CSA Z10651-4:24

CSA Preface This is the second edition of CSA Z10651-4, Lung ventilators — Part 4: Particular requirements for user- powered resuscitators, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard, ISO 10651-4:2023 (second edition, 2023-03). It supersedes the previous edition, published in 2008 as CSA Z10651-4 (adopted ISO 10651-4:2002). For brevity, this Standard will be referred to as "CSA Z10651-4" 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, Quebec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of 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 This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [23] as indicated in Annex F.