scope:

This International Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. NOTE A plume evacuation system (PES) can be a functionally independent component of a medical device that has other functions. 

This International Standard is applicable to

a) portable and mobile plume evacuation systems,

b) local stationary plume evacuation systems,

c) dedicated central pipeline systems for plume evacuation systems, and

d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

* This International Standard does not apply to active and passive devices used to evacuate plume generated during invasive (e.g. laparoscopic or endoscopic) procedures.

This International Standard 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;

NOTE Some other aspects of laser safety are covered by IEC 60825 (see Reference[7]).

e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.