Hitec Medical MDR amahugurwa - Ibisobanuro byamagambo ya MDR

Igikoresho c'ubuvuzi

Yerekeza ku gikoresho icyo ari cyo cyose, ibikoresho, ibikoresho, porogaramu, gushiramo, reagent, ibikoresho, cyangwa ikindi kintu cyakoreshejwe gusa cyangwa gihujwe nuwabikoze kubikorwa bimwe cyangwa byinshi byihariye byubuvuzi mumubiri wumuntu:

• Gusuzuma, gukumira, gukurikirana, guhanura, guhanura, kuvura cyangwa gukuraho indwara;
• Gusuzuma, gukurikirana, kuvura, gutabarwa, n'indishyi z'imvune cyangwa ubumuga;
• Kwiga, gusimbuza, no kugenzura imikorere ya anatomique, physiologique, cyangwa patologique;
• Tanga amakuru binyuze muri vitro yo gupima ingero ziva mumubiri wumuntu, harimo ingingo, amaraso, hamwe nuduce twatanzwe;
• Akamaro kayo kaboneka cyane cyane muburyo bwumubiri nubundi buryo, bitanyuze muri farumasi, immunologiya, cyangwa metabolism, cyangwa nubwo ubwo buryo burimo, bigira uruhare gusa;
• Ibikoresho bifite intego cyangwa kugenzura
• Byakoreshejwe byumwihariko mugusukura, kwanduza, cyangwa kubuza ibikoresho.

Igikoresho gikora

Igikoresho icyo aricyo cyose gikora nkisoko yingufu usibye kwishingikiriza kumubiri wumuntu cyangwa uburemere, nimirimo ihindura ubwinshi bwingufu cyangwa guhindura ingufu.Ibikoresho bikoreshwa mugukwirakwiza ingufu, ibintu, cyangwa ibindi bintu hagati yibikoresho bikora nabarwayi nta mpinduka nini ihari ntibishobora gufatwa nkibikoresho bikora.

Igikoresho gitera

Igikoresho icyo aricyo cyose cyinjira mumubiri wumuntu binyuze mumiyoboro karemano cyangwa hejuru.

Ipaki

Uruvange rwibicuruzwa bipakiye hamwe kandi bigurishwa kubwubuvuzi bwihariye.

Uruganda

Umuntu usanzwe cyangwa wemewe gukora cyangwa kuvugurura byimazeyo igikoresho cyangwa igikoresho cyateguwe, cyakozwe, cyangwa cyavuguruwe rwose kandi kigurisha igikoresho munsi yizina cyangwa ikirango.

Kuvugurura byuzuye

Ukurikije ibisobanuro byakozwe nuwabikoze, bivuga kuvugurura byuzuye ibikoresho byashyizwe kumasoko cyangwa byakoreshejwe, cyangwa gukoresha ibikoresho byakoreshejwe mugukora ibikoresho bishya byubahiriza aya mabwiriza kandi bigaha ibikoresho byavuguruwe ubuzima bushya. 

Uhagarariye uburenganzira

Umuntu uwo ari we wese usanzwe cyangwa wemewe n'amategeko wagaragaye mu muryango w’ubumwe bw’ibihugu by’Uburayi wakiriye kandi akemera uruhushya rwanditse rutangwa n’uruganda ruherereye hanze y’ubumwe bw’ibihugu by’Uburayi kugira ngo rufate ibyemezo byose mu izina ry’uruganda rukurikije inshingano zashyizweho n’aya Mabwiriza ku ruganda.

Abatumiza mu mahanga

Umuntu uwo ari we wese usanzwe cyangwa wemewe n'amategeko wagaragaye mu muryango w’ubumwe bw’ibihugu by’Uburayi ushyira ibikoresho biva mu bihugu bya gatatu ku isoko ry’Uburayi.

Abatanga

Umuntu uwo ari we wese usanzwe cyangwa wemewe n'amategeko mubitanga, usibye uwabikoze cyangwa uwatumije mu mahanga, ashobora gushyira igikoresho ku isoko kugeza igihe kizakoreshwa.

Kumenyekanisha ibikoresho byihariye (UDI)

Urukurikirane rw'imibare cyangwa inyuguti zakozwe binyuze mu kumenyekanisha ibikoresho bizwi ku rwego mpuzamahanga no kumenyekanisha code, bituma habaho kumenyekanisha neza ibikoresho byihariye ku isoko.