CSA Preface

This is the first edition of CAN/CSA-ISO/TS 17665-3, Sterilization of health care products ? Moist heat ? Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 17665-3 (first edition, 2013-04-15). At the time of publication, ISO/TS 17665-3:2013 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO.

Scope

This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.

NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO 17664).