ANSI/AAMI/ISO 11737-2:2019
Current
The latest, up-to-date edition.
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
English
09-12-2019
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-734-1
|
| Pages |
29
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11737-2:2019 | Identical |
| 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 |
| AAMI CR513:2024 | Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing |
| AAMI TIR16:2023 | Microbiological aspects of ethylene oxide sterilization |
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