摘要 |
PURPOSE: A method for manufacturing a sterilized and calibrated biosensor-based medical device is provided to produce the device simply and economically and to sterilize an assembled and packed device. CONSTITUTION: The method(300) for manufacturing a sterilized and calibrated biosensor-based medical device comprises the steps of: (310) forming at least one sterilized biosensor-based medical device by sterilizing at least one biosensor-based medical device comprising a biosensor reagent composition; and (320) calibrating the biosensor reagent composition of the sterilized biosensor-based medical device. A radiation sterilizing technology, particularly gamma radiation sterilization is used in the sterilizing step. |