Ukuhlelwa kwemveliso phantsi kwe-MDR
Ngokusekelwe kusetyenziso olucetywayo lwemveliso, yahlulwe ngamanqanaba amane omngcipheko: I, IIa, IIb, III (Iklasi I ingahlulwa ibe yi-Is, Im, Ir, ngokweemeko zokwenyani;ezi ndidi zintathu zikwafuna isatifikethi somntu wesithathu ngaphambi kokufumana isatifikethi seCE.IPO.)
Imigaqo esekelwe kwimigaqo yokuhlelwa ihlengahlengiswa ukusuka kwi-18rules kwixesha le-MDD ukuya kwi-22rules
Hlela iimveliso ngokusekelwe kumngcipheko;xa isixhobo sonyango siphantsi kwemithetho emininzi, umgangatho ophezulu wokuhlelwa komgaqo usetyenziswa.
| Tukusetyenziswa okwethutyana | Ibhekisa kusetyenziso oluqhubekayo olulindelekileyo olungadlulanga kwimizuzu engama-60 |
| Short-ukusetyenziswa kwexesha | Ibhekisa kusetyenziso oluqhelekileyo olulindelekileyo phakathi kwemizuzu engama-60 kunye neentsuku ezingama-30. |
| Mde-ukusetyenziswa kwexesha | Ibhekisa kusetyenziso oluqhubekayo olulindelekileyo ngaphezulu kweentsuku ezingama-30. |
| Body orifice | Nakuphi na ukuvuleka kwendalo emzimbeni, kunye nomphezulu wangaphandle we-eyeball, okanye naluphi na ukuvulwa okusisigxina, okufana ne-stoma. |
| Izixhobo ezihlaselayo zotyando | Izixhobo ezihlaselayo ezingena emzimbeni ukusuka phezulu, kubandakanywa ne-mucous membranes ye-orifices yomzimba ngexesha lotyando |
| Rizixhobo zotyando ezisebenzisekayo | Ibhekisa kwisixhobo esilungiselelwe ukusetyenziswa ngotyando ngokusika, ukugrumba, ukusarha, ukukrwela, ukukrwela, ukumbamba, ukushwabana, ukucheba okanye iindlela ezifanayo, esingadityaniswanga kuso nasiphi na isixhobo sonyango esisebenzayo kwaye sinokuphinda sisetyenziswe emva kokulungiswa okufanelekileyo. |
| Izixhobo zonyango ezisebenzayo | Nasiphi na isixhobo esisebenzayo, nokuba sisetyenziswa sodwa okanye sidityaniswe nezinye izixhobo, ukuxhasa, ukuguqula, ukubuyisela okanye ukubuyisela ukusebenza kwebhayoloji okanye ulwakhiwo ngenjongo yokunyanga okanye ukunciphisa isifo, ukwenzakala okanye ukukhubazeka. |
| Izixhobo ezisebenzayo zokuxilongwa kunye nokuvavanya | Ibhekisa kuso nasiphi na isixhobo esisebenzayo, nokuba sisetyenziswa sodwa okanye zidityanisiwe nezinye izixhobo, ezisetyenziselwa ukubona, ukuxilonga, ukufumanisa, okanye ukunyanga ukuphazamiseka komzimba, imeko yempilo, isifo, okanye ukuzalwa kakubi. |
| Cinkqubo yokujikeleza kwe-entral | Ibhekisa ku: umthambo we-pulmonary, umthambo onyukayo we-aorta, i-arch aorta, i-aorta ehlayo ene-arterial bifurcation, i-coronary artery, i-carotid artery eqhelekileyo, i-carotid artery yangaphandle, i-carotid artery yangaphakathi, i-cerebral artery, i-brachiocephalic trunk, i-cardiac vein, i-pulmonary vein, i-carotid vein, i-vena cava. |
| Cinkqubo ye-nervous yangaphakathi | ibhekisa ebuchotsheni, kwi-meninges nakwi-spinal cord |
Imigaqo 1 ukuya 4. Zonke izixhobo non-invasive zeClass I ngaphandle kokuba:
Ukugcina igazi okanye olunye ulwelo lomzimba (ngaphandle kweengxowa zegazi) Udidi IIa;
Sebenzisa iKlasi ye-IIa ngokunxulumene nezixhobo ezisebenzayo zeKlasi IIa okanye ngaphezulu;
Utshintsho ekubunjweni kolwelo lomzimba udidi lwe-IIa/IIb, udidi lokunxitywa kwenxeba IIa/IIb.
Umthetho 5. Izixhobo zonyango ezihlasela umzimba womntu
Ukusetyenziswa kwexeshana (izinto zokunyanzeliswa kwamazinyo, iiglavu zoviwo) Iklasi I;
Ukusetyenziswa kwexesha elifutshane (i-catheters, iilensi zoqhagamshelwano) Iklasi IIa;
Ukusetyenziswa kwexesha elide (i-stents ye-urethral) Iklasi IIb.
Imithetho 6 ~ 8, izixhobo zokwenzakala ngotyando
Izixhobo zotyando eziphinda zisetyenziswe (iiforceps, izembe) Udidi I;
Ukusetyenziswa kwexeshana okanye elifutshane (iinaliti ze-suture, iiglavu zotyando) Iklasi IIa;
Ukusetyenziswa kwexesha elide (pseudoarthrosis, lens) Iklasi IIb;
Izixhobo zokunxibelelana nenkqubo ye-circulatory ephakathi okanye inkqubo ye-nervous central Class III.
Umgaqo 9. Izixhobo ezinika okanye zitshintshise amandla iClass IIa (imisiphaizivuseleli, izixhobo zombane, oomatshini bokufota ulusu, izixhobo zokuva)
Ukusebenza ngendlela enokuba yingozi (i-high-frequency electrosurgery, lithotripter ye-ultrasonic, incubator yosana) Iklasi IIb;
Ukukhutshwa kwemitha ye-ionizing ngeenjongo zonyango (i-cyclotron, i-accelerator ye-linear) Udidi IIb;
Zonke izixhobo ezisetyenziselwa ukulawula, ukufumanisa okanye ukuchaphazela ngokuthe ngqo ukusebenza kwezixhobo ezisebenzayo (i-defibrillators implantable, implantable loop recorders) Iklasi III..
Ixesha lokuposa: Dec-13-2023