Musi waMay 25, 2017, iyo EU Medical Device Regulation (MDR Regulation (EU) 2017/745)yakaziviswa zviri pamutemo,nenguva yekuchinja yemakore matatu. Zvakanga zvakarongwa kuti zvinyatsoshanda kubva muna Chivabvu 26, 2020. Kuti vape makambani nguva yakawanda yekuenderana nemirau mitsva uye kuve nechokwadi chekuti zvigadzirwa zvinosangana nezvinodiwa. IEuropean Commission yakagamuchira chirevo chekuwedzera nguva yekushandura musi wa 6 January 2023. Maererano nechikumbiro ichi, nguva yekushandura yezvigadzirwa zvepamusoro-njodzi ichawedzerwa kubva muna May 26, 2024 kusvika December 31, 2027; nguva yekushandura yemidziyo ine njodzi yakaderera uye yepakati ichawedzerwa kusvika Zvita 31, 2028; Kirasi III inosimwa tsika Iyo nguva yekushandura yemidziyo ichawedzerwa kusvika Chivabvu 26, 2026.
Kuti unzwisise zvinodikanwa zvemakemikari zveEU Medical Device Regulation MDR, unofanira kutanga wanzwisisaCMR uye EDCs zvinhu.
CMR zvinhuCMR ndiyo chidimbu cheCarcinogenic carcinogenic substance, Mutagenic gene mutagenic substance uye Reprotoxic reproductive toxic substance. Sezvo zvinhu zveCMR zvine njodzi dzisingaperi, dzinofanirwa kudzorwa uye kudzikiswa. Zviuru zvezvinhu zveCMR zvakaziviswa kusvika pari zvino, uye nhamba icharamba ichiwedzera mune ramangwana. Zvinoenderana nengozi yavo, ivo vanonyanya kukamurwa muzvikamu zvitatu zvinotevera:
CMR: 1A--Yakaratidza kuve necarcinogenic, mutagenic uye yekubereka chepfu mhedzisiro pavanhu
CMR: 1B——Zvakatsinhirwa nekuedza kwemhuka kuti zvinogona kukonzera mhedzisiro mitatu iri pamusoro pamuviri wemunhu
CMR: 2——Mamwe mabhuku anoratidza kuti zvinogona kukonzera mhedzisiro mitatu iri pamusoro pamuviri wemunhu. Chinhu cheCMR chinogona kuve nechinhu chimwe kana anopfuura eCMR njodzi. Kana iine akawanda CMR hazard hunhu, inozoiswa muzvikamu zvinoenderana nechero njodzi hunhu, Semuyenzaniso:
Benzene is carcinogenic 1A uye teratogenic 1B zvinhu; (Carc. Cat. 1A, Muta. Cat. 1B)
Lead (II) chromate is carcinogenic 1B, reproductive toxicity 1A zvinhu; (Carc. Cat. 1B, Repr. Cat. 1A)
Dibutyltin dichloride iri teratogenic chikamu 2, reproductive toxicity chikamu 1B chinhu; (Muta. Katsi. 2, Repr. Cat. 1B)
Benzo(a)pyrene is carcinogenic 1B, teratogenic 1B, uye kubereka muchetura 1B; (Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).EDCs zvinhuEDCs zvinhu ndeye Endocrine-Kuvhiringidza Kemikari endocrine inovhiringidza kemikari zvinhu, izvo zvinoreva zvinhu zvemakemikari zvinogona kukanganisa endocrine basa remunhu kubva kunze kwekunze. Kemikari yakagadzirwa nevanhu iyi inogona kupinda mumuviri wemunhu kana dzimwe mhuka kuburikidza neketani yechikafu (chikafu) kana kubata, uye kukanganisa hurongwa hwavo hwekubereka. Ivo vanozokanganisa synthesis, kuburitsa, kufamba, metabolism, uye musanganiswa wezvinhu zvinowanzovanzwa mumuviri, activate kana kumisa endocrine system, uye nekudaro kuparadza basa rayo mukuchengetedza kugadzikana uye kutonga kwemuviri.
EU Medical Device RegulationMDR
MDR ndiyo musimboti wekuwana wemidziyo yekurapa kupinda mumusika weEU. Chinangwa chayo chikuru ndechekuona kuchengetedzeka uye kushanda kwezvigadzirwa zvemidziyo yekurapa mukati mehupenyu hwese, uye kubata michina yekurapa inotengeswa mumusika weEU nenzira yakarongeka kuchengetedza veruzhinji. Utano uye Kuchengeteka Kwemurwere. Kuunzwa kwemutemo uyu kunoreva zvakare kuti iyo yapfuura inoshanda yekurapa mudziyo wekuraira (AIMD, 90/385/EEC) uye passive medical device dhairekitori (MDD, 93/42/EEC) ichatsiviwa zvishoma nezvishoma. Zvakasiyana nemirau yakapfuura, inodikanwa muMDR Chinyorwa 52 uye Chitsauko II Annex I 10.4.1 kuti zvinhu zveCMR/ECDs zvinofanirwa kudzivirirwa pamidziyo nezvikamu zvazvo kana zvinhu zvine maitiro anotevera:
01 Inopindira, uye yakanangana nemuviri wemunhu, senge orthopedic implants, nzeve yekuyera thermometer misoro, nezvimwewo;
02 inoshandiswa kuendesa zvinodhaka, zvinwiwa zvemuviri kana zvimwe zvinhu (kusanganisira magasi) kumuviri wemunhu, senge machubhu ekufema, nezvimwewo;
03 inoshandiswa kutakura kana kuchengetedza kuti iunzwe Zvinodhaka, zvinwiwa zvemuviri kana zvinhu (kusanganisira magasi) kumuviri wemunhu, senge infusion zvishandiso, nezvimwe.
EU Medical Device Regulation (MDR)Zvinorambidzwa uye Zvinodiwa
Zvinoenderana nemirairo yeMDR, zvinodikanwa kusimbisa zvishandiso zvekurapa uye zvikamu zvazvo uye zvinhu, uye kudzivirira kuunganidzwa kwezvinhu zvinotevera zvinodarika 0.1 (W / W)%: 1) Carcinogenic, mutagenic kana kubereka chepfu (CMR) zvinhu: chikamu 1A kana 1B, maererano neTafura 3.1 yeChikamu 3 cheAnnex VI yeMutemo No 1272/2008 yeParamende yeEuropean uye yeKanzuru (CLP Regulation). 2) Zvinhu zvine endocrine zvinokanganisa zvivakwa (EDCs) zvine humbowo hwesainzi hunoratidza kuti zvinogona kuve nemhedzisiro pahutano hwevanhu, zvinozivikanwa zvinoenderana negwaro rakatsanangurwa muChikamu 59 cheMutemo 2 weParamende yeEuropean uye yeKanzuru No 1907/2006. (REACH Regulation), kana zvinoenderana neKutongwa neChinyorwa 5(3) cheMutemo (3) No 528/2012 yeParamende yeEuropean uye yeKanzuru. Kana huwandu hwezvinhu zveCMR/EDCs hwakakwira kupfuura 0.1%, mugadziri wemudziyo acharatidza kuvepo kwezvinhu izvi pamudziyo wacho pachawo uye kurongedzerwa kwechikamu chimwe nechimwe, uye nekupa runyoro runosanganisira mazita ezvinhu uye kudzika kwazvo. Kana chinangwa chekushandiswa kwechigadzirwa chakadaro chichisanganisira kurapwa kwevana, vakadzi vane pamuviri kana vanoyamwisa, uye mamwe mapoka evarwere anoonekwa seari panjodzi yekukuvadzwa nezvinhu zvakadaro uye/kana zvinhu, mirairo yekushandiswa ichataura kuti mapoka evarwere anogona kutarisana nawo. njodzi yakasara, uye matanho akakodzera, kana zvichibvira.
RoHS-Kurambidzwayekushandiswa kwezvimwe zvinhu zvine ngozi mumagetsi nemagetsi
Kana zviyedzo uye zvekuongorora zvinodiwa zveRoHS, REACH uye zvimwe zvinongedzo zvazadzikiswa, isu tichiri kuda mhinduro dzebvunzo dzemakemikari zvinhu zvinodiwa neMDR? Iyo EU RoHS Directive chiyero chinosungirwa. Zvigadzirwa zvemagetsi nemagetsi zvinodzorwa uye zvikamu zvinoenderana zvinofanirwa kunge zvakaderera pane zvinodiwa nezvinhu zvinorambidzwa. Iro rairo rinofanirwa kucherechedzwa kana uchitumira kunze zvigadzirwa zvemagetsi zvekurapa kuEU.
Iyo REACH mirau inonyanya kutarisa pane zvinotevera zviviri zvinodiwa mumidziyo yekurapa yekudzora uye yekuzivisa(Chinyorwa 7 (2)): Kana kuunganidzwa kwechinhu chepamusoro-soro (SVHC) chiri> 0.1% uye huwandu hwese hwekutengesa kunze huri> 1 ton / gore, chinhu chacho chinofanira kuziviswa kuEuropean Chemicals Agency (ECHA) , pakati pezvimwe zvinhu, zvinogonawo kusanganisira zvinodiwa zvekufambiswa kwemashoko pamwe chete neketani yekugovera. Zvinhu zvinorambidzwa uye zvinorambidzwa (Chisungo 67): Zvekushandisa zvakanyanya kana kana chigadzirwa chine zvinhu zvinorambidzwa uye zvinorambidzwa zvinodarika muganhu, kugadzira uye kushandiswa kunorambidzwa.
Kurongedza uye Kurongedza Waste Directive-Directive 94/62/EC (PPW)Packaging and Packaging Waste Directive (Directive on Packaging and Packaging Waste) inonyanya kutara masimbi mana anorema mumidziyo yekurongedza uye miganho yekuisa uye kurongedza marara kudzokorodza. Zvinoenderana neChinyorwa 22(i) chemutemo uyu, nyika dzenhengo dzeEU dzinofanirwa kuona kuti kubva munaChikumi 30, 2001, zvinhu zvadzo zvekurongedza kana zvekurongedza hazvigone kuve nesimbi ina dzinorema (cadmium, hexavalent chromium, lead, mercury) uye kuzara kwavo. Zvose hazvifaniri kudarika 100 ppm. European Union yakapa Directive 2013/2/EU pa2013.02.08 kuti idzokorore Packaging Materials uye Packaging Waste Directive (Directive 94/62/EC, PPW). Iyo dhairekitori nyowani inochengetedza zvakafanana ina zvese zvinodikanwa zvezvinhu zvinokuvadza mumidziyo yekurongedza: lead, cadmium, mercury, uye hexavalent chromium, uye ichiri kugumira ku100ppm, inoshanda munaGunyana 30, 2013. Zvinoenderana nezvinodiwa zvePPW, iyo chigadzirwa kurongedza. yemugadziri anofanira kusangana nezvinodiwa zvekusakuvadza, kurongedzazve kushandiswa, kudzokorodza kwemarara ekurongedza zvinhu uye dzimwe nzira dzekuvandudza, uye kuderedzwa kwekupedzisira kuraswa. Zvinyorwa zvakagadzirirwa zvinonzi packaging materials. Njodzi yekuteerera ongororo mushumo/kusimbisa.
EU inobhadhariswa michina yekurapa inofanirwa kutevedzera mirairo mitatu yeMDR, RoHS uye REACH
Izvo zvinodiwa zvekuteerera zveMDR, RoHS uye REACH zvakafanana kune imwe neimwe. Zvishandiso zvekurapa zvinogara zvakaiswa pamusika weEU zvinofanirwa kutevedzera zvinodiwa nemirairo mitatu iyi, nepo zvigadziriso zvekurapa zvisiri pasi pemirairo yeRoHS. Pakati pavo, REACH uye RoHS mirau ndiyo hwaro, uye kune zvekurapa zvishandiso zvinoenderana neMDR Annex I 10.4.1 yakatarwa, CMR/EDCs kemikari yekuongorora zvinhu inofanira kuitwa. Pamusoro pezvo, zvishandiso zvekurapa zvinofanirwa kutevedzera zvinodiwa neMDR mirau kwete chete kuzadzisa zvinodiwa zveRoHS neREACH mirau, asiwo kurongedza chimwe nechimwe chemakemikari chinhu zvichienderana nekugadzirwa kwezvinhu uye njodzi dzazvo pakusarudza nzira yekuongorora yakakodzera kuti ive nechokwadi. kuti michina yekurapa inokodzera Zvishandiso zvakasiyana zvinoedzwa kuongororwa zvine musoro.
Nguva yekutumira: Sep-06-2023