Yuav Ua Li Cas Tsim Nyog Tau Txais H₂O₂ Transfer Needle Chaw Tsim Tshuaj

Tsawg-kub plasma sterilizerH₂O₂ Transfer Needlesfeem ntau yog ib feem ntawm OEM consumable cassettes / cov khoom siv los yog muag raws li kev saib xyuas txhua xyoo. Chav tsev tus nqi yog me me, tab sis cov khoom tawm los yog cov dej xau ua rau tag nrho cov sterilizer. Muaj coob tus neeg hauv tsev kho mob ntau ntxiv, cov neeg thib peb cov neeg ua haujlwm tsis muaj menyuam, thiab cov tuam txhab pabcuam kev pabcuam los ntawm H₂O₂ Hloov Cov Koob Chaw Tsim Tshuaj rau OEM / ODM sib npaug. Yuav xaiv tus neeg xa khoom zoo li cas?

Daim ntawv pov thawj & QMS - ISO 13485 Yog Yuav Tsum Tau

Lub chaw yuav tsum tuav daim ntawv pov thawj ISO 13485 uas siv tau nrog cov kev qhia txog "tsim cov khoom siv kho mob / cov khoom hloov pauv cov kua dej". Yog tias cov khoom lag luam yog 510 (k) lossis CE MDR cov khoom siv, cov chaw tsim khoom yuav tsum txhawb nqa DHF (Design History File), DMR (Device Master Record), thiab kev soj ntsuam kev pheej hmoo (FMEA). General ISO 9001-tsuas yog cov khw muag khoom siv tshuab tsis tsim nyog.

Cov txheej txheem tseem ceeb muaj peev xwm txheeb xyuas (Nyob ntawm chaw lossis chaw taws teeb)

Swiss-type tshuab dhos:Citizen Cincom R04 los yog sib npaug -nug txog kev tswj cov kev pab cuam, cov cuab yeej offset records, first-article & in-process inspection zaus.

Rotary swaging:2-tuag / 4-tuag swaging tshuab tsis tau (kev cuam tshuam zaus, qauv tuag, pub) nrog SOP; txoj kev ntsuas swaged tip concentricity (runout gauge / vision system).

Laser vuam:nyob rau hauv tsev los yog subcontracted? Hauv tsev ⇒ tshuaj xyuas cov cav ntsuas, helium lossis kev ntsuas ntsuas ntsuas; subcontracted ⇒ xyuas subcontractor ISO & incoming inspection.

Electropolishing / passivation:da dej muaj pes tsawg leeg / pH / temp / lub sij hawm tswj; ASTM B912 cov lus qhia ua raws.

Ntxuav & ntim:zaum kawg yaug dej conductivity kaw tom qab ntxuav ultrasonic; Ntim cheeb tsam huv si (pom zoo 10,000 lossis tswj); particle tswj ntawm lim membrane capture check.

Dimensional & Functional Prototyping

Kev kuaj ntshav yuav tsum muaj xws li:

① Daim ntawv qhia txog kev tshuaj xyuas tag nrho (hex hla-pas, bore ID, lub taub hau bevel, lub xub pwg nrhiav qhov ntev)

② Kev kuaj xyuas haum nrog cov qauv ntsuas qhov ntsuas qhov sib dhos- qhov xav tau, O-ring compression, nruj torque tsim nyog

③ Static siab tuav (piv txwv li, 0.4 MPa simulated H₂O₂ kua, Ntau tshaj lossis sib npaug li 5 min tsis muaj npuas / poob)

④ Stopper coring test siv tus qauv grey butyl roj hmab stoppers -yuav tsum tsis muaj coring (coring-free), thiab rov foob tom qab 5 qhov ntxig

Compatibility & IP ceev faj

Koob yog atau tshaj interface ib feem(xws li, haum STERRAD® 100NX injector chaw nres nkoj). Tus neeg tsim khoom tuaj yeem thim rov qab-tus kws tshaj lij los ntawm qhov ntev tshaj tawm nkaus xwb-yuav tsum tsis txhob luam OEM logo lossis ntim khoom uas qhia txog OEM tiag. Sau kom meej meej "Tshaj nrog ..." tsis yog "Qhov tseeb ...". NDA los tiv thaiv cov neeg siv khoom tshwj xeeb qhov ntev / qhov chaw specs.

MOQ, Traceability & Tom qab-muag

Hom MOQ 3,000-5,000 pcs / ntau; coj lub sij hawm 6-10 lub lis piam (tsis-sterile bulk nyob rau hauv PE hnab + desiccant + thawv). Txhua ntau traceable rau raw khoom thaum tshav kub kub No., EP da dej ntau, weld parameter teeb. Cov ntaub ntawv CAPA tau cog lus rau cov teeb meem hauv cheeb tsam-xws li, O-ring groove pitting qhia ⇒ kev tshawb nrhiav pib hauv 24 teev.

Cov chaw tsim khoom lag luam uas nthuav qhia cov ntaub ntawv saum toj no, koom tes hauv kev ntsuas kom haum, thiab hwm tus ciam teb IP yog tus nyiam OEM tus khub mus sij hawm ntev.