Electron beam sterilization of medical devices

摘要

A method of sterilizing a medical device having a surface which includes a bioactive material, especially heparin, involves placing the medical device in a package having a drying agent therein. The package is flushed with a non-reactive gas at least one time. A vacuum is created within the package at least one time to remove any remaining gases and moisture. The package is sealed. The package and the medical device are exposed to one or more doses of electron beam radiation for a predetermined period of time and at a predetermined dose level and temperature.