ISO 04802-1-2023.docx

INTERNATIONA1.STANDARDISO4802-1editionFourth202342G1.assware-Hydro1.yticresistanceoftheinteriorsurfacesofg1.asscontainers一Pefminationbytitrationmethodandc1.assificationVerrerie-Resistancehydro1.ytiquedessurfacesinternesdesrecipientsenVerrePartie1:Determinationparana1.yseUtnmetriqueetc1.assificationReferencenumberISO4802-1.:2023(E)©ISO2023COPYRIGHTPROTECTEDDOCUMENT©ISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmk<nroni(ncm11ni10tf1.*Mqn1.C6pW11opypMRHt1.onmaytheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbe1.oworISO'smemberbodyinthecountryoftherequester.f),WV>fifiHipB1.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOtnnhnfaaibif1.i>n11taaR!wcekWppbcingbody1.irnEWf1.iaftStandbjteGf(nowhh1.1.y1.ante<mitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.ectrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenancearedyiFFHSOfISo雇吃帼卜es,s肺1.id1.m3限而叫般硼融蝌闾tc嚓CordanCeJ新theeditoria1.ru1.esoftheISO/IECDirectives.Part2(seewwsv.iso.org/direc1.ives).N(叼黄区n1.s)a比Sn1%ntakes1.*2"?挑也凿jSonc1.f信出信Bf加隔h8超琳同f醐承第SiVedaimCdpatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocumentISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimp1.ementthisdocument.However,imp1.ementorsare懈怖翻琳躺/mj，wWjSOQFg/眸IentS洗蝮油那ion,扁MMSPOn赖岫油嬲9的阳躲Ora"suchpatentrights.Anytradeusedinthisconstitutenameendorsement.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand燃涵龈检幽aa明曲;T制'0)aSSEif1.眦噩inw小限R到OnBar池网JSdead期Qccs槐r¼11isoorgisoforeword.htmI.机抵(三卑依VP昂盟照y"画蚓成/初苗"临座,刚汽76Transfusion,infusionandinjection,andThisfourtheditioncance1.sandrep1.acesthethirdedition(ISO4802-1:2016),whichhasbeentechnica1.1.yrevised.Themainchangesareasfo1.1.ows:addingacomp1.etedescriptionofthecategoriesHCt1.rHCr2fHCt3rHCtB,HCtD;a1.igningtheautoc1.avingtothePh.Eur.;inc1.udingcontainersupto0,5m1.fi1.1.ingvo1.ume.A1.istofa1.1.partsintheISO4802seriescanbefoundontheJSOwebsite.6iWiM6dSh6g触fifiSByII心thiscahXQUR4R11Www6JHeH1.MH43ffinationa1.standardsbody.AIntroductionThisdocumentis1.arge1.ybasedonatestmethodapprovedbytheInternationa1.CommissiononG1.ass(jK1.Qi)；iff1.cbiur31.6roraitfeeg)isg2m1toarters.DwroftrtyandAna1.ysis,formeasuringthehydro1.yticresistanceTheEuropeanPharmacopoeiaCommissionhasadoptedtheprincip1.eofthedeterminationbytitration瞅腐片段肥明盛都现加d蒯屈酶Containersdas©硒1骷辘解和热W秸勰嘛indedinjec屏恪preparations.麴曲i融用楠维独棉新渊侬豳槌祝脚懒曲脚眼械躺itiMresu1.&moreparticu1.ar,theautoc1.avingcyc1.eisdescribedindetai1.用碉品i苑2,也近&能泯祖科8搬担6喇y咫裱SiStanCe,cvta财COnta蛔minat1.OnCu总掘5帆WaSedcategories.HCtIg1.asscontainersaresuitab1.eformostpreparationswhetherornotforparentera1.administration.HC2g1.asscontainersaresuitab1.eformostacidicandneutra1.aqueouspreparationswhetherornotforparentera1.administration.hMh由此1.*1.ion<iUJttM"邯CfoHe甑NIIM油收!油心融rauofmi领喇QW1.由RM*dionsto。龊涧Wi砌Iandforpreparationsnotforparentera1.administration.HCtDg1.asscontainersareingenera1.suitab1.efor1.owerdemandsonhydro1.yticresistance(ContainerC1.ass>1GB4andHGB5accordingtoISO719).ISO4802-1.=2023(E)INTERNATIONA1.STANDARDG1.asswareHydro1.yticresistanceoftheinteriorsurfacesofg1.asscontainersDeterminationbytitrationmethodandc1.assification1 Scopea) SubjectedfordeterminingIheathydro1.yticresistance11)min.interiorresistanceofIneasuredcontainerstitrationb) c1.assificationthemethodscontainersaccordingdocumenthydro1.yticresistanceoftheinteriorsurfaces2 Normativereferencesconstitutesrequirements1.atesteditiondoment.referencedreferences,(inc1.udingarnendments)app!ies.app1.ies.ISO648,1.aboratoryg1.assware-Sing1.e-vo1.umepipettesISO720,G1.assHydro1.yticresistanceofg1.assgrainsat121Methodoftestandc1.assificationISO3819,1.aboratoryg1.asswareBeakers3 TermsanddefinitionsISOandIECmaintaintennino1.ogydatabasesforuseinstandardizationatthefo1.1.owingaddresses：3.1 IECE1.ectropcdia:JVaibbIearhmwww.e1.e<E>pedia.sN/ampou1.eNotcc1.oscd,cntry:Ampou1.csf1.amcsca1.ing,thin-wa1.1.cdandhaveacapacitynorma1.1.yupto30m1.TheyarcintendedtoPart1:Thisdocumentspecifies:amethodtoattackbywater(121±1)for(60oftheThesurfacesisg1.assbywhenofaknowna1.iquotportionoftheextractionso1.utionproducedwithhydroch1.oricacidso1.ution,inwhichcasetheresistanceisinverse1.yproportiona1.tothevo1.umeofacidrequired;adeterminedbyofg1.assspecifiedthistheThefo1.1.owin