Nigute ushobora kubona amakuru yicyemezo mpuzamahanga kubimuga byabamugaye?

Nigute ushobora kubona amakuru yicyemezo mpuzamahanga kubimuga byabamugaye?

Kubona ibyemezo byimpamyabumenyi mpuzamahanga kubimuga byamashanyarazi bikubiyemo intambwe zikurikira nibisabwa:

1. Sobanukirwa n'amabwiriza akurikizwa
Ibimuga by'amashanyarazibafite ibyangombwa bitandukanye bisabwa mubihugu no mukarere. Mu muryango w’ubumwe bw’ibihugu by’Uburayi, amagare y’ibimuga akeneye kubahiriza ibisabwa n’amabwiriza agenga ibikoresho by’ubuvuzi (MDR) [Amabwiriza (EU) 2017/745] hamwe n’amabwiriza y’imashini (MD) [2006/42 / EC]. Byongeye kandi, hakenewe gusuzumwa amabwiriza ya Electromagnetic Compatibility Directeur (EMC Diregiteri) [2014/30 / EU] hamwe nubuyobozi buke bwa voltage (LVD) [2014/35 / EU].

2. Gusuzuma guhuza n'intambwe zemeza
Gutondekanya ibicuruzwa no guhuza inzira ihitamo: Menya ibyiciro byintebe yintebe yamashanyarazi hanyuma uhitemo inzira yo gusuzuma ihuza. Intebe y’ibimuga y’amashanyarazi muri rusange ishyirwa mu byiciro by’ubuvuzi byo mu cyiciro cya mbere, ariko kubera ko irimo amashanyarazi, birashobora gukenera gusubirwamo numubiri wabimenyeshejwe
Isuzuma rya Clinical: Ababikora bakeneye gukora isuzuma ryamavuriro kugirango bagaragaze umutekano nigikorwa cyibikoresho
Gucunga ibyago: Gucunga ibyago bikorwa hakurikijwe ISO 14971 kugirango umenye kandi ugabanye ingaruka zishobora kubaho mugihe cyubuzima bwibikoresho
Gutegura inyandiko ya tekiniki: Harimo ibisobanuro byibicuruzwa, raporo yisuzuma ryamavuriro, raporo yo gucunga ibyago, inganda ninyandiko zigenzura ubuziranenge, nibindi.
Itangazo ryujuje ubuziranenge (DoC): Uruganda rukeneye gushyira umukono no gutanga imenyekanisha ryujuje ubuziranenge ruvuga ko igare ry’ibimuga ry’amashanyarazi ryubahiriza amabwiriza yose y’ubumwe bw’ibihugu by’Uburayi
Isubiramo ry'umubiri ryamenyeshejwe: Hitamo urwego rumenyeshejwe kugirango rusuzume kandi rwemeze inyandiko ya tekiniki y'ibicuruzwa, gucunga ibyago, gusuzuma ivuriro, n'ibindi.

3. Ibisabwa byihariye kubyemezo bya CE
Icyemezo cya CE cy’ibimuga by’ibimuga by’ubumwe bw’ibihugu by’Uburayi bigomba gukurikiza ibipimo bya EN 12184, byerekana ibisabwa byihariye n’uburyo bwo gupima intebe z’ibimuga. Ibizamini birimo ibizamini byumutekano, imbaraga nogupima umutekano, kugerageza feri, hamwe numutekano wamashanyarazi no gupima imikorere

4. Ibisabwa kugirango icyemezo cya FDA 510K
Muri Amerika, intebe y’ibimuga y’amashanyarazi, nkibikoresho byubuvuzi byo mu cyiciro cya II, bigomba gutsinda FDA 510K isubiramo inyandiko. Ibi birimo intambwe nkisesengura risanzwe rishobora gukoreshwa, inyandiko zihari no kugarura amakuru, kugereranya isoko no kwandika inyandiko

5. Kubona ibaruwa yemewe
Nyuma yo gutsinda icyemezo cya FDA 510K, igare ryibimuga ryamashanyarazi rizahabwa ibaruwa yemewe, ninyandiko yingenzi yemeza ko ibicuruzwa byubahirizwa

6. Ibindi byemezo
Usibye icyemezo cya CE na FDA 510K, amagare y’ibimuga ashobora no gukenera gutanga izindi mpamyabumenyi mpuzamahanga, nk'icyemezo cya CB (Komisiyo mpuzamahanga y’amashanyarazi ya komisiyo ishinzwe ibizamini byo gupima ibicuruzwa)

Mugukurikiza intambwe n'ibisabwa haruguru, ababikora barashobora kwemeza ko amagare y’ibimuga yujuje ibyangombwa bisabwa n’isoko mpuzamahanga, bityo bikinjira mu buryo bwemewe n’umutekano ku isoko.