Nigute Reta zunzubumwe zamerika zigenga ubuziranenge numutekano wibiryo byafunzwe?

Ikigo gishinzwe ibiryo n'ibiyobyabwenge muri Amerika (FDA) gifite inshingano zo gushyiraho, gutanga no kuvugurura amabwiriza ya tekiniki ajyanye n'ubwiza n'umutekano by'ibiribwa byafunzwe muri Amerika. Amabwiriza ya Leta zunze ubumwe z’Amerika 21CFR Igice cya 113 agenga itunganywa ry’ibicuruzwa by’ibiribwa bikomoka kuri acide nkeya n’uburyo bwo kugenzura ibipimo bitandukanye (nk'ibikorwa by'amazi, agaciro ka PH, indangagaciro ya sterilisation, n'ibindi) mugikorwa cyo gukora ibicuruzwa byafashwe. Ubwoko 21 bwimbuto zafunzwe, nka pome ya pome, amata yimbuto, imbuto zumye, cheri, nibindi, byateganijwe muri buri gice cyigice cya 145 cyamabwiriza ya 21CFR. Igisabwa nyamukuru ni ukurinda kwangirika kwibiryo, kandi ubwoko bwibicuruzwa byose bigomba gutunganywa ubushyuhe mbere cyangwa nyuma yo gufungwa no gupakira. Byongeye kandi, amabwiriza asigaye ajyanye nibisabwa ubuziranenge bwibicuruzwa, harimo ibikenerwa byibikoresho fatizo, ibikoresho byuzuzwa byifashishwa, ibikoresho bidakenewe (harimo inyongeramusaruro y'ibiribwa, ibyubaka umubiri, nibindi), hamwe nibirango byibicuruzwa nibisabwa nimirire. Byongeye kandi, umubare wuzuye wibicuruzwa no kumenya niba icyiciro cyibicuruzwa byujuje ibyangombwa biteganijwe, ni ukuvuga ko icyitegererezo, igenzura ridasanzwe hamwe nuburyo bwo kugena ibicuruzwa byateganijwe. Amerika ifite amabwiriza ya tekiniki yerekeye ubwiza n’umutekano by’imboga zafunzwe mu gice cya 155 cya 2CFR, zirimo ubwoko 10 bwibishyimbo byafashwe, ibigori byafunzwe, ibigori bitaryoshye, n’amashaza. Usibye gusaba ubuvuzi mbere cyangwa nyuma yo gukora ibicuruzwa bipfunyitse bifunze, amabwiriza asigaye ajyanye ahanini nubwiza bwibicuruzwa, harimo ibicuruzwa biva mu mahanga n’ibisabwa ubuziranenge, gushyira mu byiciro ibicuruzwa, ibikoresho byongeweho (harimo inyongeramusaruro zimwe na zimwe), hamwe n’ubwoko bw’ibitangazamakuru byangiza, hamwe n’ibisabwa byihariye kugira ngo ibicuruzwa bishoboke, harimo n’ibicuruzwa byafashwe mu mazi, bikoreshwa mu mazi, ibishishwa byuzuye ibishishwa hamwe na tuna. Amabwiriza ya tekiniki ateganya neza ko ibicuruzwa byabitswe bigomba gutunganywa mbere yo gufungwa no kubipakira kugirango birinde kwangirika. Mubyongeyeho, ibyiciro byibikoresho fatizo bisobanuwe neza, kimwe nubwoko bwibicuruzwa, kuzuza ibikoresho, impapuro zipakira, gukoresha inyongeramusaruro, kimwe n'ibirango n'ibisabwa, guca imanza zujuje ibisabwa, n'ibindi.