Chiba koob Manufacturing txheej txheem Thiab Core Machining Technology

Los ntawm Kev Kho Mob Stainless Hlau Tube mus rau Sterile tiav cov khoom

https://radiopaedia.org/articles/chiba-needle

CovSib needle zoo li yooj yim structurally - ib tug hollow nyias raj ntxiv rau ib tug yas hub - tsis tau nws cov txheej txheem tsim imposes stringent yuav tsum rau precision machining thiab huv si ntau lawm. Ib qho kev tsim tawm raug tsim los ntawm lub chaw tsim khoom muaj koob npe Chiba koob yog raws li hauv qab no:

Kauj Ruam 1: Raw Material Inspection & Tube Cutting​

Xaiv seamless capillary tubing ntawm SUS304, SUS316, lossis SUS316L ua raws li ASTM F899 lossis ISO 7153-1, nrog OD kam rau ua nyob rau hauv ± 0.01 hli thiab phab ntsa thickness uniformity tsawg dua los yog sib npaug rau ± 5%. IQC txheeb xyuas cov tshuaj muaj pes tsawg leeg, hardness (feem ntau HV300-380), ncaj, thiab sab hauv phab ntsa roughness (Ra <0.4 μm). Txiav kom tiav ntev + txheej txheem nyiaj pub dawb (feem ntau yog +3-5 mm) siv lub tshuab CNC raj; deburr ob kawg.

Kauj Ruam 2: Tube Sizing & Forming​

Yog tias qhov tshwj xeeb ID / OD sib xyaw ua ke (nyias- cov phab ntsa phab ntsa) yuav tsum tau ua, yuav tsum tau ua tiav qhov kev txiav txim siab lub raj los yog qhov loj me. Qee lub tuam txhab siv micro-indentations lossis laser- cim centimeter nplai ntawm nruab nrab -section - qhov ntsuas qhov tob yuav tsum tau tswj nruj me ntsis kom tsis txhob ua rau lub raj tsis muaj zog lossis tsim cov ntsiab lus kev ntxhov siab.

Kauj Ruam 3: Koob Tip Sib Tsoo (sib tsoo & Beveling)​

Qhov no yog cov txheej txheem tseem ceeb tshaj plaws rau rab koob Chiba. CNC micro- pub pob zeb diamond log sib tsoo ua rau lub kaum sab xis (feem ntau 20℃-35 degree, classical 25℃-30℃luv bevel). High- kab kawg ua cov kev sib tsoo zoo kawg nkaus kom tshem tawm cov micro-burrs thiab me ntsis puag ncig ntawm ntug ntug sab nrauv kom tiv thaiv "fishmouth" deformation. Franseen tip variants xav tau 3-axis ib txhij sib tsoo los tsim peb qhov sib npaug sib npaug ntawm cov txiav. Tom qab sib tsoo, 100% kev tshuaj xyuas microscopic yog ua los tsis lees paub cov npoo, cov lus qhia chipped, thiab asymmetric bevels.

Kauj Ruam 4: Sab Hauv Phab Ntsa Polishing & Ntxuav​

Electropolishing (ECP) los yog hloov kho txhua yam polishing txo cov phab ntsa sab hauv Ra kom qis dua 0.2 μm, txo cov cell / ntshav adhesion thiab txhim kho aspiration patency. Qhov no yog ua raws los ntawm ntau-theem purified dej yaug, ultrasonic degreasing, thiab deionized dej yaug kom huv si tshem tawm cov khib nyiab thiab cov txheej txheem kua residues.

Kauj Ruam 5: Stylet Fabrication & Fit Testing​

Lub stylet sab nraud txoj kab uas hla yog me ntsis me dua lub cannula puab txoj kab uas hla (clearance approx . 5-15 μm). Tom qab kev ntxig, nws yuav tsum swb du yam tsis muaj kev ua si ntau dhau. Fit test feem ntau siv go/no-go gauges lossis optical projection piv. Qee cov qauv muaj cov stylet ntsis maj mam chamfered los tiv thaiv kev txeeb.

Kauj Ruam 6: Sub-Kev sib dhos - Hub Moulding / Xovxwm-Fitting​

Lub koob raj lub taub hau yog sib txuas los yog mechanically crimped rau ABS / PC / Luer Lock hub, kom ntseeg tau tias muaj qhov xau{0}} hlau dawb- mus rau - yas interface. Qhov tob nres (sliding limiter nplhaib ua los ntawm PE los yog PP) yog haum rau lub raj lub cev. Kev sib sau ua ke tau ua nyob rau hauv Chav Kawm 100,000 lossis Chav Kawm 10,000 chav huv, nrog cov neeg ua haujlwm hnav khaub ncaws tiv thaiv- cov khaub ncaws zoo li qub thiab cov tsho ntiv tes.

Kauj Ruam 7: Thaum kawg ntxuav, ziab & ntim​

Tom qab- sib dhos, chav ua tiav tau txais isopropanol / dej ntshiab ntxuav → cua kub lossis lub tshuab nqus tsev kom qhuav → kuaj pom tag nrho → thauj khoom rau hauv Tyvek / ntawv qib kho mob- hnab yas lossis hlwv. Tom qab tso cov ntsuas sab hauv, nws raug rau EO sterilization (lossis gamma irradiation), tom qab ntawd los ntawm kev kuaj tsis muaj menyuam (sterility, EO residue, endotoxin).

Kauj Ruam 8: Kev Tswj Xyuas Zoo​

Cov khoom tseem ceeb QC suav nrog: qhov ntev (OD / ID / ntev / bevel lub kaum sab xis) ntsuas qhov muag, lub ntsej muag ntse / puncture quab yuam kuaj (kev nkag mus rau cov khoom siv hluav taws xob lossis silicone simulant), cannula-stylet haum (ntxig / tshem tawm lub zog), sab hauv lumen huv si (particulate count), kev kuaj pom ntawm hub - thiab evaporation tube TS EN ISO 10993 cytotoxicity / rhiab heev / hemolysis Tag nrho cov txheej txheem yog tswj hwm los ntawm ISO 13485 system nrog batch-theem traceability.

Cov tuam txhab lag luam zoo kuj txheeb xyuas qhov kev sib tsoo quab yuam-kev nkag mus ua hauj lwm nkhaus ntawm rab koob, ua kom puncture quab yuam hauv qab tus qauv siv los ntawm cov qauv kev lag luam (xws li, 22G Chiba koob nkag mus rau 0.25 mm silicone membrane nrog quab yuam tsawg dua lossis sib npaug rau XN, raws li kev lag luam tus qauv), yog li quantifying lub subjective "sharpness.