Ndezvipi zvinodiwa nevagadziri vewiricheya yemagetsi pakutengesa kunze?

Ndezvipi zvinodiwa nevagadziri vewiricheya yemagetsi pakutengesa kunze?
Semhando yechishandiso chekurapa, kutengeswa kunze kwenyika kwemawiricheya emagetsiinosanganisira nhevedzano yezvitupa uye zvinodiwa setifiketi. Zvinotevera ndizvo zvakakosha izvovagadziri vemagetsi mawiricheyazvinodiwa paunenge uchitumira kunze:

1. Tevedzera zvinodiwa nemutemo wenyika inotarirwa
US FDA chitupa
Mawiricheya emagetsi anoiswa seClass II michina yekurapa muUnited States uye inoda kuendesa magwaro e510K kuFDA uye kuongororwa kwehunyanzvi neFDA. Nheyo ye510K ndeyekuratidza kuti mudziyo wekurapa wakaziviswa wakaenzana nemudziyo wakatengeswa zviri pamutemo muUnited States.

EU CE certification
Zvinoenderana neEU Regulation (EU) 2017/745, mawiricheya emagetsi anoiswa seKirasi I michina yekurapa. Mushure meKirasi I michina yekurapa yaedzwa yakakodzera chigadzirwa uye kuwana mishumo yebvunzo, uye mushure mekunyora magwaro ehunyanzvi anoenderana nezviyero zvinoenderana nezvinodiwa, anogona kuendeswa kumumiriri ane mvumo weEU kuti anyorese uye chitupa cheEC chinogona kupedzwa.

UKCA certification
Magetsi mawiricheya uye scooters emagetsi zvinotumirwa kuUK. Zvinoenderana nezvinodiwa zveUKMDR2002 zvekurapa mudziyo mirairo, iwo Kirasi I michina yekurapa. Nyorera UKCA certification sezvinodiwa.

Swiss certification
Magetsi mawiricheya uye scooters emagetsi zvinotumirwa kuSwitzerland. Zvinoenderana nezvinodiwa zveOMedDO zvekurapa mudziyo mirairo, iwo Kirasi I michina yekurapa. Zvinoenderana nezvinodiwa nevamiriri veSwitzerland uye kunyoreswa kweSwitzerland

2. Mitemo yenyika uye indasitiri zviyero
Mitemo yenyika
"Electric wheelchairs" chiyero chenyika cheChinese chinonongedza misimboti uye modhi yekupa mazita, zvinodiwa zvepasi, zvinodikanwa zvegungano, zvimiro, zvinodiwa zvekushanda, simba rinodiwa, kunonoka kwemurazvo, mamiriro ekunze, simba uye hurongwa hwekutonga zvinodiwa, uye nzira dzinoenderana dzekuyedza uye kuongorora. mitemo yemagetsi mawiricheya.

Indasitiri mitemo
"Safety technical Specifications yeLithium-ion Mabhatiri neBattery Packs yeMagetsi Wheelchairs" chiyero cheindasitiri, uye dhipatimendi rinokwanisa iBazi reIndasitiri neRuzivo Tekinoroji.

3. Hunhu hwekutarisira hurongwa
ISO 13485 uye ISO 9001
Vazhinji vagadziri vemagetsi emagetsi mawiricheya vanopasa ISO 13485 uye ISO 9001 quality management system certification kuti ive nechokwadi chekuti chigadzirwa chemhando uye masisitimu emanejimendi anosangana nenyika dzepasirese.

4. Battery uye charger kuchengetedza zviyero
Lithium bhatiri kuchengetedza zviyero
Mabhatiri eLithium anoshandiswa mumawiricheya emagetsi anofanirwa kutevedzera zviyero zvekuchengetedza, senge GB/T 36676-2018 "Safety zvinodiwa uye nzira dzekuyedza dzemabhatiri e-lithium-ion uye bhatiri mapaketi emagetsi mawiricheya"

5. Kuongororwa kwechigadzirwa uye kuongororwa kwekuita
Performance test
Magetsi mawiricheya anofanirwa kuyedzwa kuti aite sei zvinoenderana nezviyero zvepasi rose senge ISO 7176 nhevedzano kuti ive nechokwadi chekuchengetedza uye kuvimbika kwavo.
Biological testing
Kana iri wiricheya yemagetsi, kuongororwa kwebiological kunodiwawo kuona kuti zvinhu zvacho hazvina kukuvadza kumuviri wemunhu.
Chengetedzo, EMC uye software yekuongorora bvunzo
Magetsi mawiricheya anodawo kupedzisa kuchengeteka, EMC uye software yekuongorora bvunzo kuti ive nechokwadi chekuchengetedzwa kwemagetsi uye kuenderana kwemagetsi kwechigadzirwa.

6. Export magwaro uye chiziviso chekuteerera
Mumiriri ane mvumo weEU
Kutumira kunze kwenyika kuEU kunoda mumiriri ane mvumo weEU anoteerera kubatsira vagadziri nekukurumidza uye nemazvo kugadzirisa matambudziko akasiyana.
Declaration of conformity
Mugadziri anofanirwa kuburitsa chiziviso chekuenderana kuratidza kuti chigadzirwa chinoenderana nezvose zvinoshanda zvinotarisirwa zvinodiwa.

7. Zvimwe zvinodiwa
Kurongedza, kuisa mazita, mirayiridzo
Iko kurongedza, kuisa mazita, mirairo, nezvimwe zvechigadzirwa zvinofanirwa kuenderana nezvinodiwa zvinotarisirwa zvemusika unotangwa.
SRN uye UDI application
Pasi pezvinodiwa neMDR, mawiricheya anotengeswa kunze kwenyika semidziyo yekurapa anofanirwa kupedzisa kunyorera kweSRN neUDI uye ozvipinza mudura reEUDAMED.

Muchidimbu, vagadziri vemagetsi mawiricheya vanofanirwa kutevedzera akatevedzana ezvitupa uye zvitupa zvinodikanwa pavanotumira kunze zvigadzirwa kuona kuti zvigadzirwa zvinogona kupinda mumusika unonangwa zvakanaka. Izvi zvinodikanwa hazvingosanganisi kuchengetedzwa uye kushanda kwechigadzirwa, asi zvakare zvinosanganisira hunhu hwekutonga masisitimu, zviyero zvekuchengetedza bhatiri, kuongororwa kwechigadzirwa uye kuongororwa kwekuita uye zvimwe zvinhu. Kutevedzera iyi mirau ndiyo kiyi yekuona kuti vagadziri vemagetsi mawiricheya vanogona kubudirira kukwikwidza mumusika wepasi rose.