irine gociriZe biosamedicino inJineria
irine gociriZe biosamedicino inJineria
irine gociriZe biosamedicino inJineria
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klasifikacia (direqtivis danarTi IX, EC 93/42)<br />
• klasifikacia Sedgenilia klasifikaciis wesebis mixedviT, romlebic<br />
mocemulia direqtivebis damateba IX-Si (klasifikaciis 18 wesi)<br />
• samedicino mowyobilobebi iyofa Semdeg klasebad: I, IIa, IIb, III.<br />
• mowyobilobis<br />
procedurebs.<br />
klasi ganapirobebs Sesabamis dadgenis optimalur<br />
mowyobilobebi,<br />
klsad Semdegnairad:<br />
romlebic mocemulia direqtiviT, dajgufebulia 4<br />
• klasi I – zogadad miCneulia, rogorc dabali riskis,<br />
• klasi IIa - zogadad miCneulia, rogorc saSualo riskis,<br />
• klasi IIb - zogadad miCneulia, rogorc saSualo riskis,<br />
• klasi III - zogadad miCneulia, rogorc maRali riskis.<br />
klasebi<br />
(xifaTs):<br />
Seesatyviseba samedicino mowyobilobis potenciur risks<br />
samedicino aparati<br />
“pre-marketuli” (wina-sabazro) procedurebi<br />
mniSvnelovani moTxovnebi<br />
klasifikaciis wesebi<br />
saregistracio<br />
klasebi I, IIa, IIb, III<br />
organoebi<br />
sur. 1.5<br />
21<br />
Sesabamosobis<br />
dadgenis<br />
procedurebi<br />
“CE”<br />
niSani
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