Ua tiav Kev Ntsuam Xyuas Ntawm Trocar Needle Manufacturing Processes

Los ntawm Kev Kho Mob Stainless Hlau Ua rau ISO 13485 Kev Tswj Xyuas Zoo

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Covkoob trocarzoo nkaus li yooj yim structurally-obturator ntxiv rau cannula-tab sis nws cov kev tsim khoom muaj xws li precision hlau machining, polymer txhaj molding, huv chav sib dhos, thiab nruj sterility validation. Nws yog ib tug neeg sawv cev ntawm Class II lossis III cov khoom siv kho mob nrog cov txheej txheem ntev ntev.

Yam Khoom Txheej Txheem Flow:

1. Kev xaiv cov khoom siv

• Obturator (npog koob taub) thiab Cannula (hlau cannula feem):​ Kev kho mob -qib stainless hlau SUS304 lossis SUS316L, xav tau kev tiv thaiv corrosion, siab zog, thiab ua raws li ISO 10993-1 biocompatibility.
• Yas cannula lub cev (tso pov tseg trocar):​ Kev kho mob - qib polycarbonate (PC) lossis ABS, pob tshab rau kev soj ntsuam yooj yim; seal valve: kho mob silicone lossis thermoplastic elastomer.

2. Hlau Part Machining (CNC / Swiss tig / sib tsoo)

Stainless hlau bar stock undergoes ntxhib tig → tiav tig los ntawm CNC lathes los yog tsis siv neeg Swiss - hom lathes → tsim conical/pyramidal ntsej muag (bladed) los yog blunt conical ntsej muag (bladeless) ntawm lub ntsis.

Cov lus qhia tau dhau los ua kev sib tsoo kom ua tiav qhov tseeb, tsis muaj micro- chipping ntawm cov npoo, thiab Ra nto roughness tsawg dua lossis sib npaug li 0.2 μm kom txo cov ntaub so ntswg.

Cannula lub cev tau nkag mus tob- qhov drilling / kos duab, txiav, chamfering, passivation / electropolishing rau corrosion kuj.

3. Kev kho cua sov thiab kev kho deg

Martensitic stainless hlau obturators xav tau lub tshuab nqus tsev quenching + tempering rau HRC 35-45 kom tswj tau ntug toughness; Austenitic SUS316L feem ntau tsuas yog ua rau cov tshuaj annealing thiab passivation.

Passivation/ultrasonic tu kom tshem tawm cov khib nyiab thiab cov hlau ions dawb.

4. Polymer Txhaj Moulding thiab sib dhos

PC cannulas, ABS tuav, thiab silicone foob li qub yog txhaj molded nyias; foob ​​li qub yuav tsum tau tswj compression txheej txheem.

Kev sib dhos ntawm obturator thiab cannula haum, installation ntawm airtight valve thiab insufflation chaw nres nkoj tau ua tiav hauv Chav Kawm 100,000 lossis Chav Kawm 10,000 chav huv. Ntxig / rho tawm damping yuav tsum yog nruab nrab, thiab tiv thaiv - kev tshem tawm cov xauv ruaj khov.

5. Nyob rau hauv -Txoj kev thiab kev soj ntsuam zaum kawg

• Dimensional soj ntsuam:OD / ID, ntev, lub kaum sab xis projection tag nrho lossis kuaj kuaj.
• Puncture kev ua tau zoo:Cov ntaub so ntswg simulated (PU / tsiaj lub plab phab ntsa) nkag mus rau lub zog tsawg dua los yog sib npaug los teeb tsa lub siab.
• Airtightness:Pressurized mus rau 15 mmHg, siab tswj, to taub tus nqi ntsuas Tsawg dua los yog sib npaug rau 0.1 L / min.
• Zoo thiab sharpness:Kev tshuaj xyuas microscopic ntawm qhov taw tes rau qhov tsis muaj cov npoo dov lossis burrs.
• Biological / Tshuaj:Cytotoxicity, rhiab heev, intracutaneous reactivity (ISO 10993 series), thiab EO residue Tsawg dua lossis sib npaug li 10 ug / g (yog tias EO sterilized).

6. Ntim thiab Sterilization

Blister lub thawv + Tyvek lidstock cua sov sealing, sau nrog batch naj npawb / hnub tas sij hawm / UDI.

EO sterilization los yog Co-60 irradiation sterilization, nrog rau cov txheej txheem sterilization validation nrog rau ib nrab-lub voj voog / Bacillus stearothermophilus kev sib tw xeem.

Quality System Requirements:

Cov neeg tsim khoom yuav tsum ua raws li ISO 13485: 2016 kev tswj hwm kev ua haujlwm zoo uas suav nrog kev tsim qauv, kev tshuaj xyuas cov khoom lag luam (stainless steel / silicone / yas pellets xav tau COA thiab ISO 13485 ntawv pov thawj), txheej txheem validation (IQ / OQ / PQ), batch traceability, thiab kev ceeb toom tsis zoo. Kev xa tawm mus rau EU xav tau CE Cov Ntaub Ntawv Txuj Ci uas muaj cov ntaub ntawv tswj hwm kev pheej hmoo (ISO 14971) thiab cov ntaub ntawv soj ntsuam kev soj ntsuam (txoj kev sib npaug lossis kev tshuaj xyuas cov ntaub ntawv).

Cov ntaub ntawv khoom lag luam uas koj muab tau hais txog plaub- cov txheej txheem ntawm "Kev Xaiv Cov Khoom Siv → Txiav / Shaping → Cannula Assembly → QC" thiab ISO 9001 / ISO 13485 ntawv pov thawj, uas yog ib qho kev qhia meej ntawm cov lus hais saum toj no ua tiav cov txheej txheem tsim khoom{{3} zoo{4}B thiab cov ntaub ntawv pov thawj rau cov neeg siv khoom.