Ua raws li ISO 13485: Yuav Ua Li Cas V3 Infusion Needle Standards Xauv Ntiaj Teb Kev Lag Luam

Raws li kev lag luam thoob ntiaj teb cov zaub mov thiab luam yeeb nce kev nkag mus rau hauv kev lag luam, cov neeg European thiab North American regulators tau nruj me ntsis txog kev nyiam huv, traceability, thiab kev tswj kom zoo. Ntau cov koob tshuaj hauv tsev tseem nyob qis qis - xaus kev lag luam hauv zos vim tsis muaj ntawv pov thawj ua raws. Breaking no pwm, lubV3 Infusion koobCov chaw tsim khoom siv ISO 13485 Kev Tswj Xyuas Kev Kho Mob Zoo Tshaj Plaws nrog ISO 9001: 2015, ua tiav kev nkag mus rau txawv teb chaws automation mov chains.

Thaum ISO 9001 muab lub hauv paus hauv paus rau kev yuav khoom, tsim khoom, thiab xa khoom, ISO 13485-tsim yog tsim los rau cov khoom siv kho mob- hais txog kev tswj hwm kev pheej hmoo thiab tag nrho lub neej traceability. Ua raws li cov txheej txheem no rau cov khoom lag luam yog ib qho kev lag luam ua lag luam. Cov chaw tsim khoom tau txheeb xyuas qhov kev pheej hmoo tseem ceeb: cov taub burrs ua rau muaj kab mob sib kis, kev sib txuas tsis ua haujlwm ua rau cov dej xau, stainless hlau corrosion tso tawm ions, thiab cov khib nyiab seem los ntawm kev ntxuav. Cov kev tswj tau raug tsim los rau txhua tus.

Thaum lub sij hawm tsim, engineers nruj nreem xam cov xov tsis thiab orifice qhov ntev, archiving tag nrho cov kev hloov kho. Machining leverages Citizen L12-1M7 kom tswj tau ± 0.01 hli kam rau ua, nrog rau cov tshuab tsis tau nkag rau hauv digitally. Txhua txheej txheem- laser vuam, electropolishing, passivation, thiab tu-feature in-process inspections and operator logs. Cov khoom tiav yog khaws cia rau kev kuaj; txhua qhov teeb meem zoo tuaj yeem taug qab rov qab mus rau ntau cov khoom siv raw, kev teeb tsa tshuab, thiab cov neeg ua haujlwm ntawm batch tooj. Qhov traceability no yog qhov tseem ceeb ntawm kev yuav khoom rau cov neeg yuav khoom thoob ntiaj teb.

Feem ntau cov neeg siv khoom siv rab koob tau txiav txim siab rau ISO 9001, saib ISO 13485 raws li tus nqi - txwv tsis pub overkill. Txawm li cas los xij, cov chaw tsim khoom tau lees paub qhov sib txawv: zaub mov-qib kua dej xav tau kev kho mob- qib kev nyab xeeb. Qhov kev nruj me ntsis no muab cov nyiaj tau txais txiaj ntsig zoo tshaj plaws -Cov tuam txhab European thiab Cov Neeg Esxias Qab Teb Hnub Tuaj automation tseem ceeb tshaj ISO 13485 cov neeg muab ntawv pov thawj, ua rau V3 koob los ua tus qauv ntawm cov neeg hlau tuaj txawv teb chaws.

Nyob rau hauv kev sib tw toj roob hauv pes ntawm Suav tivthaiv exports, kev sib tw ntawm tus nqi ib leeg yog unsustainable. Kev ua raws cai yog tus yuam sij rau kev qhib kev lag luam thoob ntiaj teb. Cov ntaub ntawv V3 ua pov thawj tias kev lees txais cov qauv thoob ntiaj teb thiab kev ua raws li cov lus qhia ntau lawm txhawb kev sib tw thiab khiav tawm ntawm tus nqi qis - nqi ntxiab.