BS PD ISO/TS 21387:2020
Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
- Standard No.
- BS PD ISO/TS 21387:2020
- Release Date
- 2020
- Published By
- British Standards Institution (BSI)
- Lastest
- BS PD ISO/TS 21387:2020
- Scope
- This document 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. It 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. Additionally, it 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.
BS PD ISO/TS 21387:2020 history
- 2020 BS PD ISO/TS 21387:2020 Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release