head_banner

Xov Xwm

Tam sim no, tus mob tshiab li kab mob coronavirus (COVID-19) muaj kev sib kis kis ntau. Kev kis thoob ntiaj teb yog kuaj lub peev xwm ntawm txhua lub teb chaws los tawm tsam kev sib kis mob. Tom qab cov txiaj ntsig zoo ntawm kev tiv thaiv kev kis mob thiab kev tswj hwm nyob hauv Suav teb, ntau lub lag luam hauv tsev npaj siab txhawb lawv cov khoom los pab lwm lub teb chaws thiab cov cheeb tsam sib koom ua ke tiv thaiv tus kabmob. Thaum Lub Peb Hlis 31, 2020, Tsoomfwv Saib Xyuas Kev Lag Luam, General Administration ntawm kev coj noj coj ua thiab Tsoom Fwv Saib Xyuas Kev Siv Tshuaj hauv Tuam Tshoj tau tshaj tawm cov ntawv tshaj tawm txog cov cuab yeej kho mob ntsig txog kev tiv thaiv kabmob sib kis (xws li nrhiav cov khoom siv, lub qhov ncauj kev kho mob, khaub ncaws tiv thaiv kev kho mob, lub tshuab ua pa thiab infrared tus pas ntsuas kub), uas tau hais tias txij lub Plaub Hlis 1, cov neeg xa khoom ntawm cov khoom lag luam yuav tsum ua pov thawj tias lawv tau txais cov ntawv sau npe ntawm cov cuab yeej siv kho mob hauv Tuam Tshoj Thiab ua tau raws cov qauv zoo ntawm cov teb chaws xa tawm lossis thaj chaw. Cov kev lis kev cai muaj peev xwm tso cov khoom lag luam tsuas yog tom qab lawv tau ntawv pov thawj raws li kev tsim nyog.

Daim ntawv tshaj tawm sib koom tes tau qhia tias Tuam Tshoj muaj kev ntseeg siab rau qhov ua tau zoo ntawm cov khoom siv khomob. Hauv qab no yog cov ntawv sau qee cov teeb meem uas yooj yim tsis meej pem thaum xa tawm mus rau European Union thiab Tebchaws Asmeskas.

cov koom pheej nyob sab Europe

(1) Txog CE cim

CE yog lub zej zog nyob sab Europe. CE kos yog EU txheej txheem qauv rau cov khoom lag luam uas teev hauv EU. Hauv kev ua lag luam EU, CE daim ntawv pov thawj belongs rau cov ntawv pov thawj kev tswj hwm cov ntawv pov thawj. Txawm hais tias cov khoom lag luam tsim los ntawm cov lag luam nyob hauv EU lossis cov khoom lag luam tsim nyob hauv lwm lub teb chaws xav ua kom muaj kev ywj pheej hauv EU kev ua lag luam, CE kos yuav tsum tau dhau los ua kom pom tias cov khoom lag luam ua raws li cov kev cai yooj yim ntawm tus qauv tshiab ntawm kev sib raug zoo thiab kev tsim qauv. Raws li cov cai ntawm PPE thiab MDD / MDR, cov khoom lag luam xa tawm mus rau EU yuav tsum muaj daim ntawv lo nrog CE cim.

(2) Txog Daim Ntawv Pov Thawj

Tso rau lub cim CE yog qib kawg ua ntej cov khoom lag luam nkag rau hauv kev ua lag luam, qhia tias txhua tus txheej txheem tau ua tiav. Raws li qhov yuav tsum tau ua ntawm PPE thiab MDD / MDR, cov khoom siv tiv thaiv tus kheej (xws li chav III tus kheej daim npog tiv thaiv) los yog cov khoom siv kho mob (xws li chav kawm I kev kho mob npog qhov ncauj) yuav tsum raug ntsuas los ntawm lub cev (NB) pom zoo los ntawm European Union. Cov. Cov cuab yeej siv kho mob CE daim ntawv pov thawj yuav tsum tau muab los ntawm lub cev ceeb toom, thiab daim ntawv pov thawj yuav tsum muaj tus naj npawb ntawm lub cev ceeb toom, uas yog, plaub tus lej cim.

3 ples Piv txwv ntawm cov tseev kom muaj rau cov tshuaj tiv thaiv kev kis mob

1. Cov qhov ncauj qhov ntswg tau muab faib ua qhov ncauj qhov ntswg kev kho mob thiab qhov ncauj qhov ntswg tiv thaiv tus kheej.

 

Raws li en14683, cov ntsej muag looj tau muab faib ua ob pawg: hom I thiab hom II / IIR. Daim npog Hom I tsuas yog tsim nyog rau cov neeg mob thiab lwm tus neeg txhawm rau txhawm rau txo kev kis mob thiab kis tus mob, tshwj xeeb yog kis mob sib kis lossis sib kis. Daim npog ntsej muag Hom II feem ntau yog siv los ntawm cov kws kho mob hauv chav ua haujlwm lossis lwm qhov chaw kho mob nrog cov kev xav tau zoo sib xws.

2. Cov ris tsho tiv thaiv: cov khaub ncaws tiv thaiv tau muab faib ua cov khaub ncaws tiv thaiv kev kho mob thiab cov khaub ncaws tiv thaiv tus kheej, thiab nws cov kev tswj hwm cov ntsiab lus zoo ib yam li cov ntsej muag npog. Cov txheej txheem European ntawm cov khaub ncaws tiv thaiv kev kho mob yog en14126.

(4) Xov xwm tshiab

EU 2017/745 (MDR) yog cov cai tshiab rau EU kev kho mob cov khoom siv. Raws li kev hloov kho tshiab ntawm 93/42 / EEC (MDD), txoj cai yuav pib ua haujlwm thiab yuav ua tiav tag nrho thaum Lub Tsib Hlis 26, 2020. Lub Peb Hlis 25, European Commission tau tshaj tawm cov lus pom zoo rau ncua kev siv MDR los ntawm ib xyoos, uas tau xa tawm thaum lub Plaub Hlis Ntuj rau kev pom zoo los ntawm European Parliament thiab Council ua ntej lub Tsib Hlis tas. Ob lub MDD thiab MDR qhia meej qhov ua haujlwm ntawm cov khoom kom ntseeg tau tias muaj kev noj qab haus huv thiab kev nyab xeeb rau cov neeg siv.


Lub sij hawm tshaj tawm: Lub Ib Hlis-18-2021