Nūhou

I kēia manawa, ke pālahalaha nei ka maʻi ahulau coronavirus hou (COVID-19). Ke hoʻāʻo nei ka laha honua i ka hiki o kēlā me kēia ʻāina ke hakakā i ka maʻi ahulau. Ma hope o nā hopena maikaʻi o ka pale ʻana a me ka kaohi ʻana i nā maʻi ahulau ma Kina, nui nā ʻoihana kūloko e manaʻo e hoʻolaha i kā lākou huahana e kōkua i nā ʻāina a me nā wahi ʻē aʻe e kūʻē like i ka maʻi ahulau. Ma Malaki 31, 2020, ua hoʻopuka ke Kuhina Kālepa, ka Luna Hoʻokele Nui o nā dute a me ka State Drug Administration o Kina i kahi hoʻolaha hui e pili ana i nā mea lapaʻau e pili ana i ka pale ʻana i nā maʻi ahulau coronavirus (e like me nā pahu ʻike, nā masks lapaʻau, nā lole pale lapaʻau, nā ventilators a me nā thermometers infrared), kahi e ʻōlelo nei mai ʻApelila 1, pono nā mea hoʻopuka aku o ia mau huahana e hōʻoia ua loaʻa iā lākou ka palapala hōʻoia hoʻopaʻa inoa o nā mea lapaʻau ma Kina a hoʻokō i nā kūlana maikaʻi o nā ʻāina a i ʻole nā ​​​​wahi e hoʻopuka aku ana. Hiki i nā dute ke hoʻokuʻu i nā waiwai ma hope o ka hōʻoia ʻia ʻana he kūpono.

Ua hōʻike ka hoʻolaha hui ʻana e hoʻopaʻa nui ana ʻo Kina i ka maikaʻi o nā lako lapaʻau i hoʻouna ʻia aku. Eia ka hōʻuluʻulu manaʻo o kekahi mau pilikia e maʻalahi ke huikau i ka wā e hoʻouna aku ai i ka ʻAhahui ʻEulopa a me ʻAmelika Hui Pū ʻIa.

ʻahahui ʻEulopa

（1） E pili ana i ka māka CE

ʻO CE ke kaiāulu ʻEulopa. ʻO ka māka CE ke kumu hoʻoponopono o ka EU no nā huahana i helu ʻia ma ka EU. Ma ka mākeke EU, pili ka palapala hōʻoia CE i ka palapala hōʻoia hoʻoponopono koi. Inā makemake nā huahana i hana ʻia e nā ʻoihana i loko o ka EU a i ʻole nā ​​​​huahana i hana ʻia ma nā ʻāina ʻē aʻe e kaʻapuni manuahi ma ka mākeke EU, pono e hoʻopili ʻia ka māka CE e hōʻike i ka hoʻokō ʻana o nā huahana i nā koi kumu o ke ʻano hou o ka hoʻohālikelike ʻenehana a me ka hoʻohālikelike ʻana. Wahi a nā koi o PPE a me MDD / MDR, pono e lepili ʻia nā huahana i lawe ʻia aku i EU me ka māka CE.

（2） E pili ana i nā palapala hōʻoia

ʻO ke kāpili ʻana i ka māka CE ka hana hope loa ma mua o ke komo ʻana o ka huahana i ka mākeke, e hōʻike ana ua pau nā kaʻina hana āpau. Wahi a nā koi o PPE a me MDD / MDR, pono e loiloi ʻia nā lako pale pilikino (e like me ka pale pale pilikino papa III) a i ʻole nā ​​​​lako lapaʻau (e like me ka sterilization pale maka lapaʻau papa I) e ke kino i hoʻomaopopo ʻia (NB) i ʻike ʻia e ka European Union. Pono e hoʻopuka ʻia ka palapala hōʻoia CE o ka hāmeʻa lapaʻau e ke kino i hoʻomaopopo ʻia, a pono e loaʻa i ka palapala hōʻoia ka helu o ke kino i hoʻomaopopo ʻia, ʻo ia hoʻi, ke code ʻehā huahelu kū hoʻokahi.

（3） Nā laʻana o nā koi no nā huahana pale ahulau

1. Ua māhele ʻia nā pale maka i nā pale maka lapaʻau a me nā pale maka pale pilikino.

Wahi a en14683, ua māhele ʻia nā pale maka i ʻelua mau māhele: ʻano I a me ke ʻano II / IIR. ʻO ka pale maka ʻano I kūpono wale nō no nā mea maʻi a me nā poʻe ʻē aʻe e hōʻemi i ka pilikia o ka maʻi a me ka laha ʻana, ʻoiai i ka hihia o nā maʻi lele a i ʻole nā ​​​​maʻi ahulau. Hoʻohana nui ʻia ka pale maka ʻano II e nā kauka lapaʻau i loko o ka lumi hana a i ʻole nā ​​​​wahi lapaʻau ʻē aʻe me nā koi like.

2. Nā lole pale: ua māhele ʻia nā lole pale i nā lole pale lapaʻau a me nā lole pale pilikino, a ua like nā koi hoʻokele me nā mea o nā masks. ʻO ke kūlana ʻEulopa no nā lole pale lapaʻau ʻo en14126.

4 Nūhou hou loa

He kānāwai lapaʻau EU hou ʻo EU 2017 / 745 (MDR). Ma ke ʻano he mana i hoʻonui ʻia o 93 / 42 / EEC (MDD), e hoʻokō piha ʻia ke kānāwai ma Mei 26, 2020. Ma Malaki 25, ua hoʻolaha ke Komisina ʻEulopa i kahi manaʻo e hoʻopanee i ka hoʻokō ʻana o MDR i hoʻokahi makahiki, i waiho ʻia i ka hoʻomaka o ʻApelila no ka ʻae ʻia e ka ʻAhaʻōlelo ʻEulopa a me ka ʻAha Kūkākūkā ma mua o ka hopena o Mei. Ua kuhikuhi ʻo MDD a me MDR i ka hana o ka huahana e hōʻoia i ke olakino a me ka palekana o nā mea hoʻohana.