Raws li qhov kev thov thoob ntiaj teb rau cov khoom siv kho mob pov tseg zoo txuas ntxiv mus, cov koom haum tswj hwm hauv Tebchaws Europe thiab Tebchaws Meskas tab tom ua kom muaj kev ua raws li txoj cai - tshwj xeeb tshaj yog rau cov koob txhaj tshuaj thiab cov khoom siv sau ntshav. Cov cuab yeej kho mob tseem ceeb no raug tshuaj xyuas ntau ntxiv vim lawv siv dav hauv kev kuaj mob, kev txhaj tshuaj tiv thaiv kab mob, thiab kev saib xyuas tus neeg mob.
Rau cov chaw tsim khoom, cov neeg xa khoom tuaj, thiab cov neeg faib khoom, kev nkag siab txog cov qauv no tsis yog tsuas yog hais txog kev ua raws li cov kev cai lij choj xwb - nws yog qhov tseem ceeb rau kev ua kom muaj kev nyab xeeb ntawm cov khoom, txhim kho kev nkag mus rau hauv kev ua lag luam, thiab tsim kom muaj kev ntseeg siab mus sij hawm ntev.
Kev tsom mus rau Kev Nyab Xeeb thiab Kev Taug Qab
Hauv ob lub tebchaws European Union thiab Tebchaws Meskas, kev nyab xeeb ntawm tus neeg mob yog qhov tseem ceeb tshaj plaws tom qab kev hloov pauv tshiab. Piv txwv li, EU Txoj Cai Tswjfwm Khoom Siv Kho Mob (MDR), uas tau hloov pauv tag nrho MDD yav dhau los hauv xyoo 2021, hais txog kev ntsuam xyuas kev kho mob, kev ntsuam xyuas kev pheej hmoo, thiab kev saib xyuas tom qab kev lag luam.
Hauv Tebchaws Meskas, FDA's 21 CFR Ntu 820 (Kev Tswj Xyuas Qhov Zoo) tseem yog lub hauv paus rau cov qauv tsim khoom. Txawm li cas los xij, cov kev hloov tshiab tom ntej uas sib haum nrog ISO 13485 yuav tsom mus rau kev taug qab thiab kev sau ntawv - tshwj xeeb tshaj yog rau cov khoom siv Class II xws li koob txhaj tshuaj thiab cov raj sau ntshav.
Qhov no txhais li cas rau cov neeg muab khoom? Txhua theem ntawm txoj saw hlau xa khoom—txij li kev xaiv cov khoom siv raw mus txog rau kev ntim khoom—tam sim no yuav tsum taug qab thiab txheeb xyuas tau.
Kev Ntsuas Txog Biocompatibility thiab Sterility Assurance
Vim muaj kev txhawj xeeb ntxiv txog cov neeg mob cov tshuaj tiv thaiv thiab kev pheej hmoo ntawm kev ua qias tuaj, kev kuaj biocompatibility tsis yog qhov xaiv tau lawm. Cov neeg tswj hwm European thiab Asmeskas xav kom muaj kev kuaj xyuas tob tob raws li cov qauv ISO 10993 kom paub tseeb tias cov ntaub ntawv siv hauv cov koob txhaj tshuaj, lancets, thiab cov raj muaj kev nyab xeeb rau tib neeg kov.
Tsis tas li ntawd xwb, cov txheej txheem ua kom tsis muaj kab mob (xws li ethylene oxide lossis gamma irradiation) yuav tsum ua tau raws li cov kev cai pov thawj uas tau teev tseg hauv ISO 11135 lossis ISO 11137. Kev lees paub tias tsis muaj kab mob yog qhov tseem ceeb heev rau cov khoom uas tau ntim ua ntej lossis siv rau hauv kev sau ntshav ncaj qha.
Rau cov neeg yuav khoom kho mob thiab cov neeg xa khoom tuaj, qhov no txhais tau tias kev xaiv cov neeg muag khoom uas tuaj yeem muab cov ntawv qhia txog kev tsis muaj menyuam thiab cov txheej txheem raug lees paub yog qhov tseem ceeb dua yav dhau los.
Cov Khoom Siv Uas Muaj Kev Xav Txog Ib puag ncig thiab Cov Kev Cai Rau Kev Ntim Khoom Uas Ruaj Khov
Nyob rau xyoo tas los no, kev ruaj khov tau hloov pauv ntawm cov lus tshaj tawm kev lag luam mus rau kev cia siab ntawm kev cai lij choj. EU tab tom txhawb kom txo cov yas siv ib zaug xwb thiab cov tshuaj lom neeg rau ib puag ncig. Txawm hais tias cov khoom kho mob feem ntau zam tsis pub txwv, tab sis muaj kev nyuaj siab ntxiv kom siv cov khoom siv rov ua dua tshiab lossis cov khoom siv bio-based txhua qhov chaw uas ua tau.
Ib yam li ntawd, kev ua lag luam hauv Tebchaws Meskas—tshwj xeeb tshaj yog cov koom haum loj hauv kev yuav khoom kho mob—tab tom soj ntsuam cov khoom raws li lawv qhov cuam tshuam rau ib puag ncig. Cov ntim khoom uas txo cov khib nyiab, lossis cov khoom siv ua los ntawm cov khoom siv tsis muaj BPA thiab DEHP, tab tom dhau los ua cov qauv nyiam.
Rau cov chaw tsim khoom siv sau ntshav thiab cov koob txhaj tshuaj, kev hloov kho rau cov kev cia siab no yuav tsis tsuas yog ua raws li kev cai xwb - tab sis kuj txhim kho kev sib tw.
Qhov Tseem Ceeb ntawm Kev Sau Npe Kom Tseeb thiab Kev Ua Raws Cai UDI
Cov koom haum tswj hwm tab tom tawm tsam qhov tseeb ntawm kev sau ntawv. EU MDR thiab US FDA ob leeg xav kom cov khoom muaj cov ntawv sau Unique Device Identifiers (UDI), hnub tas sij hawm, tus lej batch, thiab kev hais lus rau cov lag luam uas lawv muag.
Yog ua tsis tau raws li cov qauv no ces yuav ua rau kev lis kev cai qeeb, kev hu rov qab, lossis kev poob kev nkag mus rau hauv kev ua lag luam. Kev xaiv cov txheej txheem ntim khoom thiab daim ntawv lo uas txhawb nqa cov kev cai lij choj ntawm daim ntawv lo yog ib kauj ruam tseem ceeb hauv kev ua kom muaj kev ua haujlwm ntshuam/xa tawm zoo.
Kev Tswj Xyuas Cov Cai nrog Kev Ntseeg Siab
Kev taug kev nyob rau hauv ib puag ncig kev cai lij choj nyuaj hauv Tebchaws Europe thiab Tebchaws Meskas xav tau ntau dua li kev ua raws li txoj cai yooj yim xwb - nws xav tau kev npaj ua ntej, kev lees paub cov khoom lag luam tas mus li, thiab kev ua tib zoo saib xyuas cov qauv tshiab.
Rau cov neeg yuav khoom, cov neeg xa khoom tuaj, thiab cov kws kho mob ib yam nkaus, kev paub txog cov cai tshiab kawg hauv cov koob txhaj tshuaj thiab cov khoom siv sau ntshav yog qhov tseem ceeb rau kev txiav txim siab ntse.
Xav paub tseeb tias koj cov khoom siv kho mob pov tseg ua tau raws li cov qauv kev cai lij choj thoob ntiaj teb? Hu rau Sinomed hnub no thiab tshawb nrhiav seb peb cov kev daws teeb meem txhawb nqa koj txoj kev ua raws li txoj cai thiab lub hom phiaj zoo li cas.
Lub sijhawm tshaj tawm: Lub Rau Hli-23-2025
