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.