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Uqeqesho lwe-Hitec Medical MDR – Ukuhlelwa kwemveliso phantsi kwe-MDR(Inxalenye 2）

Umthetho we-10. Izixhobo zokuxilonga kunye nokuvavanya

Izixhobo ezisetyenziselwa ukukhanyisa (izibane zovavanyo, iimicroscopes zotyando) Udidi I;

Ngomfanekiso we-radiopharmaceuticals emzimbeni (ikhamera ye-gamma) okanye ukuxilongwa ngokuthe ngqo okanye ukufumanisa iinkqubo ezibalulekileyo zomzimba (i-electrocardiogram, i-brain motor, isixhobo sokulinganisa uxinzelelo lwegazi lwe-elektroniki) Iklasi IIa;

Isetyenziselwa ukubeka esweni imisebenzi ye-physiological kwiimeko ezinobungozi (abahlalutyi begesi yegazi ngexesha lotyando) okanye ukukhupha i-ionizing radiation kwaye isetyenziselwa ukuxilongwa okanye unyango (i-X-ray diagnostic machines,) i-Class IIb..

Umthetho we-11. I-Software esetyenziselwa ukubonelela ngolwazi lokuthatha izigqibo kwiinjongo zokuxilonga okanye zonyango Udidi lwe-IIa

Umgaqo we-12. Izixhobo ezisebenzayo ezilawula ukungena kunye nokuphuma kweziyobisi okanye ezinye izinto emzimbeni womntu Udidi IIa (i-aspirators, iimpompo zokubonelela)

Njengomsebenzi ngendlela enokuba yingozi (i-narcotics, i-ventilators, oomatshini be-dialysis) Udidi IIb

Umthetho we-13. Zonke ezinye izixhobo zonyango ezisebenzayo zezeKlasi yoku-I

Ezinje: isibane sokujonga, isitulo samazinyo, isitulo esinamavili sombane, ibhedi yombane

SokhethekileyoRules

Umthetho we-14. Izixhobo eziqulethe amayeza ancedisayo kunye neencindi zegazi lomntu njengamacandelo uKlasi III

Okunje: isamente yamathambo e-antibiotics, izixhobo zonyango ezinengcambu yomsele, ii-catheters ezigqunywe ngamayeza okubulala iintsholongwane.

Umthetho we-15, izixhobo zocwangciso-ntsapho

Zonke izixhobo ezisetyenziselwa ucwangciso okanye ukuthintela usulelo lwezifo ezosulela ngokwabelana ngesondo (izicwangcisi) Udidi IIb;

Izixhobo ezifakelwayo okanye eziphazamisayo zexesha elide (izixhobo ze-tubal ligation) Udidi lwesithathu

Umthetho we-16. Izixhobo ezicociweyo okanye ezicociweyo

Zonke izixhobo ezisetyenziselwa kuphela ukubulala iintsholongwane okanye ukubulala iintsholongwane zihlelwa njengeClass IIa;

Zonke izixhobo ezenzelwe ngokukodwa ukubulawa kweentsholongwane, ukucocwa, kunye nokuhlanjululwa kweelensi zoqhagamshelwano zehydrated zihlelwa njengeKlasi IIb..

Umthetho we-17. Izixhobo zokurekhoda imifanekiso ye-X-ray yokuxilonga i-Class IIa

Umthetho we-18, izixhobo ezenziwe kwiithishu, iiseli okanye izinto eziphuma kwimvelaphi yomntu okanye yesilwanyana, Udidi III

Ezinje ngeevalvu zentliziyo yebhayoloji ethathwe kwisilwanyana, ukunxitywa kwe-xenograft, izihluzi ze-collagen zedermal

Umthetho we-19. Zonke izixhobo ezibandakanya okanye eziqulethe i-nanomaterials

kunye nokubanakho ukuvezwa okuphezulu okanye okuphakathi kwangaphakathi (i-nanomaterials yokuzalisa amathambo eyonakalisayo) Udidi III;

Ukubonisa amandla aphantsi okuvezwa kwangaphakathi (i-nano-coated bone fixation screws) Udidi lwe-IIb;

Ibonisa amandla angabonakaliyo okuvezwa kwangaphakathi (izinto zokuzaliswa kwamazinyo, ii-nanopolymers ezingenakonakala) Udidi lwe-IIa

Umthetho wama-20. Izixhobo ezihlaselayo ezijoliswe ekulawuleni iziyobisi ngokuphefumla

Zonke izixhobo ezihlaselayo eziphathelele kwimibhobho yomzimba (i-inhalants yonyango lokubuyisela inikotini) Udidi lwe-IIa;

Ngaphandle kokuba indlela yesenzo inefuthe elibonakalayo ekusebenzeni nasekukhuselekeni kwemveliso yonyango elawulwayo kunye nezo zijoliswe kunyango lweemeko ezisongela ubomi Iklasi II b.

Umthetho wama-21. Izixhobo ezibandakanya izinto ezifakwe kwi-orifice yomzimba okanye ezifakwe eluswini.

Ukuba bona, okanye i-metabolites yabo, ifakwe kwisisu okanye i-gastrointestinal tract okanye inkqubo yomzimba, injongo iphunyeziwe (i-sodium alginate, i-xyloglucan) i-Class III.;

Igalelwa eluswini, emngxunyeni wempumlo, nakumqolo womlomo ngaphezulu kombhobho kunye nokufezekisa injongo yayo kule mingxuma (izitshizi zempumlo kunye nomqala,) Udidi IIa.;

Kuzo zonke ezinye iimeko (ilahle elisebenzayo ngomlomo, i-hydrated eye drops) i-Class IIb

Umthetho we-22. Izixhobo zonyango ezisebenzayo kunye nobuchule obudibeneyo bokuxilonga

Izixhobo zonyango ezisebenzayo (iinkqubo zokuhanjiswa kwe-insulin ezivaliweyo ngokuzenzekelayo, i-defibrillators yangaphandle ezenzekelayo) kunye nemisebenzi edibeneyo okanye edibeneyo yokuxilonga eyona nto iphambili kunyango lwesigulane kunye nesixhobo (i-defibrillators yangaphandle ngokuzenzekelayo) i-Class III.