Yiziphi iziqu abakhiqizi bezihlalo ezinamasondo zikagesi okudingeka babe nazo ukuze bathunyelwe ngaphandle?

Yiziphi iziqu abakhiqizi bezihlalo ezinamasondo zikagesi okudingeka babe nazo ukuze bathunyelwe ngaphandle?
Njengohlobo lwedivayisi yezokwelapha, ukuthunyelwa kweizihlalo zabakhubazekile zikagesiibandakanya uchungechunge lweziqu nezimfuneko zesitifiketi. Okulandelayo yiziqu ezisemqoka lokhoabakhiqizi bezihlalo zabakhubazekile zikagesiokudingeka ube nakho lapho uthekelisa:

1. Ukuthobelana nezidingo zokulawula zezwe okuhlosiwe
Isitifiketi se-US FDA
Izihlalo ezinamasondo zikagesi zihlukaniswa njengemishini yezokwelapha ye-Class II e-United States futhi idinga ukuhambisa amadokhumenti angu-510K ku-FDA futhi ibuyekezwe ubuchwepheshe yi-FDA. Umgomo we-510K uwukufakazela ukuthi idivayisi yezokwelapha emenyezelwe ilingana kakhulu nedivayisi emakethe ngokusemthethweni e-United States.

Isitifiketi se-EU CE
Ngokuvumelana ne-EU Regulation (EU) 2017/745, izihlalo zabakhubazekile zikagesi zihlukaniswa njengemishini yezokwelapha ye-Class I. Ngemuva kokuthi imishini yezokwelapha ye-Class I isihloliwe umkhiqizo ofanele futhi zithole imibiko yokuhlolwa, futhi ngemva kokuhlanganiswa kwemibhalo yezobuchwepheshe ehlangabezana nezindinganiso ngokuya ngezidingo zokulawula, ingathunyelwa kummeleli ogunyaziwe we-EU ukuze abhaliswe futhi nesitifiketi se-CE singaqedwa.

Isitifiketi se-UKCA
Izihlalo zabakhubazekile zikagesi nezikuta zikagesi zithunyelwa e-UK. Ngokwezidingo zemithetho yedivayisi yezokwelapha ye-UKMDR2002, ingamadivayisi ezokwelapha e-Class I. Faka isicelo sesitifiketi se-UKCA njengoba kudingeka.

Isitifiketi saseSwitzerland
Izihlalo zabakhubazekile zikagesi nezikuta zikagesi zithunyelwa eSwitzerland. Ngokwezidingo zemithetho yedivayisi yezokwelapha ye-oMedDO, iyimishini yezokwelapha ye-Class I. Ngokwezidingo zabameleli baseSwitzerland kanye nokubhaliswa kweSwitzerland

2. Amazinga kazwelonke kanye namazinga emboni
Izindinganiso zikazwelonke
“Izihlalo ezinamasondo zikagesi” izinga likazwelonke laseShayina elibeka imigomo nemithetho yokuqamba amamodeli, izimfuneko zendawo, izidingo zokuhlanganisa, izidingo zobukhulu, izidingo zokusebenza, izidingo zamandla, ukuncipha komlilo, isimo sezulu, izidingo zesistimu yokulawula amandla kanye nezindlela zokuhlola ezihambisanayo. imithetho yezihlalo zabakhubazekile zikagesi.

Izindinganiso zezimboni
“Izicaciso Zobuchwepheshe Zokuphepha Zamabhethri e-Lithium-ion namaphakethe Ebhethri ezihlalo ezinamasondo zikagesi” izinga lemboni, futhi umnyango onekhono wuMnyango Wezimboni Nobuchwepheshe Bolwazi.

3. Uhlelo lokuphatha ikhwalithi
I-ISO 13485 kanye ne-ISO 9001
Abakhiqizi abaningi bezihlalo ezinamasondo zikagesi bazophasa isitifiketi se-ISO 13485 kanye ne-ISO 9001 yokuphathwa kwekhwalithi ukuze baqinisekise ukuthi ikhwalithi yomkhiqizo nezinhlelo zokuphatha zihlangabezana namazinga omhlaba.

4. Amazinga okuphepha kwebhethri neshaja
Izindinganiso zokuphepha kwebhethri ye-lithium
Amabhethri e-lithium asetshenziswa ezihlalweni zamasondo zikagesi adinga ukuthobela izindinganiso zokuphepha ezihambisanayo, njenge-GB/T 36676-2018 “Izimfuneko zokuphepha nezindlela zokuhlola zamabhethri e-lithium-ion namaphakethe ebhethri ezihlalo ezinamasondo zikagesi”

5. Ukuhlolwa komkhiqizo kanye nokuhlolwa kokusebenza
Ukuhlolwa kokusebenza
Izihlalo ezinamasondo zikagesi zidinga ukuhlolwa ukusebenza kwazo ngokwezindinganiso zamazwe ngamazwe njenge-ISO 7176 series ukuze kuqinisekiswe ukuphepha nokwethembeka kwazo.
Ukuhlolwa kwezinto eziphilayo
Uma kuyisihlalo esinamasondo sikagesi, ukuhlolwa kwebhayoloji kuyadingeka ukuze kuqinisekiswe ukuthi impahla ayinabungozi emzimbeni womuntu.
Ukuphepha, i-EMC nokuhlolwa kokuqinisekisa isofthiwe
Izihlalo ezinamasondo zikagesi nazo zidinga ukuqedela ukuphepha, i-EMC kanye nokuhlolwa kokuqinisekiswa kwesoftware ukuze kuqinisekiswe ukuphepha kukagesi nokuhambisana kwe-electromagnetic komkhiqizo.

6. Thumela amadokhumenti kanye nesimemezelo sokuthobela umthetho
Ummeleli ogunyaziwe we-EU
Ukuthumela ku-EU kudinga ummeleli ogunyaziwe we-EU ukusiza abakhiqizi ekuxazululeni izinkinga ezihlukahlukene ngokushesha nangokunembile.
Isimemezelo sokuvumelana
Umkhiqizi udinga ukukhipha isimemezelo sokuvumelana ukuze afakazele ukuthi umkhiqizo uthobela zonke izimfuneko zokulawula ezisebenzayo.

7. Ezinye izidingo
Ukupakisha, ukulebula, imiyalelo
Ukupakishwa, ukulebula, imiyalelo, njll. komkhiqizo kudingeka kuhambisane nezidingo zokulawula zemakethe eqondiwe.
Isicelo se-SRN ne-UDI
Ngaphansi kwezidingo ze-MDR, izihlalo zabakhubazekile ezithunyelwa kwamanye amazwe njengemishini yezokwelapha kufanele ziqedele ukusetshenziswa kwe-SRN ne-UDI bese zizifaka ku-database ye-EUDAMED.

Kafushane, abakhiqizi bezihlalo ezinamasondo zikagesi badinga ukulandela uchungechunge lwezidingo zokufaneleka nezitifiketi lapho bethumela imikhiqizo kwamanye amazwe ukuze baqinisekise ukuthi imikhiqizo ingangena emakethe eqondiwe kahle. Lezi zidingo azihlanganisi ukuphepha nokusebenza ngempumelelo komkhiqizo kuphela, kodwa futhi zihlanganisa izinhlelo zokuphatha ikhwalithi, amazinga okuphepha kwebhethri, ukuhlolwa komkhiqizo kanye nokuhlolwa kokusebenza nezinye izici. Ukuthobela le mithetho kuwukhiye wokuqinisekisa ukuthi abakhiqizi bezihlalo ezinamasondo zikagesi bangaqhudelana ngempumelelo emakethe yomhlaba.