labarai

Hitec Medical MDR horo - Samfuran rarraba ƙarƙashin MDR(Sashe 2)

Dokar 10. Kayan aikin bincike da gwaji

Kayayyakin da ake amfani da su don haskakawa (fitilun gwaji, na'urorin tiyata) Class I;

Don daukar hoto na radiopharmaceuticals a cikin jiki (camera gamma) ko don ganewar asali kai tsaye ko gano mahimman hanyoyin ilimin lissafi (electrocardiogram, injin kwakwalwa, kayan auna karfin jini na lantarki) Class IIa;

An yi amfani da shi don saka idanu ayyukan ilimin lissafin jiki a cikin yanayi masu haɗari (masu nazarin iskar gas na jini yayin tiyata) ko fitar da ionizing radiation da amfani da shi don ganewar asali ko magani (na'urorin gano X-ray,) Class IIb.

Doka 11. Software da ake amfani da shi don samar da bayanan yanke shawara don dalilai na bincike ko na warkewa Class IIa

Dokar 12. Na'urori masu aiki waɗanda ke sarrafa shigarwa da fita na kwayoyi ko wasu abubuwa a cikin jikin mutum Class IIa (masu neman, famfo mai wadata)

Kamar aiki ta hanya mai hatsarin gaske (magungunan narcotic, ventilators, na'urorin dialysis) Class IIb

Doka ta 13. Duk sauran na'urorin likitanci masu aiki na cikin Class I

Kamar su: fitilar kallo, kujeran hakori, keken guragu na lantarki, gadon lantarki

Sna musammanRules

Doka ta 14. Na'urorin da ke ɗauke da magunguna masu taimako da kuma fitar da jinin ɗan adam a matsayin sassan Class III

Kamar su: simintin kashi na ƙwayoyin cuta, kayan aikin jiyya na tushen ƙwayoyin cuta, ƙwayoyin cuta masu rufaffiyar maganin hana ruwa.

Dokar 15, kayan aikin tsarin iyali

Duk na'urorin da ake amfani da su don hana haihuwa ko don hana yaduwar cututtukan da ake ɗauka ta hanyar jima'i (maganin hana haihuwa) Class IIb;

Na'urorin da za a iya dasa su ko na dogon lokaci (na'urorin ligation na tube) Class III

Doka ta 16. Na'urori masu tsabta ko haifuwa

Duk kayan aikin da aka yi amfani da su na musamman don ƙazanta ko ƙazanta an rarraba su azaman Class IIa;

Duk kayan aikin da aka ƙera musamman don lalata, tsaftacewa, da kuma kurkura na ruwan tabarau masu ruwa da ruwa an rarraba su azaman Class IIb.

Doka ta 17. Kayan aiki don yin rikodin hotunan bincike na X-ray Class IIa

Doka ta 18, kayan aikin da aka ƙera daga kyallen takarda, sel ko abubuwan asali na asalin mutum ko dabba, Darasi na III

Irin su bawul ɗin zuciya na halitta wanda aka samo daga dabba, suturar xenograft, filler collagen dermal.

Doka 19. Duk na'urori masu haɗawa ko masu ɗauke da nanomaterials

tare da yuwuwar bayyanar babban ko matsakaici na ciki (nanomaterials masu cika ƙashi mai lalacewa) Darasi na III;

Nuna ƙananan yuwuwar bayyanar ciki (nano mai rufin ƙasusuwan gyaran ƙashi) Class IIb;

Yana nuna yuwuwar sakaci don bayyanar ciki (kayan cika hakori, nanopolimers marasa lalacewa) Class IIa

Doka ta 20. Na'urori masu lalata da aka yi niyya don gudanar da kwayoyi ta hanyar shaka

Duk na'urori masu ɓarna da suka shafi ɓangarorin jiki (inhalants don maganin maye gurbin nicotine) Class IIa;

Sai dai idan yanayin aikin yana da tasiri mai mahimmanci akan inganci da amincin samfuran magani da aka gudanar da waɗanda aka yi niyya don kula da yanayin barazanar rai Class II b

Doka ta 21. Na'urorin da suka ƙunshi abubuwan da aka gabatar ta hanyar bangon jiki ko shafa akan fata

Idan su, ko metabolites ɗin su, suna shiga cikin ciki ko ƙananan ƙwayar gastrointestinal ko tsarin jiki, an cimma manufar (sodium alginate, xyloglucan) Class III.;

Ana shafa fata, kogon hanci, da kogon baka a sama da pharynx kuma don cimma manufar da aka yi niyya a cikin wadannan cavities (fashin hanci da makogwaro,) Class IIa;

A duk sauran lokuta (baki mai kunnawa ta baki, ruwan ido mai ruwa) Class IIb

Dokar 22. Kayan aikin jiyya mai aiki tare da iyawar bincike mai haɗaka

Na'urorin warkewa masu aiki (tsarin isar da insulin rufaffiyar madauki, na'urori masu sarrafa kansa na waje) tare da haɗaɗɗun ayyukan bincike ko haɗaka waɗanda sune babban mahimmancin jiyya na marasa lafiya tare da na'urar (masu lalata na waje ta atomatik) Class III