AAMI ISO 11140-4 : 2007 : R2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
05-09-2020
English
01-01-2012
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11140-4:2007
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
color of the substrate and of the changed or
unchanged indicator system by determination of
relative reflectance density
Annex D (normative) Determination of uniform color 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 color change
on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated aging 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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