Tag Nrho Lub Neej Tswj Ntawm Lub Tshuab Nqus Tsev-Kev Pab Cuam Lub Cev Lub Cev Muaj Zog Raws Li ISO 13485 Ncej
Jun 12, 2026
1. Tsim thiab Kev Txhim Kho: Risk-Triven DFMEA
Raws li ISO 14971, cov tuam txhab lag luam yuav tsum txheeb xyuas cov kev ua tsis tau zoo ntawm VABB koob, xws li rab koob pob txha, txiav hniav jamming, nqus cov pa tawm thiab cov cim tsis raug. Cov txheej txheem lees txais raug txhais rau txhua qhov kev pheej hmoo; Piv txwv li, lub taub hau tawg quab yuam yuav tsum siab dua los yog sib npaug rau 15 N, txheeb xyuas los ntawm peb -point bending tests.
Cov khoom tsim tawm muaj xws li engineering drawings, khoom specifications, txheej txheem flowcharts thiab soj ntsuam cov phiaj xwm. Txhua qhov kev hloov pauv tsim yuav raug tshuaj xyuas kev tswj hwm kev pheej hmoo.
2. Kev tshuaj xyuas cov khoom xa tuaj: Qhov Kev Pov Hwm Zoo
- Tshuaj muaj pes tsawg leeg: C, Cr, Ni thiab Mo cov ntsiab lus txheeb xyuas los ntawm optical emission spectrometry;
- Dimensional raug: Sab nraud diameters (1.27–2.77 mm sib thooj rau 10G–14G) thiab puab diameters ntsuas los ntawm laser micrometers nrog ib tug kam rau ua ntawm ± 0.01 hli;
- Hardness: HRC qhov tseem ceeb tau sim siv Rockwell hardness tester;
Deg tsis xws luag: Kev soj ntsuam pom kev pab los ntawm cov magnifiers txhawm rau txhawm rau khawb thiab qhov pits.
Cov khoom tsis sib xws yog raug cais tawm tam sim ntawd thiab xa rov qab mus rau cov neeg xa khoom.
3. Kev Tswj Xyuas Txheej Txheem: SPC thiab Hauv -Kev Tshuaj Xyuas Kab
Statistical Process Control (SPC) yog siv rau cov txheej txheem tseem ceeb xws li milling, laser npav thiab electropolishing. Tsib cov qauv raug coj mus kuaj txhua 30 feeb rau qhov ntsuas qhov loj me, nrog X̄-R cov kab kos tswj tau npaj rau kev saib xyuas lub sijhawm tiag tiag. Kev tsim khoom yuav tsum nres tam sim ntawd yog tias muaj ntau tshaj qhov txwv.
Piv txwv li, lub kaum sab xis yog teev raws li 25℃± 1 degree; Peb qhov kev nyeem tsis zoo sib law liag ua rau muaj kev tshuaj xyuas rau cov cuab yeej hnav. Confocal microscopes ua qhov chaw kuaj xyuas ntawm laser npav qhov tob hauv - kab kom tswj tau qhov ntau ntawm 15 ± 5 μm.
4. Kev tshuaj xyuas cov khoom tiav: Ntau -Txoj Cai Tso Tawm
- 100% kev soj ntsuam qhov ntev: Tag nrho cov lus piav qhia qhov ntev tau txheeb xyuas los ntawm cov phiaj xwm profile lossis ntsuas qhov muag;
- Puncture force test: Universal test machines ntsuas qhov siab tshaj plaws quab yuam uas yuav tsum tau rau lub taub hau kom nkag mus rau 5 hli - tuab silicone cov ntaub so ntswg simulant, nrog tus nqi siab tshaj plaws ntawm tsawg dua los yog sib npaug rau 3 N;
- Kev ntsuas lub tshuab nqus tsev: Tom qab tso rau −80 kPa thiab kaw lub valve, lub siab poob yuav tsum tsis pub tshaj 5 kPa hauv 30 vib nas this;
- Kev kuaj tsis muaj menyuam: Post ethylene oxide (EO) ua kom tsis muaj menyuam, ntsuas kab mob lom thiab kuaj tsis muaj menyuam raug ua raws li ISO 11737;
- Kev pom kev pom: 100% kev kuaj pom pom nrog xoom kam rau cov pob xeb, burrs lossis qhov tsis pom tseeb.
5. Tshaj tawm - Kev Tshawb Fawb Kev Lag Luam: CAPA thiab Kev Txhim Kho Nruam
Ib qho xwm txheej tsis zoo tshaj tawm cov ntaub ntawv khaws cia los taug qab cov neeg siv khoom tsis txaus siab thoob ntiaj teb, xws li ncej dabtsi yog khoov thiab cov ntaub so ntswg txhaws. Kev tshuaj xyuas kev tswj xyuas ib xyoos ib zaug txheeb xyuas cov ncauj lus tsis txaus siab.
Raws li ib qho piv txwv: peb tsab ntawv ceeb toom ntawm qhov txawv txav ntawm cov hniav tsis zoo nyob rau hauv ib lub hlis twg ua rau muaj kev tshawb nrhiav Kev Kho thiab Tiv Thaiv Kev Ua Haujlwm (CAPA), uas tau txheeb xyuas qhov tsis txaus ntawm cov hniav tsis zoo los ntawm kev kho cua sov. Cov txheej txheem quenching tau hloov kho tom qab. Txhua qhov kev kho kom raug yuav tsum muaj kev lees paub ntawm kev ua tau zoo ua ntej raug kaw.
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