Amakuru

Kugeza ubu, Novel Coronavirus (Covid-19) icyorezo kirakwirakwira. Ikwirakwizwa ku isi rirageragezwa nubushobozi bwa buri gihugu kugirango urwanye icyorezo. Nyuma y'ibisubizo byiza byo gukumira no kugenzura icyorezo no kugenzura mu Bushinwa, imishinga myinshi yo mu rugo irashaka guteza imbere ibicuruzwa byabo kugira ngo ifashe ibindi bihugu n'uturere bifatanye no kurwanya icyorezo. Ku ya 31 Werurwe 2020, Minisiteri y'Ubucuruzi, Ubuyobozi bwa Gasutamo n'Ubuyobozi bwa Leta bw'Ubushinwa bwatangaga itangazo ku bijyanye no gukumira no ku ya 1 Mata, ibihugu byo kurinda ibikoresho byo ku ya 1 Mata, bikaba byo kurinda ibikomoka ku bicuruzwa. Kohereza ibihugu cyangwa uturere. Imigenzo irashobora kurekura ibicuruzwa nyuma yo kwemezwa nkibisabwa.

Itangazo rihuriweho ryerekana ko Ubushinwa bwahaye akamaro gakomeye ku bwiza bwo gutanga ubuvuzi. Ibikurikira nincamake yibibazo bimwe byoroshye kutitiranya mugihe cyohereza hanze mubumwe bwiburayi na Amerika.

Umuryango w'ubumwe bw'ibihugu by'Uburayi

(1) Ibyerekeye CE Ikimenyetso

CE ni umuryango wu Burayi. GC Ikimenyetso nicyitegererezo cyurwego rwa EU cyibicuruzwa byashyizwe ahagaragara muri EU. Mu isoko rya EU, CE CEEMFIRI N'INGENZI ZIKURIKIRA. Niba ibicuruzwa byakozwe n'inzego ziri mu bihugu by'Uburayi cyangwa ibicuruzwa byakorewe mu bindi bihugu bifuza gukwirakwiza mu bwisanzure mu isoko ry'ibanze by'uburyo bushya bw'uburyo bushya bwo guhuza tekinike no mu rwego rwo kugena. Ukurikije ibisabwa na PPE na MDD / MDR, ibicuruzwa byoherejwe hanze muri EU bigomba kwandikwa na CE Mark.

(2) kubyerekeye ibyemezo

Kwicara muri CE Ikimenyetso cyanyuma mbere yuko ibicuruzwa binjira ku isoko, byerekana ko inzira zose zarangiye. Ukurikije ibyangombwa bya PPE na MDR / MDR, ibikoresho birinda III (nka shuri rya III kugiti cyawe) cyangwa ibikoresho byubuvuzi (nkishuri i mesk yubuvuzi (NB) byemewe numuryango w'ubumwe bw'Uburayi. Igikoresho cyo kwa muganga CE kigomba gutangwa numubiri ubimenyeshwa, kandi icyemezo kigomba kugira umubare wurwego rwumenyeshejwe, ni ukuvuga kode idasanzwe.

(3) Ingero zibisabwa ibicuruzwa byo gukumira icyorezo

1. Masike igabanijwemo masike yubuvuzi na masike yo gukingira.

Nk'uko EN14683, masike yagabanijwemo ibyiciro bibiri: andika I naho Andika II / IIR. Andika i mask ibereye gusa abarwayi nabandi bantu kugabanya ibyago byo kwandura no kwanduza, cyane cyane kubibazo byindwara zandura cyangwa ibyorezo. Andika mask ya II ikoreshwa cyane cyane nabaganga bashinzwe ubuvuzi mucyumba cyo gukora cyangwa ibindi bidukikije nibisabwa nkibisabwa.

2. Imyenda ikingira: Imyambarire ikingira igabanijwemo imyenda yo gukingira ubuvuzi n'imyambaro yo kurinda umuntu, hamwe n'ibisabwa mu micungire birasa ahanini n'iy'amafoto. Igipimo cy'Uburayi cy'imyenda yo kurinda ubuvuzi ni EN14126.

(4) Amakuru agezweho

EU 2017/745 (MDR) ni amabwiriza mashya ya EU. Nka verisiyo yazamuye ya 93/42 / EEC (MDD), amabwiriza azashyirwa mu bikorwa kandi yashyizwe mu ntangiriro z'ishyirwa mu bikorwa ry'umwaka umwe kugira ngo yemererwe n'inama y'iburayi. Byombi MDD na MDR bigaragaza imikorere yibicuruzwa kugirango ubuzima bwumutekano numutekano byabakoresha.