Hauv kev lag luam khoom siv kho mob, ntim khoom yog ntau tshaj li lub thawv ntim khoom; Nws yog qhov tseem ceeb "Sterile Barrier System" (SBS) thoob plaws hauv cov khoom lag luam lub neej. Raws li ib tus kws tshaj lij cov khoom siv hauv chav huv huv, peb nkag siab cov kev xav tau nruj uas ISO 13485 tus qauv muab tso rau hauv daim ntawv kho mob. Qhov no tsis yog ib qho teeb meem ntawm kev tswj hwm kev ua raws cai - nws yog ib qho teeb meem ntawm kev nyab xeeb ntawm tus neeg mob.
Hauv qab no yog xya qhov tseem ceeb uas cov ntawv ntim khoom kho mob yuav tsum tau ua raws li ISO 13485 daim ntawv pov thawj lub luag haujlwm:
1. Exceptional Microbial Barrier Function
ISO 13485 qhia txog kev tswj hwm kev pheej hmoo. Daim ntawv kho mob yuav tsum tau thaiv cov kab mob, kab mob, thiab cov kab mob thaum tso cai rau kom tsis muaj menyuam (xws li Ethylene Oxide, Chav, lossis Gamma Irradiation) nkag mus. Qhov nyiaj tshuav no yog qhov qhia tau zoo tshaj plaws rau Daim Ntawv Kho Mob Qib, kom ntseeg tau tias cov khoom tseem tsis muaj menyuam nyob hauv nws lub txee lub neej.
2. Yam tsawg kawg nkaus Particle Emission (Low Linting)
Nyob rau hauv ib puag ncig huv si, txawm tias qhov me me ntawm cov fiber ntau tuaj yeem dhau los ua qhov chaw paug. Standard - daim ntawv kho mob raws cai yuav tsum xyuas kom meej tias fiber ntau puas huv si thiab tsis muaj hmoov av los yog lint thaum tev los yog torn. Qhov no yog qhov tseem ceeb rau kev tswj xyuas qhov huv ntawm cov cuab yeej kho mob precision.
3. Lub cev muaj zog thiab tshuab ua haujlwm siab
Kev ntim khoom kho mob tau txais kev nyuaj siab los ntawm kev sib txhuam, kev sib txhuam, thiab qhov muaj peev xwm punctures thaum thauj thiab khaws cia. TS EN ISO 13485 Cov neeg tsim khoom yuav tsum ua cov kev sim nruj nruj ntawm lub zog tensile, tawg lub zog, thiab tsim kua muag. High- cov ntaub ntawv zoo yuav tsum tiv thaiv lub cuab yeej thaum tswj kev ncaj ncees ntawm kev tsis muaj menyuam.
4. Superior Seal Integrity thiab Peelability
Ib qho "Clean Peel" yog ib qho ntawm cov kev kho mob tseem ceeb tshaj plaws rau cov kws kho mob. Daim ntawv yuav tsum tsim kom muaj kev sib txuam thiab ruaj ntseg nrog cov yeeb yaj kiab sib xyaw. Thaum qhib, lub foob yuav tsum tev kom du yam tsis muaj fiber ntau tearing lossis delamination, tiv thaiv kev sib kis ntawm qhov chaw.
5. Kev Nyab Xeeb Kev Nyab Xeeb thiab Biocompatibility
Raws li ISO 13485 cov kev cai tswj kom zoo, daim ntawv kho mob yuav tsum tsis txhob muaj cov tshuaj phem -xws li cov tshuaj fluorescent whitening agents, hnyav hlau, los yog tshuaj lom additives - uas tuaj yeem txav mus rau hauv lub cuab yeej. Kev tswj cov khoom siv raw thaum lub sijhawm tsim khoom yog qhov tseem ceeb tshaj plaws hauv peb lub Hoobkas kev tswj xyuas kom zoo.
6. nruj Batch Traceability
Lub hauv paus ntawm ISO 13485 system yog nyob rau hauv "pob tshab traceability." Raws li tus neeg xa khoom, peb yuav tsum sau tag nrho cov txheej txheem ntawm txhua daim ntawv Kho Mob Qib Ntawv, los ntawm cov ntaub ntawv nyoos thiab txheej txheej mus rau kev tshuaj xyuas zaum kawg. Kev tswj xyuas cov ntaub ntawv nruj no muab cov chaw tsim khoom siv kho mob nrog kev ntseeg siab thiab cov ntaub ntawv xav tau rau kev soj ntsuam xyuas.
7. Sterilization Compatibility thiab ruaj khov
Cov khoom siv kho mob sib txawv yuav tsum tau ua kom tsis muaj menyuam sib txawv. Cov ntaub ntawv tsim nyog yuav tsum tswj hwm lawv cov khoom qub ntawm lub cev thiab cov teeb meem cuam tshuam tom qab muaj kev kub ntxhov siab -qhov kub thiab txias ntawm cov pa roj fumigation, tsis tas yuav ua rau tawg lossis cuam tshuam kev ua haujlwm foob.
Xaiv cov khoom ntim uas ua raws li ISO 13485 yog qhov yuav tsum tau ua ua ntej rau cov khoom siv kho mob nkag mus rau hauv lub lag luam thoob ntiaj teb. Raws li cov chaw tsim khoom tau nkag siab tob hauv cov khoom siv huv huv thiab kev tiv thaiv kev lag luam, peb tau cog lus los muab kev ua haujlwm siab -Daim Ntawv Kho Mob Qib. Los ntawm cov txheej txheem huv huv huv thiab kev tswj xyuas cov txheej txheem, peb pab cov neeg siv khoom thoob ntiaj teb kom ntseeg tau tias muaj menyuam tsis taus ntawm txhua yam khoom kho mob hauv ib puag ncig kev tswj hwm.
