M00008859
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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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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
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
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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | Canadian Standards Association |
Pages | |
ISBN |