Rarraba samfur a ƙarƙashin MDR
Dangane da abin da aka yi niyya na amfani da samfurin, an raba shi zuwa matakan haɗari guda huɗu: I, IIa, IIb, III (Ana iya rarraba Class I zuwa Is, Im, Ir., bisa ga ainihin yanayi;waɗannan nau'ikan guda uku kuma suna buƙatar takaddun shaida na ɓangare na uku kafin samun takardar shaidar CE.IPO.)
An daidaita sharuɗɗan bisa ƙa'idodin rarrabawa daga ƙa'idodi 18 a cikin lokacin MDD zuwa ka'idoji 22
Rarraba samfuran bisa ga haɗari;lokacin da na'urar likita ta kasance ƙarƙashin ƙa'idodi da yawa, ana amfani da ƙa'idar rarraba mafi girma.
| Tamfani na zamani | Yana nufin ci gaba da amfani na yau da kullun wanda ba zai wuce mintuna 60 ba |
| Short-lokacin amfani | Yana nufin amfani na yau da kullun tsakanin mintuna 60 zuwa kwanaki 30. |
| Dogon-lokacin amfani | Yana nufin ci gaba da amfani na yau da kullun fiye da kwanaki 30. |
| Bbakin ciki | Duk wani buɗaɗɗen halitta a cikin jiki, da kuma saman fuskar ƙwallon ido, ko kowane buɗewar wucin gadi na dindindin, kamar stoma. |
| Kayayyakin Cin Hanci na Tiya | Na'urori masu cin zarafi waɗanda ke shiga cikin jiki daga saman, gami da ta hanyar ɓangarorin mucosa na sassan jikin jiki yayin tiyata |
| Rkayan aikin tiyata masu amfani | Yana nufin na'urar da aka yi niyya don amfani da tiyata ta hanyar yanke, hakowa, sarewa, gogewa, guntuwa, matsewa, raguwa, sausaya ko makamancin haka, wanda ba a haɗa shi da kowace na'urar likita mai aiki kuma ana iya sake amfani da ita bayan aiki mai dacewa. |
| Kayan aikin warkewa masu aiki | Duk wata na'ura mai aiki, ko ana amfani da ita ita kaɗai ko a haɗe tare da wasu na'urori, don tallafawa, musanya, musanya ko maido da aiki ko tsarin halitta don manufar magani ko rage cuta, rauni ko nakasa. |
| Na'urori masu aiki don ganewar asali da gwaji | Yana nufin kowace na'ura mai aiki, ko ana amfani da ita ita kaɗai ko a haɗe tare da wasu na'urori, da ake amfani da su don ganowa, ganowa, ganowa, ko kula da cutar ta jiki, yanayin lafiya, cuta, ko nakasawar haihuwa. |
| Ctsarin jini na ciki | Yana nufin: jijiya na huhu, hawan aorta, archaorta, saukowa aorta tare da bifurcation arterial, jijiyoyin jini, jijiya carotid na kowa, jijiya carotid na waje, jijiya carotid na ciki, jijiya na ciki, ganga brachiocephalic, jijiya na zuciya, jijiya na huhu, mafi girma a cikin vena caviar. wuta cava. |
| Ctsarin juyayi na ciki | yana nufin kwakwalwa, meninges da kashin baya |
Dokoki 1 zuwa 4. Duk na'urorin da ba masu cin zali ba suna cikin Class I sai dai idan:
Don ajiyar jini ko wasu ruwan jiki (banda jakar jini) Class IIa;
Yi amfani da Class IIa dangane da na'urori masu aiki na Class IIa ko mafi girma;
Canji a cikin nau'in ruwan jiki IIa/IIb, nau'in suturar rauni IIa/IIb.
Dokar 5. Na'urorin likitanci waɗanda ke mamaye jikin ɗan adam
Aikace-aikacen wucin gadi (kayan matsawar hakori, safar hannu na gwaji) Class I;
Amfani na ɗan gajeren lokaci (catheters, ruwan tabarau na lamba) Class IIa;
Amfani na dogon lokaci (stents na urethra) Class IIb.
Dokokin 6 ~ 8, kayan aikin rauni na tiyata
Kayan aikin tiyata da za a sake amfani da su (ƙarfi, gatari) Class I;
Amfani na ɗan lokaci ko na ɗan gajeren lokaci (aluran suture, safar hannu na tiyata) Class IIa;
Amfani na dogon lokaci (pseudoarthrosis, ruwan tabarau) Class IIb;
Na'urorin da ke hulɗa da tsarin jini na tsakiya ko tsarin juyayi na tsakiya Class III.
Doka ta 9. Na'urorin da ke bayarwa ko musanya makamashi Class IIa (tsokokistimulators, lantarki drills, fata phototherapy inji, ji Aid)
Yin aiki a cikin wani yanayi mai haɗari (maɗaukakin aikin lantarki, ultrasonic lithotripter, incubator na jarirai) Class IIb;
Fitarwa na ionizing radiation don dalilai na warkewa (cyclotron, mai saurin layi) Class IIb;
Duk na'urorin da aka yi amfani da su don sarrafawa, gano ko kai tsaye suna shafar aikin na'urori masu aiki (na'urorin da za a iya dasa su, masu rikodin madauki) Class III..
Lokacin aikawa: Dec-13-2023