"Qhov zoo li zoo - Vim li cas peb tseem xav tau kev lees paub?"
"Peb tau luam ib feem, ua tiav qhov chaw, thiab txhua yam zoo li zoo tag nrho. Vim li cas koj qhia peb tias peb tseem xav tau kev lees paub?"
Yog tias koj ua haujlwm nrog Hlau 3D Printing, tshwj xeeb tshaj yog rau cov ntawv kho mob zoo li Titanium DMLS 3D Printing Bracket, cov lus nug no tuaj txog txhua lub sijhawm.
Los ntawm kev xav ntawm kev lag luam, nws nkag siab:
Ib feem yog tiav
Qhov ntev yog qhov tseeb
Cov khoom tsim nyog
Yog li vim li cas mus ntxiv?
Nov yog qhov tseeb - thiab nws tseem ceeb heev:
Hauv kev lag luam kho mob, ib feem tsuas yog suav tias yog kev ntseeg siab yog tias tag nrho cov txheej txheem - suav nrog kev tshaj tawm -kev ua haujlwm - raug siv tau.
Tsis yog sim ib zaug xwb. Tsis yog tshuaj xyuas xwb.
Ua pov thawj tias ua haujlwm tsis tu ncua, txhua lub sijhawm.
Cia peb rhuav qhov no ua lus Askiv, uas koj yuav piav qhia rau tus neeg siv khoom lossis tus thawj tswj hwm qhov project.
Qhov "Validation" tiag tiag txhais tau li cas (Piv txwv yooj yim)
Kev lees paub tsis yog kev sim xwb.
Kev lees paub=ua pov thawj koj cov txheej txheem tsis tu ncua ua rau muaj kev nyab xeeb thiab muaj txiaj ntsig zoo.
Raws li US Food and Drug Administration cov lus qhia:
Thaum qee yam khoom yam ntxwv tsis tuaj yeem txheeb xyuas tag nrho los ntawm kev tshuaj ntsuam xyuas, cov tuam txhab tsim khoom yuav tsum siv cov txheej txheem hloov
Vim li cas qhov no tseem ceeb:
Qee qhov tseem ceeb ntawm Additive Hlau 3D Printing qhov chaw tsis tuaj yeem kuaj xyuas ntawm txhua chav, xws li:
Kev ntxhov siab sab hauv
Nthuav lub neej
Ntev -lub sij hawm durability
Yog vim li cas thiaj li yuav tsum muaj kev lees paub - vim tias kev tshuaj xyuas ib leeg tsis txaus.
Yog vim li cas Post-Kev ua tiav qhov tseeb yog qhov tseem ceeb hauv Kev Kho Mob 3D Printing
1. Tshaj tawm -Kev Ua Haujlwm ncaj qha txhais cov khoom kawg
Tom qab Hlau 3D Printing, qhov tsis tiav.
Nws tseem xav tau:
Kev kho cua sov
Nto xov
Ntxuav
Sterilization
Raws li FDA cov txheej txheem txheej txheem:
Tshaj tawm - cov kauj ruam ua haujlwm xws li ntxuav, polishing, thiab ua kom tsis muaj menyuam yog ib feem ntawm kev tsim khoom ua haujlwm thiab cuam tshuam rau qhov kawg ntawm cov cuab yeej zoo
Qhov ntawd txhais li cas hauv kev muaj tiag:
Titanium DMLS 3D Printing Bracket ua ntej thiab tom qab kev tshaj tawm -kev ua haujlwm tuaj yeem muaj:
Sib txawv zog
Txawv deg cwj pwm
Txawv kev ruaj ntseg profile
Yog li yog tias kev tshaj tawm - kev ua haujlwm tsis raug lees paub, koj cov khoom kawg tsis tuaj yeem kwv yees.
2. Koj tsis tuaj yeem kuaj txhua ntu yam tsis muaj kev puas tsuaj
Nov yog qhov kev sib tw tseem ceeb.
Koj tuaj yeem tshawb xyuas:
Qhov ntev
Nto roughness
Tab sis koj tsis tuaj yeem sim txhua ntu rau:
Kev ua haujlwm qaug zog
Sab hauv microstructure
Ntev - lub sij hawm ruaj khov
FDA hais meej meej:
Thaum kev ntsuam xyuas yog kev puas tsuaj lossis ua tsis tau zoo, cov txheej txheem yuav tsum muaj kev lees paub
Qhov ntawd yog qhov tseeb rau feem ntau SLM / DMLS hlau qhov chaw.
3. Additive Manufacturing muaj ntau qhov sib txawv
Piv nrog rau kev siv ib txwm siv, Additive Hlau 3D Printing qhia:
Txheej -los ntawm - txheej variation
Qhov sib txawv ntawm thermal stress
Microstructure inconsistency
Kev tshawb fawb FDA pom zoo tias:
Tseem muaj qhov tsis paub meej thiab qhov sib txawv hauv cov txheej txheem tsim khoom ntxiv, ua qhov kev lees paub tseem ceeb rau kev nyab xeeb thiab kev ua haujlwm.
Hauv cov ntsiab lus yooj yim:
Ntau qhov sib txawv=xav tau kev lees paub ntxiv.
4. Kev tso cai pom zoo nyob ntawm cov txheej txheem uas tau lees paub
Cov cuab yeej kho mob tsis pom zoo raws li qhov pom.
Lawv raug pom zoo raws li:
Kev nyab xeeb
Kev ua tau zoo
Tswj txheej txheem
FDA ntsuam xyuas:
Tsim
Khoom siv
Cov txheej txheem tsim khoom (nrog rau kev tshaj tawm -kev ua haujlwm)
Tsis muaj kev lees paub=tsis muaj pov thawj ntawm qhov sib xws=kev pheej hmoo ntawm kev tsis lees paub.
Yog vim li cas Post-Kev ua tiav qhov kev lees paub tseem ceeb dua li kev lees paub luam ntawv
Cov neeg yuav khoom feem ntau tsom rau cov txheej txheem luam ntawv.
Tab sis ntawm no yog qhov tseeb:
Post{0}}kev ua tiav yog qhov ua tiav qhov kawg tau tsim.
Piv txwv:
Kauj ruam luam ntawv:
Txhais cov duab
Tshaj tawm - kev ua haujlwm:
Txhais lub zog
Txhais kev nyab xeeb ntawm qhov chaw
Txhais durability
Yog li txawm tias kev luam ntawv zoo tag nrho, cov ntawv tshaj tawm tsis zoo - kev ua tiav kev lees paub tseem tuaj yeem ua tsis tiav.
Dab tsi yuav tsum tau ua kom muaj tseeb hauv Post-Kev Ua Haujlwm?
Yog tias koj ua haujlwm nrog lub tuam txhab hlau 3D luam ntawv, cov kauj ruam no feem ntau yuav tsum muaj kev lees paub:
1. Kev kho cua sov (Stress Relief / HIP)
Tswj kev ntxhov siab sab hauv
cuam tshuam rau kev siv tshuab
2. Nto tiav
cuam tshuam lub neej qaug zog
cuam tshuam biocompatibility
3. Cov txheej txheem ntxuav
tshem cov hmoov thiab cov kab mob
tseem ceeb rau kev nyab xeeb
4. Sterilization Compatibility
yuav tsum tsis txhob degrade cov khoom
yuav tsum rov ua dua
5. Machining / kawg ua tiav
cuam tshuam qhov tseeb qhov tseeb
cuam tshuam kev sib dhos
Txhua kauj ruam yuav tsum yog:
txhais
tswj
rov ua tau
ntaub ntawv
Cov Ntaub Ntawv Tiag: Yog vim li cas qhov kev lees paub dhau los ua qhov hloov pauv
Ib tus neeg siv khoom tau mus cuag Sunhingstones nrog rau txoj haujlwm kho mob titanium.
Qhov xwm txheej:
Siv Hlau 3D Printing
Tsim validated
Prototype ua tiav
Teeb meem:
Tshaj tawm - kev ua haujlwm tsis raug cai
Kev kho cua sov sib txawv ntawm cov khoom siv
Nto finishing inconsistent
Qhov tshwm sim:
Cov txiaj ntsig kuaj tsis sib xws
Kev cai xa ntawv qeeb
Peb ua dab tsi:
Txhais tag nrho cov ntawv tshaj tawm -processing validation protocol
standardized tsis
tsim cov ntaub ntawv traceable
Qhov tshwm sim:
Kev ua haujlwm ruaj khov ntawm cov khoom siv
Ua tiav rov- kev sim
Txoj kev pom zoo du
Sunhingstones kuj tau hais nyob rau hauv ESTA-Txoj kev sib tham txog kev lag luam rau kev tswj xyuas kev siv tau zoo hauv cov hlau 3D luam ntawv lub Hoobkas ua haujlwm - tshwj xeeb tshaj yog rau kev siv kho mob.
Common Misunderstandings (Tus Nqi Them Sijhawm thiab Nyiaj)
Cia peb tshem cov no:
"Yog tias nws dhau kev tshuaj xyuas, nws zoo"
Kev tshuaj xyuas ≠ validation
"Validation tsuas yog rau luam ntawv xwb"
Post{0}} kev ua tiav yog qhov tseem ceeb sib npaug
"Peb tuaj yeem lees paub tom qab"
Kev lees paub yuav tsum ua raws li kev tsim khoom
"Txoj kev vam meej txhais tau tias kev ua tiav ntau lawm"
Kev tsim khoom yuav tsum muaj kev lees paub nruj dua
Yuav ua li cas yog tias koj hla Post -Ua tiav qhov tseeb?
Cia peb ua siab ncaj - ntawm no yog qhov feem ntau tshwm sim:
Kev cai ncua sij hawm
Yuav tsum tau kuaj ntxiv
Cov khoom tsis sib xws
Batch -rau -batch variation
Muaj kev pheej hmoo ua tsis tiav
Kev xav tsis zoo
Cov nqi siab dua
Rov ua dua
kev xa rov qab
Hla validation ib txwm raug nqi ntau dua tom qab.
Yuav Ua Li Cas Kom Ua Tau Zoo (Cov Lus Qhia)
Yog tias koj tab tom nrhiav Metal 3D Printing, ntawm no yog qhov koj yuav tsum ua:
1. Txhais tag nrho cov hauj lwm ua ntej
Ua ntej kuaj los yog xa
2. Xaiv ib tus neeg tsim khoom uas muaj kev paub dhau los
Nrhiav:
kev kho mob qhov project
validated txheej txheem
3. Txheem txhua kauj ruam
ruaj tsis
tswj cov cuab yeej
4. Sau txhua yam
cov ntaub ntawv txheej txheem
cov ntaub ntawv xeem
batch traceability
5. Ua qauv tsim thiab ntau lawm
Zam kev hloov pauv loj tom qab
FAQ
Vim li cas thiaj li yuav tsum muaj kev lees paub hauv kev kho mob 3D luam ntawv?
Vim tias tsis yog txhua yam khoom lag luam tuaj yeem raug txheeb xyuas los ntawm kev tshuaj xyuas, tshwj xeeb tshaj yog rau kev ua haujlwm sab hauv thiab ntev -.
Puas yog kev tshaj tawm -kev ua haujlwm yuav tsum muaj kev lees paub?
Yog - nws cuam tshuam ncaj qha rau cov khoom kawg kev nyab xeeb thiab kev ua haujlwm.
Yuav ua li cas yog tias kev tshaj tawm - kev ua haujlwm tsis raug cai?
Koj muaj kev pheej hmoo tsis sib haum xeeb thiab kev cai tsis lees paub.
Puas yuav tsum muaj kev lees paub rau titanium 3D luam tawm qhov chaw?
Tau - tshwj xeeb tshaj yog rau daim ntawv thov kev kho mob xws li kev cog qoob loo lossis cov khoom siv.
Kuv puas tuaj yeem tso siab rau kev sim qauv?
Tsis muaj - ntau lawm yuav tsum tau muaj cov txheej txheem validated nyob rau hauv tej yam kev mob tiag tiag.
Kuv yuav ua li cas thiaj lees paub kev tshaj tawm - ua tiav?
Los ntawm kev txhais, tswj, thiab sau ntawv txhua kauj ruam thiab ua pov thawj cov txiaj ntsig zoo ib yam.
Kev xav zaum kawg - Kev lees paub yog dab tsi ua rau nws "qib kho mob"
Yog tias muaj ib yam uas yuav tsum nco ntsoov, nws yog qhov no:
Hauv kev kho mob Hlau 3D Printing, qhov sib txawv ntawm "ib feem" thiab "khoom" yog qhov tseeb.
Tsis muaj validation:
koj tsis tuaj yeem ua pov thawj tsis sib xws
koj tsis tuaj yeem lav kev nyab xeeb
koj tsis tuaj yeem hla kev tshuaj xyuas
Pib Nrog Cov Txheej Txheem Ua Tau Zoo - Tsis yog ib feem luam tawm xwb
Yog tias koj tab tom tsim ib qhov project siv Additive Hlau 3D Printing los yog tsim ib Titanium DMLS 3D Printing Bracket, tsis txhob tso qhov kev lees paub raws li qhov kev xav tom qab.
Xa koj cov duab kos thiab cov ntaub ntawv thov rau peb.
Peb yuav pab koj:
txhais ib tug validated workflow
align prototyping nrog ntau lawm
txo qhov kev pom zoo
Tsis muaj kwv yees. Tsis muaj kev ncua. Tsuas yog cov txheej txheem koj tuaj yeem ntseeg tau.
Cov ntaub ntawv
FDA - Cov txheej txheem ntawm 3D Printing Medical Devices
FDA - Kev txiav txim siab rau cov khoom siv kho mob Additive Manufactured
FDA - Lub luag haujlwm ntawm 3D Printing hauv Kev Cai
FDA – Additive Manufacturing Research Program
Kev lag luam tshaj tawm txog kev tsim khoom ntxiv validation thiab variability