Ni izihe mpamyabumenyi abakora amagare y’ibimuga bakeneye kugira ibyoherezwa mu mahanga?

Ni izihe mpamyabumenyi abakora amagare y’ibimuga bakeneye kugira ibyoherezwa mu mahanga?
Nubwoko bwibikoresho byubuvuzi, kohereza hanzeibimuga by'amashanyaraziikubiyemo urukurikirane rw'impamyabumenyi n'ibisabwa. Ibikurikira nubushobozi nyamukuru ibyoabakora ibimuga by'amashanyarazibakeneye kugira igihe cyohereza hanze:

1. Kurikiza ibisabwa n'amategeko agenga igihugu kigenewe
Icyemezo cya FDA muri Amerika
Intebe z’ibimuga by’amashanyarazi zashyizwe mu byiciro by’ubuvuzi byo mu cyiciro cya II muri Amerika kandi zigomba gutanga FDA 510K kandi zigasuzumwa na tekiniki na FDA. Ihame rya 510K ni ukwemeza ko ibikoresho byubuvuzi byatangajwe bihwanye cyane nigikoresho cyagurishijwe byemewe n'amategeko muri Amerika.

Icyemezo cya EU CE
Dukurikije amabwiriza y’ubumwe bw’ibihugu by’Uburayi (EU) 2017/745, amagare y’ibimuga ashyirwa mu byiciro by’ubuvuzi byo mu cyiciro cya mbere. Nyuma y’ibikoresho by’ubuvuzi byo mu cyiciro cya mbere bipimishije ibicuruzwa kandi bikabona raporo y’ibizamini, kandi nyuma yo gukora inyandiko tekinike yujuje ubuziranenge hakurikijwe ibisabwa n’amabwiriza, birashobora gushyikirizwa uhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi kugira ngo byiyandikishe kandi icyemezo cya CE kirangire.

Icyemezo cya UKCA
Intebe z’ibimuga n’amashanyarazi byoherezwa mu Bwongereza. Ukurikije ibisabwa n’amabwiriza y’ubuvuzi UKMDR2002, ni ibikoresho byubuvuzi byo mu cyiciro cya mbere. Saba icyemezo cya UKCA nkuko bisabwa.

Icyemezo cy'Ubusuwisi
Intebe z’ibimuga n’amashanyarazi byoherezwa mu Busuwisi. Ukurikije ibisabwa byubuvuzi bwa oMedDO, nibikoresho byubuvuzi byo mucyiciro cya mbere. Ukurikije ibisabwa abahagarariye Ubusuwisi no kwiyandikisha mu Busuwisi

2. Ibipimo byigihugu nibipimo byinganda
Ibipimo byigihugu
"Intebe z’ibimuga by’amashanyarazi" ni igipimo cy’igihugu cy’Ubushinwa giteganya ijambo n’amahame y’izina ry’icyitegererezo, ibisabwa ku buso, ibisabwa mu nteko, ibisabwa mu bipimo, ibisabwa mu mikorere, ibisabwa imbaraga, kutagira umuriro, ikirere, ingufu n’ubugenzuzi bukenewe, hamwe nuburyo bwo gupima no kugenzura amategeko yintebe yibimuga.

Ibipimo nganda
"Umutekano wa tekiniki yihariye ya Batiri ya Litiyumu-ion na Bateri za Batiri ku ntebe z’ibimuga by’amashanyarazi" ni urwego rw’inganda, kandi ishami ribishoboye ni Minisiteri y’inganda n’ikoranabuhanga mu itumanaho.

3. Sisitemu yo gucunga neza
ISO 13485 na ISO 9001
Abakora ibimuga byinshi byamashanyarazi bazatsinda ISO 13485 na ISO 9001 ibyemezo bya sisitemu yo gucunga ubuziranenge kugirango barebe ko ubuziranenge n’ibicuruzwa byujuje ubuziranenge mpuzamahanga

4. Ibipimo byumutekano wa bateri na charger
Ibipimo byumutekano wa batiri ya Litiyumu
Batteri ya lithium ikoreshwa mu magare y’ibimuga y’amashanyarazi igomba kubahiriza ibipimo by’umutekano bijyanye, nka GB / T 36676-2018 “Ibisabwa by’umutekano hamwe nuburyo bwo gupima bateri ya lithium-ion hamwe nudupapuro twa batiri ku ntebe z’ibimuga”.

5. Kugerageza ibicuruzwa no gusuzuma imikorere
Ikizamini cyimikorere
Intebe z’ibimuga zikoresha amashanyarazi zigomba gupimwa kugirango zikore hakurikijwe amahame mpuzamahanga nka seriveri ya ISO 7176 kugirango umutekano wabo wizere
Kwipimisha ibinyabuzima
Niba ari igare ry’ibimuga ry’amashanyarazi, harasabwa kandi ibinyabuzima kugirango harebwe niba ibikoresho bitagira ingaruka ku mubiri w’umuntu
Umutekano, EMC n'ibizamini byo kugenzura software
Intebe z’ibimuga zikeneye kandi kuzuza umutekano, EMC hamwe na verisiyo yo kugenzura software kugirango harebwe umutekano w’amashanyarazi hamwe na electromagnetic ihuza ibicuruzwa

6. Kohereza inyandiko hanze no kumenyekanisha kubahiriza
Uhagarariye uburenganzira bwa EU
Kwohereza mu bihugu by’Uburayi bisaba ko uhagarariye Umuryango w’ubumwe bw’ibihugu by’Uburayi ufasha abayikora mu gukemura vuba kandi neza ibibazo bitandukanye
Itangazo ryo guhuza
Uruganda rukeneye gutanga imenyekanisha ryerekana ko ibicuruzwa byujuje ibisabwa byose byemewe n'amategeko

7. Ibindi bisabwa
Gupakira, kuranga, amabwiriza
Gupakira, kuranga, amabwiriza, nibindi bicuruzwa bigomba kubahiriza ibisabwa kugenga isoko rigenewe
Porogaramu ya SRN na UDI
Mubisabwa na MDR, intebe yimuga yoherejwe hanze nkibikoresho byubuvuzi bigomba kurangiza gusaba SRN na UDI hanyuma ikabinjiza mububiko bwa EUDAMED

Muri make, abamugaye bafite ubumuga bwibimuga bakeneye gukurikiza ibyangombwa byujuje ibyangombwa no gutanga ibyemezo mugihe bohereza ibicuruzwa hanze kugirango barebe ko ibicuruzwa byinjira mumasoko yagenewe neza. Ibi bisabwa ntabwo bikubiyemo gusa umutekano nubushobozi bwibicuruzwa, ahubwo bikubiyemo sisitemu yo gucunga neza, ibipimo byumutekano wa batiri, gupima ibicuruzwa no gusuzuma imikorere nibindi bintu. Kubahiriza aya mabwiriza nurufunguzo rwo kwemeza ko abakora amagare y’ibimuga bashobora guhangana neza ku isoko ryisi.