Designation:F1903−18StandardPracticeforTestingforCellularResponsestoParticlesinvitro1ThisstandardisissuedunderthefixeddesignationF1903;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoverstheassessmentofcellularresponsestowearparticlesanddegradationproductsfromimplantedmaterialsthatmayleadtoacascadeofbiologicalresponsesresultingindamagetoadjacentandremotetissues.Inordertoascertaintheroleofparticlesinstimulatingsuchresponses,thenatureoftheresponses,andtheconsequencesoftheresponses,establishedprotocolsareneeded.Thisisanemerging,rapidlydevelopingarea,andtheinformationgainedfromstandardprotocolsisnecessarytointerpretcellularresponsestopar-ticlesandtodetermineifthesecorrelatewithinvivoresponses.Sincetherearemanypossibleandestablishedwaysofdeter-miningresponses,asinglestandardprotocolisnotstated.However,welldescribedprotocolsareneededtocompareresultsfromdifferentinvestigatorsusingthesamematerialsandtocomparebiologicalresponsesforevaluating(ranking)differentmaterials.Forlaboratorieswithoutestablishedprotocols,recommendationsaregivenandindicatedwithanasterisk(*).1.2Sincethepurposeofthefollowingtestproceduresistopredicttheresponseinhumantissues,theuseofhuman(preferablymacrophagelineage)cellsisrecommended.However,theuseofnon-macrophagecelllineageortheuseofcellsfromnon-humanandnon-primatesourcesmaybeaccept-able.Thesourceofthecellsorthecelllineusedshouldbejustifiedbasedonthecellularresponsesundertestand/ortissueofinterest.Non-humancellsshouldnotbeusedifthereisevidenceofpossiblecross-speciesdifferenceforspecifictestresultsastheresultsofthisinvitrotestmaynotcorrespondtoactualhumanresponse.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcer...
