Abstract
Various technical and regulatory considerations must be addressed in order to sterilize disposable medical devices by ionizing radiation. Current practices specific to electron beam-based sterilization events are discussed and include material compatibility testing, dose setting, dose mapping, process validation and process control associated with the accelerator/conveyor system. Projected trends in regulatory guideline development are made relative to the appearance and implementation of reliable high power machine-generated sources of electrons operating in the energy range of 0.3–12 MeV.
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