Yiziphi izitifiketi ezigunyaziwe ezinazo izimaski zokwelashwa kokukhanya okubomvu zeSunsred? Yiziphi izindinganiso zomhlaba wonke ezihlangabezana nazo?

I-Sunsred ibheka ukuphepha nokuthobela imithetho njengezimiso eziphakeme kakhulu; imikhiqizo yethu ithole "amapasipoti" agunyaziwe ezimakethe ezinkulu zomhlaba!

Amamaski ethu okwelapha ngokukhanya okubomvu anohlu oluphelele lwezitifiketi zomhlaba wonke kanye nezindinganiso zokuthobela imithetho eqinile:

Izitifiketi Zogunyazo Zomhlaba Wonke:

FDA 510K: Ngithole imvume ye-US Food and Drug Administration's 510K Premarket Notification clearance, okuyimfanelo ebalulekile yokungena emakethe yezokwelapha yase-US.

I-CE, i-FCC, i-RoHS: Iphumelele isitifiketi sokuphepha se-EU CE, isitifiketi sokuhambisana nogesi se-US FCC, kanye nesitifiketi semvelo se-RoHS, okuqinisekisa ukuthi imikhiqizo ihlangabezana nezidingo zomthetho zezimakethe ezinkulu zomhlaba.

Izindinganiso Zokuhlola Eziqinile:

EN 62471: Uphumelele ukuhlolwa kokuphepha kwe-photobiological.

EN 55014 / 60601-1-2: Ihambisana nezindinganiso zokuhambisana kwe-electromagnetic.

IEC 60601-1: Ihlangabezana nezindinganiso ezijwayelekile zokuphepha kwemishini kagesi yezokwelapha.

Ubuhle Ezinhlelweni Zokuphatha Ikhwalithi:

I-ISO 9001 kanye ne-ISO 13485: Iqinisekiswe yizinhlelo zokuphatha ikhwalithi zomhlaba wonke kanye nezinhlelo zokuphatha ikhwalithi yamadivayisi ezokwelapha.

ISO 10993-1: Kuhambisana nezindinganiso zokuhlola izinto eziphilayo zamadivayisi ezokwelapha.

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