CSA Z16571:26

Description

CSA Preface This is the second edition of CSA Z16571, Systems for evacuation of plume generated by medical devices , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 16571 (second edition, 2024-03). It supersedes the previous edition, published in 2016 as CSA ISO 16571 (adopted ISO 16571:2014). For brevity, this Standard will be referred to as “CSA Z16571” throughout. CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Medical Gas Systems, under the jurisdiction of the CSA Technical Committee on Perioperative Safety and the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope 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.