title: Programmatic Assessment of Potential Induced Radioactivity in Electron Beam Sterilization of Healthcare Products.
abstract: 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.
authors.affiliation: *P. O. Box 11599, Charlotte, NC 28220; †Johnson & Johnson Sterility Assurance, Raritan, NJ; ‡Synergy Health, Tullamore, Ireland.
authors.forename: Mark
authors.initials: M
authors.lastname: Smith
authors.forename: John
authors.initials: J
authors.lastname: Logar
authors.forename: Alan
authors.initials: A
authors.lastname: Montgomery
authors.forename: Olivier
authors.initials: O
authors.lastname: Vrain
mesh_terms: D004583:Electrons; D004866:Equipment Contamination / Q000517:prevention & control*; D004864:Equipment and Supplies / Q000592:standards*; D006283:Health Physics / Q000592:standards; D038622:Internationality; D011834:Radiation Monitoring / Q000592:standards*; D011835:Radiation Protection / Q000592:standards*; D011868:Radioisotopes / Q000032:analysis* / Q000528:radiation effects; D013242:Sterilization / Q000592:standards*
chemical_list: D011868:Radioisotopes