Reba: 0 Umwanditsi: Muhinduzi wurubuga Gutangaza Igihe: 2026-09-09 Inkomoko: Urubuga
Ibiciro by'ibiribwa bisize aluminiyumu bikoreshwa cyane mubipfunyika ibiryo, ibyokurya, ibikoresho, ibiryo n'ibikoni. Iyo byoherejwe mu bihugu by’Uburayi n’amasoko yo muri Amerika ya Ruguru, kubahiriza umutekano w’ibiribwa ni itegeko. Igipfundikizo nicyo kintu cyingenzi mugupima ibiryo, nubwo substrate ari aluminium. Abaguzi benshi nababikora bitiranya ibyangombwa byemeza nibizamini hagati ya FDA na (EU) No 10/2011. Iyi ngingo itondekanya ibyangombwa byubahirizwa byubumwe bw’ibihugu by’Uburayi na Amerika ya Ruguru, ikanasobanura neza ibizamini byuzuye munsi ya FDA 21 CFR na EU 10/2011 kuri aluminiyumu isize amabara.
Amabwiriza (EC) No 1935/2004: Amabwiriza ngenderwaho kubikoresho byose byo guhuza ibiryo hamwe ningingo zo muri EU, bikubiyemo ibara ryometse kuri aluminiyumu igizwe (aluminium substrate + coating organic). Irasaba gukurikiranwa, nta kurekura ibintu byangiza no kuyikora Itangazo ryubahiriza (DoC).
Amabwiriza (EU) No 10/2011: Igipimo nyamukuru cyibikoresho byo gutwikisha plastike hejuru yubutaka bwicyuma, kugenga monomers, inyongeramusaruro, pigment nimbibi zimuka ziterwa na organic.
Amabwiriza (EU) No 2023/2006: Uburyo bwiza bwo gukora (GMP) kubikoresho byo guhuza ibiryo.
1.Itangazo ryubahirizwa (DoC): Kwiyitirira ubwabyo bitangwa nuwabikoze, gutondekanya ibikoresho, ibishushanyo mbonera, ibisubizo byikizamini cyimuka hamwe nuburyo bwo guhuza ibiryo. Ni itegeko mbere yo gushyira ibicuruzwa ku isoko rya EU.
2. Raporo y'ibizamini bya laboratoire ya gatatu ya EU 10/2011, uhereye muri laboratoire yemewe nka SGS, TÜV, Intertek.
3.Ibintu bifatika byerekana ko bisize: resin, pigment, imiti ikiza ninyongeramusaruro bigomba gushyirwa kurutonde rwibintu byiza byuburayi.
4.Byifuzo ariko bikunze gusabwa: Raporo yikizamini cya LFGB (Ubudage busabwa guhuza ibiryo byigihugu), EN ibipimo bya aluminium substrate (EN 601 / EN 602).
FDA ntabwo itanga ibicuruzwa 'ibyemezo '. Abatanga isoko batanga ibyangombwa bya FDA hiyongereyeho raporo y'ibizamini bya laboratoire yemewe kugirango berekane ibara ryuzuye aluminiyumu ryujuje Umutwe 21 CFR.
21 CFR Igice cya 175.300: Ibiryo byongeweho ibiryo bitaziguye - ibishishwa bya resinous na polymeric (ingingo ikoreshwa cyane mubyiciro byibiribwa bitwikiriye aluminium).
Ingingo zijyanye: 21 CFR Igice cya 177 kubikoresho bya polymer, 21 CFR 178.3297 kubiryo-bihuza amabara.
Kanada Ubuzima Bwibiryo Byubuzima Ibikoresho byoherejwe: amabara asize aluminiyumu agomba kwerekana ibisubizo byikuramo kandi biremereye ugereranije nibipimo bya FDA. Raporo yikizamini cyibiryo byabandi basabwa nabatumiza hanze.
ISO 9001 Sisitemu yo gucunga neza
ISO 22000 / HACCP yo kugenzura umusaruro wibiribwa
RoHS (bidashoboka, akenshi bisabwa nabaguzi kugenzura ibyuma biremereye)
Muri rusange ingamba zo kwimuka zifata ihererekanyabubasha ryibintu byose bidahindagurika biva mubitereko byibiribwa.
Abigana:
Simulant A: 10% Ethanol (ibiryo byo mu mazi, inzoga)
Simulant B: 3% acide acike (ibiryo bya acide nkumutobe wimbuto, isosi y'inyanya)
Simulant D2: Amavuta ya elayo (ibiryo binuze / amavuta)
Imipaka: ≤10 mg / dm² cyangwa 60 mg / kg
Ubushyuhe bwikizamini & igihe: byatoranijwe ukurikije imikoreshereze yabigenewe (ububiko bukonje, icyumba cyicyumba, guteka / guteka ubushyuhe bwo hejuru)
Gerageza intego yagabanijwe hamwe ntarengwa ntarengwa:
Ibyuma biremereye: Isasu (Pb), Cadmium (Cd), Mercure (Hg), Chromium Hexavalent Cr (VI)
Bisphenol A (BPA) n'ibikomoka kuri Bisphenol
Formaldehyde
Phthalates (DEHP, DBP, BBP nibindi)
Abandi ba monomers ninyongera byanditswe muri EU 10/2011 Umugereka
Reba niba coating resin, monomer, pigment, inyongera zashyizwe kurutonde rwiza rwa EU
Kugenzura / kubuzwa kugenzura ibintu: PFAS, inyongeramusaruro zimwe na zimwe
Impumuro, uburyohe, inenge yatwikiriye, gukuramo, gusibanganya ibara nyuma yo kwibizwa mu buryo bumwe.
Icyitonderwa: Umuryango w’ubumwe bw’ibihugu by’Uburayi 10/2011 wibasiye ibikoresho bya pulasitiki, ariko bireba ibice bya pulasitiki kama ya plastike kuri aluminiyumu, ibyo bikaba ari ibara ry’ibiribwa ryuzuye ibara rya aluminiyumu. Icyuma cya aluminiyumu gikurikira EC 1935/2004 hamwe n’inama y’Uburayi ikemura ibyuma.
FDA ikoresha ibintu bitatu bisanzwe bivamo ubwoko bwibiryo bigenewe nubushyuhe bukoreshwa:
Amazi yamenetse (bigana ibiryo byamazi)
8% Ethanol (ibiryo birimo inzoga)
n-Heptane (bigana ibiryo binuze, amavuta)
Ubushyuhe bwikizamini hamwe nigihe bimara bihuye nibisabwa nyabyo: kubika ubushyuhe bwicyumba, gukonjesha, kubika ubukonje, guteka ubushyuhe bwo hejuru / gushyushya.
Ibikururwa byose bidahindagurika bigomba kuba byujuje imipaka yasobanuwe muri 21 CFR 175.300.
Kurongora, kadmium nibindi byuma biremereye biva mubitereko munsi ya acide.
Ibisigarira, imiti ikiza, pigment, inyongeramusaruro bigomba kuba byemewe na FDA byemewe
Pigment zubahiriza 21 CFR 178.3297
Kugenzura uburyo bwo gukiza ibintu: gukira kutuzuye bizatera gukuramo monomer birenze
Gufata neza, kurwanya ruswa, kwihanganira kubira, kurwanya ibishishwa (ntabwo ari itegeko rya FDA riteganijwe, ariko birakenewe cyane kubipakira no guteka).
Intego yibanze: EU 10/2011 ifite SML isobanutse kubintu amagana yibintu; FDA yibanze kubikuramo byose hiyongereyeho urutonde rwiza rwo kwemeza ibikoresho bibisi.
Ifishi yemewe: EU isaba DoC imenyekanisha + ikizamini cyimuka; FDA yishingikiriza kurutonde rwibikoresho no gukuramo ikizamini nta cyemezo cyemewe.
Sisitemu ya Simulant: EU ikoresha 10% Ethanol, 3% acide acike, amavuta ya elayo; FDA ikoresha amazi, 8% Ethanol na n-heptane.
Amategeko y'ibyuma biremereye: Umuryango w'ubumwe bw’ibihugu by’Uburayi ushyiraho imipaka ntarengwa yo kwimuka ku byuma biremereye; FDA igenzura ibyuma biremereye ikoresheje ibizamini bivanwa.
Emeza amaherezo-gukoresha ibintu byambere: gupakira ubukonje gusa cyangwa guteka ubushyuhe bwo hejuru, kugirango uhitemo ubushyuhe bwikigereranyo hamwe na simulant. Ikizamini kitari cyo kizatesha agaciro raporo.
Icyitegererezo cyikigereranyo kigomba gukoresha formula imwe yo gutwikira, gutwikira ubunini hamwe no gukiza nkibikorwa byinshi.
Tegura dosiye yuzuye ya tekiniki: icyemezo cya alloy, coating material raw MSDS, raporo yikizamini, DoC (EU), inyandiko zerekana neza.
Kubicuruzwa bibiri-byoherejwe (EU + USA), kora ibizamini byombi EU10 / 2011 na FDA 21 CFR muri laboratoire imwe yemewe kugirango ugabanye igiciro nigihe cyo kuyobora.
Kohereza ibicuruzwa byo mu rwego rwibiribwa bisize aluminiyumu muri EU no muri Amerika ya ruguru bikenera uduce twihariye two kubahiriza. Umuryango w'ubumwe bw’ibihugu by’Uburayi urasaba EC1935 / 2004, EU10 / 2011 ibizamini byo kwimuka hamwe nuwabikoze DoC. Amerika y'Amajyaruguru (USA) ikurikira FDA 21 CFR Igice cya 175.300 ikizamini gishobora gukururwa no kwemeza ibikoresho fatizo. Gusobanukirwa n'ibizamini byuzuye bya EU10 / 2011 na FDA bifasha abayikora kwirinda ifungwa rya gasutamo, kwanga ibicuruzwa ndetse n’inshingano z’umutekano w’ibiribwa, kandi ishyigikira ubufatanye buhamye hamwe n’ibipfunyika ibiryo, ibikoresho byo mu gikoni hamwe n’abaguzi b’ibiribwa ku isi.
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