Txoj Kev Zoo Rau Kev Nkag Mus Rau Vascular Access Infusion Needle Chaw Tsim Tshuaj

https://www.mayoclinic.org/tests-procedures/breast-biopsy/about/pac-20384812

Taw qhia: Kev cai raws li Lifeline of Medical Devices

Hauv kev lag luam khoom siv kho mob, qhov zoo tsis yog qhov ntsuas ntawm 99% piv rau 99.9%; nws yog qhov sib txawv binary ntawm txoj sia thiab kev tuag. RauVascular Access Infusion KoobCov tuam txhab tsim khoom, qhov twg cov cuab yeej ua txhaum ntawm daim tawv nqaij thaiv kom nkag mus rau hauv cov hlab ntsha, qhov kev tswj xyuas zoo (QMS) tsis muaj - sib tham. ISO 13485: 2016 yog qhov ntsuas thoob ntiaj teb lees paub. Kev ua tiav daim ntawv pov thawj, raws li Kev Ua Cuam Tshuam tau ua nrog nws "National High-tech Enterprise" kev lees paub hauv xyoo 2019, qhia txog cov chaw tsim khoom cog lus rau kev tswj hwm kev pheej hmoo thiab kev tswj cov txheej txheem.

Tsim thiab Kev Tswj Xyuas Kev Txhim Kho (Clause 7.3): Mitigating Risk ntawm Qhov Chaw

TS EN ISO 13485 Kev tswj hwm nruj ntawm kev tsim cov khoom tsim tawm, kev tsim tawm, thiab kev hloov pauv. Rau ibVascular Access Infusion Needle Chaw tsim tshuaj paus, kev tsim kho tshiab11 Gauge 4 Inch Lengthkoob suav nrog kev txhais cov kev xav tau ntawm kev kho mob (xws li, "xav tau ntau dua hauv cov neeg mob rog") rau hauv cov kev qhia tshwj xeeb (puab txoj kab uas hla, lub taub geometry). Engineering teams tsim2D / 3D Drawings, txhais cov ntaub ntawv (Stainless hlauqib), cov txheej txheem (Necking, Swaging, Sib Tsoo), thiab validation raws tu qauv. Qhov tseem ceeb, kev tswj hwm kev pheej hmoo raws li ISO 14971 tau koom ua ke thoob plaws. Tej zaum yuav muaj kev phom sij- pob txha taub hau, kev mob ntxiv, kev kis kab mob- yuav tsum tau txheeb xyuas, ntsuas, thiab txo qis los ntawm cov qauv tsim (xws li, qhov tob nres, cov hubs ntxiv). Txhua yam kev ua ub no raug sau tseg rau hauv Cov Ntaub Ntawv Keeb Kwm Tsim (DHF), kom ntseeg tau tias kev taug qab thiab kev lav phib xaub.

Txheej txheem validation thiab Environmental Controls

Muaj ntau txoj kev tsim khoom rau aVascular Access Infusion Koobyog "cov txheej txheem tshwj xeeb"- cov zis tsis tuaj yeem lees paub los ntawm kev tshuaj xyuas tom ntej (xws li,Electropolishing, Laser Txiav, sterilization). ISO 13485 xav tau Kev Tsim Kho Kev Tsim Nyog (IQ), Kev Tsim Nyog Ua Haujlwm (OQ), thiab Kev Tsim Nyog Ua Haujlwm (PQ) ua ntej kev tsim khoom. Piv txwv li, validatingElectropolishingsuav nrog kev lees paub lub zog ruaj khov, da dej concentration / kub tswj (IQ), txiav txim siab qhov ntsuas tam sim no / lub sij hawm tsis zoo (OQ), thiab ua kom pom qhov zoo sib xws ntawm cov khoom tsim khoom (PQ). Kev saib xyuas ib puag ncig ntawm chav huv (ISO Chav Kawm 7 lossis 8 rau kev sib dhos) yog qhov yuav tsum tau ua. Batch cov ntaub ntawv yuav tsum tau ntes ua tiav traceability-los ntawm cov khoom siv raw mus rau cov khoom siv cav thiab tus neeg teb xov tooj IDs- tsim qhov kaw - cov ntaub ntawv voj voog.

Kev Tswj Xyuas Kev Muag Khoom thiab Kev Tswj Xyuas Kev Muag Khoom

Kev ua tau zoo nyob ntawm cov khoom tuaj. Cov khoom siv tseem ceeb rau aVascular Access Infusion Needle Chaw tsim tshuaj pausmuaj xws li stainless hlau tubing, ntim khoom, thiab lubricants. ISO 13485 yuav tsum muaj kev ntsuam xyuas tus neeg muag khoom thiab cov txheej txheem pom zoo. Kev soj ntsuam xyuas tus neeg muag khoom QMS, cov chaw, thiab keeb kwm kev ua haujlwm. Tsuas yog cov neeg muag khoom pom zoo raug teev tseg. Cov khoom nkag tau raug tshuaj xyuas: tubing rau qhov ntev thiab qhov tsis zoo; ntim rau seal kev ncaj ncees thiab microbial barrier zog. RauCustom featureCov lus thov cuam tshuam nrog subcontracting (xws li, tshwj xeeb coatings), kev cog lus yuav tsum qhia meej meej txog kev lees paub thiab lub luag haujlwm zoo.

Ncej -Kev soj ntsuam kev lag luam: Kaw cov lus rov qab voj

Kev ua raws cai txuas ntxiv dhau lub rooj vag Hoobkas. ISO 13485 qhia txog Kev Tshaj Tawm -Kev Tshawb Fawb Kev Lag Luam (PMS) thiab kev ceeb toom ceev faj. Yog tias tus kws kho mob qhia txog qhov nyuaj rau kev ntxig ib qhoUltra-Ntsuab Trocar Tip koob, covVascular Access Infusion Needle Chaw tsim tshuaj pausyuav tsum tshawb nrhiav. Qhov no suav nrog kev tshuaj xyuas cov qauv khaws cia, cov ntaub ntawv tsim khoom, thiab cov khoom siv calibration cav. Yog tias muaj qhov laj thawj (piv txwv li, aSib tsooLub tshuab drift) tau pom, CAPA (Kev Kho thiab Tiv Thaiv Kev Ua Haujlwm) tau pib: rov kho cov cuab yeej, hloov kho cov lus qhia ua haujlwm, rov cob qhia cov neeg ua haujlwm, thiab txheeb xyuas qhov ua tau zoo. Cov ntaub ntawv no- lub voj voog uas tau tsav ua kom muaj kev txhim kho tas mus li. Rau siab - thev naus laus zis kev lag luam zoo li Kev coj ua, kev ua raws li ISO 13485 tsis yog daim ntawv pov thawj nkaus xwb tab sis yog ib feem tseem ceeb ntawm kev coj noj coj ua ntawm kev lag luam, tsim kev ntseeg siab tseem ceeb rau kev ua lag luam thoob ntiaj teb.