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CSA ISO 11140-3 : 2018

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CSA ISO 11140-3 : 2018

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST

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
                      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

Abstract

Describes 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.

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association