CAN/CSA-Z23747:18 (R2023)

CSA Preface This is the second edition of CAN/CSA-Z23747, Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23747 (second edition, 2015-08-01). It supersedes the previous edition published in 2008 as CAN/CSA-Z23747 (adopted ISO 23747:2007). For brevity, this Standard will be referred to as “CAN/CSA-Z23747” throughout. 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 Care Technology & Systems, 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 International Standard specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device. Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E. NOTE Additional aspects of environmental impact are addressed in ISO 14971.