.BS EN ISO 10079-1 pdf download.