What is ISO/TS 21387 about ?
ISO/TS 21387 in an international standard which discusses about requirements and routine processer for sterilization of medical devices.
ISO/TS 21387 provides guidance on the requirements that apply when parametric release is used to release the product after exposure to the sterilization process.
ISO/TS 21387 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.
Who is ISO/TS 21387 for ?
ISO/TS 21387 on sterilization of medical devices is applicable to:
- Companies dealing with ethylene oxide sterilization
- Medical companies using sterilization process
Why should you use ISO/TS 21387 ?
Ethylene oxide sterilization process is a low-temperature process which uses ethylene oxide gas to reduce the level of infectious agents.
ISO/TS 21387 provides guidance and requirements for ethylene oxide sterilization process such as absolute humidity (AH), gas concentration, humidity and relative humidity (RH). ISO/TS 21387 also provides the quality management system for sterilization process.
Ethylene oxide sterilization process is provided with product safety, quality and performance in ISO/TS 21387. This can help in manufacturing the requirement of ethylene oxide sterilization process for sterilization of medical device.