AAMI ISO 11140-5 : 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS
Hardcopy , PDF
09-05-2020
English
01-01-2012
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11140-5:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Indicator system
5.1 Format
5.2 Performance
6 Indicator
6.1 Format
6.2 Performance
7 Packaging and labeling
8 Quality assurance
9 Sampling conditioning
Annex A (normative) Determination of the degree of
contrast between the color of the substrate
and the indicator agent
Annex B (normative) Method of determining uniform
color change on exposure to saturated steam
Annex C (normative) Method for determining indicator
color change on exposure to dry heat
Annex D (normative) Method for determining transfer of
indicator agent to standard test pack
Annex E (normative) Standard test pack
Annex F (normative) Method of determining non-uniform
color change on exposure to a standard fault
condition
Annex G (normative) Steam exposure apparatus
Bibliography
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