Designation:F1876–98(Reapproved2003)e1StandardSpecificationforPolyetherketoneetherketoneketone(PEKEKK)ResinsforSurgicalImplantApplications1ThisstandardisissuedunderthefixeddesignationF1876;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.e1NOTE—Table2waseditoriallycorrectedinJune2003.1.Scope1.1Thisspecificationcoverspolyetherketoneetherketoneke-tone(PEKEKK)resinsinvirginformsassuppliedbyavendor,suchasflakes,pellets,blocks,andsoforth.Itprovidesrequirementsandassociatedtestmethodsforthesethermoplas-ticswhentheyaretobeusedinthemanufacturingofintracorporealdevices,suchassurgicalimplantsorcompo-nentsofsurgicalordentaldevices.1.2Aswithanymaterial,somecharacteristicsmaybealteredbytheprocessingtechniques,suchasmolding,extru-sion,machining,assembly,sterilization,andsoforthrequiredfortheproductionofaspecificpartordevice;therefore,propertiesoffabricatedformsoftheseresinsshouldbeevaluatedusingtestmethodsthatareappropriatetoassuresafetyandefficacyasagreeduponbythevendor,purchaser,andregulatingbodies.1.3ThepropertiesincludedinthisspecificationarethoseapplicableforPEKEKKresinsonly.Fabricatedforms,materialorformscontainingcolorants,fillers,processingaids,orotheradditives,aswellaspolymerblendsthatcontainPEKEKK,arenotcoveredbythisspecification.1.4Thisspecificationisdesignedtorecommendphysical,chemical,andbiologicaltestmethodstoestablishareasonablelevelofconfidenceconcerningtheperformanceofvirginPEKEKKresinsforuseinmedicaldevices.Thepropertieslistedshouldbeconsideredinselectingmaterialaccordingtothespecificend-userequirements.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedD...
