【摘要】 本工作对医疗保健产品采用电子加速器辐射灭菌的关键因素进行了探讨。通过对ISO11137标准的理解以及在实践中得出的经验,确定了电子加速器安装鉴定中需要形成的文件运行鉴定、性能鉴定及常规监控方法。安装鉴定、运行鉴定、性能鉴定及常规监控构成了电子束对医疗保健产品辐射灭菌过程控制的关键要素。更多还原

【Abstract】 The key factors involved in the sterilization of health-care products irradiated by electron accelerators were investigated in this paper based on the requirements of ISO 11137 and the experiences in practice.The files should be constructed in installation qualification(IQ),the general method used to do the operational qualification(OQ),performance qualification(PQ) and routine monitoring.IQ,OQ,PQ and routine monitoring were the bases of the process control of sterilization while the irradiation of health-care products was performed by electron accelerators.更多还原