amakuru

Hitec Medical MDR amahugurwa - Gutondekanya ibicuruzwa munsi ya MDR（Igice 2）

Ingingo ya 10. Ibikoresho byo gusuzuma no gupima

Ibikoresho bikoreshwa mu gucana (amatara yo gusuzuma, microscopes yo kubaga) Icyiciro I.；

Kumashusho ya radiofarmaceuticals mumubiri (kamera ya gamma) cyangwa mugupima neza cyangwa gutahura inzira zingenzi zifatika (electrocardiogram, moteri yubwonko, ibikoresho byapima umuvuduko wamaraso) Icyiciro cya IIa；

Ikoreshwa mugukurikirana imikorere ya physiologique mubihe bishobora guteza akaga (abasesengura gazi yamaraso mugihe cyo kubagwa) cyangwa gusohora imirasire ya ionizing kandi ikoreshwa mugupima cyangwa kuvura (imashini isuzuma X-ray,) Icyiciro cya IIb.

Ingingo ya 11. Porogaramu ikoreshwa mu gutanga amakuru yo gufata ibyemezo bigamije gusuzuma cyangwa kuvura Icyiciro cya IIa

Ingingo ya 12. Ibikoresho bifatika bigenzura kwinjiza no gusohoka kwibiyobyabwenge cyangwa ibindi bintu mumubiri wumuntu Icyiciro cya IIa (abifuza, pompe zitanga)

Nkakazi muburyo bushobora guteza akaga (ibiyobyabwenge, umuyaga, imashini ya dialyse) Icyiciro IIb

Ingingo ya 13. Ibindi bikoresho byose byubuvuzi bikora mubyiciro I.

Nka: itara ryo kwitegereza, intebe y amenyo, igare ryibimuga, uburiri bwamashanyarazi

SumwiharikoRules

Ingingo ya 14. Ibikoresho birimo imiti yingoboka hamwe namaraso yabantu nkibigize Icyiciro cya III

Nka: antibiyotike yamagufa ya sima, antibiyotike irimo ibikoresho byo kuvura imizi, catheters yashizwemo na anticoagulants

Ingingo ya 15, ibikoresho byo kuboneza urubyaro

Ibikoresho byose bikoreshwa mu kuboneza urubyaro cyangwa mu gukumira kwanduza indwara zandurira mu mibonano mpuzabitsina (kuringaniza imbyaro) Icyiciro cya IIb;

Ibikoresho byimurwa cyangwa birebire byigihe kirekire (ibikoresho bya tubal ligation) Icyiciro cya III

Ingingo ya 16. Ibikoresho bisukuye cyangwa byahinduwe

Ibikoresho byose bikoreshwa gusa mugukwirakwiza cyangwa kwanduza byashyizwe mucyiciro cya IIa;

Ibikoresho byose byabigenewe byumwihariko byo kwanduza, gusukura, no kwoza ibyuma bifata imiyoboro byashyizwe mucyiciro cya IIb.

Ingingo ya 17. Ibikoresho byo gufata amashusho ya X-ray yo gusuzuma Icyiciro IIa

Ingingo ya 18, ibikoresho bikozwe mu ngingo, ingirabuzimafatizo cyangwa ibikomoka ku bantu cyangwa ku nyamaswa, Icyiciro cya III

Nkibikomoka ku nyamaswa zikomoka ku nyamaswa, imyambarire ya xenograft, yuzuza dermal

Ingingo ya 19. Ibikoresho byose birimo cyangwa birimo nanomaterial

hamwe nubushobozi bwo hejuru cyangwa buringaniye imbere (kwangirika kwamagufwa yuzuye nanomateriali) Icyiciro cya III;

Kugaragaza ubushobozi bwimbere bwimbere (nano-yashizwemo amagufwa yo gukosora) Icyiciro IIb;

Yerekana ubushobozi budasanzwe bwo kwerekana imbere (ibikoresho byuzuza amenyo, nanopolymers idasenyuka) Icyiciro cya IIa

Ingingo ya 20. Ibikoresho bitera bigamije gutanga ibiyobyabwenge muguhumeka

Ibikoresho byose bitera bijyanye na orifike yumubiri (guhumeka kubuvuzi bwa nikotine) Icyiciro IIa;

Keretse niba uburyo bwibikorwa bugira ingaruka zikomeye kumikorere numutekano wibicuruzwa bivura imiti byatanzwe nibigamije kuvura indwara zangiza ubuzima Icyiciro cya kabiri b

Ingingo ya 21. Ibikoresho bigizwe nibintu byinjijwe binyuze muri orifice yumubiri cyangwa bigashyirwa kuruhu

Niba bo, cyangwa metabolite yabo, binjiye mu gifu cyangwa munsi ya gastrointestinal tract cyangwa sisitemu yumubiri, intego yagezweho (sodium alginate, xyloglucan) Icyiciro cya III;

Bikoreshejwe kuruhu, mu mazuru, no mu kanwa hejuru yumunwa no kugera kubyo bagenewe muri ibyo byobo (gutera izuru n'umuhogo,) Icyiciro cya IIa;

Mubindi bihe byose (amakara akoreshwa mumanwa, ibitonyanga byamaso) Icyiciro IIb

Ingingo ya 22. Ibikoresho bifatika byo kuvura bifite ubushobozi bwo gusuzuma

Ibikoresho bifatika byo kuvura (sisitemu yo gutanga insuline yikora-yikora, sisitemu yo hanze ya defibrillator) hamwe nibikorwa byo kwisuzumisha hamwe hamwe nibikorwa byingenzi byo kuvura abarwayi hamwe nigikoresho (defibrillators zo hanze) Icyiciro cya III