Kev Kho Mob Titanium Alloy Cov Khoom Xaiv Cov Ntawv Qhia: Tsis txhob muaj ntawv pov thawj txaus ntshai thiab tus nqi ruaj ntseg zoo dua

Ib qho cuab yeej ua raws li qhov ua tau raws li cov qauv tab sis kev tso npe raug tsis lees paub. Ib tug Suav orthopedic startup peb koom tes nrog tsim ib hom tshiab ntawm intervertebral fusion ntaus ntawv thiab xaiv siv aerospace-qib TC4 (GB/T 2965) los txo cov nqi. Txawm li cas los xij, thaum xa daim ntawv teev npe NMPA, lub chaw saib xyuas ncaj qha tsis lees txais nws: Cov qauv hauv aerospace tsis txwv cov kev pheej hmoo ntawm cov kab mob xws li hlau thiab oxygen hauv lub cev. Lub tuam txhab raug yuam kom yuav cov ntaub ntawv uas tau ntsib GB / T 13810 "Titanium thiab Titanium Alloy Processing Materials for Surgical Implants" thiab ua cov kev ntsuam xyuas lom neeg ntxiv. Qhov project tau ncua 8 lub hlis thiab ua rau poob ntxiv ntawm 400,000 yuan.Tuam Tshoj Super Tech Co., Ltd.tsuas yog muab kev kho mob - cov ntaub ntawv qib uas ua raws li ASTM F136, ISO 5832, thiab GB/T 13810 tus qauv. Txhua batch los nrog cov ntaub ntawv tiav (MTR) tau lees paub los ntawm ISO 13485, suav nrog cov tshuaj muaj pes tsawg leeg, cov khoom siv kho tshuab, UT daim duab tshuaj ntsuam, thiab cov nplej loj, txhawb nqa koj daim ntawv thov FDA / CE / NMPA.

Lub tuam txhab tau ua tiav cov qauv xa tawm tab sis ntsib teeb meem cuam tshuam txog kev xa khoom thaum lub sijhawm tsim khoom loj. Ib lub chaw tsim khoom siv hluav taws xob nyob sab Europe tau kos npe rau daim ntawv cog lus nrog tus neeg muag khoom qub raws li kev cog lus ntawm "4 lub lis piam xa khoom". Txawm li cas los xij, thaum lub sijhawm muag khoom siab tshaj plaws, lawv tau ntsib qhov tsis txaus ntawm daim txhuam cev titanium los ntawm tus neeg muag khoom ntws, uas txuas ntxiv lub sijhawm xa mus rau 14 lub lis piam. Cov kab ntau lawm tau raug kaw vim muaj cov khoom siv tsis txaus, ua rau poob ntawm cov ntawv cog lus txhua xyoo nrog ob lub tsev kho mob sab saum toj hauv lub teb chaws Yelemees. Tom qab ntawd, lawv tau koom tes nrog pebTuam Tshoj Super Tech Co., Ltd.thiab tsis tau ntsib tej teeb meem li ntawd txij thaum ntawd los. Cov neeg siv khoom tau hais tias nyob rau hauv kev lag luam khoom siv kho mob, kev ruaj ntseg ntawm cov saw hlau tseem ceeb tshaj qhov ua ob peb xees pheej yig dua ntawm tus nqi.

Qhov zoo ntawm qhov dub qhov twg tus nqi qis yuav ua rau cov khoom seem siab yog qhov zais tus nqi tua neeg tshaj plaws. Ib tus neeg siv khoom tau yuav ib pawg ntawm titanium rods los ntawm cov uas tsis yog - ntseeg siab ntawm tus nqi qis dua 15%. MTR tau pom tias cov khoom siv kho tshuab tau "tsim nyog". Txawm li cas los xij, thaum lub sijhawm CNC machining ntawm qhov sib sib zog nqus threads, cov seem seem tau nce mus rau 22%. Los ntawm kev tshuaj ntsuam metallographic, lub hauv paus ua rau yog cov flecks ntau dhau (Beta Spots) hauv cov khoom, uas ua rau tsis sib xws hauv cov cheeb tsam hauv zos. Dab tsi zoo li cov nqi khaws cia tau ploj tag nrho hauv lub sijhawm ua haujlwm machining. Txhawm rau daws qhov mob taw tes ntawm kev ua thiab scrapping, pebTuam Tshoj Super Tech Co., Ltd.tau ua raws li "ob chav tswj tus qauv": nruj me ntsis txwv qhov sib txawv xws li oxygen thiab nitrogen kom ua rau qaug zog lub neej; ua random soj ntsuam ntawm siab - magnification metallography rau txhua batch kom tshem tawm cov me ntsis thiab inclusions, thiab xyuas kom meej stability ntawm CNC txiav.

Kev lag luam khoom siv hlau kho mob tam sim no tab tom hloov pauv tsis tau, cuam tshuam ncaj qha rau koj qhov kev yuav khoom:
Lub traceability ntawm cov ntaub ntawv tau dhau los ua qhov yuav tsum tau muaj rau kev yuav khoom. Nrog rau kev ua raws li FDA thiab EU MDR cov cai, Cov Khoom Siv Passport tau dhau los ua qhov tseem ceeb ntawm cov txheej txheem tshuaj xyuas. Daim ntawv teev cov khoom siv yooj yim ib leeg tsis txaus rau kev pom zoo; ib qho kev ua tiav ntawm cov ntaub ntawv hluav taws xob los ntawm lub tshuab hluav taws xob melting, cov keeb kwm ua kom sov rau UT yuav tsum tau muab. Cov neeg muag khoom uas tsis muaj ISO 13485 daim ntawv pov thawj tau raug tshem tawm sai heev. Peb muaj tag nrho cov khoom pov thawj los xyuas kom meej qhov kev pom zoo ntawm koj cov khoom.

Vim muaj qhov xwm txheej geopolitical thiab kev hloov pauv hauv logistics, ntau lub teb chaws tshuab ua lag luam tau raug yuam kom tso tseg decentralized kev yuav khoom. Tam sim no lawv nyiam xaiv cov neeg muag khoom nrog cov khoom lag luam siab (xws li cov tsev khaws khoom sib koom ua ke rau kev npaj cov khoom lag luam) thiab cov khoom siv dav dav - muaj peev xwm muab Ti-6Al-4V ELI raws li lub hauv paus, nrog rau muab tantalum (Ta) raws li thaj chaw thiab molybdenum (Mo) raws li cov khoom siv. Qhov no txo ​​qis cov nqi tswj.Tuam Tshoj Super Tech Co., Ltd.muaj warehouses nyob rau hauv ntau qhov chaw xws li lub teb chaws Yelemees thiab lub tebchaws United States. Cov khoom lag luam khoom lag luam tshaj 50 tus qauv specifications. Rau qhov xav tau ceev tshaj plaws ASTM F136 Ti-6Al-4V ELI rods (Φ6-50mm) thiab Gr2 ntshiab titanium daim hlau (0.5-10mm), peb lav rau tib hnub xa khoom, tshem tawm tag nrho cov kev pheej hmoo ntawm koj cov khoom nres vim cov khoom tsis txaus.