Ukuhlukaniswa komkhiqizo ngaphansi kwe-MDR
Ngokusekelwe ekusetshenzisweni okuhlosiwe komkhiqizo, uhlukaniswe ngamaleveli amane engozini: I, IIa, IIb, III (Ikilasi I lingahlukaniswa libe yi-Is, Im, Ir, ngokwemibandela yangempela;lezi zigaba ezintathu nazo zidinga isitifiketi somuntu wesithathu ngaphambi kokuthola isitifiketi se-CE.IPO.)
Imigomo esekelwe emithethweni yokuhlukanisa ilungiswa kusukela ku-18rules esikhathini se-MDD kuya ku-22rules
Hlela imikhiqizo ngokusekelwe engcupheni;lapho idivayisi yezokwelapha ingaphansi kwemithetho eminingi, umthetho wokuhlukanisa wezinga eliphezulu uyasetshenziswa.
| Tukusetshenziswa kwesikhashana | Isho ukusetshenziswa okuqhubekayo okulindelekile okujwayelekile okungadluli imizuzu engama-60 |
| Short-ukusetshenziswa kwethemu | Isho ukusetshenziswa okuvamile okulindelekile phakathi kwemizuzu engama-60 nezinsuku ezingama-30. |
| Mude-ukusetshenziswa kwethemu | Kubhekiselwa ekusetshenzisweni okuqhubekayo okulindelekile okungaphezu kwezinsuku ezingama-30. |
| Body orifice | Noma yikuphi ukuvuleka okungokwemvelo emzimbeni, kanye nendawo engaphandle yenhlamvu yeso, nanoma yikuphi ukuvulwa kokwenziwa okuhlala njalo, okufana ne-stoma. |
| Izinsimbi Zokuhlinza Ezihlaselayo | Imishini ehlaselayo engena emzimbeni isuka phezulu, okuhlanganisa nolwelwesi lwamafinyila oluphuma emlonyeni ngesikhathi sokuhlinzwa |
| Rizinsimbi zokuhlinza ezisebenzisekayo | Isho idivaysi ehloselwe ukuhlinza ngokusika, ukubhoboza, ukusaha, ukuklwebula, ukuchopha, ukugoqa, ukuncipha, ukugunda noma izindlela ezifanayo, ezingaxhumekile kunoma iyiphi idivayisi yezokwelapha esebenzayo futhi engasetshenziswa kabusha ngemva kokucubungula okufanele. |
| Imishini yokwelapha esebenzayo | Noma iyiphi idivayisi esebenzayo, kungakhathaliseki ukuthi isetshenziswa yodwa noma ihlanganiswe nezinye izisetshenziswa, ukusekela, ukuguqula, ukufaka esikhundleni noma ukubuyisela ukusebenza kwebhayoloji noma ukwakheka ngenjongo yokwelapha noma ukudambisa izifo, ukulimala noma ukukhubazeka. |
| Amadivayisi asebenzayo okuxilongwa nokuhlola | Isho noma iyiphi idivayisi esebenzayo, kungakhathaliseki ukuthi isetshenziswa yodwa noma ihlanganiswe nezinye izisetshenziswa, esetshenziselwa ukuthola, ukuxilonga, ukuthola, noma ukwelapha ukuphazamiseka kokuphila, isimo sezempilo, isifo, noma ukukhubazeka kokuzalwa. |
| Cisistimu ye-circulatory engaphakathi | Kubhekiselwa ku: umthambo wamaphaphu, ukwehla kwe-aorta, i-arch aorta, i-aorta eyehlayo ene-arterial bifurcation, i-coronary artery, i-common carotid artery, i-carotid artery yangaphandle, i-carotid artery yangaphakathi, i-cerebral artery, i-brachiocephalic trunk, i-cardiac vein, i-pulmonary vein, i-carotid vein, vena cava. |
| Cuhlelo lwezinzwa lwangaphakathi | ibhekisela ebuchosheni, kuma-meninges kanye nomgogodla |
Imithetho 1 kuya ku-4. Wonke amadivaysi angavamisi angaphansi Kwekilasi I ngaphandle uma:
Okokugcina igazi noma olunye uketshezi lomzimba (ngaphandle kwezikhwama zegazi) Isigaba IIa;
Sebenzisa i-Class IIa ngokuxhumene namadivayisi asebenzayo e-Class IIa noma ngaphezulu;
Ushintsho ekubunjweni koketshezi lomzimba isigaba IIa/IIb, isigaba sokubopha amanxeba IIa/IIb.
Umthetho 5. Imishini yezokwelapha ehlasela umzimba womuntu
Ukusetshenziswa kwesikhashana (izinto zokucindezelwa kwamazinyo, amagilavu okuhlola) Ikilasi I;
Ukusetshenziswa kwesikhathi esifushane (ama-catheter, ama-contact lens) I-Class IIa;
Ukusetshenziswa isikhathi eside (ama-stents e-urethral) I-Class IIb.
Imithetho 6~8, amathuluzi okulimala kokuhlinzwa
Amathuluzi okuhlinza angasetshenziswa kabusha (ama-forceps, izimbazo) Ikilasi I;
Ukusetshenziswa kwesikhashana noma okwesikhashana (izinaliti ze-suture, amagilavu okuhlinzwa) I-Class IIa;
Ukusetshenziswa isikhathi eside (pseudoarthrosis, lens) Isigaba IIb;
Amadivayisi athintana nesistimu yokujikeleza emaphakathi noma isistimu yezinzwa emaphakathi Ikilasi III.
Umthetho 9. Amadivayisi anikeza noma ashintshanisa amandla Ikilasi IIa (imisiphaizikhuthazi, imishini kagesi, imishini yokwelapha isikhumba, izinsiza-kuzwa)
Ukusebenza ngendlela engase ibe yingozi (high-frequency electrosurgery, ultrasonic lithotripter, infant incubator) Isigaba IIb;
Ukukhishwa kwemisebe ye-ionizing ngezinjongo zokwelapha (i-cyclotron, i-accelerator eqondile) I-Class IIb;
Wonke amadivayisi asetshenziselwa ukulawula, ukuthola noma ukuthikameza ngokuqondile ukusebenza kwamadivayisi asebenzayo afakelwayo (ama-defibrillator afakelwayo, izirekhoda ze-loop ezifakelwayo) Ikilasi III..
Isikhathi sokuthumela: Dec-13-2023