Malamulo a EU ndi zofunikira pakutumiza kunja kwa zida zachipatala

Pa Meyi 25, 2017, EU Medical Device Regulation (MDR Regulation (EU) 2017/745)idakhazikitsidwa mwalamulo,ndi nthawi ya kusintha kwa zaka zitatu. Poyamba zidakonzedwa kuti zizigwiritsidwa ntchito mokwanira kuyambira pa Meyi 26, 2020. Kuti apatse mabizinesi nthawi yochulukirapo kuti agwirizane ndi malamulo atsopano ndikuwonetsetsa kuti zinthuzo zikukwaniritsa zofunikira. Bungwe la European Commission linavomereza ndondomeko yowonjezera nthawi ya kusintha kwa 6 January 2023. Malinga ndi ndondomekoyi, nthawi yosinthira zida zowonongeka idzawonjezeka kuyambira May 26, 2024 mpaka December 31, 2027; nthawi yosinthira zida zokhala ndi chiopsezo chochepa komanso chapakatikati idzawonjezedwa mpaka pa Disembala 31, 2028; Mwambo wokhazikika wa Class III Nthawi yosinthira zida idzakulitsidwa mpaka Meyi 26, 2026.

 

Kuti mumvetsetse zofunikira zamakemikolo za EU Medical Device Regulation MDR, muyenera kumvetsetsa kayeCMR ndi EDCs zinthu.

Mtengo wa CMRCMR ndi chidule cha Carcinogenic carcinogenic substance, Mutagenic gene mutagenic substance ndi Reprotoxic reprotoxic reproductive substance toxic substance. Popeza zinthu za CMR zili ndi zowopsa zosatha, ziyenera kuyendetsedwa mosamalitsa komanso zoletsedwa. Zinthu zikwizikwi za CMR zalengezedwa mpaka pano, ndipo chiwerengerocho chipitilira kuwonjezeka mtsogolo. Malingana ndi zoopsa zawo, amagawidwa makamaka m'magulu atatu awa:

CMR: 1A——Zatsimikiziridwa kuti zili ndi kawopsedwe ka carcinogenic, mutagenic ndi uchembele pa anthu

CMR: 1B——Zatsimikiziridwa ndi kuyesa kwa nyama kuti zingayambitse zotsatira zitatu pamwambapa pa thupi la munthu

CMR: 2——Zolemba zina zimanena kuti zingayambitse zotsatira zitatu zomwe zili pamwambazi pathupi la munthu. Chinthu cha CMR chikhoza kukhala ndi chiwopsezo chimodzi kapena zingapo za CMR. Ikakhala ndi zoopsa zambiri za CMR, imagawidwa molingana ndi chiwopsezo chilichonse, mwachitsanzo:

Benzene ndi carcinogenic 1A ndi teratogenic 1B zinthu; (Carc. Cat. 1A, Muta. Cat. 1B)

Mtsogoleri (II) chromate ndi carcinogenic 1B, kawopsedwe ka uchembere 1A zinthu; (Carc. Cat. 1B, Repr. Cat. 1A)

Dibutyltin dichloride ndi gulu teratogenic 2, uchembele kawopsedwe gulu 1B mankhwala; (Muta. Cat. 2, Repr. Cat. 1B)

Benzo(a) pyrene ndi carcinogenic 1B, teratogenic 1B, ndi ubereki poizoni 1B; (Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).Zinthu za EDCZinthu za EDCs ndi Endocrine-Disrupting Chemicals endocrine kusokoneza zinthu za mankhwala, zomwe zimatanthawuza zinthu za mankhwala zomwe zingasokoneze ntchito ya endocrine yaumunthu kuchokera kuzinthu zakunja. Mankhwala opangidwa ndi anthuwa amatha kulowa m'thupi la munthu kapena nyama zina kudzera munjira yazakudya (zakudya) kapena kukhudzana, ndikusokoneza ubereki wawo. Adzasokoneza kaphatikizidwe, kumasulidwa, kusuntha, kagayidwe, ndi kuphatikiza kwa zinthu zomwe nthawi zambiri zimatulutsidwa m'thupi, kuyambitsa kapena kuletsa dongosolo la endocrine, ndikuwononga gawo lake pakusunga bata ndi kuwongolera thupi.

EU Medical Device RegulationMDR

MDR ndiye njira yopezera zida zamankhwala kuti zilowe mumsika wa EU. Cholinga chake chachikulu ndikuwonetsetsa chitetezo ndi magwiridwe antchito a zida zamankhwala munthawi yonse ya moyo wawo, ndikuwongolera zida zamankhwala zomwe zimagulitsidwa pamsika wa EU m'njira mwadongosolo kuti ziteteze anthu. Thanzi ndi Chitetezo cha Odwala. Kukhazikitsidwa kwa lamuloli kumatanthauzanso kuti malangizo am'mbuyomu achipatala (AIMD, 90/385/EEC) ndi passive medical device Directive (MDD, 93/42/EEC) adzasinthidwa pang’onopang’ono. Mosiyana ndi malamulo am'mbuyomu, ndikofunikira mu Article 52 ya MDR ndi Mutu II Annex I 10.4.1 kuti zinthu za CMR/ECDs ziyenera kupewedwa pazida ndi zigawo zake kapena zida zomwe zili ndi izi:

01 Intrusive , komanso kukhudzana mwachindunji ndi thupi la munthu, monga implants mafupa, khutu kuyezetsa thermometer mitu, etc.;

02 yomwe imagwiritsidwa ntchito popereka mankhwala, madzi amthupi kapena zinthu zina (kuphatikiza mpweya) m'thupi la munthu, monga machubu opumira, ndi zina zotero;

03 yogwiritsidwa ntchito ponyamula kapena kusungira kuti iperekedwe Mankhwala osokoneza bongo, madzi amthupi kapena zinthu (kuphatikiza mpweya) kupita mthupi la munthu, monga zida zolowetsera, ndi zina.

EU Medical Device Regulation (MDR)Zoletsa ndi Zofunikira

Malinga ndi malamulo a MDR, ndikofunikira kutsimikizira zida zamankhwala ndi zigawo zake ndi zida, ndikupewa kuchuluka kwa zinthu zotsatirazi zopitilira 0.1 (W / W)%: 1) Carcinogenic, mutagenic kapena reproductive toxic (CMR) zinthu: gulu 1A kapena 1B, malinga ndi Table 3.1 ya Gawo 3 la Annex VI ya Regulation No 1272/2008 ya European Parliament and of the Council (CLP) Malamulo). 2) Zinthu zomwe zili ndi endocrine zosokoneza katundu (EDCs) zomwe zili ndi umboni wasayansi wotsimikizira kuti zitha kukhala ndi zotsatirapo zoyipa paumoyo wamunthu, zodziwika motsatira ndondomeko yomwe yafotokozedwa mu Article 59 ya Regulation 2 ya European Parliament ndi Council No 1907/2006 (REACH Regulation), kapena molingana ndi Woweruza ndi Ndime 5(3) ya Lamulo (3) No 528/2012 ya Nyumba Yamalamulo yaku Europe ndi Council. Ngati kuchuluka kwa zinthu za CMR/EDCs ndikwambiri kuposa 0.1%, wopanga zida aziwonetsa kukhalapo kwa zinthu izi pachidachocho komanso kulongedza kwagawo lililonse, ndikupereka mndandanda kuphatikiza mayina azinthuzo ndi kuchuluka kwake. Ngati cholinga chogwiritsa ntchito chida choterechi chikuphatikiza chithandizo cha ana, amayi apakati kapena oyamwitsa, ndi magulu ena odwala omwe akuwoneka kuti ali pachiwopsezo chovulazidwa ndi zinthu zotere ndi/kapena zida, malangizo ogwiritsira ntchito anena kuti magulu odwalawa angakumane nawo. chiopsezo chotsalira, ndi njira zoyenera zodzitetezera, ngati n'koyenera.

RoHS-Kuletsaza kugwiritsa ntchito zinthu zina zowopsa pazida zamagetsi ndi zamagetsi

Ngati zoyezetsa ndi kuwunika kwa RoHS, REACH ndi malangizo ena zakwaniritsidwa, kodi timafunikirabe zotsatira za kuyezetsa kwa mankhwala omwe MDR amafunikira? EU RoHS Directive ndi muyezo wovomerezeka. Zinthu zamagetsi zoyendetsedwa ndi magetsi ndi zida zofananira ziyenera kukhala zochepa kuposa zofunikira za zinthu zoletsedwa. Ndi chitsogozo chomwe chiyenera kutsatiridwa potumiza zida zamagetsi zamagetsi ku EU.

Malamulo a REACH amayang'ana kwambiri zofunika ziwiri zotsatirazi pazida zamankhwala kuti ziwongolere komanso zidziwitso(Ndime 7 (2)): Pamene kuchuluka kwa zinthu zomwe zimadetsa nkhawa kwambiri (SVHC) ndi> 0.1% ndipo voliyumu yonse yotumiza kunja ndi> 1 ton/chaka, chinthucho chiyenera kudziwitsidwa ku The European Chemicals Agency (ECHA) , mwa zina, chitha kuphatikiziranso zofunikira pakusamutsa zidziwitso pamayendedwe operekera. Zinthu zoletsedwa ndi zoletsedwa (Ndime 67): Pazinthu zogwiritsiridwa ntchito mwachindunji kapena ngati chinthucho chili ndi zoletsedwa komanso zoletsedwa kupitilira malire, kupanga ndi kugwiritsa ntchito ndikoletsedwa.

Packaging and Packaging Waste Directive-Directive 94/62/EC (PPW)Packaging and Packaging Waste Directive (Directive on Packaging and Packaging Waste) imafotokoza makamaka zitsulo zinayi zolemera muzoyikamo ndi malire a ndende ndi kulongedza zinyalala zobwezeretsanso. Malinga ndi Ndime 22(i) ya lamuloli, mayiko omwe ali m'bungwe la EU akuyenera kuwonetsetsa kuti kuyambira Juni 30, 2001, zida zawo zopakira kapena zopakira sizingakhale ndi zitsulo zinayi zolemera (cadmium, hexavalent chromium, lead, mercury) ndi kuchuluka kwake konse. Zonse siziyenera kupitirira 100 ppm. European Union inapereka Directive 2013/2/EU pa 2013.02.08 kuti iwunikensonso Packaging Materials and Packaging Waste Directive (Directive 94/62/EC, PPW). Lamulo latsopanoli likusunga zofunikira zinayi zomwezo za zinthu zovulaza muzoyikapo: lead, cadmium, mercury, ndi hexavalent chromium, ndipo akadali ochepa ku 100ppm, akugwira ntchito pa Seputembara 30, 2013. Malinga ndi zofunikira za PPW, kuyika kwazinthu. Wopangayo akuyenera kukwaniritsa zofunikira zosavulaza, kulongedzanso, kubwezeretsanso zinthu zotayirira komanso mitundu ina ya kusinthika, ndi kuchepetsa kutaya komaliza. Zolemba zokonzedwa zimatchedwa zida zonyamula. Lipoti la kutsata kwangozi / kutsimikizira.

Zida zamankhwala zolipiridwa ndi EU ziyenera kutsatira malamulo atatu a MDR, RoHS ndi REACH

Zofunikira pakutsata kwa MDR, RoHS ndi REACH ndizofanana. Zida zamankhwala zomwe zimayikidwa pamsika wa EU ziyenera kutsatira zomwe zili m'malamulo atatuwa, pomwe zida zachipatala zomwe sizimatsatira malamulo a RoHS. Mwa iwo, malamulo a REACH ndi RoHS ndiwo maziko, ndipo pazida zamankhwala zomwe zimagwirizana ndi mafotokozedwe a MDR Annex I 10.4.1, kuyezetsa kwa mankhwala a CMR/EDCs kuyenera kuchitidwa. Kuphatikiza apo, zida zamankhwala zimayenera kutsatira zofunikira za malamulo a MDR osati kungokwaniritsa zofunikira za RoHS ndi REACH, komanso kugawa mankhwala aliwonse potengera kupanga zinthu ndi kuopsa kwake posankha njira yoyenera yowunikira kuti zitsimikizire. kuti zida zamankhwala ndizoyenera Zida zosiyanasiyana zimayesedwa kuti ziwunikire bwino zinthu.