I.S. EN 11140-4:2007
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English
01-01-2007
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system format
6 Performance requirements
7 Packaging and labelling
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
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