CAN/CSA-ISO/TS 17665-3:17 (R2022)
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 (Adopted ISO/TS 17665-3:2013, first edition, 2013-04-15)
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.
For brevity, this Standard will be referred to as “CAN/CSA-ISO/TS 17665-3” throughout.
The ISO Technical Specification was reviewed for Canadian adoption by the SCC Mirror Committee to ISO/TC 198, under the jurisdiction of the CSA Technical Committee on Medical Device Reprocessing and 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.
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).