ANSI/AAMI/ISO 11737-1:2018
Current
The latest, up-to-date edition.
Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products
English
24-01-2018
Specifies general criteria to be applied in the estimation of the population of viable microorganisms on a medical device or component, raw material or device packaging.
| Committee |
TC 198
|
| DevelopmentNote |
New child AMD 1 2021 is added
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-693-1
|
| Pages |
76
|
| ProductNote |
New child AMD 1 2021 is added
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11737-1:2018 | 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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