ГОСТ 32634-2020.docx
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1、MEXrOCyf1.APCTBEHHbIiiCOBET110CTAHAAPTM3A1.(SH,METPonorMHSCEPTHHKAUHW(MC)INTERSTATECOUNCI1.FORSTANDARDIZATION.METRO1.OGYANDCERTIFICATIONOCT326342020(SC)MEKOCyAAPCTBEHHb1.kiCTAHAPTMeTOIqb1.HCnb1.TaHk1.访nobo3A6mctbmk)xmmmm6Ckom11po1.qyMhMHaopraHM3MUeJIOBeKaPA3BEf1.AHMEKOXWINVITROMeTOAb1.CMC11OJ1b3OBaH
2、MMPeKOHCTPyHPOBaHHO。MeJ1.OBeHeCKOro311MApMMCa(OECD431:2016,Guide1.ineforthetestingofchemica1.s.Invitroskincorrosion:reconstructedhumanepidermis(RHE)testmethod,MOD)3AaHyeoH11ManbHoeMocaCaHAapwHopM202111peAMcnoBne1.4e11M,OCHOBHbie11pMHqnnbho6uvte11pavnanp。BeAeHumpa6onoMexrocyAapciBeHHowCTaHapw33unnyca
3、HBnebOCT1.0MexrocyAapcTBeHHaRcwciewaCTaHAaPTH3a4nn.OCHOeHb1.enonoxeHMMOCT1.2MexrocyaapcTBeHHaf1.CMCTeMacaHaapwaunn.CraHf1.apTbiMexrocyf1.apcTBeHHbie.npaonnaHPeKOMeHAaUHHnoMexrocyAapcBeHHMCTaHAaPTM3aux.11pannapaspa6ov,11pwhriha,06HOBneHvmMOTMeHb1.ACbcaohma0CTaHAaPTC1 11O11OTOB11EHPec11y611naHCKMMywwa
4、pHWM11peA11pnRTMMBenopyocKMviryapceHhbiMHCTMTyrMponorHM(BhMM)a0CH0Mco6ctbghhoonepeeoaHapyccMA3baHr1103bHH0wepcunAOKyMeHa,ya3aHH0r0B11ye52 BHECEHocyf1.apciBHHbMkommttomnocaHapw3auMwPecny6nnnBenapycb3 11PMHATMjrocyapcBHHbMcobiomnocaH4apTM3auww.MeTPOnOrMHMcpnnauMM(pooono30AHBapf1.2020r.Ns126-11)3a11pwH
5、Rve11poronBa11n:KPaTKOeHaHA4H0BawnCTPaMHnoMKIweo3166)00497ApMCHMf1.BenapycbKa3acaHKnpW3MAPoccmaTa*MKncaHy36eHCaHKCTPQXHnoMKHCO31661(XM97AMBYKZKGRUTJUZCxpam9HH0k8hw8xo3h阳HauMwabHcoopra11aoCTaHaapTHjauMK3A0onorw11jPec11y6nnMApmghmroccaHAapPec11y6nnMSenapycboccaHf1.apPc11y6nnMKaaaxcraHKbprw3CaAapPoccTa
6、Hf1.aprT0xnaHf1.apy3caHap4 11pna30MeaepantHoroareHTCaoTeXHMqeCKOMyPerynKPoeaHMK)wMeponornMo18waA2021r.Nq376-ctMeMOCyAaPCTBeHHbiiCTaHQaPTOCT326342020BBe4eHBewconeBKaUeCYBea-UWOHanbHoroCTaHAaPTaPoccwcoieAepau11c1HiOna2021r.5 HacTOf1.iUkiMcaHapf1.0nf1.ecf1.MonHnupOBaHXb1.MnoOTHOineHHK)MeMyHaPoAHOMyAOKy
7、MHyOECD431:201611PyoBACTonoTeCTv1.POBaHHK)XMMMMeCXHXBeIUeCYB.PaabeAaHweKO)KMinvitro:ZeTOAKCnbITaHH只PeKOHCTPyMPoBaHHorOMenOBeUeCKOro311MAepMvca(RHE)(Guide1.ineforthetestingofchemica1.s.Invitroskincorrosion:reconstructodhumanepidermis(RHE)testmethod-.MOD)11yeMM3weHeHurerocpyypbAnanpMBef1.eHHRbcooBecne
8、c11paBMaMM.ycaHneHHbMnbOCT1.5110pa3-aenw4.2m4.3).MexAyHapOAHbiiiAoKyMeHrpa3pa60aHOPraH1.43auneaoHMVMecoro8pyAHmCrBanpa3MTMROECD(OrganisationforEconomicCooperationandDeve1.opment).HanweHOBaHMeHaCTOaIUerOCraHAaPTam3mhhoOTHoCHTenbHOHaHNeHOBaHKaya3aHH0r0wey-Hapof1.HoroAOKyZeXTaayA3KHcHaV1.MeKOBaHHaMs.np
9、viHATbiPZMbCymeCTByKxMeMowneceMe)rocy-AapcTBeHHbixCTaHf1.aPtob.ConocaneHMeCTPyKTyPb1.HaCTOame0cauapa8cpyypovyaaHHoMeWyHaPo刖。ao-ywHa11pwBef1.eHbAOnonHHTenbHOMnpwnoxeHUM11A6B3AMEHOCT32634-2014k1.HopMaauf1.oeee11uueucmue(npepatueHuueucmuff)MaCmoameocmandapmauu3Me-HenuuHeMyHameppumopuuya3QHHNbteaocyapcm
10、ny611uyemcf6ya3amenHaUUoHaRbHbfXCmaxdapmoeu3aeaeMbtxe3mu2ocyapcma,amaxcemuMMmePHom11acaumacoomemcmy-KWUXHawoHa11bHOpeaHO8nocmandapmuauuu.BCfiyyao6pecMompa.u3MenenuuuomMGHuUaCmoQUXe&cmandapmacoomeemcmeytomafiuh-opMaw6yemo11y611oaHaHa0ua11bH0MUHmepnem-caumeMeocyapcmeHHoocoemanocmaHapmu3auu,Memponoauuu
11、cepmuauuuKamanoMMe)xeocydapcmeeHHbteCmaHdaPmbSCaHf1.apIHHpF,00pF11GHH,2021BPoocwhckoweAepauwwHaCTOa山w口ca11apHeMO)KeT6wb11o11HorbK)w11wHaCTHMHoBc11pow3BeAeH,TwpaxnpoBaHHpacnpocpaHHbKaUecIBeowuna11bHoroM3AaHHA6e3pa3peHMAe4panbH0r0areHcBanoTeXXkNeCKOMyPerynUPOBaXHK)HMeTPonOrMHBBeAeHHePa3eAaHneoncor11ac
12、HOnPe(QeneHK),npHBef1.eHHOMybCornacoBaHHoviHano6a11b11Mypo-HecnceMeKnaCCV1.nauHHMaPKMPOBKHXKMMHeCK11poAyunnOpran3aunnOSbeAHHeHHbixHaqnw(CCOOH)1,npe4caBnf1.eco6omHo6paMMoe0BpeM(AeHMekoxm.oopoepBnf1.ecf1.BHaHMb1.MHep030M31111AepMucawAePZb1、11ocneHaHeCeHVmHaoyHCCneayeMQaXHMHUeCKOii11poAyu11M-O6hob-ne11
13、Haf1.PeAaXUWaPyXOBOAeT8anonpoeeaeHHK)HCnb1.TaHH口Na431(OECD431),HaOCHOBeooporoorooB11eHaCTO只WHncaHap,ycaHaBnnaeMeTOAinvitro.113onAoi4MMHeHnwunpoBabBeIUeCTBanCmneHj1.HHeBbObiBaKJmnepa3beaneko)km.KaKaonpeycMpeHpe6B3HMAMHCCOOH(1.AaHHOePyKoBOACrBOo6ec11HMaeB3M*HbnaccMuauMk11poAyu11H.0611aAau4eMpa3be4amMM
14、4etcBnew.Ha8。TBeTCTBymne110naccbOnaCHoCTx.OqHacco6hoctwXMMHMecKOM11poAyMMBb3bBabpa3bezaHeoxMo6whho11peA11onaraenc-onb3BaMena6opaop11bxXMBOTHb1.X(PyKoBOACTBoOECDnonpooeenMK)HCnbITaHH伪NQ404(OECD404);BnepBbie11pnHRob1981r.,11epecM0peH0b1992,2002S2015rr.)(2.BAOnOnHeHKeKMeTOIQyOECD431anHjQHpB3HbMp11HATbT
15、ax)KeABaAPyrMXMeTOaaMCnbITaHK1.iinOaPeAez1.eHHapa3be4ameroAeMCTBMRXHMHHCKOW11pAyKQMH.11pviBAeHHba)iuerohpa3b6Aa)iueroAeMCTBKaHaoxy,BntHaBc6aHeCXOnbKOMAyne,bnpeenaxoopbixCrpynnHpoeaHbip11MeHAeMbiemctomhmkwHHopMaqMHMMeToAb1.MCCneAoeaHiriM.KCOaeP)KMTHe-06x0AHNHeya33HHR,acau4t1ecR:(i)06061.MeHHaMHCnonb3
16、。HaHVmHMeK)IUHXCaAaHHbix,11onyHHHbxbxoaeHCnb1.TaH而nnnhhumnyewQnaOUeHKHc11oco6hocthXKMhHeCKo1npoayunwb3bBabpa3jQpaxe-HueMpa3bezaHMekoxm,aTaKXe(三)b6opaOnTMMaJ1.bHOrO110A0Aa11pB3HMKHBHMv11ope6HcnbAononHmenbHNXMCnbrraXMaX6.f1.oyMHOECD4316bnnepb11pmhrtb2004r.1.a3aenaKAb110Aeprancf1.S3MeHeHHaz:b2013r.oraH
17、ero6bnnBKniOYeXb1.AOnOnHHTenbHb1.eMeToAb1.WCnb1.TaHWHHaPeKoHCTPyvIPOBaHHOM11enoeesecKOMsrwiep”SCe(RhE)cbo3moxhoctbk)11pnweHeHMATaKHXwe00B即11accvauMupa3b-eaatomewxhmhmcckownpoyunncPaMeneHHeMHanoanaccbOnaCHOCY凡mb2015.KorAaoh6bn11pwBHbcooBecBwec11onoxeHMMnpyoBARi4eroAOKyMeHTaIATAhAononHeHOnHCaHHeMa11be
18、p-HawBHoroMeTof1.a03MepHMMxw3HecnocoHcnneM.BOECD431npMBeA6HbYeTb1.PeBanwxpoBaHHbixMeToAaV1.CnbITaHn,KaxAb1.nH3oopbxochob3hHaKCnOnb30BaHWWCePKHXOBbInyCKaeMXXo6pa3uooRhE.Hccne4o0aHWRHaoaepez3pvenbH0HBanH-AaUHV1.7,aTaICKenocneywiMweBanHAaUHOHHbIem811aoBaHHa8-106b1111npoeeeHbibOTHOuJeHHMCDeAyKW1.XAByXMe
19、ToAO,11peACaneHHbx11aPbIHKe11,12:EpiSkinwStandardMode1.(SM)KEpiDermSkinCorrosivityTeSt(SCT)(EP1.-200)(BanHA叩OBaHHbIepeepHTHbMeTOAb1.(BPM).11oHTOraMWCCnef1.oeaHMW6b1.J1.M11Of1.OTOBneHb1.PeK(WeHaUMXBCOOTBeTCT8KKCKOTOPbIMK11pMMeHeHHey11OMHyTb1.XBbiiueBPMboeperocyAapcBeHHoroperynnpoaHHR只QnyCXaeTcf1.11rp
20、a3nn11eHMApa3ba)iuki(P)MHepa3bAaomnx(HP)Bemec0,aEpiSkinwaxerzoxeSCnOnb30BaTbCazwaOaPeAeDeHWapwaA-nexHcnpa3b%aK)IHSXBe14ecBKycanOBneHHbaMAnahhAnaccaMOnaCHOCm13-15.Ka6binoOnpeaeneHOBXOAeBaT1.tVIaUMHHa0cH0enpnHf1.txca11apo3enBHcu.ABaApyrwxcyHNHapbHeMeTOAaHCnbnaHnHapa3beAaHHeo*winWfRCHCnOnb3。BaHHeMMOAen
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