Cov European Union feem ntau siv Cov Khoom Siv Kho Mob CE Certification Regulation MDR 2017/745/EU kom lees paub cov hlau 3D- cov khoom siv kho mob luam tawm. Npog tag nrho cov ntsej muag los ntawm kev tsim cov khoom lag luam mus rau kev tsim khoom mus rau kev tshaj tawm - kev lag luam tawm, qhov kev tswj hwm no tswj hwm cov txheej txheem nruj ntawm qhov zoo, kev nyab xeeb, thiab kev ua tau zoo ntawm cov cuab yeej kho mob. FDA (Food and Drug Administration) tau tsim cov txheej txheem thiab cov txheej txheem los tswj cov ntawv pov thawj ntawm cov cuab yeej kho mob, suav nrog 21 CFR Part 820 (Kev Tswj Xyuas Kev Tswj Xyuas Zoo rau Cov Khoom Siv Kho Mob), 21 CFR Part 807 (Kev Sau Npe thiab Tshaj Tawm Txog Cov Khoom Siv Kho Mob), thiab lwm yam, hauv Tebchaws Meskas. Rau peb yam khoom siv kho mob-xws li kev kho mob orthopedic implants-Lub National Medical Products Administration (NMPA) tswj xyuas cov ntawv tso cai tsim khoom thiab cov khoom sau npe hauv Suav teb, yog li yuav tsum tau ua cov khoom siv los kuaj xyuas nruj thiab cov txheej txheem tso cai.
Cov khoom siv kho mob kho mob thiab cov khoom kho mob kho mob tuaj yeem sib cais raws li qhov zoo thiab kev siv ntawm cov khoom ua nrog hlau 3D luam ntawv. Cov neeg tsim khoom yuav tsum tsim cov khoom kho mob tshwj xeeb rau cov neeg mob tshwj xeeb, kho lawv raws li cov lus qhia kho mob. Cov khoom zoo li no tsis hu rau daim ntawv pov thawj los ntawm lub cev raug xaiv. Cov khoom siv kho mob Customized xav kom cov tuam txhab tsim khoom loj, sib sau ua ke, nruab, thiab debug lawv ua ntej siv, lossis lawv xav kom cov kws kho mob hloov kho lawv nyob ntawm qhov xav tau tshwj xeeb ua ntej siv. Piv txwv li, ua ntej siv, cov cuab yeej phais yuav tsum tau hloov kho rau cov neeg mob tshwj xeeb, yog li cov khoom siv no nyob ntawm kev koom tes ntawm cov ntawv pov thawj lub cev.
EN ISO 13485: 2016 (Raws li yuav tsum muaj rau Kev Tswj Lub Hom Phiaj ntawm Kev Tswj Xyuas Cov Khoom Siv Kho Mob Zoo) EN ISO 14971: 2019 (Cov cuab yeej kho mob - Cov cuab yeej kho mob nrog Kev Tswj Xyuas Kev Nyab Xeeb); TS EN ISO 10993: 1-20 (Kev ntsuas tshuaj lom neeg ntawm cov khoom siv kho mob); thiab lwm yam. Cov lus qhia no tswj cov hlau 3D luam tawm cov khoom kho mob hauv ntau lub spheres, suav nrog kev ntsuam xyuas kev lom neeg, kev tswj hwm kev pheej hmoo, thiab kev tswj xyuas kom zoo.
Kev txiav txim siab txog qhov yuav tsum tau muaj thiab lub hom phiaj: Txawm tias lawv cov khoom lag luam loj heev -tsim cov cuab yeej phais lossis cov khoom cog rau cov neeg mob tshwj xeeb, cov kws kho mob lossis cov chaw tsim khoom yuav tsum ua kom pom tseeb cov qauv thiab cov hom phiaj ntawm lawv cov khoom. Cov ntsiab lus no yuav pab txhawb kev ua haujlwm tom qab.
Kev sau cov ntaub ntawv 3D yog kev ntes cov neeg mob lub cev cov ntaub ntawv siv cov tshuab luam ntawv lossis cov cuab yeej kho mob, xws li X-ray scanning, CT, lossis kev kho mob ntawm cov khoom lom neeg tau txais los ntawm kev siv ultrasonic scan lossis magnetic resonance imaging. Tsim 3D qauv los ntawm cov ntaub ntawv no siv cov cuab yeej ua qauv kho mob. Cov ntaub ntawv tseem muab cov qauv 3D tam sim no uas koj tuaj yeem rub tawm thiab hloov kho raws li xav tau.
3D qauv tsim thiab txhim kho: Thaum koj muaj tus qauv 3D, siv cov kws tshaj lij 3D qauv cov cuab yeej los hloov thiab txhim kho nws, kho nws daim ntawv, tsim, thiab lwm yam kom tau raws li qhov xav tau kev kho mob. Tsis tas li ntawd, cov cuab yeej pabcuam ntxiv xws li lub qhov lossis cov cim tau muab tso ua ke los txhim kho cov khoom luam tawm zoo.
Cov khoom siv xaiv thiab luam ntawv thev naus laus zis: Xaiv cov txheej txheem 3D luam ntawv tsim nyog nyob ntawm cov khoom siv qhov xav tau-photopolymerisation, melt deposition, laser sintering, thiab lwm yam.Simultaneously xaiv cov ntaub ntawv hlau tsim nyog, suav nrog titanium alloys, stainless hlau, nickel-raws li alloys, thiab lwm yam. Ntau yam ntaub ntawv hlau yuav tsum muaj ntau yam zoo, thiab lwm yam. rau hauv cov khoom xws li tsim nyog lub zog, hnav tsis kam, thiab corrosion kuj.
Tshawb xyuas cov yam ntxwv thiab kev faib tawm ntawm cov cuab yeej hlau 3D luam ntawv. Tshawb xyuas cov yam ntxwv ntawm cov cuab yeej rau hlau 3D luam ntawv, paub meej txog ntau yam ntawm cov lus qhia uas lawv haum, thiab faib cov cuab yeej los ntawm kev soj ntsuam kev pheej hmoo.
Xaiv lub cev rau kev tshaj tawm thiab cov txheej txheem ntsuas kev ua raws. Xaiv cov txheej txheem ntsuam xyuas kev ua raws cai raws li hom khoom siv. Yog xav tau kev koom tes ntawm lub cev ceeb toom, xaiv qhov tsim nyog.
Txheeb xyuas cov txheej txheem tseem ceeb rau kev koom tes thiab cov kev xav tau. Xyuas kom tseeb tias cov khoom ua tau raws li cov txheej txheem kev sib koom ua ke thiab cov kev cai yooj yim.
Tsim cov ntaub ntawv thev naus laus zis: Tsim cov ntaub ntawv qhia ntxaws ntxaws suav nrog cov txheej txheem tsim khoom, cov khoom siv sib xyaw, kev tshuaj xyuas thiab kev ntsuas kev ua haujlwm, tsim cov khoom tsim thiab kev ua haujlwm, thiab lwm yam ntaub ntawv. Cov ntawv tshaj tawm kev tshaj tawm yuav tsum muaj cov lus piav qhia meej thiab tsis meej meej kom cov neeg ua pov thawj tuaj yeem ntsuas cov khoom muaj kev nyab xeeb thiab kev ua haujlwm.
Ua ib qho kev pheej hmoo soj ntsuam txog kev phom sij cuam tshuam nrog cov khoom lag luam ua nrog hlau 3D luam ntawv thiab tsim cov tswv yim tswj kev pheej hmoo tsim nyog.
Xa daim ntawv thov ua ntej -kev ua lag luam: Xaiv hom tsim nyog ua ntej- daim ntawv thov kev lag luam raws li cov khoom lag luam kev faib tawm thiab cov yam ntxwv, uas yuav suav nrog 510(k), PMA, HDE (kev zam kev siv cuab yeej cuab tam), lossis kev sib xyaw ua ke ntawm cov no. Daim ntawv thov tshwj xeeb yuav cia siab rau qhov tshwj xeeb ntawm cov khoom, qib ntawm kev pheej hmoo, thiab lub xeev ntawm kev ua lag luam rau cov khoom zoo li.
Kev tshuaj xyuas thiab kev soj ntsuam: Lub cev lees paub yuav dhau mus thiab ntsuas qhov hloov pauv - hauv kev ua ntej - daim ntawv thov kev lag luam. Lwm lub sijhawm - kev tshuaj xyuas cov ntaub ntawv, kev sim kuaj, kev sim tshuaj, thiab lwm yam - tuaj yeem yog ib feem ntawm cov txheej txheem tshuaj xyuas. Hais txog cov ntsiab lus ntawm cov ntaub ntawv thev naus laus zis, cov ntaub ntawv pov thawj kev ua haujlwm, cov txiaj ntsig ntawm kev sim tshuaj, thiab lwm yam, cov ntawv pov thawj tuaj yeem nug cov lus nug lossis xav tau cov ntaub ntawv ntxiv.
Pom zoo thiab muaj ntawv pov thawj: Cov khoom pov thawj yuav raug pom zoo rau kev muag khoom, thiab daim ntawv pov thawj sib txuam yuav raug muab yog tias cov ntawv pov thawj pom zoo rau cov khoom siv, txiav txim siab nws ua raws li cov txheej txheem ntawm cov cai thiab cov qauv. Hom ntawv thov ua ntej yuav txiav txim siab daim ntawv pov thawj tshwj xeeb-510(k), PMA, HDE, lossis lwm yam.
Cov neeg tsim khoom ntawm cov khoom lag luam uas tau ua tiav daim ntawv pov thawj CE yuav tsum tsim cov lus tshaj tawm ntawm kev sib haum xeeb thiab kos cov cim CE.
Cov ntawv sau npe nyob sab Europe raws li EU- pom zoo tus neeg sawv cev: Yog tias cov khoom tsim los muag hauv EU, EU- tus neeg sawv cev pom zoo yuav tsum muaj npe thiab sau npe hauv Tebchaws Europe.
Kev tsim khoom siv kho mob yuav tsum ua kom tiav cov txheej txheem rau daim ntawv pov thawj tsim los ntawm kev tswj xyuas qhov zoo, suav nrog thoob ntiaj teb ISO 13485 rau kev cog qoob loo. Tsim kom muaj kev tswj xyuas kom zoo yuav pab cov tuam txhab lag luam lav qhov traceability, manufacturing, lossis repeatability ntawm lawv cov khoom thiab lawv cov kev ua tau zoo. Txhawm rau lav kev ua raws li cov txheej txheem tsim nyog, cov koom haum hauv cheeb tsam yuav tshuaj xyuas cov txheej txheem kev tswj xyuas zoo hauv cov tuam txhab tsim khoom.
Kev xaiv cov khoom siv: Ib qho tseem ceeb ntawm cov hlau 3D luam ntawv cog lus yog cov khoom siv. Kev siv thib peb- tog hmoov cov ntaub ntawv yuav tsum tau hloov kho cov khoom ntws thiab ua rau muaj kev txhawj xeeb txog cov khoom sib xws. Kev siv cov khoom siv hmoov tuaj los ntawm cov chaw tsim khoom qub yuav ua rau cov khoom lag luam nce nqi. Cov neeg tsim khoom yuav tsum yog li muab cov nqi khoom siv thiab kev txhawj xeeb txog kev nyab xeeb tseem ceeb tshaj plaws txij li pib.
Kev xaiv cov khoom siv: Kev ua tiav cov khoom ruaj khov kev tsim khoom hnyav heev nyob ntawm qhov zoo thiab tsim nyog ntawm cov cuab yeej siv. Ib qho khoom siv yuav tsum tau mob siab rau tsim ib hom khoom siv rau kev tsim khoom siv kho mob. Tsis tsuas yog ib lub tshuab tsis tuaj yeem ua kom muaj kev nyab xeeb, tab sis nws kuj tsis tuaj yeem dhau daim ntawv pov thawj kho mob thaum siv rau ntau txoj haujlwm.
Cov txheej txheem zoo ib yam nyob ntawm tib neeg tsawg - lub sijhawm sib txuas ntawm lub tshuab thiab cov qauv kev ruaj ntseg siab. Los ntawm kev txhim kho lawv cov txheej txheem kev tsim khoom, ntau lub tsev kho mob tau ua tiav ntau qhov siab - theem kev cog qoob loo.
Cov txheej txheem tshuaj lom neeg, uas feem ntau siv 3-5 xyoos los sau cov ntaub ntawv lees paub txog biocompatibility ntawm cov cuab yeej kho mob, suav nrog cytotoxicity thiab genetic toxicity tests. Cov kev tshawb fawb soj ntsuam yuav tsum ua ntej lub sijhawm npaj los ntawm cov tuam txhab lag luam kom lav cov ntaub ntawv tiav thiab raug.
Ntau lub tebchaws thiab thaj chaw muaj kev hloov pauv tsis tu ncua; Cov neeg tsim khoom yuav tsum tau ua tib zoo saib xyuas cov kev hloov pauv hauv cov cai no, hloov kho lawv cov ntawv pov thawj sai sai, thiab xyuas kom meej tias lawv cov khoom ib txwm ua raws li cov txheej txheem kev cai.
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