Pehea e koho ai i nā kukui ʻokiʻoki: ʻO ke alakaʻi hōʻoia piha CE, ISO 13485 & FDA no ke kūʻai ʻana i ka haukapila

Mea kākau: Micare Medical Engineering Team | Paʻi ʻia: ʻAukake 13, 2026

Ke loiloi kahi hui kūʻai haukapila i nā ʻōnaehana kukui ʻoki kino, ʻo ka palapala hōʻoia hoʻoponopono ka mea mua - a ʻaʻole hiki ke kūkākūkā ʻia. ʻO kahi kukui ʻoki kino me ka ʻole o ka palapala hōʻoia kūpono ʻaʻole ia he pilikia kūʻai wale nō; he kuleana ia no ka palekana o ka mea maʻi.

Hōʻike kēia alakaʻi i nā palapala hōʻoia koʻikoʻi, nā mea e pono ai kēlā me kēia, a pehea e hōʻoia ai i ka mālama ʻana o ka mea hoʻolako ma mua o kou kau inoa ʻana i kahi kauoha kūʻai.

No ke aha he mea nui ka palapala hōʻoia ma mua o nā pepa kikoʻī

Hana nā kukui ʻokiʻoki i nā wahi koʻikoʻi kahi i hiki ʻole ai ke hāʻule. Ua hoʻokumu nā kino hoʻoponopono ma ʻAmelika Hui Pū ʻIa, ʻEulopa, a me ka honua holoʻokoʻa i nā ʻōnaehana hōʻoia e hōʻoia i:

• Palekana uila - ka pale ʻana i ka haʻalulu, ke ahi, a i ʻole ka hoʻopilikia electromagnetic me nā lako OR ʻē aʻe
• Palekana Photobiological - e hōʻoiaʻiʻo ana ʻaʻole e hōʻino nā nalu māmā i ka retina i nā hui ʻokiʻoki i ka wā o nā kaʻina hana hoʻolōʻihi
• Ka hilinaʻi mīkini - ke kūpaʻa o ka lima, nā helu ukana articulation, a me ka palekana hoʻokuʻu
• Hoʻohālikelike i ka sterility - nā mea i hiki ke kū i ka hoʻomaʻemaʻe pinepine ʻia me nā disinfectants papa haukapila

ʻAʻohe manaʻo o kahi pepa kikoʻī e hōʻike ana i ka "160,000 lux" inā ʻaʻole i hoʻāʻo ʻia ke kukui e like me IEC 60601-2-41 - ke kūlana honua e wehewehe pono ana i ke ʻano o ka hana ʻana o nā mea hoʻomālamalama ʻoki kino a pehea e pono ai ke ana ʻia kēlā waiwai lux.

Nā Papahana Hōʻoia Nui ʻEkolu

1. ʻAe ʻia e ka FDA (Mākeke o ʻAmelika Hui Pū ʻIa)

Pono nā kukui ʻoki kino i kūʻai ʻia ma ʻAmelika Hui Pū ʻIa e loaʻa ka ʻae FDA 510(k) ma o ke Center for Devices and Radiological Health (CDRH). ʻO ke code huahana ʻo FSY (Surgical Light Source).

Nā mea e pono ai ka 510(k):

• Hōʻikeʻike o ke kūlike nui i kahi mea predicate i loaʻa ma ka mākeke US
• Hoʻāʻo hana ma lalo o IEC 60601-1 (Palekana Laulā) a me IEC 60601-2-41 (Nā koi kūikawā no nā kukui ʻokiʻoki)
• Hoʻāʻo hoʻohālikelike electromagnetic (EMC) e like me IEC 60601-1-2
• Ka hoʻouna ʻana i nā palapala loea, ka lepili ʻana, a me nā hōʻike hoʻāʻo i ka FDA

Pehea e hōʻoia ai: E kipaʻIkepili Hoʻolaha Premarket FDA 510(k)a huli ma ka inoa ʻoihana a i ʻole ke code huahana FSY. E hōʻike kahi helu 510(k) kūpono (ʻano: K######) i ka mea noi, ka inoa hāmeʻa, ka lā hoʻoholo, a me ka hoʻohana i manaʻo ʻia.

⚠️ Hae ʻulaʻula: He mea hoʻolako e koi ana "ua ʻāpono ʻia e ka FDA" no kahi mea lapaʻau Papa II. Hoʻomaʻemaʻe ka FDA (ʻaʻole ʻae) i nā mea hana 510(k). Inā ʻaʻole hiki i kahi mea hoʻolako ke hāʻawi i kahi helu-K, e noi i nā palapala - inā ʻaʻole hiki iā lākou ke hana, mai hoʻomau.

Kumuwaiwai koʻikoʻi o ka FDA:accessdata.fda.gov— waihona ʻikepili hiki ke huli ʻia o nā hāmeʻa a pau i hoʻomaʻemaʻe ʻia.

2. Ka Hōʻailona CE (ʻAhahui ʻEulopa a me nā Mākeke EEA)

He mea koi ʻia ka māka CE (Conformité Européenne) no nā kukui ʻokiʻoki i kūʻai ʻia ma ka EU a me ka ʻĀpana Hoʻokele Waiwai ʻEulopa. Ma lalo o ke EU Medical Device Regulation (MDR 2017/745), nāna i pani piha i ka MDD kahiko i Mei 2021, ua hoʻokaʻawale ʻia nā kukui ʻokiʻoki he mau hāmeʻa Class IIa.

Nā mea e pono ai ka CE MDR 2017/745:

• Palapala loea e hōʻike ana i ke kūlike me nā Koina Palekana a me ka Hana Laulā (GSPR) ma Annex I
• He Hōʻike Loiloi Lapaʻau (CER) - ʻoiai no nā mea hana ʻaʻole invasive, pono ka mea hana e hōʻike i nā hōʻike lapaʻau
• ʻŌnaehana Hoʻokele Kūlana i hōʻoia ʻia e ISO 13485:2016 e kahi Kino Hoʻolaha
• Hōʻike Hoʻohālikelike i kau inoa ʻia e kahi ʻElele i ʻae ʻia e ka EU inā aia ka mea hana ma waho o ka EU
• Ka hoʻopaʻa inoa ʻana ma ka waihona ʻikepili EUDAMED (hoʻolaha pae ʻia; koi ʻia i kēia manawa no ka hoʻopaʻa inoa ʻana o UDI a me nā mea hana keaka)

Pehea e hōʻoia ai:

1. E noi i ka Hōʻike Hoʻohālikelike (DoC) - pono ia e papa inoa i ke kānāwai MDR kikoʻī, ka inoa a me ka helu ID o ke Kino Hoʻomaopopo ʻia, a me ka hoʻokaʻawale ʻana o ka huahana.
2. E hōʻoia i ke Kino Hoʻomaopopo ʻia maʻIkepili waihona NANDO o ke Komisina ʻEulopa.
3. E hōʻoia i kau inoa ʻia ka DoC e kahi ʻElele i ʻae ʻia e ka EU inā aia ka mea hana ma waho o ka EU.

⚠️ Hae ʻulaʻula: He māka CE me ka ʻole o ka helu Notified Body. No nā mea hana Papa IIa, ʻaʻole ʻae ʻia ka haʻi ponoʻī ʻana o ke kūlike ma lalo o MDR. ʻAʻole kūlike kahi māka CE me kahi pūlima a ka mea hana wale nō a ʻaʻohe helu NB.

3. ISO 13485:2016 — ʻŌnaehana Hoʻokele Kūlana

ʻAʻole ʻo ISO 13485 he palapala hōʻoia huahana - he palapala hōʻoia ia no ka ʻōnaehana maikaʻi hana. Eia nō naʻe, ʻo ia kēia:

• Pono ʻia ma ke ʻano he kumu no ka māka ʻana o CE ma lalo o MDR
• Manaʻo ʻia e nā keʻena kūʻai haukapila ma ke ʻano he hōʻike o ka kaohi ʻana i ke kaʻina hana hana
• ʻO ke kumu e nānā ai nā Kino Hoʻomaopopo i kahi mea hana ma mua o ka hāʻawi ʻana i ka ʻae ʻia o ka palapala loea

ʻO nā mea i komo i loko o nā loiloi ISO 13485:

• Nā kaohi hoʻolālā a me ka hoʻomohala ʻana (hiki ke hahai ʻia mai ke kikoʻī a i ka huahana i hoʻopau ʻia)
• Ka hōʻoia o ka mea hoʻolako a me ka nānā ʻana e hiki mai ana
• Ka hōʻoia ʻana o ke kaʻina hana
• Nā ʻōnaehana hana hoʻoponopono a me ka pale ʻana (CAPA)
• Ka nānā ʻana ma hope o ka mākeke a me ka lawelawe ʻana i nā hoʻopiʻi

Pehea e hōʻoia ai: E noi i ka palapala hōʻoia ISO 13485 o kēia manawa. E hōʻoia ua hoʻopuka ʻia e kahi kino hōʻoia i ʻae ʻia (e nānā i ka māka IAF MLA o ke kino hōʻoia), uhi i ka laulā huahana pili, a he lā palena pau kūpono.

IEC 60601-2-41: Ke Kūlana ʻenehana ma hope o nā Palapala Hōʻoia

ʻO nā ʻōnaehana hōʻoia āpau ma luna nei e pili ana iā IEC 60601-2-41:2022, ke kūlana honua i kapa ʻia"Nā lako uila lapaʻau - Māhele 2-41: Nā koi kūikawā no ka palekana kumu a me ka hana koʻikoʻi o nā kukui ʻokiʻoki a me nā kukui no ka hōʻoia ʻana."

Ho'ākāka kēia kūlana:

ʻO ke kukui ʻoki kino i hoʻāʻo ʻia a hōʻoia ʻia e IEC 60601-2-41 e kahi keʻena hoʻokolohua ʻaoʻao ʻekolu i ʻae ʻia e hōʻoia ʻia kēia mau palena - ʻaʻole i hōʻike ponoʻī ʻia.

ʻOkoʻa koʻikoʻi: "Ua hoʻāʻo ʻia e IEC 60601-2-41" e ka lab ponoʻī o ka mea hana ≠ "i hōʻoia ʻia e IEC 60601-2-41" e kahi CB (Certification Body) i ʻae ʻia. E noi mau i ka hōʻike hoʻāʻo ʻaoʻao ʻekolu, ʻaʻole wale ka pepa kikoʻī.

Ua paʻi ʻia ke kūlana IEC e ka International Electrotechnical Commission. E komo iā ia mahale kūʻai pūnaewele.iec.ch.

Hoʻohālikelike Palapala Hōʻoia e ka Mākeke

7 mau nīnau e nīnau ai i kekahi mea hoʻolako kukui ʻoki kino

Ma mua o ke kau inoa ʻana i kahi ʻaelike kūʻai, e noi i nā pane i kākau ʻia no kēia mau mea:

1. "E ʻoluʻolu e hāʻawi mai i kāu helu K 510(k) (no nā mea kūʻai aku ma ʻAmelika Hui Pū ʻIa) a i ʻole kāu helu hōʻike CE Declaration of Conformity me ka Notified Body (no nā mea kūʻai aku ma EU)."
2. "ʻO wai ka mea nāna i hana i kāu hoʻāʻo IEC 60601-2-41 - kāu keʻena hoʻokolohua kūloko a i ʻole kahi keʻena hoʻokolohua CB ʻaoʻao ʻekolu i ʻae ʻia? E ʻoluʻolu e hāʻawi mai i ka hōʻike hoʻāʻo."
3. "He aha ka laulā o kāu palapala hōʻoia ISO 13485:2016? Uhi ia i ka hoʻolālā a me ka hoʻomohala ʻana, a i ʻole ka hana ʻana wale nō?"
4. "ʻO wai kou ʻElele i ʻae ʻia e EU?" (Pono no nā mea hana ʻaʻole no EU e kūʻai aku ana i loko o ka EU)
5. "He aha kāu kaʻina hana kiaʻi ma hope o ka mākeke? Loaʻa iā ʻoe kahi ʻōnaehana kiaʻi hāmeʻa lapaʻau?"
6. "He aha ke ola i helu ʻia o ka modula LED, a he aha ke kulekele palapala hoʻokō no ka hoʻopuka kukui?"
7. "Hiki iā mākou ke hoʻonohonoho i kahi loiloi hale hana, a i ʻole ua helu ʻia kāu hale hana me kekahi mau kino hōʻoia kaulahao hoʻolako haukapila e like me Achilles, Avetta, a i ʻole DUNS i hōʻoia ʻia?"

ʻAʻole pono ka mea hoʻolako i hiki ʻole ke pane maopopo i nā nīnau 1–4 a ma ke kākau ʻana e neʻe i kāu papa inoa mea kūʻai aku i ʻae ʻia.

Pehea e hoʻokokoke ai ʻo Micare i ka hoʻokō ʻana

Ua hana ʻo Micare Medical i nā ʻōnaehana kukui ʻoki kino mai ka makahiki 2007 mai kā mākou hale hana ma Nanchang, Kina. ʻO kā mākou huahana:

• Ua kākau inoa ʻia ʻo FDA — ua kākau inoa ʻia kā mākou hale hana a me ka laina huahana kukui ʻokiʻoki me ka US Food & Drug Administration
• Ua hōʻoia ʻia ʻo CE ma lalo o ke kahua hoʻoponopono hāmeʻa lapaʻau EU (MDR 2017/745)
• Hana ʻia ma lalo o ka ʻōnaehana hoʻokele maikaʻi ISO 13485:2016
• Ua hoʻāʻo ʻia e IEC 60601-2-41 no ka hoʻomālamalama ʻana, ka hāʻawi ʻana i ke kala, a me nā palena palekana uila
• Loaʻa me nā hōʻike hoʻāʻo ʻaoʻao ʻekolu a me nā palapala hoʻokō piha no nā koi kūʻokoʻa i hōʻoia ʻia e ka mākeke

No nā hui kūʻai haukapila e koi ana i nā pūʻolo palapala loea piha - me ka hōʻoia hoʻopaʻa inoa FDA, ka Hōʻike Hoʻohālikelike, ka palapala hōʻoia ISO 13485, a me nā hōʻike hoʻāʻo IEC 60601-2-41 - e kelepona i kā mākou hui kūʻai aku ma waho mainfo@micare.cna i ʻole ma osurgicallight.com/contact-us.

Nā nīnau i nīnau pinepine ʻia

Q: Ua lawa anei ka māka CE e kūʻai aku i nā kukui ʻoki kino ma UK ma hope o Brexit? A: ʻAʻole. Mai Ianuali 1, 2021, koi ʻo UK i ka māka UKCA (UK Conformity Assessed) no nā mea lapaʻau i kau ʻia ma ka mākeke UK. He wā hoʻololi ko nā mea i hōʻailona ʻia me CE, akā pono nā mea hana e loaʻa i ka māka UKCA ma o kahi Kino i ʻāpono ʻia e UK. Noho kūlike nā kūlana loea me nā koi EU MDR.

Q: Hiki i kahi haukapila ma ʻAmelika Hui Pū ʻIa ke kūʻai i kahi kukui ʻoki kino nona wale nō ka māka CE? A: ʻAʻole. Pono ka ʻae ʻia ʻana o ka FDA 510(k) no nā kukui ʻoki kino i kūʻai ʻia a kūʻai ʻia aku ma ʻAmelika Hui Pū ʻIa. ʻAʻole i hoʻokō ka māka CE i nā koi FDA. Pono nā ʻōnaehana ʻelua i nā noi kaʻawale a me nā palapala hoʻāʻo kaʻawale, ʻoiai ʻo ka hapa nui o ka hoʻāʻo loea ma lalo (IEC 60601 series) e pili pū ana.

Q: He aha ka ʻokoʻa ma waena o FDA 510(k) a me FDA PMA? A: ʻO nā kukui ʻokiʻoki (code huahana FSY) he mau mea hana Class II a hoʻomaʻemaʻe pinepine ʻia ma o ke ala 510(k), kahi e koi ai i ka hōʻike ʻana i ke kūlike nui me kahi mea hana predicate i kūʻai ʻia ma ke kānāwai. Ua mālama ʻia ka PMA (Premarket Approval) no nā mea hana Class III, kiʻekiʻe-pilikia (e laʻa, nā mea hana cardiac implantable) a koi i ka ʻikepili hoʻokolohua lapaʻau. ʻAʻole ʻoe e ʻike i nā kukui ʻokiʻoki e hele ana ma o PMA ma lalo o nā kūlana maʻamau.

Q: ʻEhia pinepine e pono ai ke hōʻoia hou ʻia ʻo ISO 13485? A: He ʻekolu makahiki ka mana o nā palapala hōʻoia ISO 13485, me nā loiloi kiaʻi i koi ʻia ma nā makahiki ʻekahi a me ʻelua. I ka hopena o ke kaʻina hana ʻekolu makahiki, pono kahi loiloi hōʻoia hou piha. E nānā mau i ka lā hoʻopuka a me ka lā pau o ka palapala hōʻoia i ka wā e nānā ai i nā palapala a ka mea hoʻolako.

Q: He aha ka palena iki o ka lux output e pono ai no ke kukui ʻoki kino i loko o kahi lumi hana? A: Kuhikuhi ʻo IEC 60601-2-41 i ka palena iki o 40,000 lux ma ke kikowaena o ke kahua kukui, i ana ʻia ma 1 mika mai ke poʻo kukui. No nā ʻoki kino hohonu paʻakikī (e laʻa, ʻōpū, thoracic), makemake ʻia nā kukui e hāʻawi ana i 80,000–160,000 lux me ka hāʻawi kala maikaʻi (Ra ≥ 90). E hōʻoia mau i ka ana ʻia ʻana o nā waiwai lux e like me ke ʻano hana IEC 60601-2-41, ʻaʻole nā ​​ana kahua manuahi.

Hōʻuluʻulu manaʻo

ʻO ke koho ʻana i kahi kukui ʻokiʻoki i hōʻoia ʻia e pono ai ka hōʻoia ʻana i nā palapala ma nā pae ʻekolu:

1. ʻAe ʻia ka mākeke - FDA 510(k) no ʻAmelika Hui Pū ʻIa; CE ma lalo o MDR 2017/745 no ʻEulopa
2. ʻO ke ʻano hana - ISO 13485:2016 mai kahi kino i hōʻoia ʻia a i ʻole CB
3. Hana huahana — Nā hōʻike hoʻāʻo ʻaoʻao ʻekolu e like me IEC 60601-2-41

ʻAʻole nā ​​​​palapala kikoʻī a me nā koi kūʻai aku e pani no nā palapala hoʻokō i hōʻoia ʻia. E hāʻawi kahi mea hoʻolako hilinaʻi i nā pae ʻekolu o nā palapala me ka kānalua ʻole.

No nā nīnau e pili ana i kā mākou palapala hōʻoia a i ʻole e noi i kahi pūʻolo ʻikepili loea no kāu loiloi kūʻai, e kipa akusurgicallight.coma i ʻole e hoʻokaʻaʻike aku i kā mākou hui mainfo@micare.cn or surgicallight.com/contact-us.

Nā Kuhikuhi:

• ʻOihana Meaʻai a me nā Lāʻau Lapaʻau o ʻAmelika Hui Pū ʻIa. 510(k) ʻIkepili Hoʻolaha Ma mua o ke Kūʻai.accessdata.fda.gov
• Komisina ʻEulopa. Hoʻoponopono Hana Lapaʻau EU 2017/745. Puke Pai Kūhelu o ka EU.
• Komisina Uila ʻenehana Honua. IEC 60601-2-41:2022 — Nā kukui ʻoki kino.hale kūʻai pūnaewele.iec.ch
• ISO. ISO 13485:2016 — Nā lako lapaʻau — Nā ʻōnaehana hoʻokele maikaʻi.iso.org
• Komisina ʻEulopa. NANDO — Nā Hui i Hoʻolaha ʻia a Hoʻonohonoho ʻia e ke ʻAno Hou.ec.europa.eu