Ndi ziyeneretso ziti zomwe opanga njinga za olumala ayenera kukhala nazo potumiza kunja?

Ndi ziyeneretso ziti zomwe opanga njinga za olumala ayenera kukhala nazo potumiza kunja?
Monga mtundu wa chipangizo chachipatala, kutumiza kunja kwamipando yamagetsi yamagetsiimakhudza mndandanda wa ziyeneretso ndi zofunikira za certification. Zotsatirazi ndizo ziyeneretso zazikulu zomweopanga magetsi aku wheelchairmuyenera kukhala nazo potumiza kunja:

1. Tsatirani malamulo a dziko lomwe mukufuna
Chitsimikizo cha US FDA
Zipando zamagetsi zamagetsi zimatchedwa zida zachipatala za Class II ku United States ndipo zimayenera kutumiza zikalata za 510K ku FDA ndikuwunikiridwa mwaukadaulo ndi a FDA. Mfundo ya 510K ndikutsimikizira kuti chipangizo chachipatala chomwe chalengezedwa ndichofanana kwambiri ndi chipangizo chomwe chagulitsidwa movomerezeka ku United States.

Chitsimikizo cha EU CE
Malinga ndi EU Regulation (EU) 2017/745, mipando yamagetsi yamagetsi imasankhidwa kukhala zida zachipatala za Gulu Loyamba. Zida zachipatala za Class I zitayesedwa koyenera ndikupeza malipoti oyesa, ndipo zitapanga zikalata zaukadaulo zomwe zimakwaniritsa zofunikira zowongolera, zitha kuperekedwa kwa woyimira wovomerezeka wa EU kuti akalembetse ndipo satifiketi ya CE imatha kumaliza.

Chitsimikizo cha UKCA
Ma wheelchair amagetsi ndi ma scooters amagetsi amatumizidwa ku UK. Malinga ndi zofunikira za UKMDR2002 zida zachipatala, ndi zida zachipatala za Class I. Lemberani chiphaso cha UKCA ngati mukufunikira.

Chitsimikizo cha Swiss
Ma wheelchair amagetsi ndi ma scooters amagetsi amatumizidwa ku Switzerland. Malinga ndi zofunikira za malamulo a zida zachipatala za oMedDO, ndi zida zachipatala za Class I. Malinga ndi zofunikira za oimira Swiss ndi kulembetsa ku Switzerland

2. Miyezo ya dziko lonse ndi miyezo yamakampani
Miyezo ya dziko
"Ma wheelchairs amagetsi" ndi muyezo wadziko la China womwe umanena za terminology ndi njira zotchulira, zofunikira zapamtunda, zofunikira pagulu, zofunikira pamlingo, zofunikira pakugwira ntchito, zofunikira zamphamvu, kuchedwa kwa lawi, nyengo, mphamvu ndi machitidwe owongolera, ndi njira zoyeserera ndikuwunika. malamulo aku njinga zamagetsi zamagetsi.

Miyezo yamakampani
"Safety Technical Specifications for Lithium-ion Batteries and Battery Packs for Electric Wheelchairs" ndi muyezo wamakampani, ndipo dipatimenti yoyenerera ndi Unduna wa Zamakampani ndi Ukadaulo Wachidziwitso.

3. Njira yoyendetsera bwino
ISO 13485 ndi ISO 9001
Ambiri opanga njinga za olumala apereka chiphaso cha ISO 13485 ndi ISO 9001 Quality Management System kuti awonetsetse kuti kasamalidwe kazinthu ndi kasamalidwe kazinthu zimakwaniritsa miyezo yapadziko lonse lapansi.

4. Miyezo yachitetezo cha batri ndi chaja
Miyezo yachitetezo cha batri ya lithiamu
Mabatire a lithiamu omwe amagwiritsidwa ntchito panjinga zamagetsi amayenera kutsatira miyezo yachitetezo yofananira, monga GB/T 36676-2018 "Zofunikira pachitetezo ndi njira zoyesera zamabatire a lithiamu-ion ndi mapaketi a batire a mipando yamagetsi"

5. Kuyesa kwazinthu ndikuwunika magwiridwe antchito
Kuyesa magwiridwe antchito
Ma wheelchair amagetsi amayenera kuyesedwa kuti agwire ntchito molingana ndi miyezo yapadziko lonse lapansi monga ISO 7176 mndandanda kuti zitsimikizire chitetezo chawo komanso kudalirika.
Kuyeza kwachilengedwe
Ngati ndi chikuku chamagetsi, kuyezetsa kwachilengedwe kumafunikanso kuwonetsetsa kuti zinthuzo sizikhala zovulaza thupi la munthu.
Chitetezo, EMC ndi mayeso otsimikizira mapulogalamu
Ma wheelchair amagetsi amafunikiranso kumaliza chitetezo, EMC ndi mayeso otsimikizira mapulogalamu kuti zitsimikizire chitetezo chamagetsi ndi kuyanjana kwamagetsi kwa chinthucho.

6. Kutumiza kunja zikalata ndi chilengezo chotsatira
Woyimira wovomerezeka wa EU
Kutumiza ku EU kumafuna nthumwi yovomerezeka ya EU kuti ithandizire opanga kuthetsa mwachangu komanso molondola mavuto osiyanasiyana.
Kulengeza kogwirizana
Wopanga akuyenera kupereka chilengezo chotsatira kuti atsimikizire kuti malondawo akugwirizana ndi zofunikira zonse zoyendetsera ntchito.

7. Zofunikira zina
Kuyika, kulemba, malangizo
Kuyika, kulemba, malangizo, ndi zina zambiri za chinthucho zikuyenera kutsata zomwe msika ukufuna.
SRN ndi UDI application
Pansi pa zofunikira za MDR, njinga za olumala zomwe zimatumizidwa kunja ngati zida zamankhwala ziyenera kumaliza kugwiritsa ntchito SRN ndi UDI ndikuzilowetsa mu database ya EUDAMED.

Mwachidule, opanga njinga za olumala ayenera kutsatira mndandanda wa ziyeneretso ndi satifiketi akamatumiza zinthu kunja kuonetsetsa kuti zinthuzo zitha kulowa bwino pamsika womwe akufuna. Zofunikira izi sizimangokhudza chitetezo ndi mphamvu ya chinthucho, komanso zimaphatikizanso machitidwe oyang'anira bwino, miyezo yachitetezo cha batri, kuyesa kwazinthu ndikuwunika magwiridwe antchito ndi zina. Kutsatira malamulowa ndiye chinsinsi chowonetsetsa kuti opanga njinga zamagetsi azitha kupikisana bwino pamsika wapadziko lonse lapansi.