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Hitec Medical MDR kudzidziswa - Chigadzirwa kupatsanurwa pasi peMDR(Chikamu 2

Mutemo 10. Diagnostic uye yekuongorora michina

Zvishandiso zvinoshandiswa pakuvheneka (marambi ekuongorora, maikorosikopu ekuvhiya) Kirasi I;

Yekufungidzira kweradiopharmaceuticals mumuviri (gamma kamera) kana kuongororwa zvakananga kana kucherechedzwa kwemaitiro akakosha emuviri (electrocardiogram, brain motor, electronic blood pressure measuring instrument) Kirasi IIa.;

Inoshandiswa kutarisisa mabasa emuviri munzvimbo dzine njodzi (anoongorora gasi reropa panguva yekuvhiyiwa) kana kubudisa ionizing radiation uye inoshandiswa kuongororwa kana kurapwa (X-ray diagnostic machines,) Kirasi IIb..

 

Mutemo 11. Software inoshandiswa kupa ruzivo rwekuita sarudzo yekuongorora kana kurapa zvinangwa Kirasi IIa.

 

Mutemo 12. Zvishandiso zvinoshanda zvinotungamirira kupinda nekubuda kwezvinodhaka kana zvimwe zvinhu mumuviri womunhu Kirasi IIa (aspirators, kupa pombi)

Zvakadai sekushanda nenzira ine njodzi (narcotics, ventilators, dialysis machines) Kirasi IIb.

 

Mutemo 13. Zvimwe zvese zvinoshanda zvekurapa zvinoshandiswa ndezveKirasi I

Zvakadai se: mwenje wekutarisa, chigaro chemazino, wiricheya yemagetsi, mubhedha wemagetsi

 

SpecialRules

Mutemo 14. Midziyo ine mishonga yekubatsira uye zvinyorwa zveropa revanhu sezvikamu Chikamu III

Zvakadai se: mishonga inorwisa mabhakitiriya bone simende, mishonga inorwisa mabhakitiriya-ine mudzi canal mishonga yekurapa, catheter yakavharwa neanticoagulants.

 

Mutemo wechigumi neshanu, midziyo yekuronga mhuri

Midziyo yese inoshandiswa kudzivirira kubata pamuviri kana kudzivirira kutapurirwa kwezvirwere zvepabonde (contraceptives) Kirasi IIb;

Midziyo inodyarwa kana yenguva refu yekupinda (tubal ligation zvishandiso) Kirasi III

 

Mutemo 16. Zvishandiso zvakacheneswa kana sterilized

Midziyo yese inoshandiswa kuuraya utachiona chete kana kuuraya utachiona inoiswa seKirasi IIa;

Midziyo yese yakagadzirirwa kuuraya hutachiona, kuchenesa, uye kucheneswa kwema hydrated contact lenses inoiswa seKirasi IIb..

 

Mutemo 17. Zvishandiso zvekunyora X-ray diagnostic mifananidzo Kirasi IIa

 

Mutemo wegumi nesere, michina inogadzirwa kubva kumatishu, maseru kana zvinobva kumunhu kana mhuka, Kirasi III

Zvakadai semhuka-yakatorwa biological moyo mavharuvhu, xenograft dressings, collagen dermal fillers

 

Mutemo 19. Zvese zvishandiso zvinosanganisira kana zvine nanomaterials

ine mukana wepamusoro kana pakati nepakati kuratidzwa kwemukati (inoshatisa bhonzo-kuzadza nanomaterials) Kirasi III;

Kuratidzira kuderera kwemukati kwemukati (nano-coated bone fixation screws) Kirasi IIb;

Inoratidza isingagoneki kugona kwemukati kuratidzwa (mazino ekuzadza zvinhu, asingaparare nanopolymers) Kirasi IIa

 

Mutemo wechimakumi maviri. Zvishandiso zvinopinda zvakagadzirirwa kupa mishonga kuburikidza nekufema

Zvese zvishandiso zvinopinda zvine chekuita neorifices yemuviri (inhalants yenicotine replacement therapy) Kirasi IIa;

Kunze kwekunge maitiro echiito aine mhedzisiro yakakosha pakubudirira uye kuchengetedzeka kwechigadzirwa chemushonga chinopihwa uye icho chinotarisirwa kurapwa kwemamiriro ehupenyu anotyisidzira Kirasi II b.

 

Mutemo 21. Zvishandiso zvinosanganisira zvinhu zvinounzwa kuburikidza neburi remuviri kana kuiswa paganda.

Kana ivo, kana metabolites yavo, yakanyura mudumbu kana yakadzika gastrointestinal turakiti kana system yemuviri, chinangwa chave chaitwa (sodium alginate, xyloglucan) Kirasi III.;

Inoshandiswa paganda, mhino, uye muromo wemukanwa pamusoro pe pharynx uye kuzadzisa chinangwa chavo mumakomba aya (mumhino nepahuro sprays,) Kirasi IIa.;

Mune zvimwe zviitiko (oral activated coal, hydrated eye drops) Kirasi IIb

 

Mutemo 22. Michina yekurapa inoshingaira ine maitiro akabatanidzwa ekuongororwa

Active kurapa midziyo (otomatiki yakavharwa-loop insulin yekuendesa masisitimu, otomatiki ekunze defibrillators) ane akabatanidzwa kana akasanganiswa ekuongorora mabasa ayo ari chinhu chikuru mukurapa kwemurwere nemudziyo (otomatiki ekunze defibrillators) Kirasi III.

 


Nguva yekutumira: Zvita-22-2023