"Peb ua tiav luam ntawv - Vim li cas kev pom zoo tseem muaj teeb meem?"
"Peb tau ua tiav cov qauv tsim, luam tawm cov khoom, thiab cov khoom siv kho mob - qib ... yog li kev pom zoo yuav tsum ncaj nraim, txoj cai?"
Qhov no yog ib qho kev nkag siab tsis zoo tshaj plaws uas peb tau hnov los ntawm cov neeg siv khoom ua haujlwm nrog Hlau 3D Printing lossis thaum ntxov -theem Hlau Rapid Prototyping Technology.
Vim tias los ntawm tus neeg yuav khoom qhov kev xav, thaum muaj qhov tshwm sim, kev ua haujlwm nyuaj zoo li ua tiav.
Tab sis ntawm no yog qhov tseeb:
Kev tswj hwm kev pom zoo tsis yog raws li qhov koj luam tawm - nws yog nyob ntawm seb koj ua li cas, suav nrog kev tshaj tawm - ua haujlwm.
Thiab yog - ncej- kev ua haujlwm tuaj yeem cuam tshuam kiag li seb koj lub cuab yeej puas tau txais kev pom zoo lossis tsis lees paub.
Yog tias koj ua haujlwm nrog3D Printing Hlau Prototypinglos yog npaj ntau lawm, kab lus no yuav pab tau koj:
Nkag siab li cas kev tshaj tawm - kev ua haujlwm cuam tshuam rau kev pom zoo
Tsis txhob them nqi xa ntawv tsis ua tiav
Npaj cov ntaub ntawv zoo txij thaum pib
Cia peb tawg nws kom meej, zoo li peb xav hauv qhov kev sib tham tiag tiag.
Yog vim li cas Post-Kev ua haujlwm yog ib feem ntawm kev pom zoo (Tsis yog Kev Tsim Khoom)
Raws li US Food and Drug Administration, cov khoom siv kho mob raug soj ntsuam raws li kev nyab xeeb thiab kev ua tau zoo, thiab suav nrog tag nrho cov txheej txheem tsim khoom, tsis yog cov duab kawg nkaus xwb.
Dab tsi regulators tau tshuaj xyuas:
Tsim
Khoom siv
Cov txheej txheem tsim khoom
Tshaj tawm{0}} cov kauj ruam ua tiav
Cov qhabnias xeem
Qhov ntawd txhais tau tias:
Ncej - kev ua haujlwm tsis yog kev xaiv tom qab ua haujlwm - nws yog ib feem ntawm qhov tau tshuaj xyuas thaum lub sijhawm:
510 (k) cov ntaub ntawv
PMA (Kev pom zoo ua ntej muag khoom)
Cov ntaub ntawv technical
Post-Kev Ua Haujlwm Ncaj Ncees cuam tshuam li cas rau kev pom zoo
Cia peb xyaum.
1. Nws txiav txim seb lub cuab yeej puas ua tau raws li qhov yuav tsum tau muaj kev nyab xeeb
Tom qabHlau 3D Printing, qhov chaw tsis tiav.
Lawv tuaj yeem muaj:
Cov hmoov seem
Nto roughness
Kev ntxhov siab sab hauv
Raws li FDA cov txheej txheem qhia, kev tshaj tawm - kev ua haujlwm yuav suav nrog:
Ntxuav
Polishing
Kev kho cua sov
Sterilization
Vim li cas qhov no tseem ceeb:
Yog tias cov kauj ruam no tsis raug tswj kom raug:
Lub cuab yeej yuav ua tsis tiav kev kuaj kev nyab xeeb
Qhov kev xa tuaj yuav raug tsis lees paub
Cov neeg tswj hwm tsis pom zoo cov ntawv luam tawm nyoos - lawv pom zoo cov cuab yeej ua tiav.
2. Nws cuam tshuam rau kev ua tau zoo cov ntaub ntawv xa mus rau kev pom zoo
Thaum koj xa ib lub cuab yeej rau kev pom zoo, koj yuav tsum muab:
Mechanical kuaj
Nto zoo tau
Functional validation
Nov yog lub ntsiab lus tseem ceeb:
Tag nrho cov txiaj ntsig no yog ua raws li cov ntawv tshaj tawm - ua tiav, tsis yog qhov luam tawm.
Piv txwv:
Kev kho cua sov hloov lub zog
Nto finishing cuam tshuam lub neej qaug zog
Kev ntxuav muaj feem xyuam rau biocompatibility
Yog tias koj cov ntawv tshaj tawm - hloov pauv, koj cov ntaub ntawv xeem yuav siv tsis tau lawm.
3. Nws yuav tsum muaj tseeb thiab rov ua dua
FDA kev taw qhia kom meej meej qhia txog cov txheej txheem validation - lub ntsiab lus:
Koj yuav tsum ua pov thawj tias koj cov txheej txheem tsim khoom tsis tu ncua tsim cov khoom siv tau.
Qhov ntawd suav nrog:
Txhais cov ncej- cov kauj ruam ua tiav
Tsau tsis tau
Tswj kev ua haujlwm
Vim li cas qhov no tseem ceeb:
Yog tias koj qhov kev tshaj tawm - kev ua haujlwm tsis sib xws:
Ib batch hla
Lwm batch ua tsis tau
Qhov no tuaj yeem ua rau:
Kev pom zoo qeeb
Cov kev cai xeem ntxiv
Re- cov nqi xa ntawv
Ncej -Kev Ua Haujlwm vs Prototyping: Qhov twg ntau qhov project mus yuam kev
Thaum ua haujlwm nrogHlau Rapid Prototyping Technology, tej yam xav sai.
Hauv prototyping:
Tshaj tawm tsawg kawg - ua tiav
Tsom ntsoov rau kev tsim validation
Cov ntaub ntawv txwv
Nyob rau hauv txoj cai pom zoo:
Daim ntawv tshaj tawm tag nrho - yuav tsum tau ua tiav
Cov ntaub ntawv ntxaws ntxaws xav tau
Validation yuav tsum tau
Qhov no yog qhov uas ntau lub tuam txhab khiav mus rau qhov teeb meem.
Lawv xav tias:
"Yog tias tus qauv ua haujlwm, kev tsim khoom yuav dhau mus."
Tab sis cov kws tswj xyuas ntsuas cov xwm txheej tsim khoom kawg, tsis yog cov qauv luv luv.
Ntsiab Lus Tshaj Tawm -Cov kauj ruam ua kom cuam tshuam kev pom zoo
Yog tias koj ua haujlwm nrog lub tuam txhab hlau 3D luam ntawv, cov kauj ruam no yog qhov tseem ceeb rau kev tshuaj xyuas:
1. Kev Tswj Xyuas Kev Tiv Thaiv Kab Mob thiab Kev Tiv Thaiv
Tshem tawm cov hmoov seem thiab tshuaj lom neeg
Qhov tseem ceeb rau biocompatibility
2. Kev kho cua sov / kev ntxhov siab
Stabilizes cov khoom siv
Xyuas kom muaj kev ua haujlwm zoo
3. Nto tiav
Tswj roughness
Txhim kho kev nyab xeeb thiab kav ntev
4. Sterilization Compatibility
Yuav tsum tsis txhob degrade cov khoom
Yuav tsum tau validated
5. Kev tshuaj xyuas & cov ntaub ntawv
Sau txhua kauj ruam
Ua pov thawj ua raws
Cov kauj ruam uas ploj lawm lossis tswj tsis tau zoo tuaj yeem cuam tshuam ncaj qha rau kev pom zoo.
Cov ntaub ntawv tiag tiag: Yuav Ua Li Cas Tshaj Tawm - Kev Ua Haujlwm Ncua Kev Pom Zoo
Ib tus neeg siv khoom tuaj rau Sunhingstones tom qab ua tsis tiav.
Dab tsi tshwm sim:
Tsim: yog
Khoom siv: pom zoo
Printing: ruaj khov
Qhov teeb meem:
Tshaj tawm - kev ua haujlwm tsis yog qauv
Cov txheej txheem ntxuav tsis tau sau tseg
Nto finishing inconsistent
Qhov tshwm sim:
Txoj cai tswjfwm tau thov cov ntaub ntawv ntxiv
Kev xa ntawv ncua los ntawm ob peb lub hlis
Peb ua dab tsi:
Txhais tag nrho cov ncej- ua haujlwm ua haujlwm
Standardized txhua kauj ruam
Tsim cov ntaub ntawv traceable
Qhov kawg tshwm sim:
Dhau validation
Pom zoo tom qab xa rov qab
Client zam kev ncua ntxiv
Sunhingstones kuj tau hais nyob rau hauv ESTA-Txoj kev sib tham txog kev tswj xyuas qhov zoo ib yam ntawm cov hlau 3D luam ntawv lub Hoobkas, tshwj xeeb tshaj yog cov uas xav tau kev pom zoo los ntawm kev tswj hwm.
Feem ntau yuam kev uas ua rau kev pom zoo tsis ua tiav
Cia peb ua siab ncaj - cov no tshwm sim ntau heev:
"Post-kev ua haujlwm tsuas yog ua tiav"
Nws yog ib feem ntawm kev ntsuam xyuas kev tswj hwm
"Peb tuaj yeem ua tiav cov txheej txheem tom qab"
Cov txheej txheem yuav tsum tau txhais ua ntej xa
"Prototype data yog txaus"
Cov xwm txheej tsim khoom yuav tsum sib phim
"Txhua tus neeg muag khoom tuaj yeem tuav nws"
Kev paub kho mob tseem ceeb heev
Yuav Ua Li Cas Kom Paub Tshaj Tawm -Kev Pab Txhawb Kev Pom Zoo
Yog tias koj tab tom nrhiav Metal 3D Printing, ntawm no yog qhov koj yuav tsum ua:
1. Txhais cov txheej txheem tag nrho thaum ntxov
Ua ntej kuaj los yog xa
2. Xaiv ib tus neeg tsim khoom uas muaj kev paub dhau los
Ib tug txhim khu kev qha hlau 3D luam ntawv chaw tsim tshuaj paus yuav tsum:
Nkag siab txog kev cai lij choj
Muab cov kev ua haujlwm kom meej
3. Siv tau txhua kauj ruam
Ntxuav
Kev kho cua sov
Ua tiav
4. Sau txhua yam
Txheej txheem tsis
Kev tshuaj ntsuam xyuas
Batch traceability
5. Khaws Prototyping thiab Production Aligned
Zam kev hloov pauv loj tom qab
FAQ
Cov ntawv tshaj tawm -kev ua haujlwm puas cuam tshuam rau kev pom zoo rau cov cuab yeej kho mob?
Tau - nws yog ib feem ntawm cov txheej txheem tsim khoom tau tshuaj xyuas thaum pom zoo.
Cov cuab yeej puas tuaj yeem tsis pom zoo vim yog xa tawm - ua tiav?
Yog - tshwj xeeb tshaj yog tias cov txheej txheem tsis sib xws lossis tsis raug cai.
Kuv puas xav tau cov ntaub ntawv tshaj tawm - cov kauj ruam ua tiav?
Yog lawm - cov ntaub ntawv yuav tsum muaj rau kev tswj hwm kev xa tawm.
Puas yog prototyping txaus rau kev pom zoo?
Tsis muaj - cov txheej txheem tsim khoom yuav tsum raug lees paub cais.
Dab tsi yog qhov txaus ntshai tshaj plaws hauv kev tshaj tawm - ua tiav?
Kev tsis sib haum xeeb thiab tsis muaj kev tswj xyuas cov txheej txheem.
Kuv yuav ua li cas kom tsis txhob ncua kev pom zoo?
Ua haujlwm nrog cov neeg muag khoom paub txog thiab txheeb xyuas cov txheej txheem ntxov.
Kev xav zaum kawg - Kev pom zoo nyob ntawm tag nrho cov txheej txheem
Yog tias muaj ib yam uas yuav tsum nco ntsoov, nws yog qhov no:
Hauv Hlau 3D Printing, cov tswj hwm tsis pom zoo rau koj tus qauv tsim - lawv pom zoo rau koj cov txheej txheem.
Thiab kev tshaj tawm - kev ua haujlwm yog ib feem tseem ceeb ntawm cov txheej txheem ntawd.
Nkag siab qhov no thaum ntxov pab koj:
Zam kev ncua
Txo cov nqi
Ua lag luam sai dua
Tham nrog peb ua ntej koj xa
Yog tias koj tab tom npaj cov cuab yeej siv kho mob, tsis txhob tos kom txog thaum xa mus los xav txog kev tshaj tawm - ua tiav.
Xa koj cov duab kos thiab cov ntaub ntawv thov rau peb.
Peb yuav pab koj:
Txhais kev ua haujlwm raws txoj cai
Teem prototyping nrog ntau lawm
Npaj kom muaj kev pom zoo raws li txoj cai
Tsis muaj kwv yees. Tsis muaj rework. Tsuas yog txoj hauv kev kom pom zoo.
Cov ntaub ntawv
FDA - 3D Printing Medical Devices Txheej txheem cej luam
FDA - Cov txheej txheem ntawm 3D Printed Medical Devices
FDA - Lub luag haujlwm hauv 3D Printing Regulation
FDA - Kev txiav txim siab rau kev tsim khoom ntxiv
Kev lag luam tshaj tawm txog kev tsim khoom ntxiv validation thiab ua raws