Raws li kev xav tau thoob ntiaj teb rau cov khoom siv kho mob uas siv tau zoo txuas ntxiv mus ntxiv, cov koom haum tswj hwm hauv Tebchaws Europe thiab Tebchaws Meskas tau ntxiv dag zog rau kev ua raws cai-tshwj xeeb tshaj yog rau cov koob txhaj tshuaj thiab cov khoom siv ntshav. Cov cuab yeej kho mob tseem ceeb no tau raug tshuaj xyuas ntau ntxiv vim lawv siv dav hauv kev kuaj mob, tshuaj tiv thaiv, thiab kev saib xyuas neeg mob.
Rau cov tuam txhab, cov neeg xa khoom, thiab cov neeg xa khoom, kev nkag siab txog cov qauv kev hloov pauv no tsis yog hais txog kev ua raws li kev cai lij choj - nws yog qhov tseem ceeb los ua kom cov khoom muaj kev nyab xeeb, txhim kho kev lag luam, thiab tsim kom muaj kev ntseeg siab ntev.
Kev nruj nruj rau kev nyab xeeb thiab kev taug qab
Hauv Tebchaws Europe thiab Tebchaws Meskas, kev nyab xeeb ntawm tus neeg mob yog thawj tus tsav tsheb tom qab cov kev hloov pauv tshiab. Piv txwv li, EU's Medical Device Regulation (MDR), uas tau hloov pauv tag nrho MDD yav dhau los xyoo 2021, hais txog kev soj ntsuam tag nrho, kev ntsuas kev pheej hmoo, thiab kev soj ntsuam tom qab kev lag luam.
Hauv Teb Chaws Asmeskas, FDA's 21 CFR Part 820 (Quality System Regulation) tseem ua tus txheej txheem rau kev tsim khoom. Txawm li cas los xij, cov kev hloov tshiab tom ntej no tau ua raws li ISO 13485 yuav ua kom hnyav dua rau kev taug qab thiab cov ntaub ntawv-tshwj xeeb tshaj yog rau Chav Kawm II xws li cov koob txhaj tshuaj thiab cov hlab ntim ntshav.
Qhov no txhais li cas rau cov neeg muag khoom? Txhua theem ntawm cov saw hlau-los ntawm kev xaiv raw khoom mus rau ntim-yuav tsum tam sim no traceable thiab verifiable.
Hais txog Biocompatibility thiab Sterility Assurance
Nrog rau kev txhawj xeeb ntxiv txog tus neeg mob cov tshuaj tiv thaiv thiab kev pheej hmoo kis kab mob, kev sim biocompatibility tsis yog xaiv tau lawm. Cov neeg saib xyuas European thiab Asmeskas xav tau kev ntsuas qhov tob raws li ISO 10993 cov qauv kom paub meej tias cov khoom siv hauv cov koob txhaj tshuaj, lancets, thiab cov raj muaj kev nyab xeeb rau tib neeg kev sib cuag.
Tsis tas li ntawd, cov txheej txheem ua kom tsis muaj menyuam (xws li ethylene oxide lossis gamma irradiation) yuav tsum ua kom tau raws li qhov yuav tsum tau muaj kev lees paub tau teev tseg hauv ISO 11135 lossis ISO 11137, feem. Sterility assurance yog ib qho tseem ceeb tshwj xeeb tshaj yog rau cov khoom uas tau prefilled los yog siv nyob rau hauv ncaj qha mus sau ntshav.
Rau cov neeg yuav khoom kho mob thiab cov neeg xa khoom, qhov no txhais tau tias xaiv cov neeg xa khoom tuaj yeem muab cov ntaub ntawv qhia txog kev tsis muaj menyuam thiab cov txheej txheem siv tau yog qhov tseem ceeb dua li qhov qub.
Eco-Conscious Materials thiab Sustainable Ntim Requirements
Nyob rau hauv xyoo tas los no, sustainability tau hloov los ntawm kev lag luam lus mus rau kev tswj hwm kev cia siab. EU tab tom txhawb nqa kom txo qis ntawm cov yas siv ib zaug thiab cov khoom tsis zoo rau ib puag ncig. Txawm hais tias cov khoom siv kho mob feem ntau raug zam los ntawm kev txwv, muaj kev nyuaj siab los siv cov khoom siv rov ua dua lossis bio-raws li qhov twg los tau.
Ib yam li ntawd, Asmeskas kev ua lag luam-tshwj xeeb ntawm cov kev pabcuam kev noj qab haus huv loj-yog nce kev tshuaj xyuas cov khoom raws li lawv qhov chaw ib puag ncig. Ntim uas txo cov pov tseg, lossis cov khoom siv ua los ntawm BPA-dawb thiab DEHP-dawb cov ntaub ntawv, tau dhau los ua qauv nyiam.
Rau cov chaw tsim khoom ntawm cov khoom siv ntshav thiab cov koob txhaj tshuaj, kev yoog raws li cov kev cia siab no yuav tsis tsuas yog ua raws li kev ua raws cai-tab sis kuj txhawb kev sib tw.
Qhov tseem ceeb ntawm Kev Sau Npe thiab Kev Ua Raws Li UDI
Cov koom haum tswj hwm tab tom rhuav tshem ntawm qhov tseeb ntawm daim ntawv lo. EU MDR thiab US FDA ob leeg xav kom cov khoom lag luam kom meej meej luam tawm Cov Ntaus Ntaus Ntaus (UDI), hnub tas sij hawm, batch tooj, thiab cov lus hauv cheeb tsam rau kev lag luam uas lawv muag.
Kev ua tsis tau raws li cov qauv no tuaj yeem ua rau kev lis kev cai qeeb, rov qab los, lossis poob kev nkag mus rau hauv khw. Xaiv cov txheej txheem ntim khoom thiab daim ntawv lo uas txhawb kev tswj hwm cov ntawv sau npe yog ib kauj ruam tseem ceeb hauv kev ua kom muaj kev ua haujlwm zoo ntshuam / xa tawm.
Kev tswj xyuas cov kev cai nrog kev ntseeg siab
Kev taw qhia txog kev tswj hwm ib puag ncig nyuaj hauv Tebchaws Europe thiab Asmeskas yuav tsum muaj ntau tshaj li kev ua raws cai-nws hu rau kev npaj ua ntej, kev siv cov khoom tsis tu ncua, thiab ua tib zoo mloog rau cov qauv tshiab.
Rau cov neeg yuav khoom, cov neeg xa khoom, thiab cov kws kho mob ib yam nkaus, kev paub txog cov kev cai tshiab tshaj plaws hauv cov koob txhaj tshuaj thiab cov khoom siv ntshav yog qhov tseem ceeb rau kev txiav txim siab txog kev muag khoom ntse.
Nrhiav kom paub tseeb tias koj cov khoom siv kho mob pov tseg tau raws li cov qauv kev cai thoob ntiaj teb? Nkag mus rau Sinomed hnub no thiab tshawb xyuas seb peb cov kev daws teeb meem txhawb koj li kev ua raws thiab cov hom phiaj zoo li cas.
Post lub sij hawm: Jun-23-2025
