Designation:F3087−15StandardSpecificationforAcrylicMoldingResinsforMedicalImplantApplications1ThisstandardisissuedunderthefixeddesignationF3087;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversacrylicresinssuppliedinvirginform(typicallypellets,powder,orgranules)formedicalimplantapplications.Theco-polymersarelimitedtorandomco-polymers.Thisspecificationprovidesrequirementsandassociatedtestmethodsforthisthermoplasticwhenitisintendedforuseinmanufacturingimplantablemedicaldevicesorcomponentsofmedicaldevices.1.1.1Whileavarietyofco-monomersmaybeused,thecompositionoftheresinshallcontainpoly(methylmethacry-late)(PMMA)asitsprimaryingredient.ClassificationD788definesanacrylicmoldingcompoundas“havingatleast70%ofthepolymerpolymerizedfrommethylmethacrylate.”ThetermsPMMAandacrylicasusedhereinrefergenericallytoboththehomopolymerandtoco-polymersasdefinedabove.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques(suchasmolding,extrusion,machining,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,proper-tiesoffabricatedformsofthisresinshouldbeevaluatedusingtestmethodsthatareappropriatetoensuresafetyandefficacyasagreeduponbetweenthesupplier,purchaser,andregulatingbodies.1.3Thisspecificationallowsfordesignationofacrylicresinsforallmedicalimplantapplications.Theactualextentofperformanceandsuitabilityforaspecificapplicationshallbeevaluatedbythemedicaldevicemanufacturerandregulatingbodies.1.4Thepropertiesincludedinthisspecificationarethoseapplicableforbothunfilledacrylicpolymersandforformu-latedresinscontainingbariumsulfate.Indicatedproperties(Table1andTableX3.1)areforunfilledinjectionmoldedforms.Formscontainingfillersotherthanbariumsulfate,colorants,polymerblendsthatcontainPMMA,orreclaimedm...
