Study on Parametric Release of Ethylene Oxide Sterilization of Medical Devices.
10.3969/j.issn.1671-7104.2022.05.020
- Author:
Hongxin HUANG
1
;
Changming HU
1
;
Wenyi LIU
2
;
Wenbo CUI
3
;
Haiying XU
4
;
Peiping ZHU
2
Author Information
1. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou, 510663.
2. Suzhou GOLAS Medical Technology Co. Ltd., Suzhou, 215000.
3. Xinxiang Huaxi Sanitary Materials Co. Ltd., Xinxiang, 453412.
4. Suzhou Prosteri Medical Technology Co. Ltd., Suzhou, 215000.
- Publication Type:Journal Article
- Keywords:
parametric release;
sterility assurance level;
sterilization process parameters
- MeSH:
Ethylene Oxide;
Sterilization/methods*
- From:
Chinese Journal of Medical Instrumentation
2022;46(5):574-577
- CountryChina
- Language:Chinese
-
Abstract:
This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.
