Designing a program to assess potential induced radioactivity in electron beam sterilization of medical devices

•A program is described to evaluate induced radioactivity in electron beam.•The program entails evaluation of design prior to manufacturing.•Radiation measurement is done immediately following irradiation.•The instrument has adequate sensitivity for this purpose.

ISO 11137-1:2006 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 needs to be engrained in the process. A program was developed such that the induced radioactivity evaluation is imbedded in the development of the irradiation process.