CSA ISO 17665:25

CSA Preface

This is the first edition of CSA ISO 17665, Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard ISO 17665 (first edition, 2024-03). This Standard replaces CSA Z17665-1:09, CSA Z17665-2:09, and CAN/CSA-ISO/TS 17665-3:17.

For brevity, this Standard will be referred to as CSA ISO 17665 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 Technical Committee on Medical Device Reprocessing, 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 provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.