ANSI/AAMI/ISO 11138-2:2017(R2024)
Current
Current
The latest, up-to-date edition.
Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
16-04-2024
€110.26
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This document specifies 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 °C to 65 °C.
| Committee |
ISO/TC 198
|
| DocumentType |
Test Method
|
| ISBN |
978-1-57020-679-5
|
| Pages |
18
|
| ProductNote |
This standard is identical to ISO 11138-2.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| AAMI TIR56:2013(R2024) | Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices |
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