Zeziphi iziqinisekiso ekufuneka abavelisi bezitulo eziqhutywayo zombane babe nazo ukuze bathengiselwe kumazwe angaphandle?

Zeziphi iziqinisekiso ekufuneka abavelisi bezitulo eziqhutywayo zombane babe nazo ukuze bathengiselwe kumazwe angaphandle?
Njengodidi lwesixhobo sonyango, ukuthunyelwa ngaphandle kweizitulo zamavili zombaneibandakanya uthotho lweziqinisekiso kunye neemfuno zesiqinisekiso. Ezi zilandelayo zezona ziqinisekiso ziphambili ukubaabavelisi bezitulo zamavili zombaneKufuneka ube nayo xa uthumela ngaphandle:

1. Ukuthobela iimfuno zolawulo lwelizwe ekujoliswe kulo
Isiqinisekiso se-US FDA
Izitulo zamavili zombane zihlelwa njengezixhobo zonyango zeClass II eUnited States kwaye kufuneka zingenise amaxwebhu e-510K kwi-FDA kwaye zihlolwe ngobugcisa yi-FDA. Umgaqo we-510K kukuqinisekisa ukuba isixhobo sonyango esibhengeziweyo silingana kakhulu nesixhobo esithengiswe ngokusemthethweni eUnited States.

Isiqinisekiso se-EU CE
Ngokutsho kwe-EU Regulation (EU) 2017/745, izihlalo zabakhubazekileyo zombane zihlelwa njengezixhobo zonyango zeKlasi I. Emva kokuba izixhobo zonyango zeKlasi I zivavanywa ngokufanelekileyo kwimveliso kwaye zifumane iingxelo zovavanyo, kwaye emva kokuqulunqa amaxwebhu obugcisa ahlangabezana nemigangatho ngokweemfuno zolawulo, zinokungeniswa kummeli ogunyazisiweyo we-EU ukubhaliswa kunye nesatifikethi se-CE sinokugqitywa.

UKCA isatifikethi
Izitulo zamavili zombane kunye nezithuthuthu zombane zithunyelwa e-UK. Ngokweemfuno ze-UKMDR2002 zezixhobo zonyango, zizixhobo zonyango zodidi I. Faka isicelo sesatifikethi se-UKCA njengoko kufuneka.

Isiqinisekiso saseSwitzerland
Izitulo zamavili zombane kunye nezithuthuthu zombane zithunyelwa eSwitzerland. Ngokweemfuno ze-OMedDO yezixhobo zonyango, zizixhobo zonyango ze-Class I. Ngokweemfuno zabameli baseSwitzerland kunye nokubhaliswa kweSwitzerland

2. Imigangatho yesizwe kunye nemigangatho yoshishino
Imigangatho yesizwe
"Izitulo zamavili zombane" ngumgangatho wesizwe waseTshayina ochaza isigama kunye nemodeli yemigaqo yamagama, iimfuno zomphezulu, iimfuno zendibano, iimfuno zomda, iimfuno zokusebenza, iimfuno zamandla, ukusilela kwedangatye, imozulu, amandla kunye neemfuno zenkqubo yokulawula, kunye neendlela ezihambelanayo zovavanyo kunye nokuhlolwa. imithetho yezitulo zamavili zombane.

Imigangatho yeshishini
"IiNgcaciso zezoBugcisa boKhuseleko kwiiBatri zeLithium-ion kunye neePakethi zeBattery zeZitulo zamavili zoMbane" ngumgangatho woshishino, kwaye isebe elinobuchule liSebe lezoShishino kunye neTekhnoloji yoLwazi.

3. Inkqubo yolawulo lomgangatho
ISO 13485 kunye ne-ISO 9001
Uninzi lwabavelisi bezitulo eziqhutywayo zombane baya kupasa isiqinisekiso se-ISO 13485 kunye ne-ISO 9001 yenkqubo yolawulo lomgangatho ukuqinisekisa ukuba umgangatho wemveliso kunye neenkqubo zolawulo ziyahlangabezana nemigangatho yamazwe ngamazwe.

4. Imigangatho yokhuseleko lwebhetri kunye netshaja
Imigangatho yokhuseleko lwebhetri yeLithium
Iibhetri ze-lithium ezisetyenziswe kwizitulo zamavili zombane kufuneka zihambelane nemigangatho yokhuseleko ehambelanayo, njenge-GB / T 36676-2018 "Iimfuno zokhuseleko kunye neendlela zokuvavanya iibhetri ze-lithium-ion kunye neepakethi zebhetri kwizitulo zombane zombane"

5. Uvavanyo lwemveliso kunye novavanyo lomsebenzi
Uvavanyo lokusebenza
Izitulo ezinamavili zombane kufuneka zivavanyelwe ukusebenza ngokwemigangatho yezizwe ngezizwe efana ne-ISO 7176 series ukuqinisekisa ukhuseleko nokuthembeka kwazo.
Uvavanyo lwebhayoloji
Ukuba sisitulo esinamavili sombane, uvavanyo lwebhayoloji luyafuneka ukuze kuqinisekiswe ukuba loo nto ayinabungozi kumzimba womntu.
Ukhuseleko, i-EMC kunye novavanyo lokuqinisekisa isoftware
Izitulo zamavili zombane zikwafuna ukugqiba ukhuseleko, i-EMC kunye novavanyo lokuqinisekisa isoftware ukuqinisekisa ukhuseleko lombane kunye nokuhambelana kombane wemveliso.

6. Amaxwebhu athumela ngaphandle kunye nesibhengezo sokuthotyelwa
Ummeli ogunyazisiweyo we-EU
Ukuthumela ngaphandle kwi-EU kufuna ummeli ogunyazisiweyo we-EU ukuba ancede abavelisi ngokukhawuleza nangokuchanekileyo ukusombulula iingxaki ezahlukeneyo.
Isibhengezo sokuthotyelwa
Umvelisi kufuneka akhuphe isibhengezo sokuthotyelwa ukubonisa ukuba imveliso iyahambelana nazo zonke iimfuno zolawulo olusebenzayo.

7. Ezinye iimfuno
Ukupakishwa, iilebhile, imiyalelo
Ukupakishwa, iilebhile, imiyalelo, njl. njl. yemveliso kufuneka ihambelane neemfuno zolawulo lwemarike ekujoliswe kuyo.
Isicelo se-SRN kunye ne-UDI
Ngaphantsi kweemfuno ze-MDR, izihlalo ezinamavili ezithunyelwa ngaphandle njengezixhobo zonyango kufuneka zizalise isicelo se-SRN kunye ne-UDI kwaye zifake kwi-database ye-EUDAMED.

Ngamafutshane, abavelisi bezitulo eziqhutywayo zombane kufuneka balandele uthotho lweemfuno zesiqinisekiso kunye nesiqinisekiso xa bethumela iimveliso kumazwe angaphandle ukuqinisekisa ukuba iimveliso zinokungena kwimarike ekujoliswe kuyo ngokutyibilikayo. Ezi mfuneko azibandakanyi kuphela ukhuseleko kunye nokusebenza kakuhle kwemveliso, kodwa zikwabandakanya iinkqubo zokulawula umgangatho, imigangatho yokhuseleko lwebhetri, uvavanyo lwemveliso kunye nokuvavanya ukusebenza kunye neminye imiba. Ukuthobela le migaqo ngundoqo ekuqinisekiseni ukuba abavelisi bezitulo eziqhutywayo zombane banokukhuphisana ngempumelelo kwimarike yehlabathi.