Designation:F1906–98(Reapproved2003)StandardPracticeforEvaluationofImmuneResponsesInBiocompatibilityTestingUsingELISATests,LymphocyteProliferation,andCellMigration1ThisstandardisissuedunderthefixeddesignationF1906;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoverstheintroductionofaforeignsub-stanceintomammalianbodythatmayinducetheformationofanimmuneresponse.Theimmuneresponsemayleadtoinadvertenttissuedamageandbeanundesirableevent.Inthestandardprotocolsforbiocompatibilitytesting,variousstudiesinanimalsaredone.Theseanimalsortheirbloodandtissuescouldbeusedtodetermineifimmuneresponseshaveoccurredandwhattypeshaveoccurred.Atthecurrenttime,theimmunologictestinginbiocompatibilityprotocolsisverylimited.Techniquescanbedevelopedinthefuturewhicharesimple,reliable,andsensitive.1.2Itisthepurposeofthispracticetodelineatesomepossibletestmethods.Itmustberememberedthattheseareprotocolsforuseinbiocompatibilitytesting,theyarenotdiagnostictestsforevaluationofhumanconditions.Diagnostictestsforuseonhumansmustgothroughevaluationattheregulatoryagencies.Thetestsdescribedhereareclearlyadaptableforuseinhumansandcanbeusedforresearchpurposesandprovidedatainclinicaltrials,butarenotnecessarilyclearedfordiagnosticpurposes.Thispracticepresentselectedmethods.Othervalidatedmethodsmaybeequallyapplicable.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F619PracticeforExtractionofMedicalPlasticsF719PracticeforTestingBiomaterialsinRabbitsforPrimarySkinIrritationF720PracticeforTestingGuineaP...
