CAN/CSA-ISO 11140-5:18 (R2023)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system
6 Indicator
7 Packaging and labeling
8 Quality assurance
9 Sampling conditioning
Annex A (normative) - Determination of
                      the degree of contrast between
                      the colour of the substrate and
                      the indicator agent
Annex B (normative) - Method of determining
                      uniform colour change on
                      exposure to saturated steam
Annex C (normative) - Method for determining
                      indicator colour change on
                      exposure to dry heat
Annex D (normative) - Method for determining
                      transfer of indicator agent to
                      standard test pack
Annex E (normative) - Standard test pack
Annex F (normative) - Method of determining
                      non-uniform colour change on
                      exposure to a standard fault
                      condition
Annex G (normative) - Steam exposure apparatus
Bibliography

CSA Preface This is the first edition of CAN/CSA-ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-5 (second edition, 2007-03-15). Scope This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements.

CSA Preface This is the first edition of CAN/CSA-ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-5 (second edition, 2007-03-15). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11140-5” throughout. This Standard 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. Scope This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements.