H₂O₂ Hloov Cov koob raws li ISO 14971

Txheeb xyuas qhov txaus ntshai ntawm cov dej ntws, Clogging & Catalytic decomposition

Txawm hais tias cais raws li Class I/II cov khoom siv uas tsis tuaj yeem cog,H₂O₂ Transfer NeedleKev ua tsis tiav tuaj yeem ua rau: tshuaj lom neeg kub hnyiab los ntawm kev ua kom tsis muaj menyuam, cov tshuaj tua kab mob raug nqi / kho, lossis -tseem ceeb tshaj plaws - lub voj voog ua kom tsis muaj menyuam vim tsis noj tshuaj (ua rau tus neeg mob tsis muaj kev pheej hmoo ntawm kev pheej hmoo ntawm cov kab mob tsis zoo). Cov tuam txhab muaj lub luag haujlwm siv ISO 14971 kev tswj hwm kev pheej hmoo.

Cov piv txwv ntawm Kev Tiv Thaiv Hazard

• H₂O₂ Leakage:Tsis txaus O-ring compression / off-nominal groove qhov tob / hub tawg → tshuaj hlawv, khoom siv corrosion.
• Lumen Obstruction:Tsis zoo electropolishing txhawb siv lead ua adhesion / uncontrolled roj hmab coring khib nyiab → under-filling → cycle abort.
• Catalytic decomposition:Tsis txaus passivation / residual hlau hais → nrawm H₂O₂ kev puas tsuaj → roj tsim ntxov ntxov → lub tswb nrov.
• Septum Coring:₂O₂ cov lus qhia dull/burred → rubber fragments contaminating H₂O₂ reservoir.
• Kev sib txuas tsis raug:Tsis raug hub qhov ntev → mismatched haum → tsuag / txaws.

Risk Control Measures

Tsim:CAD validation ntawm O-ring compression; internal tswj rau swaged taub sharpness; EP + kev tshuaj xyuas cov lumens; cim interface kos duab los tiv thaiv misapplication.

Txheej txheem:100% tus pin gauging + kev soj ntsuam pom; AQL siab decay test; Ntau-sampled H₂O₂ immersion compatibility checks.

Kev sau npe:Ntshiab kos cim "Rau H₂O₂ nkaus xwb / Cov qauv sib xws / Max Reuse ___x lossis Ib Leeg Siv"; Ntau / Batch UDI.

IFU:Cov lus qhia nthuav dav txog H₂O₂ cov ntsiab lus, kev tu / ziab / khaws cia, thiab pov tseg cov txheej txheem.

Kev ntsuam xyuas qhov pheej hmoo seem & PMS

Nrog rau cov kev tswj saum toj no, cov kev pheej hmoo seem (piv txwv li, cov neeg siv khoom siv tsis raug lossis kev siv lub neej ntau dhau) raug suav tias yog qhov lees txais tau tom qab kev soj ntsuam kev pheej hmoo / txiaj ntsig. Post-Market Surveillance (PMS) cov kab ke taug qab cov lus tsis txaus siab txog kev xau / ceeb toom / crystallization. Trending anomalies ua rau kev tshawb nrhiav CAPA (saib xyuas EP tsis muaj, ID tsis sib xws, O-ring hardness). Kev koom tes nrog sterilizer OEMs ntawm kev sib koom ua ke Fault Tree Analyzes (FTA) ntxiv txhim kho tag nrho cov kev ntseeg tau.

Cov neeg tsim khoom muaj cov ntaub ntawv tswj hwm kev pheej hmoo (Risk Management Plan, FMEA tables, Risk Assessment Reports, PMS plan) qhia tau hais tias kev cog lus rau cov khoom lag luam muaj kev nyab xeeb ntau dua li cov khw muag khoom siv tshuab.