NgoMeyi 25, 2017, i-EU Medical Device Regulation (MDR Regulation (EU) 2017/745)yabhengezwa ngokusemthethweni,kunye nexesha lotshintsho leminyaka emithathu.Ekuqaleni kwakucetywe ukuba isebenze ngokupheleleyo ukususela nge-26 kaMeyi, 2020. Ukuze kunikwe amashishini ixesha elingakumbi lokuziqhelanisa nemigaqo emitsha kunye nokuqinisekisa ukuba iimveliso ziyahlangabezana neemfuno.IKhomishini yaseYurophu yamkele isiphakamiso sokwandisa ixesha lokutshintsha kwi-6 kaJanuwari 2023. Ngokwesi siphakamiso, ixesha lokuguqulwa kwezixhobo ezinobungozi kakhulu liya kwandiswa ukusuka ngoMeyi 26, 2024 ukuya kwi-31 kaDisemba 2027;ixesha lotshintsho lwezixhobo ezinomngcipheko ophantsi nophakathi liya kwandiswa ukuya kutsho kuDisemba 31, 2028;Isiko elimiliselweyo lweKlasi III Ixesha lotshintsho lwezixhobo liya kwandiswa kude kube nguMeyi 26, 2026.
Ukuqonda iimfuno zemichiza ye-EU Medical Device Regulation MDR, kufuneka uqale uqondeIzinto ze-CMR kunye ne-EDCs.
Into yeCMRI-CMR sisishunqulelo se-Carcinogenic carcinogenic substance, iMutagenic gene mutagenic substance kunye neReprotoxic reproductive substance eyityhefu.Kuba izinto ze-CMR zineengozi ezingapheliyo, kufuneka zilawulwe ngokungqongqo kwaye zibekelwe imiqathango.Amawakawaka ezinto zeCMR ziye zabhengezwa ukuza kuthi ga ngoku, kwaye inani liya kuqhubeka likhula kwixesha elizayo.Ngokweengozi zabo, bahlulahlulwe ikakhulu ngamacandelo amathathu alandelayo:
I-CMR: 1A--Ibonakaliswe ukuba ine-carcinogenic, i-mutagenic kunye nemiphumo eyityhefu yokuzala ebantwini
I-CMR: 1B——Ingqinwe ngovavanyo lwezilwanyana ukuba inokubangela ezi ziphumo zintathu zingasentla emzimbeni womntu
I-CMR: 2——Olunye uncwadi lubonisa ukuba lunokubangela ezi ziphumo zintathu zingasentla emzimbeni womntu.Into ye-CMR inokuqulatha enye okanye ngaphezulu iimpawu zobungozi zeCMR.Xa iqulethe iimpawu zobungozi ezininzi zeCMR, iya kwahlulwa ngokophawu ngalunye lwengozi, Umzekelo:
I-Benzene i-carcinogenic 1A kunye nezinto ze-teratogenic ze-1B;(Carc. Cat. 1A, Muta. Ikati. 1B)
Ilothe (II) chromate is carcinogenic 1B, ityhefu yokuzala 1A izinto;(Carc. Cat. 1B, Repr. Cat. 1A)
I-Dibutyltin dichloride luhlu lwe-teratogenic 2, i-toxicity ye-reproductive category 1B into;(Muta. Ikati. 2, Repr. Ikati. 1B)
I-Benzo (a) pyrene is carcinogenic 1B, teratogenic 1B, kunye ne-reproductive toxic 1B;(Carc. Cat. 1B, Muta. Ikati. 1B, Repr. Cat. 1B).EDCs izintoIzinto ze-EDCs ziyi-Endocrine-Disrupting Chemicals i-endocrine ephazamisa izinto zekhemikhali, ezibhekiselele kwizinto zamakhemikhali ezinokuphazamisa umsebenzi we-endocrine womntu ovela kwimithombo yangaphandle.Le khemikhali yenziwe ngumntu inokungena emzimbeni womntu okanye kwezinye izilwanyana ngekhonkco lokutya (ukutya) okanye ukudibana, kwaye ichaphazele inkqubo yazo yokuzala.Baya kuphazamisa ukuhlanganiswa, ukukhululwa, ukunyakaza, i-metabolism, kunye nokudibanisa kwezinto eziqhelekileyo ezifihliweyo emzimbeni, zisebenze okanye zithintele inkqubo ye-endocrine, kwaye ngaloo ndlela itshabalalise indima yayo ekugcineni uzinzo kunye nokulawulwa komzimba.
I-EU yoLawulo lweSixhobo sezoNyangoMDR
I-MDR ngumgaqo wokufikelela kwizixhobo zonyango ukungena kwimarike ye-EU.Injongo yalo ephambili kukuqinisekisa ukhuseleko kunye nokusebenza kakuhle kweemveliso zesixhobo zonyango kumjikelezo wobomi bonke, kunye nokulawula izixhobo zonyango ezithengiswa kwimarike ye-EU ngendlela ecwangcisiweyo yokukhusela uluntu.Impilo kunye noKhuseleko lwesigulane.Ukuqaliswa kwalo mmiselo kukwathetha ukuba umyalelo wesixhobo sonyango esisebenzayo (AIMD, 90/385/EEC) kunye ne-passive medical device directive (MDD, 93/42/EEC) iya kutshintshwa ngokuthe ngcembe.Ngokwahlukileyo kwimimiselo yangaphambili, kuyafuneka kwiSiqendu 52 se-MDR kunye neSahluko II seSihlomelo I 10.4.1 ukuba izinto ze-CMR/ECDs maziphetshwe kwizixhobo kunye namacandelo azo okanye izixhobo ezinezi mpawu zilandelayo:
01 I-Intrusive, kunye nokunxibelelana ngokuthe ngqo nomzimba womntu, njengokufakelwa kwamathambo, iintloko zokuvavanya i-thermometer yendlebe, njl.;
02 esetyenziselwa ukuhambisa iziyobisi, ulwelo lomzimba okanye ezinye izinto (kubandakanywa neegesi) emzimbeni womntu, njengetyhubhu zokuphefumla, njl.;
03 esetyenziselwa ukuthutha okanye ukugcinwa ukuze kuhanjiswe Iziyobisi, ulwelo lomzimba okanye izinto (kubandakanywa neegesi) kumzimba womntu, njengezixhobo zokuxilisa, njl.
I-EU yoLawulo lwesiXhobo sezoNyango (MDR)Izithintelo kunye neeMfuno
Ngokwemigaqo ye-MDR, kuyimfuneko ukuqinisekisa izixhobo zonyango kunye namacandelo abo kunye nezixhobo, kwaye ugweme ukuxinwa kwezinto ezilandelayo ezidlula i-0.1 (W / W)%: 1) I-Carcinogenic, i-mutagenic okanye i-reproductive toxic (CMR) izinto: udidi I-1A okanye i-1B, ngokweThebhile 3.1 yeCandelo 3 leSihlomelo VI soMgaqo we-1272/2008 wePalamente yaseYurophu kunye neBhunga (i-CLP Regulation).2) Izinto ezineempawu eziphazamisayo ze-endocrine (EDCs) ezinobungqina besayensi obubonisa ukuba zinokuba nemiphumo emibi kwimpilo yabantu, ezichongiweyo ngokuhambelana nenkqubo echazwe kwiSiqendu 59 soMgaqo we-2 wePalamente yaseYurophu kunye neBhunga No 1907/2006. (REACH Regulation), okanye ngokuhambelana neSiqendu 5(3) soMthetho (3) No 528/2012 yePalamente yaseYurophu kunye neBhunga.Ukuba umdibaniso wezinto zeCMR/EDCs ungaphezulu kwe-0.1%, umenzi wesixhobo uya kubonisa ubukho bezi zinto kwisixhobo ngokwaso kunye nokupakishwa kweyunithi nganye, kwaye abonelele ngoluhlu olubandakanya amagama ezinto kunye noxinzelelo lwazo.Ukuba injongo yokusetyenziswa kweso sixhobo kuquka unyango lwabantwana, abasetyhini abakhulelweyo okanye abancancisayo, kunye namanye amaqela ezigulane athathwa njengasemngciphekweni wokwenzakala kwizinto ezinjalo kunye/okanye imathiriyeli, imiyalelo yokusetyenziswa iyakuchaza ukuba la maqela ezigulane anokujongana nawo. umngcipheko oshiyekileyo, kunye nezilumkiso ezifanelekileyo, ukuba ziyasebenza.
RoHS-Uthinteloyokusetyenziswa kwezinto ezithile eziyingozi kwizixhobo zombane neze-elektroniki
Ukuba iimfuno zovavanyo kunye novavanyo lwe-RoHS, REACH kunye nezinye izikhokelo ziye zahlangatyezwa, ngaba sisafuna iziphumo zovavanyo lwemichiza efunwa yi-MDR?I-EU RoHS Directive ngumgangatho onyanzelekileyo.Iimveliso zombane kunye nezombane ezilawulwayo kunye neendawo ezinxulumene nazo kufuneka zibe ngaphantsi kweemfuno zezinto ezithintelweyo.Ngumyalelo ekufuneka uthathelwe ingqalelo xa uthumela izixhobo zonyango zombane kwi-EU.
Imimiselo ye-REACH igxile kakhulu kwiimfuno ezimbini ezilandelayo kwizixhobo zonyango zokulawula kunye nokwaziswa(Inqaku lesi-7 (2)): Xa ukuxinwa kwezinto ezixhalabisa kakhulu (i-SVHC) ku> 0.1% kunye nenani elipheleleyo lokuthumela ngaphandle> i-1 ton / ngonyaka, i-substance kufuneka ixelelwe kwi-European Chemicals Agency (ECHA) , phakathi kwezinye izinto, kunokubandakanya iimfuno zokudluliselwa kolwazi kunye nekhonkco lokubonelela.Izinto ezithintelweyo nezithintelweyo (Inqaku lama-67): Ukusetyenziswa kwemathiriyeli ethile okanye xa imveliso iqulethe izinto ezithintelweyo nezithintelweyo ezingaphaya komda, ukwenziwa kunye nokusetyenziswa akuvumelekanga.
UkuPakisha kunye nokuPakisha iWaste Directive-Directive 94/62/EC (PPW)UkuPakisha kunye nokuPakisha uMyalelo weNkunkuma (Umyalelo wokuPakisha nokuPakisha iNkunkuma) uchaza ubukhulu becala iintsimbi ezine ezinzima kwizinto zokupakisha kunye nemida yoxinaniso kunye nokupakishwa kwenkunkuma ngokutsha.Ngokutsho kweSiqendu 22(i) salo mthetho, amazwe angamalungu e-EU kufuneka aqinisekise ukuba ukususela ngo-Juni 30, 2001, izinto zabo zokupakisha okanye zokupakisha azikwazi ukuqulatha iintsimbi ezine ezinzima (i-cadmium, i-chromium ene-hexavalent, i-lead, i-mercury) kunye nokugxininiswa kwazo zonke.Itotali mayingabi ngaphezu kwe-100 ppm.I-European Union ikhuphe i-Directive 2013/2/EU ngo-2013.02.08 ukuze ihlaziye iPackaging Materials and Packaging Waste Directive (Directive 94/62/EC, PPW).Umyalelo omtsha ugcina iimfuno ezine zizonke ezifanayo zezinto ezinobungozi kwizinto zokupakisha: i-lead, i-cadmium, i-mercury, kunye ne-hexavalent chromium, kwaye isanqatshelwe kwi-100ppm, isebenza ngoSeptemba 30, 2013. Ngokweemfuno zePPW, ukupakishwa kwemveliso. womlimi kufuneka ahlangabezane neemfuno zokungabi nabungozi, ukupakisha ukusetyenziswa kwakhona, ukusetyenzwa ngokutsha kwezinto zokupakisha inkunkuma kunye nezinye iindlela zokuhlaziya, kunye nokunciphisa ukulahlwa kokugqibela.Amaxwebhu alungisiweyo abizwa ngokuba yimpahla yokupakisha.Ingxelo yovavanyo lokuthotyelwa kwengozi/uqinisekiso.
Izixhobo zonyango ezihlawuliswa yi-EU kufuneka zihambelane nemigaqo emithathu ye-MDR, RoHS kunye ne-REACH
Iimfuno zokuthotyelwa kwe-MDR, RoHS kunye ne-REACH zihambelana enye kwenye.Izixhobo zonyango ezikhoyo ezibekwe kwimarike ye-EU kufuneka zihambelane neemfuno zale migaqo mithathu, ngelixa izixhobo zonyango ezingasebenziyo azikho phantsi kwemigaqo ye-RoHS.Phakathi kwazo, imimiselo ye-REACH kunye ne-RoHS isisiseko, kunye nezixhobo zonyango ezithobela inkcazo ye-MDR Annex I 10.4.1, uvavanyo lwemichiza ye-CMR / EDCs kufuneka lwenziwe.Ukongeza, izixhobo zonyango kufuneka zihambelane neemfuno zemimiselo ye-MDR kungekuphela nje ukuhlangabezana neemfuno ze-RoHS kunye ne-REACH imigaqo, kodwa kunye nokuhlelwa kwezinto zekhemikhali nganye ngokusekelwe ekwenziweni kwezinto kunye nobungozi bazo xa ukhetha indlela yokuvavanya efanelekileyo yokuqinisekisa. ukuba izixhobo zonyango zifanelekile Iimathiriyeli ezahlukeneyo zivavanyelwa uvandlakanyo lweziyobisi olufanelekileyo.
Ixesha lokuposa: Sep-06-2023