PD ISO/TS 21387:2020

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.