Standards Development

Scope

This 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.

It 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).

Purpose

Certain surgical, diagnostic, and therapeutic techniques can generate noxious airborne contaminants (plume) as by-products, particularly from procedures that include the cutting, ablation, cauterization, or mechanical manipulation of target tissue by energybased devices such as lasers, electrosurgical generators, broadband light sources, ultrasonic instruments, etc. or mechanical surgical tools such as bone saws, high speed drills, and reamers. New technologies in cutting and sealing can result in less plume generation but plume remains a hazard. Energy-based contact with articles such as tubing, swabs, and skin preparation solutions will produce additional chemicals. This Standard is developed in response to awareness of the potential hazards to patients and staff of plume generated by these techniques in healthcare settings and will cover the non-interchangeability with other products or pipeline systems by design; the continuous extraction at specified pressures and flows; the use of suitable materials for all components of the system; the provision of monitoring indicators and alarm systems; the correct rating of filtration systems; the correct indication of filter life; the correct marking and labelling; the electrical and environmental testing; the correct installation; the testing, commissioning, and certification and the provision of guidance on operational management.