CSA ISO 18835:19 (R2024)

CSA Preface

This is the second edition of CSA ISO 18835, Inhalational anaesthesia systems — Draw-over anaesthetic systems, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 18835 (first edition, 2015-04-01). It supersedes the previous edition published in 2014 as CAN/CSA-ISO/TS 18835 (adopted ISO/TS 18835:2004), Inhalational anaesthesia systems — Draw-over vaporizers and associated equipment. At the time of publication, ISO 18835:2015 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO.

For brevity, this Standard will be referred to as “CSA ISO 18835” 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 basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to provide inhalational anaesthesia.

Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents.

This International Standard also includes requirements for a bellows-type manual ventilator.

NOTE 1 Requirements for automatic anaesthetic ventilators are covered by ISO 80601-2-13.

NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651-4.

This International Standard does not specify requirements for monitoring of the equipment or the patient.