CAN/CSA-ISO 11140-3:18 (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
                      strength after steam sterilization
Annex B (normative) - Estimation of visual
                      difference between colour of
                      the substrate and the changed
                      (or unchanged) indicator system
                      by determination of relative
                      reflectance density
Annex C (normative) - Determination of
                      indicator colour change on
                      exposure to dry saturated
                      steam
Annex D (normative) - Determination of
                      indicator colour change on
                      exposure to dry heat
Annex E (normative) - Accelerated ageing
                      of test samples
Annex F (normative) - Determination of
                      transfer of indicator to
                      standard test pack on
                      processing
Annex G (normative) - Determination of
                      shelf life of the product
Annex H (normative) - Steam exposure apparatus
Annex I (normative) - Determination of sensitivity
                      of the indicator to the
                      presence of air
Annex J (normative) - Air injection system
Annex K (normative) - Standard test pack
Bibliography

CSA Preface This is the first edition of CAN/CSA-ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-3 (second edition, 2007-03-15), including Technical Corrigendum 1:2007. Scope This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

CSA Preface This is the first edition of CAN/CSA-ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11140-3 (second edition, 2007-03-15), including Technical Corrigendum 1:2007. For brevity, this Standard will be referred to as “CAN/CSA-ISO 11140-3” 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 chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.