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    ГОСТ 32634-2020.docx

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    ГОСТ 32634-2020.docx

    MEXrOCyf1.APCTBEHHbIiiCOBET110CTAHAAPTM3A1.(SH,METPonorMHSCEPTHHKAUHW(MC)INTERSTATECOUNCI1.FORSTANDARDIZATION.METRO1.OGYANDCERTIFICATIONOCT326342020(SC)ME>KOCyAAPCTBEHHb1.kiCTAHAPTMeTOIqb1.HCnb1.TaHk1.访nobo3A6mctbmk)xmmmm6Ckom11po1.qyMhMHaopraHM3MUeJIOBeKaPA3BEf1.AHMEKOXWINVITROMeTOAb1.CMC11OJ1b3OBaHMMPeKOHCTPyHPOBaHHO。MeJ1.OBeHeCKOro311MApMMCa(OECD431:2016,Guide1.ineforthetestingofchemica1.s.Invitroskincorrosion:reconstructedhumanepidermis(RHE)testmethod,MOD)3AaHyeoH11ManbHoeMocaCaHAapwHopM202111peAMcnoBne1.4e11M,OCHOBHbie11pMHqnnbho6uvte11pavnanp。BeAeHumpa6onoMexrocyAapciBeHHowCTaHapw33unnycaHBnebOCT1.0«MexrocyAapcTBeHHaRcwciewaCTaHAaPTH3a4nn.OCHOeHb1.enonoxeHM«»MOCT1.2«MexrocyaapcTBeHHaf1.CMCTeMacaHaapwaunn.CraHf1.apTbiMexrocyf1.apcTBeHHbie.npaonnaHPeKOMeHAaUHHnoMexrocyAapcBeHHMCTaHAaPTM3aux.11pannapaspa6ov,11pwhriha,06HOBneHvmMOTMeHb1.ACbcaohma0CTaHAaPTC1 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B3)KX(HP1.CHighPerformance1.iquidChromatography):Bb1.COKo3euiBnaaxwf1.ocHaAxpoFaorpan.1.3 ETso:110a3ae11b,3HaMeneooporoMO)KeT6wbOUeHeHOryeMOnPeReneHHaBPeMeHHbo3-AWCTBMA.HO6xOAWMOOA11ACHMXHWR>KW3HCn6HOCHKTOKH50%.OC11HCnOnb30BaHHaCT3HAapTHoroxmmmhgckooBemeC1.BacaaaHHbiM3Ha¼HneMKoHUeHIPaUHH(cm.axICso).1.4 xM3Hec11oco6Hcbneo(ce1.1.viabi1.ity):11apaMep,OCPeAenaK)山由CyZMaPHy1.oavBHcbne0MH0wnonynRunn.HanPKMePCnO86HoCTbKneToMXbIXMKrOXOHZIPWanbHbIXAe叩POfeHa3BccaaB-11nabBHTanbHbiHXPaCHTenbMTT(3-(4,5-AWMTMnMa3on-2-M11)2,5-AneHwnepa311HM6po”w,na-3onnnCMHww).KOTOpbiw.B3a0ncwMcMoM3wepf1.eMoroKOHeMHOfO11oaaenf1.n11pooonaKCnbITaHM凡oppenwpyec06UUIMUWCnOMWA1.nMBbixMBaeMOCTbto11eo.1.5 IATA(IntegratedApproachonTestingandAssessment):MHTerpnpoeaHHbiw11oa×oakVICnb1.TaHHaNHouee.1.6 ICso:110a3aenb,SHaneHVjeooporoMo)KeT6b11bOUeHeHO11yewOnPeAeJ1.eHvmKOHUeHTPaUHHCTaHXiapTHoroB4cBa.npnKOTOP0CHwxacf1.xw3Hcnoco6HCTba11hHa50%(ICso)nohctghghhm33aHHro11epwoaB03f1.ec8n.cm.TaKXeETso.1.7 M3boHHanA03a(infinitedose):KOnHqeeTBoHCCneAyeM。口XMMHMeCKoq11p0Ay4nw,HaHDCKMoAHa3nepMwc.11peBbuja>meeonnMec8,oooeHeo6xowwo11onoromaHMepHoro11okpmtmanoeepxHOCTM311HAepMMca.M3AHMeoMUManbHoe1.8 MccneAyeManxMMHHecannpoAyun(testchemica1.):11pyunf1.KOToPaanof1.Bpraecf1.nc-11WTaHHf1.M.1.9 UVCB(unknown,ofvariab1.ecomposition,orofbio1.ogica1.origin):Be14ecBaHen3ecHrom11m11epeMHHroCOCTaBa.11po11ybKOMnneKCHb1.XPeaKUVIaw11nBe1.UeCTBa6wonorwMecoro11powc×oxeHHA.1.10 KOHTponbHaR11po6aHCOHC必,HeCnoCo6hmx(NSCodntro1.):KoH1.POnbHaa11poaAnaOUeHKHHcneuMwHcoroOKPaUJHBaHuaBHxn3HecnocoHbxTKaHax.1.11 KOHTponbHaR11po6aHCMH3Hocnoco6MMx(NSCM11gcontro1.):KOHTPoJ1.bHaa11po6aa11aOUeHKMe-CUHHHCK00OKpai1.JKBaHHf1.BXH3HCOC6Hb1.Xia11f1.x.1.12 MH0r00M110HeHTH0eBe14ecB0(mutinstituentsubstance):BeiueciBO,xapapn3yemoko-JiMMecTBeHHbiMcocaM,BoopowABeSnv1.6oneeOCHOBHb1.eCTPyKTyPHb1.ecocraennioiMweAepxacbKOnWHeCme10%11oMacce),ho<80%(oMacce).O6pa3aweMKOrOKOMnOHeHTHO0Bemecroaovc-XOAMTBFipouecce11p0W380ACTBa.Pa311MHKeM>KAyCMeCb1.OHMHOrOKOMnOHeHTHbINBeieCTBOMCOCToV1.TBtom.MoCMeCb06pa3yecf1.nyeMCOenHHeHHaAByXwnw6oneeBeiUeCTBnpvOTCyYCTBHSXHMUNecKOIipeaUmMhookom11ohhthoBeeco,Ha11poM,06pa3yecf1.bpe3ynbaeXHMHqeCKoaPeaKUHn.1.13 MTT(MTT):3-(4,50MTHTna3on2Hn)2.5AnHnnrpaaonwf1.6pOMWA:TMaaonnnchhmww-pa311MR6poMMA.1.14 Haae*Hcb(re1.iabi1.ity):110a3anboro.HTOmtoaHCnbnaHWnmoxt6bibpeannaoeaHcno-J1.yMeHHeZBc11poM3BMMb×pe3y11ba0BbPaMKaXOAHoaV1.nHpa3nnHHbx11a6opaopniibpa3HoeBpesiR11pw11pnMHeHnnoaHoroHoroxe11pooonaOhoueHHaecR11yewBbrMHCj1.eHKaBHyrpw-HMexnaSopa-T0pH0WBOCpOK3BOAMMOCTH(25).1.15 HCMTT(NSMTT):HcnunHMCoBOCCTaHOBneHWeMTT.1.16 HP(NCnoncorrosive):HepasbejQaiomaf1.1.17 OAHOKOMnOMeMTHOeBemeCTBO(Monos1.ituntsubstance):BeiMecreo.XaPaKTePH3y。MOeo-J1.HHGCTBGHHb1.MCOCTaBOM,BKOTOpOMOAHaOCHOBHaf1.CTPyXYyPHaaCOCTaB11AK>U4af1.COAepXMTCf1.KOHHH-ceHeMeHeeYeM80%(nowacce).1.18 011(ODoptica1.density):OnTMVeCKaa11noHorb.1.19 11K(PC-positivecontro1.):11onoxwbH3AKOHTpOj1.bHaanpo6a.COAoP)Ka1.MaabcKOMnoHMb1.MccnGAyeMOHCgeNb1.mo6pa6aibBaMaf1.cwcnonb3BaHMMeemeciea.aaeef1.owoAa1.OUWOnonoxwenb-HbiAonnHo6wo6ecne11nbB3MxocbyMnuBabM3MeHMMBocbboBpeweHMonwa.nonyMaeworoA11f1.110D0>KMTnbH0r0KOH1.POn凡3T0T0n0XMTnbMb1.MOTKnWKHAOHXGH6b1.TbCnni1.JKOM3aBb1.UJHHb1.M.1.20 pa3i>eAaHMekomwInvivo(skincorrosioninvivo):B3HwoeHMHGoePaTHM(XOop>*QeHMRKOXW.KOTOpOp0f1.B119TCf1.BMA1.rIMb1.MHGKpO3OM3MpMWCaHAePMbBO3HHK3»O1.Mee11OC11eHaHeCGHMAHeCDeAyeMO口XXMSMeCKo11pozyuwMHacpoAO4M.Pa3beaxueeaewcBne11accwwunpyecnoHa-J1.HHHK)3BKpOBOTHHMW,KPoBaBbaXCTpynbGB,aMpe314CyinoM3MHeHHK)OTIHKaKOXM,BbiaaaHHOMyeeo6ecuBeMuaHweM.110B11eHn>y11acoBbinaAeHKaBonoC(a11o11eunw)uujpawoB.BCoMHKTenbHbJXcny11aRxAOnXHOp0B0f1.wibCRrMCiona7onorHecoeHCCJIeAOBaH坏。nopaxHHbxyHaco.1.21 pe11eaMTHcb(re1.evance):OnwcaHMecootbtctbmaMeTOAaKCn

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