izindaba

Ukuqeqeshwa kwe-Hitec Medical MDR - Ukuhlelwa komkhiqizo ngaphansi kwe-MDR(Ingxenye 2）

Umthetho we-10. Imishini yokuxilonga nokuhlola

Izinto ezisetshenziselwa ukukhanyisa (izibani zokuhlola, izibonakhulu zokuhlinzwa) Ikilasi I;

Okokuthwebula kwemithi ye-radiopharmaceuticals emzimbeni (ikhamera ye-gamma) noma ukuxilongwa okuqondile noma ukutholwa kwezinqubo ezibalulekile zomzimba (i-electrocardiogram, injini yobuchopho, insimbi yokulinganisa umfutho wegazi nge-elekthronikhi) Isigaba IIa;

Isetshenziselwa ukuqapha imisebenzi yomzimba ezimeni eziyingozi (abahlaziyi begesi legazi ngesikhathi sokuhlinzwa) noma ukukhipha imisebe ye-ionizing futhi isetshenziselwa ukuxilongwa noma ukwelashwa (imishini yokuxilonga i-X-ray,) Isigaba IIb..

Umthetho 11. I-Software esetshenziselwa ukunikeza ulwazi lokuthatha izinqumo ngezinjongo zokuxilonga noma zokwelapha Isigaba IIa

Umthetho 12. Amadivayisi asebenzayo alawula ukungena nokuphuma kwezidakamizwa noma ezinye izinto emzimbeni womuntu Isigaba IIa (ama-aspirator, amaphampu anikezelayo)

Njengokusebenza ngendlela engaba yingozi (izidakamizwa, ama-ventilators, imishini yokuhlanza igazi) Ikilasi IIb

Umthetho we-13. Zonke ezinye izisetshenziswa zezokwelapha ezisebenzayo zingezekilasi I

Okufana nalokhu: isibani sokubuka, isihlalo samazinyo, isihlalo sabakhubazekile sikagesi, umbhede kagesi

SekhethekileRules

Umthetho 14. Amadivayisi aqukethe imithi eyisizayo kanye nezikhishwe zegazi lomuntu njengezingxenye Zesigaba III

Okufana nalokhu: usimende wamathambo we-antibiotic, izinto zokwelapha ezinezimpande eziqukethe ama-antibiotic, ama-catheter ahlanganiswe nama-anticoagulants

Umthetho we-15, izinto zokuhlela umndeni

Wonke amathuluzi asetshenziselwa ukuvimbela inzalo noma ukuvimbela ukudluliswa kwezifo ezithathelwana ngocansi (izivimbela-nzalo) Isigaba IIb;

Imishini efakelwayo noma ehlaselayo yesikhathi eside (amadivayisi e-tubal ligation) Isigaba III

Umthetho 16. Izinsimbi ezihlanziwe noma ezifakwe inzalo

Zonke izisetshenziswa ezisetshenziselwa kuphela ukubulala amagciwane noma ukubulala amagciwane zihlukaniswa njengeClass IIa;

Zonke izinto zokusebenza eziklanyelwe ngokukhethekile ukubulala amagciwane, ukuhlanza, nokuwasha amalensi okuxhumana anamanzi ahlukaniswa njengeClass IIb..

Umthetho we-17. Izinsiza zokurekhoda izithombe ze-X-ray zokuxilonga I-Class IIa

Umthetho we-18, okokusebenza okwenziwe ngezicubu, amaseli noma okuphuma kokunye okuvela kubantu noma kwezilwane, Ikilasi III

Okufana nama-valve enhliziyo etholakala esilwaneni, ama-xenograft dressings, ama-collagen dermal fillers

Umthetho 19. Wonke amadivaysi ahlanganisa noma aqukethe ama-nanomaterials

okunamandla okuchayeka ngaphakathi okuphezulu noma okulingene (ama-nanomaterials agcwalisa amathambo awonakele) Ikilasi III;

Ibonisa amandla aphansi okuchayeka angaphakathi (izikulufu zokulungisa amathambo anano-coated) Ikilasi IIb;

Ibonisa amandla angenakuqhathaniswa okuchayeka kwangaphakathi (izinto zokugcwalisa amazinyo, ama-nanopolymers angonakali) I-Class IIa

Umthetho wama-20. Imishini ehlaselayo ehloselwe ukuphatha izidakamizwa ngokuhogela

Onke amathuluzi ahlaselayo aphathelene nezimbobo zomzimba (ama-inhalants for nicotine replacement therapy) Isigaba IIa;

Ngaphandle uma indlela yesenzo inomthelela omkhulu ekusebenzeni nasekuphepheni komkhiqizo womuthi olawulwayo kanye naleyo ehloselwe ukwelapha izimo ezibeka impilo engcupheni Isigaba II b.

Umthetho 21. Amadivayisi ahlanganisa izinto ezethulwa ngembobo yomzimba noma ezifakwe esikhumbeni.

Uma wona, noma ama-metabolite awo, emuncwa esiswini noma emgudwini ophansi wesisu noma ohlelweni lomzimba, inhloso isifinyelelwe (i-sodium alginate, i-xyloglucan) Isigaba III.;

Kufakwe esikhunjeni, ekhaleni, nasekhaleni lomlomo ngaphezu komqala kanye nokufeza injongo ehlosiwe kule migodi (izifutho zamakhala nomphimbo,) Isigaba IIa;

Kuzo zonke ezinye izimo (amalahle acushwe ngomlomo, amaconsi eso ane-hydrated) Isigaba IIb

Umthetho wama-22. Imishini yokwelapha esebenzayo enamandla ahlanganisiwe okuxilonga

Imishini yokwelapha esebenzayo (amasistimu okulethwa kwe-insulin avaliwe avaliwe, ama-defibrillator angaphandle azenzakalelayo) anemisebenzi yokuxilonga edidiyelwe noma ehlanganisiwe eyisici esiyinhloko ekwelashweni kwesiguli ngocingo (ama-automated external defibrillators) Isigaba III.