National Standard Symposium of "Guidelines for Release of Process Parameters in Ethylene Oxide Steri

On May 24th, the symposium of "Guidelines for Release of Process Parameters in Ethylene Oxide Sterilization of Medical Devices" was successfully held in Cangzhou, Hebei. This meeting was hosted by the National Disinfection Technology and Equipment Standardization Technical Committee (referred to as "the Disinfection Technical Committee"), and was undertaken by Hebei Rongfeng Disinfection Equipment Co., Ltd. (referred to as "Hebei Rongfeng"). Huang Hongxin, the director of the Disinfection Technical Committee, together with the committee member and secretary-general Hu Changming, attended the meeting.

This standard was jointly compiled by Gaoshi Sterilization,AOMEI Group, Hebei Rongfeng, West China Medical Materials, Johnson & Johnson Medical, Shijie Medical, and Weigao Group (in no particular order).

Before the meeting, Wu Jian, the chairman of Hebei Rongfeng, on behalf of the hosting unit of this symposium, delivered a welcome speech, expressing warm welcome and thanks to the leaders and experts attending. Zhang Liwen, a member of the Disinfection Technical Committee and the technical vice president of Hebei Rongfeng, together with the technical department and sales service department, all participated in this meeting.

In the symposium, the participants focused on aspects such as the scope, term definitions, sterilant characteristics, process and equipment characteristics, product and process definitions, confirmation, installation qualification, operation qualification, performance qualification (PQ), review and approval, routine monitoring and control, product sterilization release, and maintaining the effectiveness of the sterilization process in the standard content. And they analyzed and discussed each standard in detail one by one. Regarding the overall framework, consistency of terms, addition or reduction of terms, the participants also put forward relevant modification suggestions.

In the next step, the writing team will modify and improve the standard content according to the feedback formed at the meeting to make it more reasonable, in line with the actual situation of ethylene oxide sterilization, and easy to understand and use. This will provide a strong guarantee and guidance for the industry standards of medical device sterilization in our country.