Kev Tswjhwm Zoo Ntawm Cov Khoom Siv Pov Tseg Trocar

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Kev Xeem Airtightness, YY / T Standards, thiab ISO 13485 Kev Ua Raws Cai

Raws li qhov ncaj qha conduit rau hauv lub cev kab noj hniav, zoo tsis xws luag nyob rau hauvpov tseg trocarstuaj yeem ua rau poob ntawm pneumoperitoneum, cov ntaub so ntswg puas, thiab txawm tias muaj kev tsis sib haum xeeb. Cov kws tshaj lij cov chaw tsim khoom siv pov tseg yuav tsum tsim kom muaj lub neej tag nrho- lub voj voog tswj kev ua haujlwm zoo npog cov khoom tuaj, hauv - txheej txheem tsim khoom, cov khoom tiav, thiab kev ua kom tsis muaj menyuam, thaum nruj me ntsis ua raws li ISO 13485 cov cuab yeej kho mob zoo tswj kev lag luam thiab cov qauv kev lag luam YY/T 1710-D 2020.

• Incoming Quality Control (IQC):Stainless hlau raj yuav tsum raug txheeb xyuas rau cov ntaub ntawv pov thawj (raws li ASTM A269 / A276 los yog sib npaug), hardness (304 stainless hlau HRC 22-25, L605 txog HRC 20-40), sab hauv / sab nraud txoj kab uas hla tolerances, thiab nto tiav qib. Yas pellets xav tau kev txheeb xyuas ntawm FDA Drug Master Files (DMF) lossis REACH / RoHS cov lus tshaj tawm ua raws, cov ntsiab lus noo noo, thiab qhov ntsuas dej ntws. Silicone cov ntaub ntawv tseem yuav tsum tau vulcanization℃thiab resilience xeem.
• Hauv -Kev Tswj Xyuas Txheej Txheem Zoo (IPQC):​ Thaum lub sij hawm Swiss- hom CNC tig, Video Measuring Systems (VMS/2D Measuring) yog siv los tshuaj xyuas qhov ntev ntawm qhov tseem ceeb -cannula sab nraud / puab diameters, sab qhov chaw, thiab chamfer kaum. Hauv seem txhaj tshuaj molding, pwm kub, ntim lub sij hawm, thiab lub sij hawm txias yog saib xyuas kom tsis txhob shrinkage thiab porosity. Txhua pwm txhaj tshuaj yog kuaj rau pob tshab thiab cov tsos mob tsis xws luag (dub me ntsis, npuas, weld kab) ntawm pob tshab taub. Ib txoj cai tshwj xeeb yuav tsum tsis txhob pom cov hlau nplaum nyob hauv cov hlab; factories feem ntau muab cov neeg ua haujlwm rau siab ua 100% kev tshuaj xyuas ntawm cov khib nyiab sab hauv uas siv cov endoscopes lossis cov teeb pom kev zoo.

Cov Khoom Ua tiav Cov Kev Ntsuas Kev Ua Haujlwm Zoo (FQC / OQC):

• Airtightness / Gas Barrier Testing:Txuas lub cannula mus rau 4 kPa pneumatic system, kaw tag nrho cov qhov qhib, thiab submerge hauv dej rau 1 feeb, yuav tsum tsis txhob muaj npuas txuas ntxiv (los yog npuas suav hauv qab qhov txwv); Tsis tas li ntawd, qhov sib txawv ntawm qhov sib txawv ntawm qhov sib txawv ntawm qhov kev ntsuas tsis siv neeg simulates sealing kev cia siab nyob rau hauv intraoperative pneumoperitoneum tej yam kev mob ntawm 12-15 mmHg.
• Kev Ntsuas Kev Sib Txuas Zog:Siv axial tensile quab yuam rau kev sib koom ua ke ntawm lub hau tiv thaiv thiab cannula, thiab insufflation valve thiab cannula (feem ntau> 20 N yam tsis muaj detachment).
• Puncture Performance:Siv cov ntaub so ntswg simulated (piv txwv li, cov thickness silicone lossis porcine plab phab ntsa) los ntsuas qhov kev quab yuam thiab "muab / tawg qhov kev xav," txheeb xyuas cov lus qhia tsim nyog.
• Ntxig / Tshem Tawm Kev Tiv Thaiv thiab Foob Lub Neej:Standard 5 mm cov twj paj nruag tau rov tso thiab thim rov qab ntau dua 500 zaug, saib xyuas kev hloov pauv quab yuam thiab cov pa tawm ntawm txhua theem.
• Cov tsos mob 100% Kev tshuaj xyuas:Tsis muaj khawb, kis kab mob, flash, lossis tsis xws li cov khoom ploj lossis tsis zoo flashing ntawm silicone li qub.
• Sterilization Process Validation thiab Sterility Assurance:​ Cov khoom tiav lawm feem ntau siv Ethylene Oxide (EO/EtO) sterilization, yuav tsum tau Txhim Kho Kev Tsim Nyog (IQ), Kev Tsim Nyog Kev Ua Haujlwm (OQ), thiab Kev Ua Haujlwm Zoo (PQ) raws li ISO 11135, txheeb xyuas qhov ua tiav ntawm SAL=10⁻⁶ sterility assurance qib, thiab kev soj ntsuam kev sib npaug ntawm Lessperg 0 GB/T 16886.7). Qee qhov hluav taws xob- qib siab siab tuaj yeem siv gamma ray sterilization (ISO 11137).

Cov ntaub ntawv thiab Traceability:Txhua batch khaws CNC machining parameter cov ntaub ntawv, electropolishing da dej tsom xam, txhaj tshuaj molding txheej txheem phaib, ntxuav / sib dhos batch ntaub ntawv, thiab sterilization batch cov ntaub ntawv kom ua tiav UDI (Unique Device Identification) traceability mus rau qhov tsawg tshaj plaws muag chav tsev. Rau cov chaw tsim khoom trocar pov tseg, cov txheej txheem zoo tsis yog qhov pib rau kev lees paub, tab sis lub hauv paus tseem ceeb rau kev khwv tau kev ntseeg siab ntawm cov tsev kho mob loj thiab cov neeg siv khoom OEM txawv teb chaws.