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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
English
01-08-2017
20-04-2024
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
Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 degrees C to 65 degrees C.
| Committee |
ISO/TC 98
|
| DevelopmentNote |
Supersedes AAMI ST21. (05/2006)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-679-5
|
| Pages |
18
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11138-2:2017 | Identical |
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