NgoMeyi 25, 2017, i-EU Medical Device Regulation (MDR Regulation (EU) 2017/745)yamenyezelwa ngokusemthethweni,nesikhathi soguquko seminyaka emithathu.Kwakuhlelelwe ukuthi isebenze ngokugcwele kusukela ngomhlaka-26 Meyi 2020. Ukuze kunikezwe amabhizinisi isikhathi esengeziwe sokuzivumelanisa nemithetho emisha futhi kuqinisekiswe ukuthi imikhiqizo ihlangabezana nezimfuneko.I-European Commission yamukele isiphakamiso sokwelula isikhathi soshintsho ku-6 January 2023. Ngokusho kwalesi siphakamiso, isikhathi sokuguqulwa kwamadivayisi anobungozi obukhulu sizonwetshwa kusukela ngoMeyi 26, 2024 kuya kuDisemba 31, 2027;isikhathi soshintsho samadivayisi anobungozi obuncane naphakathi sizonwetshwa sifike kuDisemba 31, 2028;Isiko elifakelwayo Lesigaba III Isikhathi soshintsho lwemishini sizonwetshwa kuze kube ngumhla zingama-26 kuMeyi 2026.
Ukuze uqonde izidingo zamakhemikhali ze-EU Medical Device Regulation MDR, kufanele uqale uqondeCMR kanye EDCs izinto.
Intengo ye-CMRI-CMR isifinyezo se-Carcinogenic carcinogenic substance, i-Mutagenic gene mutagenic substance kanye ne-Reprotoxic reproductive substance enobuthi.Njengoba izinto ze-CMR zinezingozi ezingapheli, kufanele zilawulwe ngokuqinile futhi zibe nemingcele.Izinkulungwane zezinto ze-CMR sezimenyezelwe kuze kube manje, futhi inani lizoqhubeka nokukhula ngokuzayo.Ngokuya ngezingozi zabo, zihlukaniswa ngokuyinhloko zibe izigaba ezintathu ezilandelayo:
I-CMR: 1A——Kufakazelwe ukuthi inomdlavuza, i-mutagenic kanye nemiphumela yobuthi yokuzala kubantu
I-CMR: 1B——Kuqinisekiswe ukuhlola kwezilwane ukuthi kungase kubangele imiphumela emithathu engenhla emzimbeni womuntu
I-CMR: 2——Ezinye izincwadi zibonisa ukuthi kungase kubangele imiphumela emithathu engenhla emzimbeni womuntu.Into ye-CMR ingaqukatha isibaluli sengozi esisodwa noma eziningi ze-CMR.Uma iqukethe izibaluli eziningi zengozi ye-CMR, izohlukaniswa ngokwesibaluli sengozi ngayinye,Isibonelo:
I-Benzene i-carcinogenic 1A kanye nezinto ze-teratogenic 1B;(Carc. Cat. 1A, Muta. Cat. 1B)
I-lead (II) chromate iyi-carcinogenic 1B, ubuthi bokuzala obungu-1A;(Carc. Cat. 1B, Repr. Cat. 1A)
I-Dibutyltin dichloride iyisigaba se-teratogenic 2, isigaba sobuthi bokuzala 1B into;(Muta. Cat. 2, Repr. Cat. 1B)
I-Benzo(a)pyrene iyi-carcinogenic 1B, i-teratogenic 1B, kanye nobuthi bokuzala obungu-1B;(Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).Izinto ze-EDCsIzinto ze-EDCs ngamakhemikhali aphazamisa i-Endocrine-Disrupting endocrine aphazamisa izinto zamakhemikhali, ezibhekisela ezintweni zamakhemikhali ezingaphazamisa umsebenzi we-endocrine womuntu ovela emithonjeni yangaphandle.Lekhemikhali eyenziwe ngumuntu ingangena emzimbeni womuntu noma kwezinye izilwane ngokusebenzisa iketango lokudla (ukudla) noma ukuthintana, futhi ithinte uhlelo lwazo lokuzala.Zizophazamisa ukuhlanganiswa, ukukhululwa, ukunyakaza, umzimba, kanye nenhlanganisela yezinto ezivame ukugcinwa emzimbeni, zenze kusebenze noma zivimbele uhlelo lwe-endocrine, futhi ngaleyo ndlela zicekele phansi indima yazo ekugcineni ukuzinza nokulawula umzimba.
I-EU Medical Device RegulationI-MDR
I-MDR iyisimiso sokufinyelela semishini yezokwelapha ukuze ingene emakethe ye-EU.Injongo yayo eyinhloko iwukuqinisekisa ukuphepha nokusebenza ngempumelelo kwemikhiqizo yemishini yezokwelapha kuwo wonke umjikelezo wempilo, kanye nokuphatha izisetshenziswa zezokwelapha ezithengiswa emakethe ye-EU ngendlela ehleleke kakhulu ukuze kuvikelwe umphakathi.Impilo Nokuphepha Kwesiguli.Ukwethulwa kwalo mthetho futhi kusho ukuthi umyalelo wedivayisi yezokwelapha osebenzayo (AIMD, 90/385/EEC) kanye nomyalelo we-passive medical device (MDD, 93/42/EEC) uzoshintshwa kancane kancane.Ngokuhlukile emithethweni yangaphambilini, kuyadingeka ku-MDR Article 52 kanye neSahluko II Annex I 10.4.1 ukuthi izinto ze-CMR/ECDs kufanele zigwenywe kumadivayisi nezingxenye zawo noma izinto ezinezici ezilandelayo:
01 Ukugxambukela , nokuthintana ngqo nomzimba womuntu, njengokufakela amathambo, amakhanda okuhlola izinga lokushisa kwendlebe, njll.;
02 esetshenziselwa ukuletha izidakamizwa, uketshezi lomzimba noma ezinye izinto (okuhlanganisa namagesi) emzimbeni womuntu, njengamashubhu okuphefumula, njll.;
03 esetshenziselwa ukuthutha noma ukugcinwa ukuze kulethwe Izidakamizwa, uketshezi lomzimba noma izinto (okuhlanganisa namagesi) emzimbeni womuntu, njengemishini yokumnika, njll.
I-EU Medical Device Regulation (MDR)Imikhawulo kanye Nezimfuneko
Ngokwemithetho ye-MDR, kuyadingeka ukuqinisekisa amathuluzi ezokwelapha kanye nezingxenye zawo nezinto zokwakha, futhi ugweme ukuhlangana kwezinto ezilandelayo ezedlula u-0.1 (W/W)%: 1) Izinto ezinobuthi ezinomdlavuza, eziguquguqukayo noma ezinobuthi bokuzala (CMR): isigaba 1A noma 1B , ngokuvumelana neThebula 3.1 Lengxenye 3 yeSijobelelo VI Somthethonqubo No 1272/2008 wePhalamende LaseYurophu kanye NoMkhandlu (I-CLP Regulation).2) Izinto ezinezakhiwo eziphazamisa i-endocrine (EDCs) ezinobufakazi besayensi obufakazela ukuthi zingase zibe nemiphumela emibi kakhulu empilweni yomuntu, ezihlonzwe ngokuhambisana nenqubo eshiwo ku-Article 59 ye-Regulation 2 yePhalamende laseYurophu kanye noMkhandlu No 1907/2006. (REACH Regulation), noma ngokuvumelana ne-Article 5(3) yoMthetho (3) No 528/2012 wePhalamende LaseYurophu kanye NoMkhandlu.Uma ukuqoqwa kwezinto ze-CMR/EDCs kungaphezu kuka-0.1%, umkhiqizi wedivayisi uzobonisa ukuba khona kwalezi zinto kudivayisi ngokwayo kanye nokupakishwa kweyunithi ngayinye, futhi anikeze uhlu olufaka amagama ezinto nokugxilisa kwazo.Uma ukusetshenziswa okuhlosiwe kwalolu cingo kubandakanya ukwelapha izingane, abesifazane abakhulelwe noma abancelisayo, namanye amaqembu eziguli athathwa njengabasengozini yokulimala okuvela kulezo zinto kanye/noma izinto zokwakha, imiyalelo yokusetshenziswa izosho ukuthi lawa maqembu eziguli angase abhekane nawo. ingozi eyinsalela, kanye nezinyathelo zokuphepha ezifanele, uma zikhona.
I-RoHS-Restrictionukusetshenziswa kwezinto ezithile eziyingozi ezintweni zikagesi neze-elekthronikhi
Uma izidingo zokuhlolwa nokuhlolwa kwe-RoHS, REACH kanye nezinye iziqondiso kuhlangatshezwane nazo, ingabe sisayidinga imiphumela yokuhlolwa kwezinto zamakhemikhali ezidingwa yi-MDR?I-EU RoHS Directive iyindinganiso eyisibopho.Imikhiqizo ye-elekthronikhi nekagesi elawulwayo kanye nezingxenye ezihlobene kufanele kube ngaphansi kunezidingo zezinto ezivinjelwe.Kuyisiqondiso okufanele sinakwe lapho kuthunyelwa imishini yezokwelapha ye-elekthronikhi ku-EU.
Imithetho ye-REACH igxile kakhulu kulezi zidingo ezimbili ezilandelayo ezinsizeni zezokwelapha zokulawula nokwazisa(I-athikili 7 (2)): Uma ukuhlangana kwento ekhathaza kakhulu (SVHC) ingu> 0.1% futhi isamba sevolumu yokuthekelisa i> 1 ton/ngonyaka, leyo nto kufanele yaziswe ku-The European Chemicals Agency (ECHA) , phakathi kwezinye izinto, kungase futhi kubandakanye izimfuneko zokudluliselwa kolwazi eduze kochungechunge lokunikezela.Izinto ezinqatshelwe nezikhawulelwe (I-athikili 67): Ngezinto ezithile zokusetshenziswa noma lapho umkhiqizo uqukethe izinto ezinqatshelwe nezikhawulelwe ezeqa umkhawulo, ukwenziwa nokusetshenziswa akuvunyelwe.
Ukupakisha nokupakisha Udoti Directive-94/62/EC (PPW)Isiyalezo Sokupakisha Nokupakishwa Kwemfucuza (Isiyalezo Sokupakishwa Nokupakishwa Kwemfucuza) sibeka ikakhulukazi izinsimbi ezine ezisindayo ezintweni zokupakisha kanye nemikhawulo yokugxilisa ingqondo kanye nokupakisha ukugaywa kabusha kwemfucuza.Ngokuvumelana ne-Article 22(i) yalo mthetho, amazwe angamalungu e-EU kufanele aqinisekise ukuthi kusukela ngomhlaka-30 Juni 2001, izinto zawo zokupakisha noma zokupakisha azikwazi ukuqukatha izinsimbi ezine ezisindayo (i-cadmium, i-chromium ene-hexavalent, i-lead, i-mercury) kanye nengqikithi yazo.Isamba akumele sidlule ku-100 ppm.I-European Union ikhiphe i-Directive 2013/2/EU ngomhla ka-2013.02.08 ukuze ibuyekeze i-Packaging Materials and Packaging Waste Directive (Directive 94/62/EC, PPW).Umyalelo omusha ugcina izimfuneko ezine eziphelele ezifanayo zezinto eziyingozi ezintweni zokupakisha: umthofu, i-cadmium, i-mercury, ne-hexavalent chromium, futhi usakhawulelwe ku-100ppm, ukusebenza ngoSepthemba 30, 2013. Ngokwezidingo ze-PPW, ukupakishwa komkhiqizo womkhiqizi kufanele ahlangabezane nezidingo zokungabi nangozi, ukuphinda ukupakisha, ukugaywa kabusha kwezinto zokupakisha imfucuza nezinye izinhlobo zokuvuselela, kanye nokunciphisa ukulahlwa kokugcina.Amadokhumenti alungisiwe abizwa ngokuthi izinto zokupakisha.Umbiko wokuhlola ukuthobela ubungozi/ukuqinisekisa.
Imishini yezokwelapha ekhokhiswa yi-EU kufanele ihambisane nemithethonqubo emithathu ye-MDR, RoHS kanye ne-REACH
Izidingo zokuthobela i-MDR, RoHS kanye ne-REACH ziyahambisana.Imishini yezokwelapha ebukhoma ebekwe emakethe ye-EU kufanele ihambisane nezidingo zale mithetho emithathu, kuyilapho imishini yezokwelapha engenzi lutho ingekho ngaphansi kwemithetho ye-RoHS.Phakathi kwayo, imithetho ye-REACH kanye ne-RoHS iyisisekelo, futhi emishinini yezokwelapha ethobela incazelo ye-MDR Annex I 10.4.1, ukuhlolwa kwekhemikhali ye-CMR/EDCs kufanele kwenziwe.Ngaphezu kwalokho, imishini yezokwelapha idinga ukuthobela izimfuneko zemithetho ye-MDR hhayi kuphela ukuze ihlangabezane nezidingo ze-RoHS kanye nemithetho ye-REACH, kodwa futhi nokuhlukanisa ikhemikhali ngayinye ngokusekelwe ekwenziweni kwezinto kanye nezingozi zazo lapho kukhethwa indlela yokuhlola efanele ukuze kuqinisekiswe ukuthi imishini yezokwelapha ifanele Izinto ezisetshenziswayo ezahlukene zihlolwa ukuze kuhlolwe izinto ezifanele.
Isikhathi sokuthumela: Sep-06-2023