Isikhokelo sokuMakisha iilensi zamehlo

Ngokuphuculwa okuqhubekayo kweemfuno zomgangatho wabathengi, iimfuno zomgangatho wabantu kwiilensi zamehlo nazo ziphuculwa ngokuthe ngcembe, kwangaxeshanye, iimfuno zehlabathi zeelensi zamehlo nazo ziya ziba ngqongqo ngakumbi.Indlela yokuchonga uphawu lwalo ngokukhawuleza?Namhlanje siza kujonga imigangatho yelensi yamehlo kunye neemfuno ezinxulumene nokumakisha kumazwe aliqela.

微信图片_20220810104229
IManyano yaseYurophu
I-European Union idinga ukuba iilensi ze-optical kufuneka zihambelane ne-Medical Devices Regulation (EU) 2017/745 kwaye ziqinisekiswe njengezifanelekileyo.Ukuze ungene kwimarike ye-EU ngokutyibilikayo, uphawu "CE" lungongezwa
eBritani
Emva kwe-Brexit, i-Great Britain idinga ukuba iilensi ze-optical kufuneka zihambelane neMimiselo ye-Medical Devices Regulations 2002 kwaye iqinisekiswe ukuba ifanelekile ngaphambi kokuba ifake uphawu lwe-"UKCA" ukungena kwimarike yendawo ngokufanelekileyo.
Iunited States
EUnited States, iilensi zamehlo zilawulwa ngokungqongqo njengezixhobo zonyango, kwaye umgangatho wabo kufuneka uhlangabezane neemfuno ze-Federal Food and Drug Administration (FDA) (21 CFR 801.410) ngaphambi kokuba zingeniswe.
eTshayina
Imarike yasekhaya idinga ukuhlangabezana neemfuno ze-GB / T 38005-2019 standard.
UVavanyo lweNtsebenzo yeMveliso ye-EUR-Isatifikethi sokusebenza ukuze abathengi basiqonde ngokukrwaquza.Abavelisi beelensi zamehlo banokubala iimpawu zokusebenza kweemveliso zabo kwesi satifikethi ukuqaqambisa ukohluka kweemveliso, ukuze kwandiswe indawo yokuthengisa yeemveliso.


Ixesha lokuposa: Sep-03-2022