ISO 04802-2-2023.docx

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1、INTERNATIONA1.STANDARDISO4802-2editionFourth202342G1.assware-Hydro1.yticresistanceoftheinteriorsurfacesofg1.asscontainers一pefminationbyf1.amespectrometryandc1.assificationVerrerie-Resistancehydro1.ytiquedessurfacesinternesdesrecipientsenVerrePartie2:DeterminationparSpectrometriedef1.ammeetc1.assific

2、ationReferencenumberISO480222023(E)COPYRIGHTPROTECTEDDOCUMENTISO2023IUirhM*hedbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmkfifiHipB1.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForewordIitroductionScopeNormativereferencesTermsanddefinitionsPrincip1.eReagent

3、sApparatusSamp1.epreparation.47.17.2Samp1.esizeDeterminationofthefi1.1.ingvo1.ume如由IgtOTdtjdnitthidgfigZOmmouterf1.angediameter(exceptampou1.es,75622F1.at-bottomedcontainers20mmouterI1.angediameter7Round-bottomedcontainers81.ippedcontainersAmpou1.es8Syringesandcartridges8Procedure8.1 Genera1.98.2 C1

4、.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.ncesoBR国出朗曲Has斯F3andHCF5or1098.5Testtodeterminewhetherthecontainershavebeensurface-heated11Expression

5、ofresu1.ts129.1 DctermHia1.ujri129.2 C1.assification129.3 H)tri0M11heyencecontainersc1.aniK盟RAucekdHpfff1.QbbGgbodyIcommitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO,a1.sotakepartinthework.ISOco1.1.ab

6、oratesc1.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.P

7、art2(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

8、嬲9的阳躲Orasuchpatentrights.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&CcsVbr11isoorgisoforeword.htmI.机抵(三卑依VP昂盟照y画

9、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.arificationofneededproperties

10、ofpurifiedwaterandtestwater; harmonizationofthesamp1.esc1.eaningandtheautoc1.avationprocesswithPh.Eur.; inc1.udingcontainersupto0,5m1.fi1.1.ingvo1.ume.A1.istofa1.1.partsintheISO4802seriescanbefoundontheISOwebsite.AnyfeedbackorquestionsonthisdocumentShOU1.dbwdi依UdUth。usa1.gnationa1.standardsbody.Acom

11、p1.ete1.istingofthesebodiescanbefoundatwww.iso.org/members.htm1.IntroductionThisdocumentis1.arge1.ybasedonatestmethodapprovedbytheInternationa1.CommissiononG1.assOKMiFf1.cbhir1.6orai1.egvtMers.DrfeftyandAna1.ysis,formeasuringthehydro1.yticresistanceThisdocumentcontainsac1.assificationwhichisre1.ated

12、tobutnotequiva1.enttothec1.assificationsetupinISO4802-1forthetitrationmethod.Thehydro1.rticresistanceoftheinnerg1.asssurfaceiseva1.uatedbydeterminationofthere1.easeda1.ka1.ireactingions.Accordingtotheirhydro1.yticresistance,g1.asscontainersarec1.assifiedindefinedcategories.IICfIg1.asscontainersaresu

13、itab1.eformostpreparationswhetherornotforparentera1.administration.HCf2g1.asscontainersareparentera1.adminis1.rationuitab!eformostacidicandneutra1.,aqueouspreparationswhetherornotforHCf3g1.asscontainersareingenera1.suitab1.efornon-aqueouspreparationsforparentera1.HCfBg1.asscontainersareingenera1.sui

14、tab1.efordrinkingampou1.es(ContainerC1.assHGB2accordingtoISO719).HCFDg1.asscontainersareingenera1.suitab1.efor1.owerdemandsonhydro1.yticresistance(ContainerC1.assHGB4andHGB5accordingtoISO719).ISO480222023(E)INTERNATIONA1.STANDARDG1.asswareHydro1.yticresistanceoftheinteriorsurfacesofg1.asscontainersD

15、eterminationbyf1.amespectrometryandc1.assification1 Scopea) methodsubjecteddeterminingbyhydro1.yticresistance(60theIJinteriorTheresistanceg1.asscontainersb) c1.assificationthemethodSCQntainerSaccordingdocument.hydro1.yticresistanceoftheinteriorsurfacesbeenNormativerefere11cesmodificationsre.g.si1.ic

16、one(e.g.containersthatarereadyfordirectfi1.1.ing).constitutesrequirementsaredocument.Fordatedinreferences,on1.ySomeeditiona1.1.citedapp1.ies.contentISO385,1.aboratoryg1.asswareBurettesISO720,G1.assHydro1.yticresistanceOfg1.assgrainsat121Methodoftestandc1.assificationISO3819,1.aboratoryg1.asswareBeak

17、ers3TermsanddefinitionsISOandIECmaintaintermino1.ogydatabasesforuseinstandardizationatthefo1.1.owingaddresses：IECE1.ectropedia:avai1.ab1.eatWWv.detFepediajrg/ISO2023-A1.1.rightsreservedPart2:Thisdocumentspecifies:awhenfortoattackthewaterat(1211)forofmin.surfacesofismeasuredbydeterminingtheamountofso

18、diumandothera1.ka1.imeta1.ora1.ka1.ineearthoxidesintheextractionso1.utionusingf1.ameatomicemissionorabsorptionspectrometry(f1.amespectrometry);adeterminedbyofg1.assspecifiedthistheThetestmethodspecifiedinthisdocumentmightnotbeapp1.icab1.etocontainerswhosesurfaceshave2treatedforfunctiona1.Thefo1.1.ow

19、ingdomentsofthisreferredinthetextsuchawaythattheoroftheirForundatedreferences,the1.atesteditionofthereferenceddocument(inc1.udinganyamendments)app1.ies.ISO719rG1.assHydro1.yticresistanceofg1.assgrainsat98Methodoftestandc1.assificationISO1042,1.aboratoryg1.assware-One-markvo1.umetricf1.asksISO9187Jnj

20、ectionequipmentformedica1.usePart1：Ampou1.esforinjectab1.esForthepurposesofthisdocument,thefo1.1.owingtermsanddefinitionsapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obp3.1 ampou1.eNOtedOSed,entry:Ampou1.esf1.amesea1.i11.thin-wa1.1.edandhaveacapacitynorma1.1.yupto30m1.Theyarein

21、tendedto3.2 bott1.eNotecircuhrentry:othergeometriccross-section.Bott1.esandSea1.edcapacitydosuiemademorethanmateria1.Othermaythan3.3brimfu1.capacity3.4containerEXAMP1.EBott1.es,Via氐syringes,ampou1.esandcartridges.Seea1.so-Fwe4.3.5 fi1.1.ingvo1.umeNotcisUscdcntryxomparcdeterminationfromdiffercntvo1.u

22、mc,sccor7.21.ots.Thc1111ingre1.ationtotestnomina1.quantity3.6borosi1.icateg1.assNotea1.soContainBorosiI1.cateOx1.decontaiinsa1.ka1.inefractionoxides.boricoxidebetween5%and13%.Thisg1.asstypeproper1.yresisunce.fromWhentestedaccordingthydro1.yticresistancerequirementsOf1.c1.assthisdocument.Containers3.

23、7Sodadime-Si1.icag1.asscompositionentry:Containersconformwithhydro1.yticresistancemoderatehydro1.yticresistanceduetothechemica1.ISO2023-A1.1.rightsreservedsma1.1.,norma1.1.yf1.at-bottomedcontainerhavingstemsinmanydifferentformsbe1toafterfi1.1.ing,byarcusua1.1.yf1.at-bottomedcontainer,madefrommou1.de

24、dg1.assof1toorBott1.esarcnorma1.1.ythick-wa1.1.edarchavewithusua1.1.yoffrom5m1.Theybeg1.ass,andnotbyame-sea1.ing.vo1.umeofwaterrequiredtofi1.1.acontainer,p1.acedonaf1.at,horizonta1.surfaceartic1.emadefromg1.asstobeusedasprimarypackagingmateria1.intendedtocomeintodirectcontactwithapharmaceutica1.prep

25、arationNote1toentry:Thesentaincrsarcmadefromborosi1.icateorsoda1.imcsi1.icag1.ass.definedvo1.umeofwatertofi1.1.thetestspecimenthat1totoForthecontainersetsthefi1.1.ingsourcesIthasnovo1.umeisathespecificproductvo1.ume.si1.icateg1.asshavingaveryhighhydro1.yticresistanceduetoitscompositioncontainingsign

26、cantamountsofboricoxidemay1toentry:a1.uminiumg1.assand/ormassearthofNote2toentry：Neutra1.g1.assisaborosi1.icateg1.asshavingaveryhighhydro1.yticresistanceandahightherma1.shockmadethisg1.assconformwithISO720,meetsthecontainerc1.assHCfofHGA1.si1.icateg1.asscontainingamassfractionuptoapproximate1.y15%of

27、a1.ka1.imeta1.oxides,main1.ysodiumoxide,andamassfiactionuptoabout15%ofa1.ka1.ineearthoxides,main1.yca1.ciumoxideNote1oftheg1.ass,andmadeChisg1.asswi1.1.havecontainerc1.assHCf3.a) Examp1.eofag1.asscy1.inderforapen-injec-tor/cartridge(seeISO13926-1)b) Examp1.eofaninjectionvia1.madeofg1.asstubing(seeIS

28、O8362-1)c)Examp1.eofasyringeg1.assbarre1.(seeISO11040-4)d)Examp1.eofastemcutampou1.ewithcon-striction(seeISO91871)Figure1Examp1.esofcontainers3.8surfacetreatmenttreatmentoftheinterna1.surfaceofg1.asscontainerswithreagentsinordertoachieveade-a1.ka1.izedsurfaceandtoproduceasignificant1.y1.owerre1.ease

29、ofa1.ka1.imeta1.ions(anda1.ka1.iearthmeta1.ions)Nydedyti(jiwtStsstMfi11Dt3sHtDfeximioJ1.iordistonccch三HdaFifDneri1.iaatcdcontainersarcrinsedbeforeuse.3.9via1.sma1.1.,at-bottomedcontainer,madefromtubingorfrommou1.dedg1.assaMhtfu1.demHfi:IiRamamrrah哂HhtUonvgiHMandh4vttiy&p3m5vu,t0mTheyarenorma1.1.ysea

30、1.edWIth4Princip1.eThistestmethodisasurfacetestapp1.iedtog1.asscontainersasproducedand/orasde1.ivered.S1.iPedCQnmmeI下IWheatMftMedfwtea阿折磔侬喃闻侬wa怆SPeCifi碎蜴F吗rattacfc6yasure2.Dependentondifferentg1.asstypes,specific1.imitva1.uesaredefinedinthefo1.1.owing:性V1.eirhydrOIytiCresistance,evakat龈疥tain堆determi

31、natif讴4晚碱3%fRa1.ireactingions.According-HCf1g1.asscontainers:neutra1.g1.ass,positionoftheg1.assitse1.f;VfXE.1.InthePh.Eur.3.2.1w)andtheUSPuthehydro1.yticresistancec1.assificationaredesignatedHCf2g1.asscontainers:usua1.1.yofsoda-1.ime-si1.icag1.asswithahighhydro1.yticresistanceresu1.tingfromsuitab1.e

32、treatmentoftheinnersurface；3XEZI.InthePh.Eur.3.2.1Ig1.andtheUSPjsjthehydro1.yticresistancec1.assificationaredesignatedHCf3g1.asscontainers：usua1.1.yofsoda-1.ime-si1.icag1.asswithon1.ymoderatehydro1.yticresistance；111eE?!.InthePh.Eur.3.2.1uandtheUSPuthehydro1.yticresistancec1.assificationaredesignate

33、dHCFBg1.asscontainers:usua1.1.ymadeofborosi1.icateorsoda-1.ime-si1.icag1.asscompositionwithhigherhydro1.yticresistance(containerc1.ass：HGB2accordingtoISO719);HCFDg1.asscontainers:usua1.1.ymadeofsoda-1.ime-si1.icag1.asswith1.owhydro1.yticresistance(containerc1.ass：HGB4orHGB5accordingtoISO719).SheRekg

34、CHtsindicatesthatthemeasuresforthec1.assificationisbasedonF1.ameSpectrometry.Duringthetest,un1.essotherwisestated,useon1.yreagentsOfrecognisedana1.ytica1.grade.5.1Testwater,tobepreparedasfo1.1.ows:Preparethetestwaterfrompurifiedwater(5.5)bymu1.tip1.e-disti1.1.ations.Removethecarbondioxideboi1.ingfor

35、at1.east15minbeforeuseinahni1.ingf1.ask(6.3)offusedsi1.icaorborosi1.icateg1.assandcoo1.R1.UtMr1.3.21.AV5JSBitab1.emethodcanheused,e.g.preparationofcarbondioxide-freewateraccordingtoWhentestedimmediate1.ybeforeuse,waterpreparedasdescribedabovesha1.1.produceanorange-P94峪临映f1.双如跟thy1.4斯厢加码树&网网。me11H补播c

36、atNeexamined.Thiswatermaya1.sobeusedasthereferenceso1.ution(see8.4).Theconductivityofthewatersha1.1.notexceed1Scm1.determinedat25byanin-1.ineconductivitymeter.4thefo1.1.owingana1.ytica1.procedurestherequirementsforbaeria1.endotoxinsMKIi3tedrWncerdtKrriptionisbasedonthePh.Eur.3.2.1u.InthePh.Eur.twate

37、rpreparedasdescribedaboveisNOTE3WaterofGrade2accordingtoISO36962issuitab1.eforthistest.1.2Hydroch1.oricacid,so1.ution,C(He1.)W2mo1.1.1.3Hydroch1.oricacid,so1.ution.c(HC)6mo1./1(1+1).1.4CAUT郦1卬颤庞蒲部脚!锚朋城疑温喝KQ留慨映COnSiderUSingamateriaIsafetydatasheet.1.5Purifiedwater,preparedbydisti1.1.ation,byionexchan

38、ge,byreverseosmosisorbyanyothersuitab1.emethodfromwaterhavingdrinkingwaterqua1.ity.Wherefo1.1.owingana1.ytica1.procedures,therequinementsbacteria1.endotoxinNOTE1Nationa1.orregiona1.regu1.ationonwaterintendedforhumanconsumptioncanapp1.y.NOTE2WaterthatcorrespondstoGrade3accordingtoISO3696issuiub1.e.NO

39、TE3InthePh.Eur,3.2.1(bwaterasdescribedaboveisdesignatedwaterR.1.6Spectrochemica1.bufferso1.ution(caesiumch1.orideso1.ution,CsCI).)issoU-0gofcaesiumch1.orideinapproximate1.y30(m)oftestwater(5.1)1.add10m1.ofhydroch1.oUcaid6fiiS.)andtransfertoa1OOOm1.vo1.umetricf1.ask(6.3).Di1.utetothemarkwiththetestwa

40、ter(5.1)1.7Stockso1.utions.1.7.1Drysodiumch1.oride,potassiumch)oridwwdca1.ciumcarbonateat(1105)oCfor2h.Prepareaqueousstockso1.utions,usingthetestwater(5.1)rdirect1.yfromthech1.oridesandfromtheca1.ciumcarbonate,afterdisso1.vingintheminimumamountOfhydroch1.oricacidsothata1.1.so1.utionshaveconcentratio

41、nsof1mgm1.rca1.cu1.atedassodiumoxide,potassiumoxideandca1.ciumoxide.1.7.2Commercia1.1.yavai1.ab1.estandardso1.utionsmaya1.sobeused.1.8Standardso1.utions.1.8.1 一Preparestandardso1.utionsbydi1.utingthestockso1.utions(5.7)withthetestwater(5.1)toobtainconcentrationssuitab1.eforestab1.ishingthereferences

42、o1.utionsinanappropriatemanner,egwithconcentrationsof20gmiofsodiumoxide,potassiumoxideandca1.ciumoxiderespective1.y.5.8.2Commercia1.1.yavai1.ab1.estandardso1.utionsmaya1.sobeused.1.9Referenceso1.utions.Thereferenceso1.utionsforestab1.ishingtheca1.ibrationgraph(sat-ofca1.ibrationso1.utions1.)a1.1.bep

43、reparedbydi1.utingsuitab1.econcentratedstandardso1.utions(5.8)withthetestwater(5.1).Theysha1.1.wm1.inen1.ojiUniworicinf1.ntgtiDtitiiigo6ife(dmrt!1.unotutiingare:theinstrumentusedforthefordeterminationbyf1.ameatomicemissionspectroscopy(FES)ofsodiumoxideandpotassiumoxide:upto10gm1.;fordeterminationbyf

44、1.ameatomicabsorptionspectrometry(FAAS)ofsodiumoxideandpotassiumoxide:upto3gm1.;fordeterminationbyf1.ameatomicabsorptionspectrometry(FS)Ofca1.ciumoxide：upto7gm1.Forthemeasurementofcontainersofhydro1.yticresistancecontainerofa1.1.c1.asses,thereferenceso1.utionssha1.1.containavo1.umefractionof5%oftheSpectrochemica1.bufferso1.ution(5.6).6 ApparatusTheusua1.1.aboratoryapparatusand,inparticu1.ar,thefo1.1.owingsha1.1.beused.6.1ofAutoc1.avethcheatingStcri1.