Kev yuav cov ntsuas kub pheej yig yog ib qho yooj yim; importing raws li tus pas ntsuas kub yog qhov kev sib tw tiag tiag. Yog tias tsis muaj ntawv pov thawj zoo, koj cov khoom xa tuaj tuaj yeem tuav ntawm kev lis kev cai, tsis kam lees los ntawm cov khw muag khoom, lossis txawm tias rov qab los. Phau ntawv qhia no qhia koj raws nraim li cas tus neeg yuav khoom yuav tsum tau txheeb xyuas ua ntej them tus ntsuas kub lub Hoobkas.
CE Marking rau European Union
Cov ntsuas kub digital thiab infrared muag hauv EU yog cov cuab yeej kho mob thiab yuav tsum nqa CE cim raws li Kev Cai Kho Mob (EU) 2017/745 (MDR). Raws li txoj cai, cov ntsuas kub ntsuas hluav taws xob yooj yim poob rau hauv Chav Kawm Kuv tus kheej - ntawv pov thawj, tab sis tsis yog - tiv tauj cov ntsuas kub infrared feem ntau xav tau lub cev ceeb toom. Koj yuav tsum tau txais daim ntawv pov thawj CE, Daim Ntawv Tshaj Tawm Txog Kev Ua Raws Cai (DoC), thiab cov ntsiab lus ntawm EU Tso Cai Sawv Cev.
FDA Requirements rau Tebchaws Meskas
Rau Asmeskas kev ua lag luam, cov chaw tsim khoom yuav tsum tuav daim ntawv tso npe FDA tsim thiab sau cov cuab yeej. Cov ntsuas hluav taws xob hluav taws xob yuav tsum ua kom tau raws li cov qauv raug xws li ASTM E1112. Koj yuav tsum muaj peev xwm txheeb xyuas cov chaw tsim khoom sau npe hauv FDA database. Ib chav tsev uas tsis muaj daim ntawv pov thawj FDA yuav tsum tsis txhob xa mus rau Tebchaws Meskas.
Dab tsi "CE Certified" yuav tsum muaj tiag
Daim ntawv pov thawj logo ntawm cov khoom yees duab txhais tau tias tsis muaj dab tsi. Tus neeg muag khoom raws cai yuav tsum muab xa mus: daim ntawv pov thawj naj npawb, lub cev tawm, hnub tas sij hawm, cov qauv tshwj xeeb them, thiab daim ntawv ntsuam xyuas kom raug. Yog tias lawv tsis tuaj yeem muab cov no raws li kev thov, daim ntawv pov thawj yuav raug theej los yog tas sij hawm.
Yuav Ua Li Cas Txheeb Xyuas Daim Ntawv Pov Thawj Koj Tus Kheej
Tshawb xyuas cov ntaub ntawv tawm ntawm lub cev (tsis yog tus neeg muag khoom tus kheej cov ntaub ntawv). Rau CE, paub meej tias lub cev ceeb toom tau teev tseg yog tiag tiag thiab tseem ua haujlwm. Rau FDA, saib cov chaw tsim khoom hauv FDA cov ntaub ntawv sau npe. Siv sijhawm kaum feeb txheeb xyuas tam sim no, thiab koj tsis txhob muaj teeb meem kev lis kev cai tom qab lub lis piam.
Cov chij liab mus taug kev deb
- Tus neeg muag khoom hais tias "CE tau lees paub" tab sis tsis tuaj yeem muab tus lej pov thawj;
- Daim ntawv pov thawj npog cov khoom sib txawv lossis hnub tas sij hawm;
- Lawv hais kom koj muab koj lub hom phiaj tso rau hauv cov chav uas nws daim ntawv pov thawj tsis hloov tau;
- Tus nqi qis dua qhov nruab nrab ntawm kev ua lag luam rau ib chav muaj ntawv pov thawj.
Certified Thermometers los ntawm Trump Medical
Trump Medical khoom siv CE thiab FDA- ntawv pov thawj digital, infrared, basal, thiab cov ntsuas dej tsis zoo, tsim nyob rau hauv ISO 13485. Peb muab cov lej pov thawj, cov ntawv xeem, thiab cov ntaub ntawv koj tuaj yeem tshawb xyuas ua ntej koj xaj. Peb kuj lees paub tias daim ntawv pov thawj tuaj yeem txhawb nqa koj daim ntawv ntiag tug.
Xav tau tus pas ntsuas kub ua tau raws li daim ntawv pov thawj?Xauj peb qhov ntaulos yognug cov ntaub ntawv pov thawj.
