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1、实用文档88BIOLOGICALREACTIVITYTESTS,INVIVOThefollowingtestsaredesignedtodeterminethebiologicalresponseofanimalstoelastomerics,plastics,andotherpolymericmaterialwithdirectorindirectpatientcontact,orbytheinjectionofspecificextractspreparedfromthematerialundertest.Itisessentialtomakeavailablethespecificsur
2、faceareaforextraction.Whenthesurfaceareaofthespecimencannotbedetermined,use0.1gofelastomeror0.2gofplasticorothermaterialforeverymLofextractionfluid.Also,itisessentialtoexercisecareinthepreparationofthematerialstobeinjectedorinstilledtopreventcontaminationwithmicroorganismsandotherforeignmatter.Three
3、testsaredescribed.TheSystemicInjectionTestandtheIntracutaneousTestareusedforelastomericmaterials,especiallytoelastomericclosuresforwhichtheappropriateBiologicalReactivityTests,InVitro87haveindicatedsignificantbiologicalreactivity.Thesetwotestsareusedforplasticsandotherpolymers,inadditiontoathirdtest
4、,theImplantationTest,totestthesuitabilityofthesematerialsintendedforuseinfabricatingcontainersandaccessoriesthereto,foruseinparenteralpreparations,andforuseinmedicaldevices,implants,andothersystems.Thesethreetestsareappliedtomaterialsormedicaldevices,ifthereisaneedforclassificationofplasticsandother
5、polymersbasedoninvivobiologicalreactivitytesting.Forthepurposeofthischapter,thesedefinitionsapply:theSampleisthespecimenundertestoranextractpreparedfromsuchaspecimen.ABlankconsistsofthesamequantityofthesameextractingmediumthatisusedfortheextractionofthespecimenundertest,treatedinthesamemannerastheex
6、tractingmediumcontainingthespecimenundertest.ANegativeControl1isaspecimenthatgivesnoreactionundertheconditionsofthetest.文案大全实用文档CLASSIFICATIONOFPLASTICSSixPlasticClassesaredefined(seeTable1).Thisclassificationisbasedonresponsestoaseriesofinvivotestsforwhichextracts,materials,androutesofadministratio
7、narespecified.Thesetestsaredirectlyrelatedtotheintendedend-useoftheplasticarticles.Thechoiceofextractantsisrepresentativeofthevehiclesinpreparationswithwhichtheplasticsarelikelytobeincontact.TheTable1
