Name:
AAMI/ISO TIR21387:2023 PDF
Published Date:
08/27/2023
Status:
Active
Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization
Provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. Provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.
| File Size : | 1 file , 350 KB |
| ISBN(s) : | 9781570208720 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 29 |
| Published : | 08/27/2023 |
