无菌医疗器械采用辐照灭菌的过程确认探讨

Discussion on the Confirmation of Sterilization Process of Irradiation Sterilization Medical Device

辐照灭菌过程是终端灭菌型无菌医疗器械生产过程中的特殊过程,其涉及的灭菌设备、剂量、环境需要严格的控制并经过确认。本文通过对辐照灭菌工艺过程确认的各个环节进行阐述,为医疗器械注册人和技术审评部门提供参考。

Irradiation sterilization is a special process with production of terminal sterile medical devices.It need to be strictly controlled and confirmed that the sterilization equipment,dose and environment.In this article,it is described which each link of the process confirmation of irradiation sterilization,in order to provide reference for medical device registrant and technical evaluation department.