UKCA daim ntawv pov thawj yog hais txog cov qauv ntawv pov thawj uas yuav tsum tau ua thaum muag khoom siv kho mob hauv khw UK. Raws li British cov cai, pib txij Lub Ib Hlis 1, 2023, cov khoom siv kho mob muag rau UK yuav tsum ua raws li UKCA daim ntawv pov thawj cov cai, hloov daim ntawv pov thawj CE yav dhau los. Tau txais UKCA daim ntawv pov thawj yuav tsum ua raws li cov kev cai thiab cov qauv ntawm tsoomfwv Askiv thiab cov koom haum cuam tshuam, thiab cov txheej txheem kev thov thiab tshuaj xyuas.
UK Conformity Assessment (UKCA) daim ntawv pov thawj yog dab tsi?
UKCA daim ntawv pov thawj yog cov txheej txheem ua raws li cov khoom siv kho mob kom tau txais kev lag luam hauv tebchaws United Kingdom (UK). Hauv tebchaws Askiv, kev qhia txog UKCA lub cim hloov pauv CE cim dhau los. Daim ntawv pov thawj no yog qhov tseem ceeb los xyuas kom meej tias koj cov cuab yeej kho mob ua tau raws li cov cai ntawm UK Medical Device Regulation (UK MDR).
Yam khoom siv kho mob twg yuav tsum tau ntawv pov thawj UKCA?
Raws li txoj cai, txhua yam khoom siv kho mob nrog qib siab dua yuav tsum tau muag hauv UK kev ua lag luam yuav tsum tau txais UKCA ntawv pov thawj. Qhov no suav nrog cov khoom tsim tawm tshiab thiab cov khoom tau pom zoo lawm.
Cov khoom siv kho mob uas xav tau UKCA daim ntawv pov thawj suav nrog tab sis tsis txwv rau: cov khoom siv kho mob compression, defibrillators, infusion twj, pacemakers, kho mob laser, cov khoom siv X-ray, thiab lwm yam. Txawm li cas los xij, cov kev cai tshwj xeeb yuav txawv raws li qhov kev faib tawm thiab lub hom phiaj. ntawm tus ntaus ntawv. Nws raug nquahu kom koj sab laj nrog lub chaw haujlwm tshaj lij lossis cov chaw haujlwm muaj feem cuam tshuam kom tau txais cov ntaub ntawv raug dua.
Kuv yuav tsum nrhiav leej twg rau UKCA ntawv pov thawj?
Yuav kom tau txais UKCA daim ntawv pov thawj rau cov khoom siv kho mob, cov tuam txhab tsim khoom yuav tsum tso siab rau lub koom haum thib peb hu ua UK Pom Zoo Lub Cev los ua kev soj ntsuam kev ua raws cai thiab ntawv pov thawj uas ua tau raws li UKCA cov cai.
Cov kauj ruam twg yuav tsum tau ua rau UKCA ntawv pov thawj?
Cov txheej txheem UKCA daim ntawv pov thawj suav nrog kev faib khoom, kev tshuaj xyuas cov ntaub ntawv, kev ntsuas kev ua haujlwm zoo thiab daim ntawv pov thawj zaum kawg. Tag nrho cov kev cai tsim nyog yuav tsum tau ua kom pom tau tias ua raws.
Txiav txim siab cov khoom lag luam: Txiav txim siab seb koj cov khoom puas xav tau UKCA daim ntawv pov thawj thiab qhov yuav tsum tau muaj daim ntawv pov thawj.
Kev npaj cov ntaub ntawv thiab kev sim: Npaj cov khoom siv cov ntaub ntawv thiab ua qhov tsim nyog kuaj thiab kev soj ntsuam ntawm cov khoom kom ua raws li EU cov qauv kev lag luam.
Tso cai rau lub cev ntawv pov thawj: Xaiv lub UK-tsim ntawv pov thawj lub cev thiab tso siab rau lawv los ntsuas thiab lees paub koj cov khoom.
Ua ib qho kev ntsuam xyuas: Lub koom haum muab ntawv pov thawj yuav ua qhov kev ntsuam xyuas ntawm cov khoom, nrog rau kev tshuaj xyuas cov ntaub ntawv thiab kev ntsuam xyuas ntawm qhov chaw.
Muab daim ntawv pov thawj: Yog tias cov khoom ua tau raws li qhov yuav tsum tau ua, lub cev ntawv pov thawj yuav muab daim ntawv pov thawj UKCA.
Lub sijhawm twg koj yuav tsum tau them sai sai rau UKCA daim ntawv pov thawj?
Tsoomfwv Askiv tau siv cov kev hloov pauv hloov pauv rau UKCA daim ntawv pov thawj. Rau cov khoom siv kho mob, lub sijhawm kawg no tau txuas ntxiv dua thaum Lub Xya Hli 2023. Lub sijhawm siv tau yog nyob ntawm kev faib khoom siv kho mob thiab hom ntawv pov thawj EU.
Qhov no txhais tau hais tias cov tuam txhab kho mob tuaj yeem tso lawv cov khoom lag luam hauv UK siv ob qho tib si UKCA thiab CE cov cim ua ntej hnub teev. Nws raug nquahu kom thov rau UKCA daim ntawv pov thawj kom ntxov li sai tau kom ntseeg tau tias kev nkag mus rau kev lag luam raws sijhawm thiab tsis txhob ncua sijhawm.
Post lub sij hawm: Dec-28-2023