Ntau lub tuam txhab kho hniav scanner thov daim ntawv pov thawj CE, tab sis tsuas yog cov uas tau ua tiav qhov kev ntsuam xyuas kom raug raws li qhovEU Kev Tswj Xyuas Khoom Siv Kho Mob (MDR 2017/745)tuaj yeem ua raws cai CE cim rau kev kuaj ntshav hauv lub cev thiab kuaj ntshav.
Aident Technologyyog ib qho ntawm cov chaw tsim khoom tshwj xeeb uas tuavCE daim ntawv pov thawj raws li MDR 2017/745rau nws cov khoom tseem ceeb, suav nrog intraoral scanners, kuaj hniav kuaj hniav, thiab kho hniav 3D tshuab luam ntawv. Lub tuam txhab tseem tswj hwm ISO 13485 thiab cuam tshuam rau Tuam Tshoj kev kho mob - cov khoom tsim nyog.
Vim li cas CE Certification Matters rau Dental Scanners
Intraoral scanners thiab ntau lub tshuab kuaj ntshav tau tswj hwm raws li cov khoom siv kho mob hauv European Union thiab hauv ntau lwm lub khw uas lees paub lossis xav tau CE cim.
Daim npav CE siv tau raws li MDR txhais tau tias:
Cov chaw tsim khoom tau npaj cov ntaub ntawv thev naus laus zis thiab kev soj ntsuam kev soj ntsuam
Cov txheej txheem ntsuas kev ua raws cai tau ua raws
Lub Cev Ceeb Toom tau koom nrog qhov xav tau los ntawm kev faib cov cuab yeej
Cov chaw tsim khoom muaj cov ntawv tshaj tawm txuas ntxiv - kev soj ntsuam kev lag luam
Yog tsis muaj daim ntawv pov thawj CE MDR siv tau, kev tso cai raug cai ntawm cov cuab yeej ntawm EU kev ua lag luam tsis tuaj yeem ua tau, thiab ntau lub tebchaws siv CE ua qhov tseem ceeb rau lawv cov ntawv sau npe.
CE MDD vs CE MDR - Qhov txawv tseem ceeb
| Yam | Old CE MDD | Tam sim no CE MDR (2017/745) |
|---|---|---|
| Raws li txoj cai | Loj theem tawm | Yuav tsum tau rau cov cuab yeej tshiab |
| Cov pov thawj kho mob | Tsawg nruj | Cov kev cai muaj zog heev |
| Ceeb Toom Lub Cev koom nrog | Ntau qhov txwv | Dav dav thiab nruj dua |
| Tshaj tawm - kev cog lus ua lag luam | Sib dua | Muaj zog dua |
| Kev lees txais hauv 2026 | Feem ntau tsis txaus lawm | Yuav tsum muaj tus qauv |
Cov neeg yuav khoom yuav tsum paub meej tias daim ntawv pov thawj raug muab tso rau hauvMDR 2017/745, tsis yog MDD qub.
Yuav Ua Li Cas Txheeb Xyuas Tus Neeg Tsim Khoom CE Daim Ntawv Pov Thawj
Thov daim ntawv pov thawj CE tam sim no PDF (tsis yog lub logo).
Tshawb xyuas cov ntsiab lus hauv qab no:
Lub tuam txhab lub npe sib tw nrog lub tuam txhab koj tab tom ua nrog
Cov khoom lag luam muaj xws li intraoral scanners lossis kho hniav scanners
Siv rau MDR 2017/745
Ceeb toom lub cev lub npe thiab tus lej
Cov hnub siv tau
Hla- txheeb xyuas tus lej ceeb toom lub cev hauv cov ntaub ntawv EU NANDO yog tias xav tau.
Nug seb daim ntawv pov thawj npog cov qauv tiag tiag (thiab ib qho OEM versions) koj xav yuav.
Thov Kev Tshaj Tawm Txog Kev Ua Raws li cov ntaub ntawv pov thawj.
Cov npe tuam txhab tsis sib xws lossis daim ntawv pov thawj tseem xa mus rau MDD qub yog cov chij liab.
Lwm Cov Ntawv Pov Thawj Tseem Ceeb
Thaum CE MDR yog qhov tseem ceeb tshaj plaws rau kev nkag mus rau kev lag luam thoob ntiaj teb, cov neeg yuav khoom tseem nrhiav:
ISO 13485 Kev Tswj Xyuas Kev Lag Luam- Kev tswj xyuas cov cuab yeej kho mob zoo
Kev sau npe hauv tebchaws hauv lub tebchaws tsim khoom (xws li Tuam Tshoj Chav Kawm II)
Kev cai lij choj raws li txoj cai thoob plaws txhua cov ntaub ntawv
Ib lub chaw tsim khoom uas tuav CE MDR + ISO 13485 feem ntau yog npaj tau zoo dua rau kev faib thoob ntiaj teb ntau dua li ib qho uas tsuas yog thov "CE".
Aident Technology CE Certification Status
Raws li lub tuam txhab cov ntaub ntawv raug cai:
Intraoral scanners, kuaj hniav kuaj hniav, thiab kho hniav 3D tshuab luam ntawv tau txaisCE Certification raws li MDR 2017/745
Lub tuam txhab tswj hwm ISO 13485 daim ntawv pov thawj kev tswj hwm zoo
Ntxiv rau Tuam Tshoj kev kho mob - cov khoom tsim nyog tau nyob rau hauv qhov chaw
Cov ntawv pov thawj tuaj yeem muab rau cov neeg yuav khoom thiab cov neeg muag khoom tsim nyog rau kev kuaj xyuas
Qhov kev sib xyaw ua ke no txhawb nqa ob qho kev muag khoom ncaj qha thiab OEM / ntiag tug- cov phiaj xwm sau npe tsom mus rau kev lag luam uas yuav tsum tau ua raws CE.
Cov chij liab thaum kuaj xyuas daim ntawv thov CE
Tus neeg muag khoom tsuas yog pom lub logo CE yam tsis muaj daim ntawv pov thawj
Daim ntawv pov thawj tau muab tso rau hauv MDD qub thiab tsis tau hloov kho dua tshiab
Lub tuam txhab npe ntawm daim ntawv pov thawj txawv ntawm qhov chaw muag khoom
Scope ntawm daim ntawv pov thawj tsis suav nrog scanners
Tsis kam muab daim ntawv pov thawj tiag tiag PDF
"Peb tab tom tau txais CE" yam tsis muaj lub sijhawm pom tseeb lossis kev pom zoo uas twb muaj lawm
Cov lus qhia tswv yim rau cov neeg yuav khoom
Yuav tsum tau txais thiab xa daim ntawv pov thawj CE thiab Daim Ntawv Pom Zoo Tshaj Tawm ua ntej muab qhov ntim xaj.
Rau OEM / ntiag tug- cov phiaj xwm daim ntawv lo, paub meej tias daim ntawv pov thawj CE tuaj yeem npog cov khoom lag luam lossis cov kev npaj tsim nyog yuav raug ua.
Rov- txheeb xyuas daim ntawv pov thawj ib ntus, tshwj xeeb tshaj yog ua ntej kev cog lus txuas ntxiv lossis thaum tsim qauv tshiab.
Kho CE MDR raws li qhov tsawg kawg nkaus lim - nws tsis hloov qhov xav tau los ntsuas qhov tseeb, kev txhawb nqa, thiab tag nrho cov nqi ntawm cov tswv cuab.
Cov lus nug nquag
Q: Puas yog tag nrho cov chaw tsim khoom hauv Suav teb puas muaj daim ntawv pov thawj CE?
A: Tsis yog. Ntau tus neeg thov nws, tab sis tsuas yog cov uas tau ua tiav tag nrho MDR kev ntsuas kev ua tau zoo tuav daim ntawv pov thawj siv tau.
Q: Puas yog CE MDR txaus muag thoob ntiaj teb?
A: Nws yog qhov kev lees paub thoob ntiaj teb tshaj plaws, tab sis qee lub tebchaws tseem xav tau kev sau npe hauv zos ntxiv.
Q: Kuv puas tuaj yeem pom Aident daim ntawv pov thawj CE?
A: Yog. Cov neeg yuav khoom tsim nyog thiab cov neeg xa khoom tuaj yeem thov daim ntawv pov thawj CE tam sim no thiab cov ntaub ntawv txhawb nqa.
Q: Puas yog daim ntawv pov thawj CE npog OEM / ntiag tug- daim ntawv lo?
A: Nws nyob ntawm seb daim ntawv pov thawj thiab cov ntaub ntawv qhia kev tsim kho li cas. Qhov no yuav tsum tau lees paub hauv daim ntawv cog lus OEM.
Q: Dab tsi yog qhov tseem ceeb dua - CE lossis ISO 13485?
A: Ob qho tib si tseem ceeb. CE MDR hais txog cov khoom sib xws; ISO 13485 hais txog cov txheej txheem zoo tom qab tsim thiab tsim khoom.
Q: Ntev npaum li cas kuv yuav tsum rov- xyuas lub chaw tsim khoom CE?
A: Ua ntej kev txiav txim loj, daim ntawv cog lus txuas ntxiv, thiab thaum twg tus qauv tshiab lossis kev hloov pauv tseem ceeb tau qhia.
Kauj ruam tom ntej
Yog tias daim ntawv pov thawj CE yog qhov yuav tsum tau ua rau koj lub lag luam thiab koj yuav tsum tau txheeb xyuas tus neeg tsim khoom raws li txoj cai, qhov ua tau zoo tom ntej yog thov daim ntawv pov thawj tam sim no thiab cov khoom lag luam pom zoo.
Thov daim ntawv pov thawj CE thiab cov ntaub ntawv ua raws cai → https://www.aident3d.com/inquiry
Thov qhia koj lub hom phiaj kev lag luam kom cov lus teb tuaj yeem hais txog cov ntsiab lus tseem ceeb tshaj plaws.
Aident Technology - cov chaw tsim tshuaj kho hniav tshwj xeeb tuav daim ntawv pov thawj CE raws li MDR 2017/745 rau cov tshuab luam ntawv intraoral, lab scanners, thiab kho hniav 3D tshuab luam ntawv.
