Ungaluthola kanjani ulwazi lwesitifiketi samazwe ngamazwe sezihlalo zabakhubazekile zikagesi?
Ukuthola ulwazi lwesitifiketi samazwe ngamazwe sezihlalo ezinamasondo zikagesi ikakhulukazi kuhilela izinyathelo nezimfuneko ezilandelayo:
1. Qonda imithethonqubo namazinga asebenzayo
Izihlalo zabakhubazekile zikagesibanezidingo ezahlukene zesitifiketi emazweni nasezifundeni ezahlukene. E-EU, izihlalo ezinamasondo zikagesi zidinga ukuthobelana nezidingo Zomthetho Wedivayisi Yezokwelapha (MDR) [Regulation (EU) 2017/745] kanye ne-Machinery Directive (MD) [2006/42/EC]. Ngaphezu kwalokho, i-Electromagnetic Compatibility Directive (EMC Directive) [2014/30/EU] kanye ne-Low Voltage Directive (LVD) [2014/35/EU] idinga ukucatshangelwa.
2. Ukuhlola ukuhambisana nezinyathelo zokuqinisekisa
Ukuhlukaniswa komkhiqizo nokukhetha indlela yokuvumelana: Nquma ukuhlukaniswa kwesihlalo esinamasondo sikagesi bese ukhetha indlela yokuhlola ukuvumelana efanele. Izihlalo zabakhubazekile ezisebenza ngogesi ngokuvamile zihlukaniswa njengemishini yezokwelapha ye-Class I, kodwa ngenxa yokuthi ihlanganisa amadrayivu kagesi, kungase kudingeke ukuthi ibuyekezwe yinhlangano eyazisiwe.
Ukuhlolwa komtholampilo: Abakhiqizi badinga ukwenza ukuhlolwa komtholampilo ukuze bafakazele ukuphepha nokusebenza ngempumelelo kwedivayisi.
Ukulawulwa kobungozi: Ukulawulwa kobungozi kwenziwa ngokuhambisana ne-ISO 14971 ukuze kuhlonzwe futhi kuncishiswe ubungozi obungaba khona phakathi nomjikelezo wempilo wedivayisi.
Ukulungiswa kwemibhalo yobuchwepheshe: Kubandakanya incazelo yomkhiqizo, umbiko wokuhlolwa komtholampilo, umbiko wokulawulwa kobungozi, imibhalo yokukhiqiza nokulawula ikhwalithi, njll.
I-Declaration of Conformity (DoC): Umkhiqizi udinga ukusayina futhi akhiphe isimemezelo sokuvumelana esisho ukuthi isihlalo esinamasondo sikagesi sithobela yonke imithetho nemigomo ye-EU esebenzayo.
Isibuyekezo somzimba owaziswayo: Khetha indikimba eyazisiwe ukuze ibuyekeze futhi igunyaze amadokhumenti ezobuchwepheshe omkhiqizo, ukuphathwa kwengozi, ukuhlolwa komtholampilo, njll.
3. Izidingo eziqondile zesitifiketi se-CE
Isitifiketi se-CE sezihlalo ezinamasondo zikagesi e-EU sidinga ukulandela izinga le-EN 12184, elicacisa izidingo ezithile nezindlela zokuhlola zezihlalo ezinamasondo zikagesi. Okuqukethwe kokuhlola kufaka ukuhlola kokuphepha kwemishini, ukuhlola amandla nokuzinza, ukuhlolwa kwesistimu yamabhuleki, nokuhlolwa kokuphepha kukagesi nokusebenza
4. Izidingo zesitifiketi se-FDA 510K
E-United States, izihlalo ezinamasondo zikagesi, njengemishini yezokwelapha ye-Class II, kufanele iphumelele ekubuyekezweni kwedokhumenti ye-FDA's 510K. Lokhu kuhlanganisa izinyathelo ezinjengokuhlaziywa kokusebenza okujwayelekile, idokhumenti ekhona kanye nokubuyiswa kwedatha, ukuqhathanisa imakethe nokubhala imibhalo
5. Ukuthola incwadi yokugunyaza
Ngemuva kokuphasa isitifiketi se-FDA 510K, isihlalo esinamasondo sikagesi sizothola incwadi yokugunyaza, okuwumbhalo obalulekile oqinisekisa ukuthotshelwa komkhiqizo.
6. Ezinye izitifiketi
Ngaphezu kwesitifiketi se-CE ne-FDA 510K, izihlalo ezinamasondo zikagesi zingase futhi zidinge ukudlula ezinye izitifiketi zamazwe ngamazwe, njengesitifiketi se-CB (Isitifiketi Sokuhlola I-International Electrotechnical Commission Electrical Product Conformity Testing)
Ngokulandela izinyathelo nezimfuneko ezingenhla, abakhiqizi bangaqinisekisa ukuthi izihlalo ezinamasondo zikagesi zihlangabezana nezidingo zokulawula zemakethe yamazwe ngamazwe, ngaleyo ndlela zingene ngokusemthethweni nangokuphepha emakethe eqondiwe.
Isikhathi sokuthumela: Dec-30-2024