Miyezo yomwe mipando ya olumala yamagetsi imayenera kutsatira pamalonda apadziko lonse lapansi

Miyezo yomwe mipando ya olumala yamagetsi imayenera kutsatira pamalonda apadziko lonse lapansi
Monga chida chofunikira chothandizira kukonzanso, mipando yamagetsi yamagetsi imagwira ntchito yofunika kwambiri pamalonda apadziko lonse lapansi. Pofuna kuonetsetsa kuti chitetezo, mphamvu ndi kutsata kwa mipando yamagetsi yamagetsi, mayiko ndi madera apanga mndandanda wa miyezo ndi malamulo. Zotsatirazi ndizo mfundo zazikulu zomwemipando yamagetsi yamagetsimuyenera kutsatira mu malonda a mayiko:

1. Miyezo yofikira msika wa EU
EU Medical Device Regulation (MDR)
Ma wheelchair amagetsi amasankhidwa kukhala zida zachipatala za Class I pamsika wa EU. Malinga ndi EU Regulation (EU) 2017/745, mipando yamagetsi yamagetsi yotumizidwa kumayiko omwe ali mamembala a EU iyenera kukwaniritsa izi:

Woimira Wovomerezeka wa EU Wogwirizana: Sankhani Woimira Wovomerezeka wa EU wogwirizana komanso wodziwa zambiri kuti athandize opanga kuthetsa mwachangu komanso molondola mavuto osiyanasiyana.
Kulembetsa katundu: Tumizani kalata yolembetsa kumayiko omwe ali membala wa EU ndipo lembani kalata yolembetsa.
Zolemba zaukadaulo za MDR: Konzani zolemba zaukadaulo za CE zomwe zimakwaniritsa zofunikira za malamulo a MDR. Nthawi yomweyo, zolemba zaukadaulo zimafunikanso kusungidwa ndi woimira EU kuti afufuze malo ovomerezeka a EU.
Declaration of Conformity (DOC): Ma Wheelchairs ndi a zida za Class I, ndipo chilengezo chotsatira chikufunikanso.
Miyezo yoyesera
TS EN 12183: Imagwira pama wheelchair omwe ali ndi katundu wosapitilira 250kg ndi mipando yapamanja yokhala ndi zida zothandizira zamagetsi
TS EN 12184 EN 12184 Zipando zoyendera magetsi zothamanga kwambiri zosapitilira 15 km / h ndikunyamula imodzi ndi katundu osapitilira 300 kg

2. Miyezo yofikira msika ku US
FDA 510 (k) satifiketi
Zipando zamagetsi zamagetsi zimatchedwa Class II zida zamankhwala ku United States. Kuti mulowe mumsika waku US, muyenera kutumiza chikalata cha 510K ku FDA ndikuvomereza kuwunika kwaukadaulo kwa FDA. Mfundo ya 510K ya FDA ndikutsimikizira kuti chipangizo chachipatala chomwe chalengezedwa ndichofanana kwambiri ndi chipangizo chomwe chagulitsidwa movomerezeka ku United States.

Zofunikira zina
Satifiketi yolembetsera: Njinga zamagetsi zotumizidwa ku United States ziyeneranso kupereka satifiketi yolembetsa.
Buku lopanga: Perekani buku latsatanetsatane lazogulitsa.
Layisensi Yopanga: Chilolezo chopanga chomwe chimatsimikizira kuti ntchitoyo ikugwirizana ndi malamulo.
Zolemba zowongolera zabwino: Onetsani zolemba zowongolera zamtundu wazinthu zopangira.
Lipoti loyang'anira katundu: Perekani lipoti lazowunikira kuti mutsimikizire mtundu wazinthu

3. Miyezo yofikira msika waku UK
Chitsimikizo cha UKCA
Ma wheelchairs amagetsi omwe amatumizidwa ku UK ndi zida zachipatala za Class I molingana ndi zofunikira za UKMDR2002 zida zachipatala ndipo ziyenera kufunsira chiphaso cha UKCA. Pambuyo pa Juni 30, 2023, zida zachipatala za Class I ziyenera kulembedwa chizindikiro cha UKCA zisanatumizidwe ku UK.

Zofunikira
Tchulani UKRP yapadera: Opanga akuyenera kufotokozera munthu wapadera wa UK Responsible Person (UKRP).
Kulembetsa kwazinthu: UKRP yamaliza kulembetsa katundu ndi MHRA.
Zolemba zaukadaulo: Pali zikalata zaukadaulo za CE kapena zolemba zaukadaulo za UKCA zomwe zimakwaniritsa zofunikira.

4. Miyezo yapadziko lonse lapansi
ISO 13485
ISO 13485 ndi muyezo wapadziko lonse lapansi wamakina oyang'anira zida zamankhwala. Ngakhale sizofunikira mwachindunji kuti mupeze msika, zimapereka chitsimikizo chaubwino pakupanga ndi kupanga zida zamankhwala.

Mapeto
Ma wheelchair amagetsi amayenera kutsatira miyezo ndi malamulo okhwima pamalonda apadziko lonse lapansi kuti atsimikizire chitetezo ndi magwiridwe antchito azinthu. Opanga akuyenera kumvetsetsa zofunikira pakuwongolera msika womwe akufuna ndikuwonetsetsa kuti zinthu zawo zikukwaniritsa miyezo yoyenera yoyesera ndiukadaulo. Potsatira miyezo imeneyi, mipando yamagetsi yamagetsi imatha kulowa bwino pamsika wapadziko lonse ndikupereka zida zapamwamba zothandizira kukonzanso kwa ogwiritsa ntchito padziko lonse lapansi.