Cov koob txhaj tshuaj ntshav poob rau hauv qeb ntawm - cov cuab yeej kho mob uas pheej hmoo siab. Lawv qhov zoo cuam tshuam ncaj qha rau kev nyab xeeb ntawm cov neeg mob ntshav thiab lawv lub neej. Cov neeg tsim khoom yuav tsum tsim thiab siv nruj me ntsis raws li ISO 13485 kev tswj xyuas zoo, kom ntseeg tau tias kev tswj xyuas zoo tau ua tiav thoob plaws txhua theem los ntawm kev nkag ntawm cov khoom siv raw mus rau kev tsim cov khoom tiav.

Incoming Material Inspection (IQC): Saib xyuas thawj lub rooj vag

Thaum tag nrho cov khoom siv raw ntawm stainless hlau 304/316 tuaj txog ntawm lub Hoobkas, lawv yuav tsum tau nrog rau daim ntawv pov thawj khoom siv (MTC). Cov neeg soj ntsuam zoo ntawm cov chaw tsim khoom yuav siv lub spectrometer los kuaj xyuas cov tshuaj muaj pes tsawg leeg thiab siv lub tshuab ntsuas metallographic los soj ntsuam cov qoob loo. Rau cov khoom siv hlau, lub hom phiaj yog txhawm rau txheeb xyuas txoj kab uas hla (feem ntau yuav tsum tau ± 0.001mm) thiab ellipticity. Txhua yam khoom tsis tsim nyog yuav raug xa rov qab thiab tsis pub "ua haujlwm nrog qhov tsis xws luag".

Kev soj ntsuam txheej txheem (IPQC): Eagle-Qhov muag pom ntawm tag nrho cov txheej txheem

Ntawm cov kab ntau lawm, kev tswj kom zoo muaj nyob txhua qhov chaw.

• Thawj -kev tshuaj ntsuam xyuas:Tom qab txhua qhov kev hloov pauv pib lossis thaum siv pwm tshiab, thawj cov khoom tsim tawm yuav tsum tau ua tiav - ntsuas qhov loj (ntev, txoj kab uas hla, ntug kaum sab xis, roughness).
• Patrol soj ntsuam:Tus kws tshuaj xyuas qhov zoo ua qhov kev tshuaj ntsuam xyuas txhua teev. Siv ib rab koob tip projector los xyuas qhov symmetry ntawm txiav ntug; siv lub ntsuas ntsuas ntsuas qhov ntsuas sab hauv thiab sab nraud; siv lub puncture force tester los xyuas qhov ntse.
• Anti-kev tswj cov khoom sib xyaw:Cov khoom sib txawv thiab cov ntaub ntawv sib txawv ntawm cov koob txhaj tshuaj yuav tsum tau muab khaws cia rau hauv cov chaw sib cais thiab ua kom pom tseeb nrog daim npav ID. Thaum hloov pwm, lub tshuab yuav tsum tau muab ntxuav kom huv si kom tsis txhob muaj cov seem ntawm cov khoom qub los ntawm kev sib xyaw.

Kev Tshuaj Xyuas Yam Khoom Kawg (FQC/OQC): Tus Neeg Saib Xyuas Qhov Kawg

Ua ntej cov khoom tiav raug xa tawm, 100% kev soj ntsuam pom thiab kev kuaj xyuas lub cev yuav tsum tau ua.

• Kev kuaj pom pom:Nyob rau hauv ib lub 10x magnifying iav, xyuas seb lub taub hau muaj chipping los yog tawg, thiab yog hais tias lub cev muaj khawb, blemishes, los yog xeb.
• Flow Test:Simulate cov ntshav ntws simulated los ntawm rab koob raj nyob rau hauv lub siab teev los xyuas seb puas muaj kev thaiv.
• Kev sib txuas lub zog kuaj:Ua ib qho kev sim tensile ntawm lub hauv paus koob thiab koob raj kom ntseeg tau tias muaj kev sib txuas ruaj ntseg thiab nws yuav tsis xoob thaum lub sij hawm puncture.
• Sterility check:Raws li GB / T 14233 tus qauv, xaiv cov qauv rau kev kuaj tsis muaj menyuam kom tsis txhob muaj kev loj hlob ntawm microbial.

Traceability System: Lub voj kaw ntawm lub luag haujlwm

Cov neeg tsim khoom yuav tsum tsim kom muaj kev paub UDI (Unique Device Identification) system. Txhua chav muag khoom tsawg kawg nkaus (lub thawv ntim khoom) muaj qhov cim barcode. Los ntawm kev luam theej duab barcode, ib tus tuaj yeem taug qab rov qab mus rau qhov cub hluav taws xob ntawm cov khoom siv raw, tus lej xov tooj, tus neeg teb xov tooj, cov ntaub ntawv tshuaj xyuas, thiab cov khoom siv kom tsis muaj menyuam ntawm cov khoom ntawd. Thaum muaj qhov tshwm sim tsis zoo, cov chaw tsim khoom tuaj yeem txheeb xyuas qhov chaw ntawm qhov teeb meem tsis pub dhau ib teev thiab pib ua cov txheej txheem rov qab sai.

Xaus

ISO 13485 system tsis yog daim ntawv pov thawj dai rau ntawm phab ntsa, tab sis theej cov ntshav ntws los ntawm cov kab ntau lawm. Cov kws tsim cov koob txhaj tshuaj tsuas tuaj yeem tau txais kev ntseeg siab ntawm kev ua lag luam thiab tiv thaiv kev noj qab haus huv ntawm cov neeg mob los ntawm kev siv cov kev tswj xyuas nruj.