Designation:F1904−14StandardPracticeforTestingtheBiologicalResponsestoParticlesinvivo1ThisstandardisissuedunderthefixeddesignationF1904;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoverstheproductionofwearparticlesanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingareaandtheinformationgainedfromstandardprotocolsisnecessarytointerpretresponses.Someoftheprocedureslistedheremay,onfurthertesting,notprovetobepredictiveofclinicalresponsestoparticulatedebris.However,onlytheuseofstandardprotocolswillestablishwhichareusefultech-niques.Sincetherearemanypossibleandestablishedwaysofdeterminingresponses,asinglestandardprotocolisnotstated.However,thisrecommendedpracticeindicateswhichneces-saryinformationshouldbesuppliedwithtestresults.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk(*).1.2Thisstandardisnotdesignedtoprovideacomprehen-siveassessmentofthesystemictoxicity,carcinogenicity,teratogenicity,ormutagenicityofthematerial.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F561PracticeforRetrievalandAnalysisofMedicalDevices,andAssociatedTissuesandFluidsF619PracticeforExtractionofMedicalPlasticsF748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevicesF1877PracticeforCharacterizationofParticles3.Summa...
