CAN/CSA-ISO 11140-5:18

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). 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.