International standard
Systems for evacuation of plume generated by medical devices
Published Mar 28, 2024
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices . This document applies to all types of plume evacuation systems ( PES s), including a) portable ; b) mobile ; c) stationary, including dedicated central pipelines; d) PES s integrated into other equipment; e) PES s for endoscopic procedures (e.g., minimally invasive, laparoscopic) This document applies to all healthcare facilities where PES s 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. This document provides guidance on the following aspects of PES s: 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. 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.
Contains information from ISO Open Data (https://www.iso.org/open-data.html), made available under the ODC Attribution License (ODC-By) v1.0.
Withdrawn · Mar 11, 2014
Published · May 5, 2026