AAMI/ISO TIR21387:2023 Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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.
AAMI/ISO TIR21387:2023 history
1970AAMI/ISO TIR21387:2023 Sterilization of health care products - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release