Kuiswa kwechigadzirwa pasi peMDR
Zvichienderana nechinangwa chekushandiswa kwechigadzirwa, chakakamurwa kuita mana enjodzi: I, IIa, IIb, III (Kirasi I inogona kukamurwa kuita Is, Im, Ir., maererano nemamiriro ezvinhu chaiwo;aya mapoka matatu anodawo chechitatu-bato certification asati awana CE chitupa.IPO.)
Matemu anobva pamitemo yekuronga anogadziriswa kubva ku18rules munguva yeMDD kusvika ku22rules
Rongedza zvigadzirwa zvinoenderana nenjodzi;kana chigadzirwa chekurapa chiri pasi pemitemo yakawanda, mutemo wepamusoro wechikamu chepamusoro unoshandiswa.
| Tkushandiswa kwenguva pfupi | Inoreva kushandiswa kunotarisirwa kuenderera mberi kusingapfuuri maminetsi makumi matanhatu |
| Short-kushandiswa kwenguva | Inoreva kushandiswa kwakajairika pakati pemaminetsi makumi matanhatu nemazuva makumi matatu. |
| Kureba-kushandiswa kwenguva | Inoreva kunotarisirwa kuenderera kushandiswa kwemazuva anopfuura makumi matatu. |
| Body orifice | Chero kuvhurika kwechisikigo mumuviri, pamwe nekunze kweziso reziso, kana chero kuvhurika kwechigarire kwekugadzira, senge stoma. |
| Kuvhiya Invasive Instruments | Zvishandiso zvinopinda mukati memuviri kubva pamusoro, kusanganisira kuburikidza ne mucous membranes ye orifices yemuviri panguva yekuvhiyiwa |
| Reusable kuvhiya zviridzwa | Zvinoreva mudziyo wakagadzirirwa kushandiswa pakuvhiya nekucheka, kuchera, kusaha, kukwesha, kuchekerera, kurovera, kuderera, kugera kana zvimwewo nzira dzakafanana, dzisina kubatana kune chero chigadziriso chekurapa chinoshanda uye chinogona kushandiswa zvakare mushure mekugadzirisa kwakakodzera. |
| Active kurapa midziyo | Chero mudziyo unoshanda, ungave uchishandiswa wega kana musanganiswa nemimwe midziyo, kutsigira, kushandura, kutsiva kana kudzoreredza kushanda kwebiological kana chimiro nechinangwa chekurapa kana kuderedza chirwere, kukuvara kana kuremara. |
| Zvishandiso zvinoshanda zvekuongororwa uye kuongororwa | Zvinoreva chero mudziyo unoshanda, ungave uchishandiswa wega kana musanganiswa nemimwe michina, unoshandiswa kuona, kuongorora, kuona, kana kurapa chirwere chepfungwa, hutano, chirwere, kana congenital malformation. |
| Ckupinda mukati circulatory system | Zvinoreva: pulmonary artery, inokwira aorta, arch aorta, ichidzika aorta ine arterial bifurcation, coronary artery, common carotid artery, yekunze carotid artery, mukati carotid artery, cerebral artery, brachiocephalic trunk, cardiac vein, pulmonary mutsinga, cava mutsinga vena cava. |
| Central nervous system | zvinoreva uropi, meninges uye musana |
Mitemo 1 kusvika 4. Midziyo yese isiri-invasive ndeyeKirasi I kunze kwekunge:
Yekuchengetedza ropa kana zvimwe zvinwiwa zvemuviri (kunze kwemabhegi eropa) Kirasi IIa;
Shandisa Kirasi IIa ine chekuita nemidziyo inoshanda yeKirasi IIa kana yepamusoro;
Shanduko mukuumbwa kwemvura dzemuviri chikamu IIa/IIb, chikamu chekupfeka maronda IIa/IIb.
Mutemo 5. Zvishandiso zvekurapa zvinopinda mumuviri wemunhu
Kushanda kwenguva pfupi (meno compression zvinhu, magurovhosi ebvunzo) Kirasi I;
Kushandiswa kwenguva pfupi (catheters, contact lens) Kirasi IIa;
Kushandiswa kwenguva refu (urethral stents) Kirasi IIb.
Mitemo 6 ~ 8, midziyo yekuvhiya yekukuvadza
Zvishandiso zvekuvhiya zvinogona kushandiswa zvakare (forceps, matemo) Kirasi I;
Kwenguva pfupi kana kushandiswa kwenguva pfupi (suture tsono, magirovhosi ekuvhiya) Kirasi IIa;
Kushandiswa kwenguva refu (pseudoarthrosis, lens) Kirasi IIb;
Zvishandiso zvinosangana nepakati circulatory system kana central nerve system Kirasi III.
Mutemo 9. Zvishandiso zvinopa kana kuchinjanisa simba Kirasi IIa (musclezvinosimudzira, zvibooreso zvemagetsi, michina yeganda phototherapy, zvinoyamura kunzwa)
Kushanda nenzira inogona kuva nengozi (high-frequency electrosurgery, ultrasonic lithotripter, infant incubator) Kirasi IIb;
Kuburitswa kweiyo ionizing radiation yezvinangwa zvekurapa (cyclotron, linear accelerator) Kirasi IIb;
Midziyo yese inoshandiswa kudzora, kuona kana kukanganisa zvakananga mashandiro ezvishandiso zvinobatika (implantable defibrillators, implantable loop recorders) Kirasi III..
Nguva yekutumira: Zvita-13-2023