AAMI ISO 10079-2:1999 pdf download – Medical suction equipment
1 Scope
This part of ISO 1 0079 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 1 0079. This part of ISO 1 0079 does not apply to electrically powered suction equipment, whether mains electricity- or battery-powered, which is dealt with in ISO 1 0079-1 , nor to suction equipment powered from a vacuum or pressure source which is dealt with in ISO 1 0079-3, 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.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 1 0079. 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 1 0079 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 5356-1 :1 996, Anaesthetic and respiratory equipment — Conical connectors — Part 1 : Cones and sockets.
ISO 8836:1 997, S uction catheters for use in the respiratory tract.
ISO 1 0079-1 :1 999 , Medical suction equipment — Part 1 : Electrically powered suction equipment — Safety requirements.
4.1 The suction equipment shall meet the requirements given in 8.1 to 8.3 after those components which are subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
4.2 Any filters installed shall either be of the disposable type or be capable of being cleaned, disinfected and/or sterilized for re-use in accordance with 4.1 .
4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
4.4 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as recommended by the manufacturer.