CSA Z17665-1:09 (R2019)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) - Guidance
Annex B (informative) - Process definition based on
        inactivation of the microbial population in its
        natural state (bioburden-based method)
Annex C (informative) - Process definition based on the
        inactivation of a reference microorganism and a
        knowledge of bioburden on product items to be
        sterilized (combined bioburden/biological
        indicator based method)
Annex D (informative) - Conservative process definition
        based on inactivation of reference microorganisms
        (overkill method)
Annex E (informative) - Operating cycles
Bibliography

CSA Preface This is the first edition of CAN/CSA-Z17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 17665-1 (first edition, 2006-08-15). This Standard replaces CAN/CSA-ISO 11134-98, Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization (adopted ISO 11134:1994). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion.

CSA Preface This is the first edition of CAN/CSA-Z17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 17665-1 (first edition, 2006-08-15). This Standard replaces CAN/CSA-ISO 11134-98, Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization (adopted ISO 11134:1994). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. Scope 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion.