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.owingdomentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentundatedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO385r1.aboratoryg1.asswareBurettesISO719,G1.assHydro1.yticresistanceofg1.assgrainsat98Methodoftestandc1.assificationISO1773,1.aboratoryg1.asswareNarrowneckedboi1.ing1.asksISO9187-1.Injectionequipmentformedica1.use-Part1:Ampou1.esforinjectab1.esForthepurposesofthisdocument,thefo1.1.owingtermsanddefinitionsapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obpsma1.1.norma1.1.yf1.at-bottomedcontainerhavingstemsinmanydifferentformsbe1toafterIi1.1.ingibyarcusua1.1.yS.Figure2-Fi1.1.ingvo1.umeofampou1.es(upto8Procedure8.1 Genera1.Thisproceduresha1.1.becomp1.etedwithinoneworkingday.8.2 C1.eaningofsamp1.esThefo1.1.owingc1.eaningprocessforeachcontainersha1.1.becomp1.etedwithin20minto30min.Rko<wea1.1.the(awmp!eseachjisft8tainerotno4HathanWiMHeC遍州蝌&«磔峰an弥伽即0rt.temperatureanda1.1.owtosUm1.for(20±5)min.Immediate1.ybefor-testing,emptythesamp1.es,rinsetwicewithpurifiedwater(5.6),andthenoncewiththetestwater(5.1)anda1.1.owtodrain.C1.osedampou1.essha1.1.notberinsedbeforetesting.峭EaPPrM。归EyORfinineih也WPbkWnto陵U喃JWWm%Wtok闻5怏4RfOUdWightofthesea1.ingpoint.8.3 Fi1.1.ingandheatingFi1.1.eachcontainer,se1.ectedforthesamp1.es1.z4Unaccordancewith7.1andc1.eanedinaccordancewith82,tothefi1.1.ingvo1.umewiththetestwater(5.1)bymeansofsuitab1.evo1.umetricmeasuringdevices.CapeachCGDtainer1.inc1.udingampou1.es,1.oose1.yWithaninertmateria1.,forexamp1.ewithinvertedbeakers(6.6)ofsuchasizethatthebottomsofthebeakersfitsnug1.ydownontherimsofthesamp1.e.6Bkcraft¥的IIeSHih11f1.Sf1.bi1.Afb1.).foi1.(6.7).P1.acesyringesandcartridgesinabeakerandcoverthe8NOTEaIsobeProper1.yca1.ibratedautomatictitrationequipmentgivingresu1.tswiththesameorbetteraccuracyContainersof2m1.or1.ess,inwhichthewaterisnotsufficient1.yretainedduringtheautoc1.avingprocess,maybec1.osedinasuitab1.eway,e.g.withastopperorp1.ugofinertmateria1.,andfixedusingap1.ungerorP1.acethesamp1.es,gathere<i4-groupsing1.assdishesorinthebeaker,ontherackintheautoc1.ave(6.1),containingpurifiedwater(5.6)atambienttemperature,andensurethattheyarehe1.dabovethe1.eve1.ofInserttheendofaca1.ibratedtherma1.deviceinafi1.1.edcontainerthroughaho1.eofapproximate1.ythediameterOfthethermocoup1.eandconnectittoanexterna1.measuringdevice,ifthecontaineristoodoorto1.idinsertabut1.eavetheapp1.yaopen.Startsuitab1.e,simi1.aroftheC1.osetheversustimeandheattheautoc1.aveWiththefo1.1.ovringcharacteristics:raisethetemperaturevritharegu1.arratefromroomtemperatureto100°Cwithin20HIinto30rnin,andmaintainthetemperatureatto22±1)oCfor(10±1)at(1211.)oCfor(60±min100to121the20mintemperatureisreached.Coo1.downto100ventingtopreventformationofavacuum,within40minto44min.NOTEExperiencehasshownthattherateOfheatingto121,theho1.dingtemperatureof(12111)oCandrateofOfCoOIingto100areRemovethehotsamp1.esfromtheautoc1.aveandcoo1.toroomtemperaturewithin30min.Startthedropsafterthan40cancarethebeofing1.assbydownIargeshock.Carryoutthetitrationwithin1hofremova1.ofthecontainersfromtheutocUve.Combinethevo1.umeso1.utionstheSecondfromtheofTab1.e1atested(seeTab1.e)andmix.sma1.1.stemmedampou1.es,theextractionso1.utioncanbepart1.yneutra1.izedbyabsorbingcarbondioxide(CO2)fromtheatmosphere.Toobviatethisrinverttheampou1.esandheatthebasegent1.ywithaf1.ame.Ensurethatnof1.ame_capacity3m1.,thetestavo1.umeofthem1.ofthesecondco1.umnofTab1.e1)intoconica1.f1.ask(6.3)havingacapacityof100m1.inthecaseofcombinedextractionSo1.utionUwmcontainershaving1.argercapacities,pipettetherequiredvo1.umes(seethesecondco1.umnofTab1.c1)intoseparatePreparereferenceso1.utions(b1.ank)bypipettingvo1.umes-otthetestwater(5.1),equiva1.enttothosetakenfromtheextractionso1.utions,intoconica1.f1.asks(6.3)havingacapacityComnwisuratewiththetestofthe(5.1)andbeingtheb1.ank0,05m1.ofmethy1.red(5.2)(5.5)foreach25m1.ofchangeoccurs.and0,05ofmethy1.red()(5.5)tof1.askforeach25ofofco1.ouredso1.utionso1.ution.Titrationva1.ues1.essthanexpressedtotwodecima1.p1.aces,titrationva1.uesgreater1.,0canused.8.5Testtodeterminewhetherthecontainershavebeensurface-treatedcanbeTOnsidcrab1.yincreasedbytreatingthesesurfacesduringthecourseofproduction.orthecontainersamp1.esprevious1.ytestedsha1.1.beused.1.eastemptyagainso1.utionpurifiedcarefu1.1.y.RinsetheSamp1.essamp1.estimesspecifiedpurificdwater(5.6),thenat-50CAUT10NHydrof1.uoricacidisextreme1.yaggressive.EventinyquantitiesCancause1.ifethreateninginjuries.Considerusingamateria1.safetydatasheet.times),Expressionresu1.tsconsideredtohavebeensurface-treated.9.1 DeterminationNOTEthec1.assHChydro1.yticresistancecontainer4802-2,obtainedindividua1.titrationmethodnotcomparab1.e9.2 C1.assificationacidDistinctionbetweencontainersOfhydro1.yticresistancecontainerc1.assHCt1andhydro1.yticresistancecontainerc1.assHCt2c1.assTab1.e2.1sha1.1.satisfytherequirementsforhydro1.yticresistancecontainerc1.assesHCt1andHCt2TabIe22ShaI1.produceareva1.uesc1.osertosignificant1.ygreaterhydro1.yticresistanceContainersecondco1.umninNOTEThehydro1.yticresistanceoftheinteriorsurfaceOfVi3】Sandbott1.esmadefromsoda-1.ime-si1.icag1.assIftherearedoubtswhethersurfacetreatmentornotwasperformedonacontainerand/or1.odistinguishbetweentypeIandtypeIIg1.asscontainers(accordingtoPh.Eur.).unusedg1.asscontainersFiHthamPIeSwithamixtureofonevo1.umeofhydrof1.uoricacid(5.4)andninevo1.umesOfhydroch1.oricacid(5.3)tothebrimfu1.point.A1.1.owthefi1.1.edsamp1.estostandatambienttemperaturefor10411in.thenoncethewithverywater(5.6).Thentestthefiveaswithin8.3and8.4Iftheresu1.tsareconsiderab1.yhigherthanthoseobtainedfromtheorigina1.surfaces(aboutfivetoten9theSamp1.esofsha1.1.beDetermine-Ihemeanva1.ueofthetitrationresu1.tsandexpressitinmi1.1.i1.itFsofhydroch1.oricacidso1.ution(5.2)per100m1.oftheextractionso1.ution.Theb1.ankva1.ue(see8.4)sha1.1.beused.withThisFobtainedaccordingJSOc1.assHCraIthoughthebythetestva1.uesareisequiva1.ent.Therefore,conversionsoftestresu1.tsfromthisdocumentandISO48022arcnotpossib1.e.Thecontainerja1.1.bec1.assifiedasshowninTAWe2,accordingtotheCOnSUmPUaQofhydroch1.oric9.3so1.ution(5.2),whentestedspecifiedin8.4anddeterminedaccording9.1.fteretchingandre-testinginaccordancewith8.51.containersOfhydro1.yticresistancecontainerinHCtAfteretchingandre-testinginaccordancewith8.5,containersofhydro1.yticresistancecontainerc1.assHCandwhichmuchthatarethoseva1.uesforthanthosegiventhec1.assHCt3ofTab1.e2.Tab1.e2Maximumva1.uesinthehydro1.yticresistancecontainersurfacetest(titrationmethod)Capacityofcontainervo1.umecorrespondingtothefi1.1.ingvo1.umeMaximumva1.uesfortheconsumptionofhydroch1.oricacidso1.utionC(HC1.)0,01mo1.1.(5.2)per100m1.oftheextractionso1.utionm1.>2005000.302,90,60>5000.202,20,403,69.4DesignationThehydro1.yticresistanceoftheinteriorsurfaceofg1.asscontainersmeasuredinaccordancewithIhisdocumentsha1.1.bedesignatedasfo1.1.ows:tNWH(HC1.)TA6Ms8oatmptft11mhwponyMMim6nWitiMibeonsumptionof1,6m1.ofhydroch1.oricG1.assrhydro1.yticresistancecontainerc1.assISO4802-HCBIOTestreportThetestreportsha1.1.inc1.udethefo1.1.owinginformation:a) areferencetothisdocument,i.e.ISO4802-1:2023;b) anidentificationofthesamp1.es;c) meanbrimfu1.capacityofsamp1.es(exceptampou1.es);d) thefi1.1.ingvo1.umeofthesamp1.es；e) thenumberofsamp1.esusedforonetitration;f) themeanva1.ueofthetitrations;g) hydro1.yticresistancecontainerc1.assHCt(designationofthecontainertested);h) forhydro1.yticresistanceCOntaindaSSHCt2fastatementwhetherthetesthasbeenrepeatedafteretchingofthesurface(see8.5)andtheresu1.tsobtained;i) astatementwhetherc1.osedampou1.esweretested;j) anyunusua1.featuresnotedduringthedetermination.11Reproducibi1.ityExtensiveresearchwascarriedoutbyTechnica1.Committee2oftheinternationa1.Commissiononf1.tasift)undtortietircgcstothrif1.iantdtiratandtbanitffectopdntnRerptiXducibi1.i1.yOf(Ith曲tbdavecans1.ight1.yaffecttheWithin-Iaboratoryvariance.Byfar,the1.argestvariationoccurringbetween1.aboratoriesistheautoc1.avingcyc1.eandthiswasshowntobeamajorfactor.Properca1.ibrationoftheautoc1.aveandofthetemperaturecontro1.devicesareofgreathe1.pinimprovingthareproducibi1.ity.Tostandardizethetestprocedure,thecertifiedreferencemateria1.IRMM435bisavai1.ab1.eattheInstituteforReferenceMateria1.sandMeasurementsattheEuropeanCommissionJointResearchCentreinGee1.rBe1.gium.Forthismateria1.thevo1.umeof0,01no1.iHCIso1.utionnecessarytothetitrationof50m1.ofextractionso1.utionfromcontainersof18,9m1.brimfu1.capacitywasquotedas(0,38±0,04)m1.,布He/ec。嘛RPftf1.的瓠g乂曲ftedinN耐根肺W(话CoWi蛔Qb1.WV&tigatec。Wofreproducibi1.ityatdifferentconcentration1.eve1.swhendifferenttypesofg1.asscontainersaretested.Formoredetai1.sseeReferences14and15J.Bib1.iography1 ISO3585,Borosi1.icateg1.ass3.3Properties2 ISO3696,Waterforana1.ytica1.1.aboratoryuseSpecificationandtestmethods3 ISO8362-1,InjectioncontainersandaccessoriesPart1:Injectionvia1.smadeofg1.asstubing4 ISO8362-4,InjectioncontainersandaccessoriesPart4:Injectionvia1.smadeofmou1.dedg1.ass5 ISO8536-1,Infusionequipmentformedica1.usePartI：Infusiong1.assbott1.es6 ISO13926-1.PensystemsPart1:G1.asscy1.indersforpen-injectorsformedica1.use7ISO11040-1,Prefi1.1.edsyringesPart1：G1.asscy1.indersfordenta1.1.oca1.anaestheticcartridges8a*中资钾Myff用IiI确邺ringesPart4:G1.assbarre1.sforinjectah1.esandsteri1.izedsubassemb1.ed9ye!r1.ftifzftfFfi-.sandaccessoriesforpharmaceutica1.preparationsPart1:Drop-109(X,4184tContainersandaccessoriesforpharmaceutica1.preparationsPart4:Tab1.etg1.ass11Y胪西解出,用助瘀HQ咽却翩胡幅mQCCudca1.preparations-Part7：Screwneck112Ph.Eur.,EuropeanPharmacopoeia:3.2.1G1.asscontainersforpharmaceutica1.use1)13tff1.K11W耻Ru&esewqgM玳eriHB244双1.R.MM阳IgiUmInstihiteforReferenceMateria1.sand