CAN/CSA-ISO 11140-4:18 (R2023)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labeling
8 Quality assurance
Annex A (normative) - Determination of
                      indicator strength during
                      and after steam sterilization
Annex B (normative) - Standard test cycles
Annex C (normative) - Estimation of visual
                      difference between colour of
                      the substrate and of the changed
                      or unchanged indicator system by
                      determination of relative reflectance
                      density
Annex D (normative) - Determination of uniform
                      colour change on exposure to
                      saturated steam
Annex E (normative) - Determination of equivalence
                      of the alternative indicator to
                      the Bowie and Dick test
Annex F (normative) - Determination of
                      reproducibility of fail conditions
                      created in a standard test pack by
                      air injection, air leak and retained
                      air systems
Annex G (normative) - Determination of
                      indicator colour change on
                      exposure to dry heat
Annex H (normative) - Determination of
                      shelf life of product
Annex I (normative) - Accelerated ageing
                      of test samples
Annex J (normative) - Steam exposure
                      apparatus and steam for
                      test purposes
Annex K (normative) - Standard test pack
Annex L (normative) - Air injection system
Bibliography

CSA Preface This is the first edition of CAN/CSA-ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-4 (second edition, 2007-03-15). Scope This part of ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads). NOTE: The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes. An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

CSA Preface This is the first edition of CAN/CSA-ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-4 (second edition, 2007-03-15). For brevity, this Standard will be referred to as “CAN/CSA-ISO 11140-4” 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 performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads). NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes. An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.