ANSI/AAMI/ISO 11138-2:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
Hardcopy , PDF
04-20-2024
English
08-01-2017
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 11138-2:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination
of resistance to ethylene oxide
sterilization
Annex B (informative) - Rationale for the inclusion
of a second minimum D value specification
as a result of changes to the test gas used
to evaluate resistance and deletion of the
requirement for a minimum D value at
30 degrees C
Bibliography
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