He aha nā hōʻailona e pono ai nā mea hana kaʻa huila uila no ka lawe ʻana aku?

He aha nā hōʻailona e pono ai nā mea hana kaʻa huila uila no ka lawe ʻana aku?
Ma ke ʻano he ʻano lāʻau lapaʻau, ʻo ka lawe ʻana aku onā noho huila uilae pili ana i kahi pūʻulu o nā hōʻailona a me nā koi hōʻoia. ʻO kēia nā ʻano koʻikoʻi nuinā mea hana noho huila uilapono e loaʻa i ka wā e lawe aku ai:

1. E hoʻokō i nā koi hoʻoponopono o ka ʻāina i kuhikuhi ʻia
US FDA palapala hōʻoia
Hoʻokaʻawale ʻia nā noho huila uila ma ke ʻano he mau lāʻau lapaʻau Class II ma ʻAmelika Hui Pū ʻIa a pono e hoʻouna i nā palapala 510K i ka FDA a loaʻa i ka loiloi loea e ka FDA. ʻO ke kumumanaʻo o 510K ka mea e hōʻoia i ka mea i hoʻolaha ʻia i ka lāʻau lapaʻau e like me ka mea i kūʻai ʻia ma ke kānāwai ma United States.

EU CE palapala hōʻoia
Wahi a ka EU Regulation (EU) 2017/745, ua helu ʻia nā noho huila uila ma ke ʻano he mau lāʻau lapaʻau Class I. Ma hope o ka hoʻāʻo ʻana o nā huahana kūpono a me ka loaʻa ʻana o nā hōʻike hōʻike, a ma hope o ka hōʻuluʻulu ʻana i nā palapala ʻenehana i kūpono i nā kūlana e like me nā koi hoʻoponopono, hiki ke waiho ʻia i ka ʻelele ʻae ʻia o EU no ka hoʻopaʻa inoa a hiki ke hoʻopau ʻia ka hōʻoia CE.

UKCA palapala hōʻoia
Hoʻouna ʻia nā noho huila uila a me nā scooter uila i UK. Wahi a nā koi o nā hoʻoponopono lāʻau lapaʻau UKMDR2002, ʻo lākou nā lāʻau lapaʻau Class I. E noi no ka palapala hōʻoia UKCA e like me ka mea e pono ai.

palapala hōʻoia Swiss
Hoʻouna ʻia nā noho huila uila a me nā scooter uila i Switzerland. E like me nā koi o nā hoʻoponopono lāʻau lapaʻau oMedDO, ʻo lākou nā lāʻau lapaʻau Class I. E like me nā koi o nā ʻelele Swiss a me ka hoʻopaʻa inoa Swiss

2. Nā kūlana aupuni a me nā kūlana ʻoihana
Nā kūlana aupuni
ʻO "nā noho huila uila" kahi maʻamau Kina e kuhikuhi ana i nā huaʻōlelo a me nā kumu hoʻohālike inoa, nā koi o ka ʻili, nā koi o ka hui, nā koi dimensional, nā koi o ka hana, nā koi ikaika, ka lapalapa ahi, ke aniau, ka mana a me nā koi ʻōnaehana hoʻomalu, a me nā ʻano hoʻokolohua kūpono a me ka nānā ʻana. nā lula no nā noho huila uila.

Nā kūlana ʻoihana
ʻO "Nā Kūlana Kūlana Palekana no nā Bateri Lithium-ion a me nā Pūʻulu Bateri no nā noho huila uila" he kūlana ʻoihana, a ʻo ke keʻena kūpono ʻo ia ka Ministry of Industry and Information Technology.

3. Pūnaehana hoʻokele maikaʻi
ISO 13485 a me ISO 9001
Nui nā mea hana huila uila e hala i ka ISO 13485 a me ISO 9001 ka hōʻoia ʻana o ka ʻōnaehana hoʻokele maikaʻi e hōʻoia i ka maikaʻi o ka huahana a me nā ʻōnaehana hoʻokele e hoʻokō i nā kūlana honua.

4. Nā kūlana palekana o ka pākaukau a me ka charger
Nā kūlana palekana pākaukau lithium
Pono e hoʻokō nā pākaukau lithium i hoʻohana ʻia i nā kaʻa huila uila me nā kūlana palekana e like me GB / T 36676-2018 "Nā koi palekana a me nā ʻano hoʻāʻo no nā pā lithium-ion a me nā ʻeke pākahi no nā noho huila uila"

5. Ho'āʻo huahana a loiloi hana
Hoao hana
Pono e hoʻāʻo ʻia nā noho huila uila no ka hana e like me nā kūlana honua e like me ka ISO 7176 series e hōʻoia i ko lākou palekana a me ka hilinaʻi.
ʻO ka hoʻāʻo olaola
Inā he noho huila uila, koi ʻia ka hoʻāʻo ʻana i ka biological no ka hōʻoia ʻana ʻaʻole pono ka mea i ke kino o ke kanaka
Palekana, EMC a me nā hōʻoia hōʻoia polokalamu
Pono nā noho huila uila e hoʻopau i ka palekana, EMC a me nā hōʻoia hōʻoia polokalamu e hōʻoia i ka palekana uila a me ka hoʻohālikelike electromagnetic o ka huahana.

6. Hoʻokuʻu aku i nā palapala a me ka ʻōlelo hoʻokō
ʻelele ʻae ʻia o EU
ʻO ka lawe ʻana aku i ka EU e koi i kahi ʻelele i ʻae ʻia e EU e kōkua i nā mea hana i ka hoʻoponopono wikiwiki ʻana i nā pilikia like ʻole.
ʻŌlelo hoʻolikelike
Pono ka mea hana e hoʻopuka i kahi hoʻolaha o ka conformity e hōʻoia i ka hoʻokō ʻana o ka huahana me nā koi hoʻoponopono āpau.

7. Nā koi ʻē aʻe
Packaging, lepili, kuhikuhi
Pono e hoʻokō i nā koi hoʻoponopono o ka mākeke i makemake ʻia ka ʻeke, ka lepili, nā ʻōlelo aʻo, a me nā mea ʻē aʻe o ka huahana
SRN a me UDI noi
Ma lalo o nā koi MDR, pono nā noho huila i lawe ʻia ma ke ʻano he lāʻau lapaʻau e hoʻopiha i ka noi o SRN a me UDI a hoʻokomo iā lākou i loko o ka waihona EUDAMED.

I ka hōʻuluʻulu manaʻo, pono nā mea hana kaʻa huila uila e hahai i ke ʻano o ka hōʻoia a me nā koi hōʻoia i ka wā e hoʻokuʻu aku ai i nā huahana no ka hōʻoia ʻana i hiki i nā huahana ke komo i ka mākeke pahuhopu. ʻAʻole pili wale kēia mau koi i ka palekana a me ka maikaʻi o ka huahana, akā pū kekahi i nā ʻōnaehana hoʻokele maikaʻi, nā kūlana palekana o ka pākaukau, ka hoʻāʻo ʻana o ka huahana a me ka loiloi hana a me nā mea ʻē aʻe. ʻO ka hoʻokō ʻana i kēia mau lula ke kī i ka hōʻoia ʻana e hiki i nā mea hana kaʻa huila uila ke hoʻokūkū kūleʻa i ka mākeke honua.