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CSA ISO 11140-4 : 2018

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CSA ISO 11140-4 : 2018

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

Canadian Standards Association

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Table of Contents

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

Abstract

Describes 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).

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association