1. Programmatic Assessment of Potential Induced Radioactivity in Electron Beam Sterilization of Healthcare Products.
- Author
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Smith M, Logar J, Montgomery A, and Vrain O
- Subjects
- Electrons, Health Physics standards, Internationality, Radioisotopes radiation effects, Equipment Contamination prevention & control, Equipment and Supplies standards, Radiation Monitoring standards, Radiation Protection standards, Radioisotopes analysis, Sterilization standards
- 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.
- Published
- 2016
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