USP 87 细胞毒性 体外试验

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1、87BIOLOGICALREACTIVITYTESTS,INVITROThefollowingtestsaredesignedtodeterminethebiologicalreactivityofmammaliancellculturesfollowingcontactwiththeelastomericplasticsandotherpolymericmaterialswithdirectorindirectpatientcontactorofspecificextractspreparedfromthematerialsunde

2、rtest.Itisessentialthatthetestsbeperformedonthespecifiedsurfacearea.Whenthesurfaceareaofthespecimencannotbedetermined,use0.1gofelastomeror0.2gofplasticorothermaterialforeverymLofextractionfluid.Exercisecareinthepreparationofthematerialstopreventcontaminationwithmicroorg

3、anismsandotherforeignmatter.Threetestsaredescribed(i.e.,theAgarDiffusionTest,theDirectContactTest,andtheElutionTest).1Thedecisionastowhichtypeoftestorthenumberofteststobeperformedtoassessthepotentialbiologicalresponseofaspecificsampleorextractdependsuponthematerial,thef

4、inalproduct,anditsintendeduse.Otherfactorsthatmayalsoaffectthesuitabilityofsampleforaspecificusearethepolymericcomposition;processingandcleaningprocedures;contactingmedia;inks;adhesives;absorption,adsorption,andpermeabilityofpreservatives;andconditionsofstorage.Evaluati

5、onofsuchfactorsshouldbemadebyappropriateadditionalspecifictestsbeforedeterminingthataproductmadefromaspecificmaterialissuitableforitsintendeduse.MaterialsthatfailtheinvitrotestsarecandidatesfortheinvivotestsdescribedinBiologicalReactivityTests,InVivo88.USPReferenceStand

6、ards11—USPHigh-DensityPolyethyleneRS.USPPositiveBioreactionRS.CellCulturePreparation—PreparemultipleculturesofL-929(ATCCcelllineCCL1,NCTCclone929;alternativecelllinesobtainedfromastandardrepositorymaybeusedwithsuitablevalidation)mammalianfibroblastcellsinserum-supplemen

7、tedminimumessentialmediumhavingaseedingdensityofabout105cellspermL.Incubatetheculturesat37±1inahumidifiedincubatorforNLT24hina5±1%carbondioxideatmosphereuntilamonolayer,withgreaterthan80%confluence,isobtained.Examinethepreparedculturesunderamicroscopetoensureuniform,nea

8、r-confluentmonolayers.[NOTE—ThereproducibilityoftheInVitroBiologicalReactivityTestsdependsuponobtaininguniform