1.1 This document specifies requirements and guidelines for systems and equipment used to evacuate
plume generated by
medical devices.
1.2 This document applies to all types of
plume evacuation systems (
PESs), including
a)
portable;
b)
mobile;
c) stationary, including dedicated central pipelines;
d)
PESs integrated into other equipment;
e)
PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic).
1.3 This document applies to all healthcare facilities where
PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
1.4 This document provides guidance on the following aspects of
PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
1.5 This document does not apply to the following:
a)
anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of
electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
| File Size : | 1
file
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| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 04/01/2024 |
