Amazinga izihlalo ezinamasondo zikagesi okudingeka zihambisane nawo ekuhwebeni kwamazwe ngamazwe

Amazinga izihlalo ezinamasondo zikagesi okudingeka zihambisane nawo ekuhwebeni kwamazwe ngamazwe
Njengethuluzi elibalulekile elisiza ekubuyiseleni, izihlalo zabakhubazekile zikagesi zidlala indima ebaluleke kakhulu ekuhwebeni kwamazwe ngamazwe. Ukuze kuqinisekiswe ukuphepha, ukusebenza kahle nokuhambisana kwezihlalo ezinamasondo zikagesi, amazwe nezifunda zenze uchungechunge lwamazinga nemithethonqubo. Okulandelayo yizindinganiso eziyinhloko ukuthiizihlalo zabakhubazekile zikagesiisidingo sokuhambisana nohwebo lwamazwe ngamazwe:

1. Amazinga okufinyelela emakethe ye-EU
I-EU Medical Device Regulation (MDR)
Izihlalo ezinamasondo zikagesi zihlukaniswa njengemishini yezokwelapha ye-Class I emakethe ye-EU. Ngokuvumelana ne-EU Regulation (EU) 2017/745, izihlalo ezinamasondo zikagesi ezithunyelwa emazweni angamalungu e-EU kufanele zihlangabezane nalezi zidingo ezilandelayo:

Othobelayo Ogunyazwe Omele I-EU: Khetha Ummeli Ogunyazwe We-EU othobelayo nonolwazi ukuze asize abakhiqizi ekuxazululeni ngokushesha nangokunembile izinkinga ezihlukahlukene.
Ukubhaliswa komkhiqizo: Thumela isicelo sokubhaliswa komkhiqizo ezweni eliyilungu lapho omele i-EU ekhona futhi ugcwalise incwadi yokubhalisa.
Imibhalo yezobuchwepheshe ye-MDR: Lungiselela imibhalo yezobuchwepheshe ye-CE ehlangabezana nezidingo zemithetho ye-MDR. Ngesikhathi esifanayo, imibhalo yezobuchwepheshe nayo idinga ukugcinwa omele i-EU ukuze kuhlolwe izindawo ezisemthethweni ze-EU.
I-Declaration of Conformity (DOC): Izihlalo ezinamasondo zingezamadivayisi Ekilasi I, futhi nesimemezelo sokuvumelana siyadingeka.
Izindinganiso zokuhlola
I-TS EN 12183: Isebenza ezihlalweni ezinamasondo ezinomthwalo ongeqile ku-250kg kanye nezihlalo ezinamasondo ezinezisetshenziswa zikagesi ezisizayo.
I-TS EN 12184 Isebenza ezihlalweni zamasondo zikagesi ezinesivinini esingeqile ku-15 km/h futhi ithwala eyodwa nomthwalo ongadluli ku-300 kg

2. Izindinganiso zokufinyelela ezimakethe zase-US
Isitifiketi se-FDA 510(k).
Izihlalo zabakhubazekile zikagesi zihlukaniswa njengemishini yezokwelapha ye-Class II e-United States. Ukuze ungene emakethe yase-US, udinga ukuthumela idokhumenti engu-510K ku-FDA futhi wamukele isibuyekezo sobuchwepheshe se-FDA. Umgomo we-FDA's 510K uwukufakazela ukuthi idivayisi yezokwelapha emenyezelwe ilingana kakhulu nedivayisi emakethe ngokusemthethweni e-United States.

Ezinye izidingo
Isitifiketi sokubhalisa: Izihlalo ezinamasondo zikagesi ezithunyelwa e-United States kufanele futhi zinikeze isitifiketi sokubhaliswa.
Imanuwali yokukhiqiza: Nikeza imanuwali enemininingwane yomkhiqizo.
Ilayisensi yokukhiqiza: Ilayisensi yokukhiqiza efakazela ukuthi inqubo yokukhiqiza ihambisana nemithethonqubo.
Amarekhodi okulawula ikhwalithi: Bonisa amarekhodi okulawula ikhwalithi yenqubo yokukhiqiza umkhiqizo.
Umbiko wokuhlolwa komkhiqizo: Nikeza umbiko wokuhlolwa komkhiqizo ukuze ufakazele ikhwalithi yomkhiqizo

3. Izindinganiso zokufinyelela emakethe yase-UK
Isitifiketi se-UKCA
Izihlalo ezinamasondo zikagesi ezithunyelwa e-UK ziyimishini yezokwelapha Yekilasi I ngokuvumelana nezimfuneko zemithetho yedivayisi yezokwelapha yase-UKMDR2002 futhi kudingeka ufake isicelo sokuthola isitifiketi se-UKCA. Ngemuva komhla zingama-30 kuJuni 2023, imishini yezokwelapha Yekilasi I kufanele imakwe ngophawu lwe-UKCA ngaphambi kokuthi ithunyelwe e-UK.

Izimfuneko
Cacisa i-UKRP eyingqayizivele: Abakhiqizi badinga ukucacisa umuntu oyingqayizivele wase-UK Responsible Person (UKRP).
Ukubhaliswa komkhiqizo: I-UKRP iqede ukubhaliswa komkhiqizo ne-MHRA.
Imibhalo yezobuchwepheshe: Kukhona imibhalo yezobuchwepheshe ye-CE noma imibhalo yezobuchwepheshe ye-UKCA ehlangabezana nezidingo.

4. Izindinganiso zamazwe ngamazwe
ISO 13485
I-ISO 13485 indinganiso yamazwe ngamazwe yezinhlelo zokuphatha ikhwalithi yedivayisi yezokwelapha. Nakuba kungeyona imfuneko eqondile yokufinyelela emakethe, inikeza isiqiniseko sekhwalithi sokuklama nokukhiqizwa kwemishini yezokwelapha.

Isiphetho
Izihlalo ezinamasondo zikagesi zidinga ukuthobela izindinganiso nemithetho eqinile ekuhwebeni kwamazwe ngamazwe ukuze kuqinisekiswe ukuphepha nokusebenza ngempumelelo kwemikhiqizo. Abakhiqizi kufanele baqonde izimfuneko zokulawula zemakethe eqondiwe futhi baqinisekise ukuthi imikhiqizo yabo ihlangabezana namazinga okuhlola afanele kanye nemininingwane yobuchwepheshe. Ngokuthobelana nalawa mazinga, izihlalo ezinamasondo zikagesi zingangena ngokushelela emakethe yamazwe ngamazwe futhi zinikeze izisetshenziswa zokusiza zokuvuselela ikhwalithi ephezulu kubasebenzisi emhlabeni jikelele.