Ma Mei 25, 2017, ka Hoʻoponopono Mea Hana Lapaʻau EU (MDR Regulation (EU) 2017/745)ua hoolaha laha ia,me ka manawa hoʻololi o ʻekolu makahiki.Ua hoʻolālā mua ʻia e hoʻopili piha ʻia mai Mei 26, 2020. I mea e hāʻawi ai i nā ʻoihana i ka manawa hou e hoʻololi ai i nā lula hou a hōʻoia i ka hoʻokō ʻana o nā huahana i nā koi.Ua ʻae ke Komisina ʻEulopa i kahi manaʻo e hoʻolōʻihi i ka manawa hoʻololi ma 6 Ianuali 2023. Wahi a kēia manaʻo, e hoʻonui ʻia ka manawa hoʻololi no nā mea hoʻoweliweli kiʻekiʻe mai Mei 26, 2024 a i Dekemaba 31, 2027;e hoʻolōʻihi ʻia ka manawa hoʻololi no nā mea haʻahaʻa haʻahaʻa a i ʻole ka lā 31 Dekemaba 2028;Papa III implantable custom E hoʻonui ʻia ka manawa hoʻololi no nā mea hana a hiki i Mei 26, 2026.
No ka hoʻomaopopo ʻana i nā koi kemika o ka EU Medical Device Regulation MDR, pono ʻoe e hoʻomaopopo muaNā mea CMR a me EDC.
Mea CMRʻO CMR ka pōkole o Carcinogenic carcinogenic substance, Mutagenic gene mutagenic substance and Reprotoxic reproductive toxic substance.No ka mea he mau pōʻino ko nā mea CMR, pono e hoʻopaʻa ʻia a kaupalena ʻia.Ua hoʻolaha ʻia nā kaukani o nā mea CMR i kēia manawa, a e hoʻomau ka nui o ka helu i ka wā e hiki mai ana.Wahi a ko lākou mau pōʻino, ua māhele nui ʻia lākou i ʻekolu mau ʻāpana:
CMR: 1A——Ua hōʻike ʻia ka loaʻa ʻana o nā hopena ʻona kino, mutagenic a me ka hānau ʻana i ke kanaka
CMR: 1B——Ua hōʻoia ʻia e nā hoʻokolohua holoholona e hiki ke hoʻoulu i nā hopena ʻekolu ma luna o ke kino kanaka
CMR: 2——Ke hoike mai nei kekahi mau palapala, he mea ia e hooulu ai i na hopena ekolu maluna o ke kino o ke kanaka.Hiki i kekahi mea CMR ke loaʻa i hoʻokahi a ʻoi aʻe paha nā ʻano pōʻino CMR.Ke loaʻa iā ia nā ʻano pōʻino CMR he nui, e hoʻokaʻawale ʻia e like me kēlā me kēia ʻano hazard, No ka laʻana:
ʻO Benzene nā mea carcinogenic 1A a me nā mea teratogenic 1B;(Carc. Cat. 1A, Muta. Cat. 1B)
ʻO ke kēpau (II) chromate he carcinogenic 1B, mea ʻawaʻawa hānau 1A;(Carc. Cat. 1B, Repr. Cat. 1A)
ʻO ka dibutyltin dichloride kahi ʻano teratogenic 2, mea ʻawaʻawa reproductive ʻano 1B;(Muta. Cat. 2, Repr. Cat. 1B)
ʻO Benzo(a)pyrene he carcinogenic 1B, teratogenic 1B, a me 1B mea ʻawaʻawa hānau;(Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B).Nā mea EDCsʻO nā mea EDCs he Endocrine-Disrupting Chemicals endocrine disrupting substances, e pili ana i nā mea kemika hiki ke hoʻopilikia i ka hana endocrine kanaka mai nā kumu waho.Hiki ke komo i loko o ke kino o ke kanaka a i ʻole nā holoholona ʻē aʻe ma o ke kaulahao meaʻai (meaʻai) a i ʻole ka hoʻopili ʻana, a pili i kā lākou ʻōnaehana hānau.E hoʻopilikia lākou i ka synthesis, hoʻokuʻu, neʻe, metabolism, a me ka hui pū ʻana o nā mea maʻamau i hūnā ʻia i loko o ke kino, hoʻāla a pale paha i ka ʻōnaehana endocrine, a laila e hoʻopau i kāna kuleana i ka mālama ʻana i ke kūpaʻa a me ka hoʻoponopono ʻana o ke kino.
Hoʻoponopono Mea Lapaʻau EUMDR
ʻO MDR ke kumu komo no nā mea lapaʻau e komo i ka mākeke EU.ʻO kāna kumu nui e hōʻoia i ka palekana a me ka maikaʻi o nā huahana lāʻau lapaʻau i ke ola holoʻokoʻa, a me ka hoʻokele ʻana i nā lāʻau lapaʻau i kūʻai ʻia ma ka mākeke EU ma kahi ʻano ʻōnaehana e pale aku i ka lehulehu.Ola a me ka Maluhia o ka ma'i.ʻO ka hoʻokomo ʻana i kēia hoʻoponopono, ʻo ia hoʻi, e hoʻololi mālie ʻia ke kuhikuhi ʻana o ka lāʻau lapaʻau ikaika mua (AIMD, 90/385/EEC) a me ke kuhikuhi ʻana o nā mea lapaʻau passive (MDD, 93/42/EEC).ʻOkoʻa i nā lula mua, koi ʻia ma ka MDR Paukū 52 a me ka Mokuna II Annex I 10.4.1 pono e pale ʻia nā mea CMR/ECDs no nā hāmeʻa a me kā lākou ʻāpana a i ʻole nā mea me kēia mau ʻano:
01 Intrusive , a me ka pilina pololei me ke kino kanaka, e like me ka orthopedic implants, pepeiao thermometer hoao poo, etc.
02 i hoʻohana ʻia e hāʻawi i nā lāʻau lapaʻau, nā wai kino a i ʻole nā mea ʻē aʻe (me nā kinoea) i ke kino o ke kanaka, e like me nā paipu hanu, a pēlā aku;
03 i hoʻohana ʻia no ka lawe ʻana a i ʻole mālama ʻia e hāʻawi ʻia Nā lāʻau lapaʻau, nā wai kino a i ʻole nā mea (me nā kinoea) i ke kino o ke kanaka, e like me nā hāmeʻa infusion, etc.
Hoʻoponopono Mea Lapaʻau Lapaʻau EU (MDR)Kāohi a me nā koi
Wahi a nā lula MDR, pono e hōʻoia i nā lāʻau lapaʻau a me kā lākou mau ʻāpana a me nā mea waiwai, a pale i ka neʻe ʻana o nā mea i ʻoi aku ma mua o 0.1 (W / W)%: 1) Carcinogenic, mutagenic a i ʻole reproductive toxic (CMR) mea: 1A a i ʻole 1B , e like me ka Papa 3.1 o ka ʻāpana 3 o Annex VI o ka Regulation No 1272/2008 o ka European Parliament a me ka Council (CLP Regulation).2) ʻO nā mea me ka endocrine disrupting properties (EDCs) i loaʻa nā hōʻike ʻepekema e hōʻike ana he hopena koʻikoʻi paha lākou i ke olakino kanaka, i ʻike ʻia e like me ke kaʻina hana i kuhikuhi ʻia ma ka Paukū 59 o ka Regulation 2 o ka European Parliament a me ka Council No 1907/2006 (REACH Regulation), a i ʻole e like me Judged by Article 5(3) of Law (3) No 528/2012 o ka European Parliament and of the Council.Inā ʻoi aku ka kiʻekiʻe o ka ʻike o nā mea CMR/EDC ma mua o 0.1%, e hōʻike ka mea hana mea hana i ke ʻano o kēia mau mea ma ka hāmeʻa ponoʻī a me ka paʻi ʻana o kēlā me kēia ʻāpana, a hāʻawi i kahi papa inoa me nā inoa o nā mea a me kā lākou mau ʻike.Inā i manaʻo ʻia ka hoʻohana ʻana o ia mea me ka mālama ʻana i nā keiki, nā wahine hāpai a lactating paha, a me nā pūʻulu maʻi ʻē aʻe i manaʻo ʻia he pilikia loa i ka pōʻino mai ia mau mea a me / a i ʻole nā mea, e ʻōlelo nā ʻōlelo aʻoaʻo no ka hoʻohana ʻana e hiki i kēia mau hui maʻi ke alo. ke koena o ka pilikia, a me ka malama pono ana, ina pili.
RoHS-Kaohio ka hoʻohana ʻana i kekahi mau mea pōʻino i nā mea uila a me nā lako uila
Inā ua hoʻokō ʻia nā koi a me ka loiloi o RoHS, REACH a me nā kuhikuhi ʻē aʻe, pono anei mākou i nā hopena hoʻāʻo o nā mea kemika i koi ʻia e MDR?ʻO ka EU RoHS Directive kahi maʻamau pono.ʻO nā huahana uila a me nā mea uila a me nā ʻāpana pili pono e emi iho ma mua o nā koi o nā mea i kaupalena ʻia.He kuhikuhi ia e pono e makaʻala i ka wā e lawe aku ai i nā mea lapaʻau uila i ka EU.
Hoʻopili nui nā lula REACH i nā koi ʻelua e pili ana i nā mea lapaʻau no ka hoʻomalu a me ka hoʻolaha(Pauku 7 (2)): Inā ʻoi aku ka nui o ka mea e hopohopo nui loa (SVHC) ma kahi o 0.1% a ʻoi aku ka nui o ka nui o ka lawe ʻana aku ma mua o 1 ton/makahiki, pono e hoʻolaha ʻia ka mea i ka European Chemical Agency (ECHA) , ma waena o nā mea ʻē aʻe, hiki ke komo i nā koi no ka hoʻoili ʻana i ka ʻike ma ke kaulahao lako.ʻO nā mea i pāpā ʻia a kapu ʻia (Pauku 67): No nā mea hoʻohana kikoʻī a i ʻole nā mea i hoʻopaʻa ʻia i loko o ka huahana ma mua o ka palena, pāpā ʻia ka hana ʻana a me ka hoʻohana ʻana.
Hoʻopili ʻia a me ka hoʻopaʻa ʻana i nā ʻōpala ʻōpala-Directive 94/62/EC (PPW)ʻO ka Packaging and Packaging Waste Directive (Directive on Packaging and Packaging Waste) ke kuhikuhi nui nei i ʻehā mau metala koʻikoʻi i loko o nā mea hoʻopili a me nā palena noʻonoʻo a me ka hoʻopili ʻana i nā ʻōpala ʻōpala.Wahi a ka Paukū 22(i) o kēia kānāwai, pono nā mokuʻāina o EU e hōʻoia mai Iune 30, 2001, ʻaʻole hiki i kā lākou ʻeke a i ʻole nā mea hoʻopihapiha ke komo i ʻehā mau metala kaumaha (cadmium, hexavalent chromium, lead, mercury) a me kā lākou ʻike nui.ʻAʻole pono ka nui ma mua o 100 ppm.Ua hoʻopuka ka European Union i Directive 2013/2/EU ma 2013.02.08 e hoʻoponopono hou i ka Packaging Materials and Packaging Waste Directive (Directive 94/62/EC, PPW).Mālama ka kuhikuhi hou i nā koi ʻehā like ʻole no nā mea ʻino i loko o nā mea hoʻopili: ke alakaʻi, cadmium, mercury, a me hexavalent chromium, a ua kaupalena ʻia i ka 100ppm, e hoʻokō ʻia i ka lā 30 Kepakemapa, 2013. E like me nā koi o ka PPW, ka pahu huahana Pono ka mea hana e hoʻokō i nā koi o ka pōʻino, ka hoʻohana hou ʻana i ka pahu, ka hana hou ʻana i nā mea hoʻopihapiha ʻōpala a me nā ʻano hana hou ʻē aʻe, a me ka hōʻemi ʻana i ka hoʻopau hope.ʻO nā palapala i hoʻomākaukau ʻia ua kapa ʻia nā mea hoʻopili.Hōʻike loiloi hoʻokō pili pilikia / hōʻoia.
Pono nā lāʻau lapaʻau i hoʻopaʻa ʻia e EU me nā lula ʻekolu o MDR, RoHS a me REACH
ʻO nā koi hoʻokō o MDR, RoHS a me REACH e like me kekahi.Pono nā lāʻau lapaʻau ola i kau ʻia ma ka mākeke EU e hoʻokō i nā koi o kēia mau lula ʻekolu, ʻoiai ʻaʻole pili nā lāʻau lapaʻau passive i nā lula RoHS.Ma waena o lākou, ʻo nā kānāwai REACH a me RoHS ke kumu, a no nā lāʻau lapaʻau e pili ana i ka MDR Annex I 10.4.1 kikoʻī, pono e hoʻokō ʻia ka hoʻāʻo ʻana o ka mea kemika CMR/EDC.Eia kekahi, pono nā lāʻau lapaʻau e hoʻokō i nā koi o nā lula MDR ʻaʻole wale e hoʻokō i nā koi o nā lula RoHS a me REACH, akā e hoʻokaʻawale pū i kēlā me kēia mea kemika e pili ana i ka hana ʻana o nā mea a me kā lākou mau pilikia i ke koho ʻana i kahi ala loiloi kūpono e hōʻoia ai. ua kūpono nā mea lapaʻau no ka Hoʻāʻo ʻia nā mea like ʻole no ka loiloi waiwai kūpono.
Ka manawa hoʻouna: Sep-06-2023