METHOD OF MANUFACTURING STERILISED AND CALIBRATED MEDICAL DEVICE BASED ON BIOSENSOR (VERSIONS) Russian patent published in 2009 - IPC A61L2/08 

FIELD: medical equipment.

SUBSTANCE: invention concerns medical device manufacturing. Method of manufacturing sterilised and calibrated medical device based on biosensor (e.g. medical device combining biosensor and lancet) containing biosensoric reagent (e.g. biosensoric reagent out of enzyme specific to analysed substance, and mediator) involves sterilisation, e.g. by gamma radiation. Then biosensoric reagent of sterilised medical device based on biosensor is calibrated. Another method of sterilised and calibrated biosensor-based medical device manufacturing involves first stage of assembly and packing of multiple medical devices with biosensoric reagent, further sterilisation by radiation to obtain multiple sterilised and packed biosensor-based medical devices. Then sterilised and packed biosensor-based medical devices are calibrated. Calibration can be performed with statistic sample out of multiple sterilised and calibrated biosensor-based medical devices.

EFFECT: omitted assembly stage in clean facility, prevented dislocation during device assembly.

19 cl, 4 tbl, 4 dwg, 2 ex