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...
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...
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