Sterilization of an Electronic Medical Device

Abstract

Radiosterilization was applied to a medical device with a “programmable memory” to allow in vivo implantation. Irradiation on a Cobalt-60 facility at 25 kGy at a dose rate of 2kGy/h corrupted the memory. Therefore an alternative sterilization method using UV was developed and validated based on ISO 11737-1 and ISO 14937. These procedures may be useful and effective for research purposes when only a small number of items might be involved but applicability at an industrial scale is unlikely.