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.Cited