CE daim ntawv pov thawj yog ib qho yuav tsum tau ua pov thawj kev nyab xeeb uas siv los ntawm EU. Nws yog lub npe hu ua "Conformité Européene" thiab nws lub hom phiaj tseem ceeb yog los xyuas kom meej tias cov khoom lag luam hauv EU ua raws li cov kev cai yooj yim rau kev noj qab haus huv, kev nyab xeeb, thiab kev tiv thaiv ib puag ncig. Nws yog ib qho tsim nyog rau cov khoom lag luam kom raug cai nkag mus rau 27 tus tswv cuab ntawm EU thiab 4 lub teb chaws ntawm European Free Trade Area. Cov qauv ntawv pov thawj yog nruj, nrog rau cov kev xav tau siab rau cov khoom lag luam, kev tswj kom zoo, thiab kev tiv thaiv kev pheej hmoo. Cov khoom lag luam uas Lysun tau txais daim ntawv pov thawj no tau dhau los ua cov khoom lag luam nruj, kev ntsuas kev pheej hmoo, thiab kev tshuaj xyuas cov ntaub ntawv, ua kom pom tseeb tias lub tuam txhab muaj peev xwm zoo tshaj plaws hauv kev tshawb fawb thiab kev tsim khoom, kev tsim khoom, thiab kev tsim khoom.
Raws li qib siab - thev naus laus zis biopharmaceutical tuam txhab tshwj xeeb hauv kev tshawb fawb, tsim khoom thiab muag hauv vitro diagnostic reagents thiab lwm yam cuab yeej, Lysun tau koom nrog hauv IVD teb tau ntau xyoo. Cov tub ntxhais R & D pab pawg muaj ntau tshaj 8 xyoo ntawm kev paub hauv kev tsim cov khoom POCT. Lawv ib txwm nruj me ntsis tswj cov khoom zoo ntawm tus qauv siab. Lawv cov khoom tau dhau los ntawm EN ISO 13485: 2016 kev tswj hwm kev tswj hwm kev lees paub zoo thiab npog cov pawg xws li cov ntsuas ntshav qabzib, cov ntsuas lipid, thiab kuaj kab mob sib kis, thiab tau siv dav hauv tsev tus kheej- kuaj, kuaj biochemistry, thiab lwm yam haujlwm. Kev nrhiav tau ntawm thawj daim ntawv pov thawj CE no tsis yog tsuas yog kev lees paub los ntawm EU ntawm Lysun cov khoom muaj zog thiab kev ua raws cai, tab sis kuj yog lub sijhawm tseem ceeb rau lub tuam txhab txhawm rau txhawm rau hla kev lag luam thoob ntiaj teb thiab koom nrog kev sib tw thoob ntiaj teb.
Raws li tus neeg saib xyuas ntawm Lysun, cov txheej txheem ntawv pov thawj no tau ua nruj me ntsis raws li EU cov lus qhia thiab cov qauv kev sib haum xeeb. Pab neeg no tau npaj cov ntaub ntawv qhia ntxaws ntxaws, suav nrog cov lus piav qhia ntawm cov khoom, cov duab kos duab, cov ntawv ceeb toom kev pheej hmoo, cov ntawv xeem thiab lwm yam ntaub ntawv tseem ceeb. Lawv koom tes nrog lub koom haum muab ntawv pov thawj kom ua tiav tag nrho cov txheej txheem ntawm kev tshuaj xyuas thiab kev sim. Thaum kawg, daim ntawv pov thawj tau ua tiav tiav. Tus neeg saib xyuas tau hais tias qhov tau txais thawj daim ntawv pov thawj CE yog qhov tseem ceeb hauv lub tuam txhab txoj kev lag luam thoob ntiaj teb. Nws yuav ntxiv dag zog rau thoob ntiaj teb kev cuam tshuam ntawm hom thiab nteg lub hauv paus ruaj khov rau kev nthuav dav ntawm cov khoom lag luam hauv Tebchaws Europe.
Saib mus rau yav tom ntej, Lysun yuav coj daim ntawv pov thawj CE thawj zaug no los ua lub sijhawm los txuas ntxiv kev tshawb fawb txog cov khoom lag luam thiab kev txhim kho thiab kev txhim kho kom zoo, thiab ua kom lub ntiaj teb nthuav dav lub tswv yim. Lub tuam txhab tau hais meej meej tias nws yuav ua tsis tu ncua rau CE daim ntawv pov thawj ua haujlwm ntawm lwm cov khoom tseem ceeb raws li txoj kev npaj tsim. Nws cia siab tias thaum kawg ntawm 2026, tag nrho lwm yam khoom hauv vitro kuaj mob raws li lub tuam txhab cov ntaub ntawv yuav tau ua tiav lawv daim ntawv pov thawj CE, ua tiav tag nrho cov kev pab cuam ntawm EU ua lag luam rau cov khoom tseem ceeb. Qhov no yuav nthuav dav thoob ntiaj teb thaj chaw ua lag luam, muab cov neeg siv khoom siab dua - zoo thiab ua tau raws li cov khoom siv tshuaj ntsuam xyuas vitro thiab cov kev pabcuam, thiab pab suav kev tsim khoom mus thoob ntiaj teb.