Nyob rau lub Tsib Hlis 25, 2017, EU Medical Device Regulation (MDR Regulation (EU) 2017/745)tau tshaj tawm officially,nrog rau lub sijhawm hloov pauv ntawm peb xyoos. Nws yog thawj zaug tau npaj ua tiav los ntawm Lub Tsib Hlis 26, 2020. Txhawm rau muab sijhawm rau cov tuam txhab lag luam kom hloov mus rau cov kev cai tshiab thiab xyuas kom cov khoom ua tau raws li qhov yuav tsum tau ua. Cov European Commission tau txais kev pom zoo los txuas ntxiv lub sijhawm hloov pauv ntawm 6 Lub Ib Hlis 2023. Raws li qhov kev pom zoo no, lub sijhawm hloov pauv rau cov cuab yeej muaj kev pheej hmoo siab yuav txuas ntxiv txij lub Tsib Hlis 26, 2024 txog rau Lub Kaum Ob Hlis 31, 2027; Lub sijhawm hloov pauv rau cov khoom siv uas pheej hmoo tsawg thiab nruab nrab yuav txuas ntxiv mus rau lub Kaum Ob Hlis 31, 2028; Class III implantable custom Lub sijhawm hloov pauv rau cov cuab yeej siv yuav txuas ntxiv mus txog lub Tsib Hlis 26, 2026.
Yuav kom nkag siab txog cov tshuaj uas yuav tsum tau ua ntawm EU Kev Tswj Xyuas Khoom Siv Kho Mob MDR, koj yuav tsum nkag siab ua ntejCMR thiab EDCs cov khoom.
CMR khoomCMR yog cov ntawv luv ntawm Carcinogenic carcinogenic substance, Mutagenic gene mutagenic substance thiab Reprotoxic reproductive toxic substance. Txij li cov tshuaj CMR muaj kev phom sij ntev, lawv yuav tsum tau tswj xyuas nruj thiab txwv. Ntau txhiab tus CMR tshuaj tau tshaj tawm txog tam sim no, thiab tus lej yuav txuas ntxiv mus ntxiv rau yav tom ntej. Raws li lawv cov kev phom sij, lawv feem ntau muab faib ua peb pawg hauv qab no:
CMR: 1A—— Ua pov thawj tias muaj cov kab mob carcinogenic, mutagenic thiab cov tshuaj tua kab mob rau tib neeg
CMR: 1B—— Nws tau raug lees paub los ntawm kev sim tsiaj txhu tias nws tuaj yeem ua rau peb qhov teebmeem saum toj no rau tib neeg lub cev
CMR: 2—— Qee cov ntaub ntawv qhia tau hais tias nws yuav ua rau peb qhov teebmeem saum toj no rau tib neeg lub cev. Ib yam khoom CMR tuaj yeem muaj ib lossis ntau tus yam ntxwv CMR txaus ntshai. Thaum nws muaj ntau yam CMR kev phom sij, nws yuav raug cais raws li txhua yam kev phom sij, Piv txwv li:
Benzene yog carcinogenic 1A thiab teratogenic 1B tshuaj; (Carc. Cat. 1A, Muta. Cat. 1B)
Lead (II) chromate yog carcinogenic 1B, kev ua me nyuam toxicity 1A tshuaj; (Carc. Cat. 1B, Repr. Cat. 1A)
Dibutyltin dichloride yog teratogenic qeb 2, kev ua me nyuam toxicity qeb 1B khoom; (Muta. Cat. 2, Repr. Cat. 1B)
Benzo(a) pyrene yog carcinogenic 1B, teratogenic 1B, thiab cov tshuaj lom 1B; (Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).EDCs cov khoomEDCs tshuaj yog Endocrine-Disrupting Chemicals endocrine cuam tshuam cov tshuaj, uas yog xa mus rau cov tshuaj uas tuaj yeem cuam tshuam rau tib neeg endocrine kev ua haujlwm los ntawm lwm qhov chaw. Cov txiv neej tsim cov tshuaj no tuaj yeem nkag mus rau tib neeg lub cev lossis lwm yam tsiaj los ntawm cov khoom noj khoom haus (kev noj haus) lossis kev sib cuag, thiab cuam tshuam rau lawv txoj kev loj hlob. Lawv yuav cuam tshuam nrog kev sib txuas, kev tso tawm, kev txav mus los, cov metabolism, thiab kev sib xyaw ua ke ntawm cov tshuaj nquag tso tawm hauv lub cev, qhib lossis cuam tshuam cov kab mob endocrine, thiab yog li rhuav tshem nws lub luag haujlwm hauv kev tswj hwm kev ruaj ntseg thiab kev tswj hwm ntawm lub cev.
EU Medical Device RegulationMDR
MDR yog txoj cai nkag mus rau cov cuab yeej kho mob kom nkag mus rau EU lag luam. Nws lub hom phiaj tseem ceeb yog ua kom muaj kev nyab xeeb thiab ua tau zoo ntawm cov khoom siv kho mob thoob plaws lub neej, thiab tswj xyuas cov khoom siv kho mob muag hauv EU ua lag luam kom muaj txiaj ntsig zoo los tiv thaiv pej xeem. Kev noj qab haus huv thiab kev nyab xeeb ntawm tus neeg mob. Kev taw qhia ntawm txoj cai no kuj txhais tau hais tias yav dhau los cov lus qhia siv khoom siv kho mob (AIMD, 90/385 / EEC) thiab cov lus qhia siv khoom siv kho mob tsis zoo (MDD, 93/42 / EEC) yuav maj mam hloov. Sib txawv ntawm cov kev cai yav dhau los, nws yuav tsum muaj nyob rau hauv MDR Tshooj 52 thiab Tshooj II Annex I 10.4.1 tias CMR/ECDs tshuaj yuav tsum raug zam rau cov khoom siv thiab lawv cov khoom lossis cov khoom siv nrog cov yam ntxwv hauv qab no:
01 Intrusive, thiab nyob rau hauv kev sib cuag nrog tib neeg lub cev, xws li orthopedic implants, pob ntseg ntsuas kub taub hau, thiab lwm yam .;
02 siv los xa cov tshuaj, kua hauv lub cev lossis lwm yam khoom siv (nrog rau cov pa roj) rau tib neeg lub cev, xws li cov hlab ua pa, thiab lwm yam;
03 siv rau kev thauj mus los lossis khaws cia Cov Tshuaj, cov kua hauv lub cev lossis cov khoom siv (nrog rau cov pa roj) rau tib neeg lub cev, xws li cov khoom siv infusion, thiab lwm yam.
EU Medical Device Regulation (MDR)Kev txwv thiab kev xav tau
Raws li MDR cov cai, nws yog ib qho tsim nyog kom paub meej tias cov cuab yeej kho mob thiab lawv cov khoom siv thiab cov khoom siv, thiab zam cov concentration ntawm cov tshuaj hauv qab no ntau dua 0.1 (W / W)%: 1) Carcinogenic, mutagenic lossis reproductive toxic (CMR) cov khoom: qeb 1A lossis 1B, raws li Table 3.1 ntawm Tshooj 3 ntawm Annex VI ntawm Txoj Cai No 1272/2008 ntawm European Parliament thiab ntawm Council (CLP Regulation). 2) Cov tshuaj nrog endocrine cuam tshuam cov khoom (EDCs) uas muaj pov thawj kev tshawb fawb ua pov thawj tias lawv tuaj yeem muaj kev cuam tshuam loj rau tib neeg kev noj qab haus huv, raug txheeb xyuas raws li cov txheej txheem teev tseg hauv Tshooj 59 ntawm Txoj Cai 2 ntawm European Parliament thiab ntawm Pawg Neeg Saib Xyuas No 1907/2006 (REACH Regulation), los yog raws li Judged los ntawm Tshooj 5(3) ntawm Txoj Cai (3) No 528/2012 ntawm European Parliament thiab ntawm Council. Yog tias qhov concentration ntawm CMR / EDCs cov khoom siab tshaj 0.1%, cov chaw tsim khoom yuav tsum qhia tias muaj cov khoom no ntawm lub cuab yeej nws tus kheej thiab ntim ntawm txhua chav tsev, thiab muab cov npe nrog rau cov npe ntawm cov khoom thiab lawv cov concentration. Yog tias lub hom phiaj siv cov cuab yeej no suav nrog kev kho cov menyuam yaus, cev xeeb tub lossis cev xeeb tub, thiab lwm pab pawg neeg mob suav tias yog qhov muaj txiaj ntsig tshwj xeeb los ntawm cov tshuaj thiab / lossis cov khoom siv, cov lus qhia rau kev siv yuav tsum hais tias cov pab pawg neeg mob no yuav ntsib. residual txaus ntshai, thiab kev ceev faj tsim nyog, yog tias muaj.
RoHS-Kev txwvntawm kev siv qee yam khoom siv phom sij hauv cov khoom siv hluav taws xob thiab hluav taws xob
Yog tias qhov kev xeem thiab kev ntsuam xyuas cov cai ntawm RoHS, REACH thiab lwm cov lus qhia tau ua tiav, peb puas tseem xav tau cov txiaj ntsig ntawm cov tshuaj lom neeg xav tau los ntawm MDR? EU RoHS Cov Lus Qhia yog tus qauv tsim nyog. Tswj cov khoom siv hluav taws xob thiab hluav taws xob thiab cov khoom muaj feem cuam tshuam yuav tsum qis dua qhov yuav tsum tau muaj ntawm cov khoom txwv. Nws yog cov lus qhia uas yuav tsum tau them sai sai rau thaum xa khoom siv hluav taws xob kho mob mus rau EU.
Cov kev cai REACH feem ntau tsom rau ob qho kev cai hauv qab no hauv cov cuab yeej kho mob rau kev tswj thiab ceeb toom(Tshooj 7 (2)): Thaum cov ntsiab lus ntawm cov khoom muaj kev txhawj xeeb siab heev (SVHC) yog> 0.1% thiab tag nrho cov khoom xa tawm yog> 1 ton / xyoo, cov khoom yuav tsum tau ceeb toom rau Lub Chaw Haujlwm Saib Xyuas Tshuaj European (ECHA) , ntawm lwm yam, kuj tseem yuav suav nrog cov kev xav tau rau kev hloov pauv cov ntaub ntawv raws cov khoom siv. Txwv tsis pub thiab txwv cov tshuaj (Tshooj 67): Rau cov khoom siv tshwj xeeb lossis thaum cov khoom muaj cov tshuaj txwv tsis pub siv thiab txwv tsis pub tshaj qhov txwv, kev tsim khoom thiab siv yog txwv.
Kev ntim khoom thiab ntim cov khoom pov tseg-Directive 94/62/EC (PPW)Kev ntim thiab ntim cov khib nyiab (Cov Lus Qhia rau Kev ntim thiab ntim khib nyiab) feem ntau hais txog plaub qhov hnyav hlau hauv cov khoom ntim thiab cov kev txwv ntau thiab ntim cov khib nyiab pov tseg. Raws li Tshooj 22(i) ntawm txoj cai lij choj no, EU cov tswvcuab yuav tsum xyuas kom meej tias txij lub Rau Hli 30, 2001, lawv cov khoom ntim lossis cov khoom ntim tsis tuaj yeem muaj plaub cov hlau hnyav (cadmium, hexavalent chromium, txhuas, mercury) thiab lawv cov concentration tag nrho. Tag nrho yuav tsum tsis pub tshaj 100 ppm. Cov European Union tau tshaj tawm Cov Lus Qhia 2013/2/EU rau 2013.02.08 los kho cov Khoom Siv thiab Ntim Cov Khoom Siv Pov Tseg (Cov Lus Qhia 94/62/EC, PPW). Cov lus qhia tshiab tswj hwm tib yam plaub tag nrho cov kev xav tau rau cov khoom tsis zoo hauv cov khoom ntim: txhuas, cadmium, mercury, thiab hexavalent chromium, thiab tseem txwv rau 100ppm, siv tau rau lub Cuaj Hlis 30, 2013. Raws li cov kev cai ntawm PPW, cov khoom ntim ntawm cov neeg tsim khoom yuav tsum ua kom tau raws li qhov yuav tsum tau ua kom tsis muaj teeb meem, ntim rov siv dua, rov ua dua cov khoom ntim pov tseg thiab lwm yam ntaub ntawv ntawm regeneration, thiab txo qhov kev pov tseg zaum kawg. Cov ntaub ntawv npaj yog hu ua cov khoom ntim. Daim ntawv qhia txog kev ua raws li kev raug mob/kev pov thawj.
EU them cov cuab yeej kho mob yuav tsum ua raws li peb txoj cai ntawm MDR, RoHS thiab REACH
Cov kev cai ua raws li MDR, RoHS thiab REACH yog sib piv rau ib leeg. Cov cuab yeej siv kho mob nyob tau muab tso rau hauv EU kev ua lag luam yuav tsum ua raws li cov cai ntawm peb txoj cai no, thaum cov khoom siv kho mob tsis raug raws li RoHS cov cai. Ntawm lawv, REACH thiab RoHS cov cai yog lub hauv paus, thiab rau cov khoom siv kho mob uas ua raws li MDR Annex I 10.4.1 specification, CMR/EDCs tshuaj ntsuam xyuas yuav tsum tau ua. Tsis tas li ntawd, cov cuab yeej siv kho mob yuav tsum ua raws li cov cai ntawm MDR cov cai tsis yog kom ua tau raws li cov cai ntawm RoHS thiab REACH cov cai, tab sis kuj tseem yuav tsum txheeb xyuas txhua yam tshuaj raws li kev tsim khoom thiab lawv cov kev pheej hmoo thaum xaiv txoj kev ntsuas tsim nyog los xyuas kom meej. tias cov khoom siv kho mob tsim nyog rau Cov khoom sib txawv raug kuaj xyuas cov khoom tsim nyog.
Post lub sij hawm: Sep-06-2023