Pehea e loaʻa ai ka ʻike hōʻoia honua no nā noho huila uila?

Pehea e loaʻa ai ka ʻike hōʻoia honua no nā noho huila uila?

ʻO ka loaʻa ʻana o ka ʻike hōʻoia honua no nā noho huila uila e pili ana i nā pae aʻe a me nā koi:

1. E hoʻomaopopo i nā kānāwai a me nā kūlana kūpono
Nā noho huila uilaloaʻa nā koi palapala hōʻoia ma nā ʻāina like ʻole a me nā ʻāina. I ka EU, pono nā noho huila uila e hoʻokō i nā koi o ka Medical Device Regulation (MDR) [Regulation (EU) 2017/745] a me ka Machinery Directive (MD) [2006/42/EC]. Eia kekahi, pono e noʻonoʻo ʻia ka Electromagnetic Compatibility Directive (EMC Directive) [2014/30/EU] a me ka Low Voltage Directive (LVD) [2014/35/EU].

2. Kaʻina loiloi conformity a me ka hōʻoia
Hoʻokaʻawale huahana a koho ala conformity: E hoʻoholo i ka hoʻokaʻawale ʻana o ka noho huila uila a koho i ke ala loiloi conformity kūpono. Hoʻokaʻawale ʻia nā noho huila uila ma ke ʻano he mau lāʻau lapaʻau Class I, akā no ka mea pili lākou i nā kaʻa uila, pono paha lākou e loiloi ʻia e kahi kino i hoʻomaopopo ʻia.
Ka loiloi kino: Pono nā mea hana e hana i nā loiloi lapaʻau e hōʻoia i ka palekana a me ka pono o ka mea hana
Hoʻokele pilikia: Hoʻokō ʻia ka hoʻokele pilikia e like me ka ISO 14971 e ʻike a hōʻemi i nā pilikia e hiki mai ana i ka wā o ke ola o ka mīkini.
Hoʻomākaukau palapala ʻenehana: Me ka wehewehe ʻana i ka huahana, ka hōʻike loiloi loiloi, ka hōʻike hoʻokele pilikia, ka hana ʻana a me nā palapala mana maikaʻi, etc.
Hōʻike o ka Conformity (DoC): Pono ka mea hana e kau inoa a hoʻopuka i kahi hōʻike o ka conformity e hōʻike ana e hoʻokō ka noho huila uila i nā lula a me nā kūlana EU pili.
Nānā kino i hoʻomaopopo ʻia: E koho i kahi kino i hoʻomaopopo ʻia e nānā a ʻae i nā palapala ʻenehana o ka huahana, ka hoʻokele pilikia, ka loiloi lapaʻau, etc.

3. Nā koi kūikawā no ka hōʻoia CE
Pono ka palapala hōʻoia CE o nā noho huila uila ma EU e hahai i ka maʻamau EN 12184, e kuhikuhi ana i nā koi kikoʻī a me nā ʻano hoʻāʻo no nā noho huila uila. ʻO ka ʻike hoʻāʻo e pili ana i ka hoʻāʻo palekana mechanical, ka hoʻāʻo ikaika a me ke kūpaʻa, ka hoʻāʻo ʻana i ka ʻōnaehana brake, a me ka palekana uila a me ka hoʻāʻo hana

4. Nā koi no ka palapala hōʻoia FDA 510K
Ma ʻAmelika Hui Pū ʻIa, pono nā noho huila uila, ma ke ʻano he mau lāʻau lapaʻau Class II, i ka loiloi palapala 510K a ka FDA. Hoʻopili kēia i nā ʻanuʻu e like me ka loiloi hoʻohana maʻamau, ka palapala i loaʻa a me ka ʻike ʻikepili, ka hoʻohālikelike mākeke a me ke kākau palapala

5. Loaʻa i kahi palapala ʻae
Ma hope o ka hala ʻana i ka palapala hōʻoia FDA 510K, e loaʻa i ka noho huila uila ka palapala ʻae, ʻo ia ka palapala nui e hōʻoia ana i ka hoʻokō ʻana o ka huahana.

6. Nā palapala hōʻoia ʻē aʻe
Ma kahi o ka CE a me ka FDA 510K hōʻoia, pono paha nā noho huila uila e hele i nā palapala hōʻoia honua ʻē aʻe, e like me ka palapala CB (International Electrotechnical Commission Electrical Product Conformity Testing Certification)

Ma ka hahai ʻana i nā ʻanuʻu a me nā koi i luna, hiki i nā mea hana ke hōʻoia i ka hoʻokō ʻana o nā noho huila uila i nā koi hoʻoponopono o ka mākeke honua, a laila e komo i ke kānāwai a me ka palekana i ka mākeke pahuhopu.