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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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Availability date: 10/27/2021
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
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).
Published | |
Document Type | Standard |
Status | Current |
Publisher | Canadian Standards Association |
Pages | |
ISBN |