Kodi mungapeze bwanji zidziwitso zapadziko lonse lapansi zapanjinga zama wheelchair?

Kodi mungapeze bwanji zidziwitso zapadziko lonse lapansi zapanjinga zama wheelchair?

Kupeza zidziwitso zapadziko lonse lapansi zapanjinga zoyendera magetsi kumakhudzanso izi:

1. Kumvetsetsa malamulo ndi miyezo yoyenera
Zida zamagetsi zamagetsikukhala ndi zofunikira zosiyanasiyana za certification m'maiko ndi zigawo zosiyanasiyana. Ku EU, mipando ya olumala yamagetsi iyenera kutsata zofunikira za Medical Device Regulation (MDR) [Regulation (EU) 2017/745] ndi Machinery Directive (MD) [2006/42/EC]. Kuphatikiza apo, mfundo za Electromagnetic Compatibility Directive (EMC Directive) [2014/30/EU] ndi Low Voltage Directive (LVD) [2014/35/EU] ziyenera kuganiziridwa.

2. Kuwunika kogwirizana ndi masitepe a certification
Kagawidwe kazinthu ndikusankha njira yofananira: Dziwani mtundu wa njinga yamagetsi yamagetsi ndikusankha njira yoyenera yowunikira. Ma wheelchair amagetsi amatchulidwa kuti ndi zida zachipatala za Class I, koma chifukwa amaphatikiza ma drive amagetsi, angafunikire kuwunikiridwa ndi bungwe lodziwitsidwa.
Kuunika kwachipatala: Opanga amayenera kuchita zowunikira kuti atsimikizire chitetezo ndi mphamvu ya chipangizocho.
Kasamalidwe ka Chiwopsezo: Kuwongolera zoopsa kumachitika molingana ndi ISO 14971 kuti azindikire ndikuchepetsa zoopsa zomwe zingakhalepo panthawi ya moyo wa chipangizocho.
Kukonzekera zolemba zaukadaulo: Kuphatikizira kufotokozera kwazinthu, lipoti lowunika zachipatala, lipoti loyang'anira zoopsa, zopanga ndi zowongolera zabwino, ndi zina zambiri.
Declaration of Conformity (DoC): Wopangayo akuyenera kusaina ndikupereka chikalata chotsimikizira kuti chikuku chamagetsi chikugwirizana ndi malamulo ndi mfundo zonse za EU.
Kuunika kwa thupi lodziwitsidwa: Sankhani bungwe lodziwitsidwa kuti liwunikenso ndikuvomereza zolemba zaukadaulo zamalonda, kasamalidwe ka zoopsa, kuwunika kwachipatala, ndi zina zambiri.

3. Zofunikira zenizeni za chiphaso cha CE
Chitsimikizo cha CE cha mipando yamagetsi yamagetsi ku EU chiyenera kutsata muyezo wa EN 12184, womwe umatchula zofunikira ndi njira zoyesera zapanjinga zamagetsi. Zomwe zimayesedwa zikuphatikiza kuyesa chitetezo pamakina, kuyesa mphamvu ndi kukhazikika, kuyesa ma brake system, komanso kuyesa chitetezo chamagetsi ndi magwiridwe antchito

4. Zofunikira pa chiphaso cha FDA 510K
Ku United States, mipando ya olumala yamagetsi, monga zida zachipatala za Gulu lachiwiri, ziyenera kudutsa kuwunika kwa chikalata cha FDA cha 510K. Izi zikuphatikiza masitepe monga kusanthula kwanthawi zonse, zolemba zomwe zilipo kale ndikubweza deta, kufananitsa msika ndi kulemba zikalata

5. Kupeza kalata yovomereza
Pambuyo podutsa chiphaso cha FDA 510K, chikuku chamagetsi chidzalandira kalata yovomerezeka, yomwe ndi chikalata chofunikira chotsimikizira kutsata kwazinthu.

6. Zitsimikizo zina
Kuphatikiza pa satifiketi ya CE ndi FDA 510K, mipando ya olumala yamagetsi ingafunikirenso kupititsa ziphaso zina zapadziko lonse lapansi, monga chiphaso cha CB (International Electrotechnical Commission Electrical Product Conformity Testing Certification)

Potsatira ndondomeko ndi zofunikira zomwe zili pamwambazi, opanga amatha kuonetsetsa kuti mipando yamagetsi yamagetsi ikukwaniritsa zofunikira zoyendetsera msika wapadziko lonse, potero amalowa mwalamulo komanso motetezeka pamsika womwe akufuna.