Name:
AAMI TIR16:2023 PDF
Published Date:
12/18/2023
Status:
Active
Publisher:
Association for the Advancement of Medical Instrumentation
Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
| File Size : | 1 file , 840 KB |
| ISBN(s) : | 9781570208782 |
| Note : | This product is unavailable in Belarus, Russia, Ukraine |
| Number of Pages : | 51 |
| Published : | 12/18/2023 |
