ISO 04802-2-2023.docx

INTERNATIONA1.STANDARDISO4802-2editionFourth202342G1.assware-Hydro1.yticresistanceoftheinteriorsurfacesofg1.asscontainers一pefminationbyf1.amespectrometryandc1.assificationVerrerie-Resistancehydro1.ytiquedessurfacesinternesdesrecipientsenVerrePartie2:DeterminationparSpectrometriedef1.ammeetc1.assificationReferencenumberISO480222023(E)COPYRIGHTPROTECTEDDOCUMENT©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.andContentsForewordIitroductionScopeNormativereferencesTermsanddefinitionsPrincip1.eReagentsApparatusSamp1.epreparation.47.17.2Samp1.esizeDeterminationofthefi1.1.ingvo1.ume如由IgtOTdtjdnitthidgfigZOmmouterf1.angediameter(exceptampou1.es,75622F1.at-bottomedcontainers>20mmouterI1.angediameter7Round-bottomedcontainers81.ippedcontainersAmpou1.es8Syringesandcartridges8Procedure8.1 Genera1.98.2 C1.eaningofsamp1.es98.4 RHbgiSandHeatiegtractionso1.utions.-108.4.1 ContainersOfhydro1.yticresistancecontainerc1.assesHCf1,HCf2andHCfBorthoseknowntobemadefromborosi1.icateg1.ass.一.一.108.4,2三捅幽qfh插砌续91.nceso<BR国出朗曲Has斯F3andHCF5or1098.5Testtodeterminewhetherthecontainershavebeensurface-heated11Expressionofresu1.ts129.1 DctermHia1.ujri129.2 C1.assification129.3 H)tri0M11heyencecontainersc1.a<shydHf1.yQcFesistancecontainerc1.assHCf.1and139.4Designation1311Testreport13Reproducibi1.ity13Bib1.iography15ForewordISO(theInternationa1.OrganizationforStandardization)isawor1.dwidefederationofnationa1.standardsttiugh(ISOmrtmiw)bMd>niK盟RAucekdHpfff1.QbbGgbodyIcommitteehasbeenestab1.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etW1.kes,s姗抬”not1.f1.fcfcww1.蝌闾ICr融OrdanCe麻theeditoria1.ru1.esoftheISO/IECDirectives.Part2(seewwsv.iso.org/direc1.ives).曲曲谶en1.a隧超OntakeS般福舐岫)瓢oncf1.部隔隔配斓岫野ntm邓创醐课蹒kgdaimcdpatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocumentISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimp1.ementthisdocument.However,imp1.ementorsare蜘临翻琳酬/mj，wWjSOQFg/眸IentS洗蝮油那ion,扁MMSPOn赖岫油嬲9的阳躲Ora"suchpatentrights.Anytradeusedinthisconstitutenameendorsenent.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOSPeCifiCtermsand幽幽蛔豳酒侬遮W即辆O)assEif1.眦聚inwe帼"1.见OnBarRWyE辟dead邮&CcsVbr¼11isoorgisoforeword.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(ISO4802-2:2016),whichhasbeentechnica1.1.yrevised.Themainchangesareasfo1.1.ows: theexp1.anationofthehydro1.yticc1.assesHCf1.rHCf2,HCF3,HCFRHCFDfordifferentg1.asstypes; c1.arificationofneededpropertiesofpurifiedwaterandtestwater; harmonizationofthesamp1.esc1.eaningandtheautoc1.avationprocesswithPh.Eur.; inc1.udingcontainersupto0,5m1.fi1.1.ingvo1.ume.A1.istofa1.1.partsintheISO4802seriescanbefoundontheISOwebsite.AnyfeedbackorquestionsonthisdocumentShOU1.dbwdi依UdU>th。usa1.gnationa1.standardsbody.Acomp1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.htm1.IntroductionThisdocumentis1.arge1.ybasedonatestmethodapprovedbytheInternationa1.CommissiononG1.assOKMiFf1.cbhir1.6orai1.egvtM'ers.DrfeftyandAna1.ysis,formeasuringthehydro1.yticresistanceThisdocumentcontainsac1.assificationwhichisre1.atedtobutnotequiva1.enttothec1.assificationsetupinISO4802-1forthetitrationmethod.Thehydro1.>rticresistanceoftheinnerg1.asssurfaceiseva1.uatedbydeterminationofthere1.easeda1.ka1.ireactingions.Accordingtotheirhydro1.yticresistance,g1.asscontainersarec1.assifiedindefinedcategories.IICfIg1.asscontainersaresuitab1.eformostpreparationswhetherornotforparentera1.administration.HCf2g1.asscontainersareparentera1.adminis1.rationuitab!eformostacidicandneutra1.,aqueouspreparationswhetherornotforHCf3g1.asscontainersareingenera1.suitab1.efornon-aqueouspreparationsforparentera1.HCfBg1.asscontainersareingenera1.suitab1.efordrinkingampou1.es(ContainerC1.assHGB2accordingtoISO719).HCFDg1.asscontainersareingenera1.suitab1.efor1.owerdemandsonhydro1.yticresistance(ContainerC1.assHGB4andHGB5accordingtoISO719).ISO480222023(E)INTERNATIONA1.ST