Status and progress in radiation sterilization of medical devices

This paper describes the features and status of radiation sterilization of medical devices in the world. The key points include establishment of modern commercial radiation company; establishment of dosimetry system; dose setting and auditing; validation of process; routine control; intranet management and product identification system; establishment of quality system; and radiation protection and safety. It is emphasized that the following should be paid great attention to in the near future: seizing opportunities for development; following the international level in construction of quality system; and establishing modern enterprise system.