Ka la 25 Mphalane 2017, Molao oa EU oa Sesebelisoa sa Bongaka (MDR Regulation (EU) 2017/745)e phatlalalitsoe ka molao,ka nako ea phetoho ea lilemo tse tharo. Qalong e ne e reriloe hore e sebetse ka botlalo ho tloha ka la 26 Motšeanong, 2020. E le ho fa likhoebo nako e eketsehileng ea ho ikamahanya le melaoana e mecha le ho netefatsa hore lihlahisoa li finyella litlhoko. Komisi ea Europe e amohetse tlhahiso ea ho atolosa nako ea phetoho ka 6 January 2023. Ho ea ka tlhahiso ena, nako ea phetoho ea lisebelisoa tse kotsi e tla atolosoa ho tloha ka May 26, 2024 ho ea ho December 31, 2027; nako ea phetoho bakeng sa lisebelisoa tse kotsi e tlase le e mahareng e tla atolosoa ho fihlela la 31 Tšitoe 2028; Tloaelo e kentsoeng ea Sehlopha sa III Nako ea phetoho ea lisebelisoa e tla eketsoa ho fihlela la 26 Motšeanong 2026.
Ho utloisisa litlhoko tsa lik'hemik'hale tsa EU Medical Device Regulation MDR, o tlameha ho utloisisa peleLintho tsa CMR le EDCs.
Lintho tsa CMRCMR ke khutsufatso ea ntho ea Carcinogenic carcinogenic, Mutagenic gene mutagenic substance le Reprotoxic tse chefo ea ho ikatisa. Kaha lintho tsa CMR li na le likotsi tse sa foleng, li tlameha ho laoloa ka thata le ho thibeloa. Liketekete tsa lintho tsa CMR li phatlalalitsoe ho tla fihlela joale, 'me palo e tla tsoela pele ho eketseha le nakong e tlang. Ho ea ka likotsi tsa bona, haholo-holo li arotsoe ka lihlopha tse tharo tse latelang:
CMR: 1A-- E netefalitsoe hore e na le litlamorao tse chefo ea kankere, ea mutagenic le ea ho ikatisa bathong
CMR: 1B——E tiisitsoe ke liteko tsa liphoofolo hore e ka baka liphello tse tharo tse ka holimo ’meleng oa motho
CMR: 2——Lingoliloeng tse ling li bontša hore e ka ’na ea baka liphello tse tharo tse ka holimo ’meleng oa motho. Ntho ea CMR e ka ba le tšobotsi e le 'ngoe ea kotsi ea CMR kapa ho feta. Ha e na le litšobotsi tse ngata tsa kotsi tsa CMR, e tla aroloa ho ea ka tšobotsi e 'ngoe le e 'ngoe ea kotsi, mohlala:
Benzene ke carcinogenic 1A le teratogenic 1B dintho; (Carc. Cat. 1A, Muta. Cat. 1B)
Lead (II) chromate ke carcinogenic 1B, chefo ea ho ikatisa 1A lintho; (Carc. Cat. 1B, Repr. Cat. 1A)
Dibutyltin dichloride ke sehlopha sa teratogenic sa 2, karolo ea 1B ea chefo; (Muta. Cat. 2, Repr. Cat. 1B)
Benzo(a)pyrene e na le carcinogenic 1B, teratogenic 1B, le chefo ea ho ikatisa 1B; (Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).Lintho tsa EDCsLintho tsa EDCs ke Endocrine-Disrupting Chemicals endocrine e senyang lintho tsa lik'hemik'hale, tse buang ka lintho tsa lik'hemik'hale tse ka sitisang mosebetsi oa endocrine oa motho ho tsoa mehloling e ka ntle. K'hemik'hale ena e entsoeng ke motho e ka kena 'meleng oa motho kapa liphoofolo tse ling ka ketane ea lijo (lijo) kapa ho kopana,' me ea ama tsamaiso ea tsona ea ho ikatisa. Li tla kena-kenana le ho qaptjoa, ho lokolloa, ho sisinyeha, metabolism, le motsoako oa lintho tse atisang ho patoa 'meleng, ho kenya tšebetsong kapa ho thibela tsamaiso ea endocrine, ka hona, e senya karolo ea eona ea ho boloka botsitso le taolo ea' mele.
Taolo ea Sesebelisoa sa Bongaka sa EUMDR
MDR ke molao-motheo oa ho fumana lisebelisoa tsa bongaka ho kena 'marakeng oa EU. Sepheo sa eona se seholo ke ho netefatsa polokeho le katleho ea lihlahisoa tsa lisebelisoa tsa bongaka nakong eohle ea bophelo, le ho laola lisebelisoa tsa bongaka tse rekisoang 'marakeng oa EU ka mokhoa o hlophisitsoeng haholoanyane ho sireletsa sechaba. Bophelo bo Botle le Tšireletseho ea Mokuli. Ho kenyelletsoa ha molao ona ho boetse ho bolela hore taelo ea pele e sebetsang ea lisebelisoa tsa bongaka (AIMD, 90/385 / EEC) le taelo ea "passive medical device" (MDD, 93/42 / EEC) e tla nkeloa sebaka butle-butle. Ho fapana le melaoana e fetileng, hoa hlokahala ho Article 52 ea MDR le Khaolo ea II Annex I 10.4.1 hore lintho tsa CMR/ECDs li tlameha ho qojoa bakeng sa lisebelisoa le likarolo tsa tsona kapa thepa e nang le litšobotsi tse latelang:
01 Ho kena-kenana le ho kopana ka ho toba le 'mele oa motho, joalo ka li-implants tsa masapo, lihlooho tsa tlhahlobo ea thermometer ea tsebe, joalo-joalo;
02 e sebelisoang ho isa lithethefatsi, maro a 'mele kapa lintho tse ling (ho kenyeletsoa likhase)' meleng oa motho, joalo ka li-tubes tsa ho hema, joalo-joalo;
03 e sebelisetsoang ho tsamaisa kapa ho boloka ho tsamaisoa Lithethefatsi, maro a 'mele kapa lintho (ho kenyeletsoa likhase)' meleng oa motho, joalo ka lisebelisoa tsa infusion, joalo-joalo.
EU Medical Device Regulation (MDR)Lithibelo le Litlhoko
Ho ea ka melao ea MDR, hoa hlokahala ho netefatsa lisebelisoa tsa bongaka le likarolo tsa tsona le lisebelisoa, le ho qoba ho bokellana ha lintho tse latelang tse fetang 0.1 (W / W)%: 1) Lintho tse nang le kankere, mutagenic kapa reproductive toxic (CMR): sehlopha 1A kapa 1B, ho ea ka Lethathamo la 3.1 la Karolo ea 3 ea Annex VI ea Regulation No 1272/2008 ea Paramente ea Europe le ea Lekhotla (CLP Regulation). 2) Lintho tse nang le thepa e senyang ea endocrine (EDCs) tse nang le bopaki ba saense bo pakang hore li ka ba le liphello tse tebileng bophelong ba batho, tse khetholloang ho latela mokhoa o boletsoeng ho Article 59 ea Molao oa 2 oa Paramente ea Europe le Lekhotla la No 1907/2006. (REACH Regulation), kapa ho ea ka Ahloloa ke Article 5 (3) ea Molao (3) No 528/2012 ea Paramente ea Europe le ea Lekhotla. Haeba bongata ba lintho tsa CMR/EDCs bo phahame ho feta 0.1%, moetsi oa sesebelisoa o tla bontša boteng ba lintho tsena sesebelisoa ka bosona le sephutheloana sa yuniti ka 'ngoe, 'me a fane ka lethathamo le kenyeletsang mabitso a lintho le maikutlo a tsona. Haeba ts'ebeliso e reriloeng ea sesebelisoa se joalo e kenyelletsa kalafo ea bana, bakhachane kapa ba anyesang, le lihlopha tse ling tsa bakuli tse nkuoang li le kotsing ea ho lematsoa ke lintho tse joalo le/kapa thepa, litaelo tsa tšebeliso li tla bolela hore lihlopha tsena tsa bakuli li ka tobana le mathata. kotsi e setseng, le mehato e nepahetseng, haeba ho hlokahala.
RoHS-Thibeloya tshebediso ya dintho tse itseng tse kotsi disebedisweng tsa motlakase le tsa elektroniki
Haeba litlhokahalo tsa tlhahlobo le tlhahlobo ea RoHS, REACH le litaelo tse ling li fihletsoe, na re ntse re hloka liphetho tsa liteko tsa lik'hemik'hale tse hlokoang ke MDR? EU RoHS Directive ke tekanyetso e tlamang. Lihlahisoa tse laoloang tsa elektroniki le tsa motlakase le likarolo tse amanang le tsona li tlameha ho ba tlase ho feta litlhoko tsa lintho tse thibetsoeng. Ke taelo e tlamehang ho eloa hloko ha ho romelloa lisebelisoa tsa bongaka tsa elektroniki ho EU.
Melao ea REACH e shebana haholo le litlhoko tse peli tse latelang lisebelisoa tsa bongaka bakeng sa taolo le tsebiso(Athikele ea 7 (2)): Ha khoele ea ntho e amehang haholo (SVHC) e le> 0.1% mme kakaretso ea kakaretso ea thomello e tsoang ho 1 ton/selemo, ntho eo e tlameha ho tsebisoa The European Chemicals Agency (ECHA) , har'a lintho tse ling, e ka boela ea kenyelletsa litlhoko tsa phetisetso ea tlhahisoleseding hammoho le ketane ea thepa. Lintho tse thibetsoeng le tse thibetsoeng (Athikele ea 67): Bakeng sa lisebelisoa tse khethehileng tsa tšebeliso kapa ha sehlahisoa se na le lintho tse thibetsoeng le tse thibetsoeng tse fetang moeli, ho etsoa le ho sebelisoa ha lia lumelloa.
Taelo ea Litšila tsa ho Paka le ho Pakete-Directive 94/62/EC (PPW)Tataiso ea ho paka le ho paka Litšila (Taelo mabapi le Packaging and Packaging Waste) e hlakisa haholo lirafshoa tse 'ne tse boima ka har'a thepa ea ho paka le meeli ea mahloriso le ho paka litšila tsa litšila. Ho latela Article 22(i) ea molao ona, linaha tseo e leng litho tsa EU li tlameha ho etsa bonnete ba hore ho tloha ka la 30 Phuptjane 2001, thepa ea tsona ea ho paka kapa ea ho paka e ke ke ea ba le lirafshoa tse 'ne tse boima (cadmium, hexavalent chromium, lead, mercury) le kakaretso ea tsona. Kakaretso ha ea lokela ho feta 100 ppm. European Union e fane ka Directive 2013/2/EU ka 2013.02.08 ho ntlafatsa Melao ea Lisebelisuoa tsa Liphutheloana le Tsamaiso ea Litšila tsa Packaging (Directive 94/62/EC, PPW). Taelo e ncha e boloka litlhoko tse tšoanang tse 'nè bakeng sa lintho tse kotsi ka thepa ea ho paka: lead, cadmium, mercury, le hexavalent chromium,' me e ntse e lekanyelitsoe ho 100ppm, e sebetsang ka September 30, 2013. Ho ea ka litlhoko tsa PPW, sephutheloana sa sehlahisoa. ea moetsi e tlameha ho fihlela litlhoko tsa ho hloka kotsi, tšebeliso ea ho paka hape, ho sebelisoa bocha ha lisebelisoa tsa ho paka lithōle le mefuta e meng ea nchafatso, le phokotso ea ho lahloa ha ho qetela. Litokomane tse lokiselitsoeng li bitsoa lisebelisoa tsa ho paka. Tlaleho/netefatso ya tekolo ya maemo a kotsi.
Lisebelisoa tsa bongaka tse lefelloang ke EU li tlameha ho latela melaoana e meraro ea MDR, RoHS le REACH
Litlhoko tsa ho lumellana le MDR, RoHS le REACH lia tšoana. Lisebelisoa tsa bongaka tse phelang tse behiloeng 'marakeng oa EU li tlameha ho latela litlhoko tsa melaoana ena e meraro, athe lisebelisoa tsa bongaka tse sa sebetseng ha li laoloe ke melao ea RoHS. Har'a tsona, melaoana ea REACH le RoHS ke motheo, 'me bakeng sa lisebelisoa tsa bongaka tse lumellanang le tlhaloso ea MDR Annex I 10.4.1, tlhahlobo ea lik'hemik'hale tsa CMR/EDCs e tlameha ho etsoa. Ntle le moo, lisebelisoa tsa bongaka li hloka ho latela litlhoko tsa melaoana ea MDR eseng feela ho fihlela litlhoko tsa melaoana ea RoHS le REACH, empa hape le ho hlopha ntho e 'ngoe le e 'ngoe ea lik'hemik'hale ho ipapisitsoe le ho etsoa ha thepa le likotsi tsa eona ha ho khethoa mokhoa o nepahetseng oa tlhahlobo ho netefatsa hore lisebelisoa li etsoa. hore lisebelisoa tsa bongaka li loketse Lisebelisoa tse fapaneng li lekoa bakeng sa tlhahlobo e utloahalang ea lintho.
Nako ea poso: Sep-06-2023