CSA ISO 11195:19 (R2024)

CSA Preface

This is the second edition of CSA ISO 11195, Gas mixers for medical use — Stand-alone gas mixers, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11195 (second edition, 2018-01). It supersedes the previous edition published in 2014 as CAN/CSA-ISO 11195 (adopted ISO 11195:1995). At the time of publication, ISO 11195:2018 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 11195” 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 document specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use.

This document does not apply to:

a) blocks of flowmeters with separate controls for the flow of each gas;

b) stand-alone gas mixers which mix oxygen with ambient air;

c) stand-alone gas mixers with more than two different gas inlets;

d) stand-alone gas mixers connected to an oxygen concentrator.