Programmatic Assessment of Potential Induced Radioactivity in Electron Beam Sterilization of Healthcare Products.

ISO 11137-1:2006 Sterilization of Healthcare Products-Radiation requires that the potential for induced radioactivity be evaluated for medical devices irradiated with electrons with energy more than 10 MeV. For a manufacturing operation where new devices are being developed, a practical program for making such an evaluation should be engrained in the process, including the device design phase, where selection of materials can make a difference in the potential for activation to occur as a result of the irradiation process. The program, which is based on general assumptions as to the likely activation processes and generalized process assessments is being implemented in three phases: (1) incorporating materials consideration in the design phase, (2) evaluating potential activation empirically, including measurement at the point of irradiation, and (3) implementing routine procedures for the program, including developing a data base of results for consideration in future design efforts.