irine gociriZe biosamedicino inJineria
irine gociriZe biosamedicino inJineria
irine gociriZe biosamedicino inJineria
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sasargebloa medikosebisaTvis, romlebic dainteresebulebi arian sakuTari<br />
muSaobis sferos aparaturul uzrunvelyofaSi.<br />
miRebulia <strong>biosamedicino</strong> aparaturis Semdegi klasifikacia:<br />
• <strong>biosamedicino</strong> aparatura<br />
• vizualizaciis aparatura;<br />
• laboratoriuli aparatura;<br />
• Terapiuli aparatura.<br />
18<br />
sadiagnostiko<br />
Terapiuli<br />
samedicino aparaturas waeyeneba rigi specifiuri moTxovnebisa maT Soris:<br />
• usafrTxoeba – samedicino aparaturas moxmarebam ziani ar unda<br />
moutanos pacientebs da personals.<br />
• efeqturoba – samedicino aparaturas meSveobiT SesaZlebeli unda<br />
iyos mosalodneli Sedegebis miRweva.<br />
• saimedooba – minimumamde unda iyos dayvanili gauTvaliswinebeli<br />
gaumarTaobis SemTxvevebi.<br />
am pirobebis dasacavad samedicino teqnikis dargSi damuSavebulia<br />
standartebi, salicenzio sistemebi. ukanaskneli 40 wlis ganmavlobaSi<br />
TiToeulma qveyanam SeimuSava sakuTari saregulacio meqanizmebi. mag:<br />
• gaerTianebuli samefo – mwarmoeblebis registracia; DHA<br />
• aSS-s mier (produqciis xarisxis kontroli);<br />
• safrangeTi – damtkiceba (hemologizacia). aparaturis savaldebulo<br />
Semowmeba;<br />
• germania – aparaturis tipis savaldebulo Semowmeba;<br />
• italia – savaldebulo registracia jandacvis erovnuli<br />
institutis Mmier.<br />
axali, saerTo evropuli ganviTarebis koncefciidan gamomdinare, saerTo<br />
evropuli bazris Sesaqmnelad damuSavda evropuli direqtivebi. direqtiva<br />
warmoadgens evrogaerTianebis kanonmdeblobis nawils da saWiroebs<br />
transformacias nacionalur kanonebSi, TiToeuli qveynisaTvis. jandacvis<br />
produqciisaTvis damuSavebulia sami direqtiva:<br />
1. aqtiuri implantirebadi samedicino mowyobilobebi<br />
-90/385/EEC 1990 wlis 20 ivnisi.<br />
2. samedicino mowyobilobebi<br />
-93/42/EEC 1993 wlis 14 ivnisi.
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