Designation:F2808−10StandardTestMethodforPerformingBehind-the-Knee(BTK)TestforEvaluatingSkinIrritationResponsetoProductsandMaterialsThatComeIntoRepeatedorExtendedContactwithSkin1ThisstandardisissuedunderthefixeddesignationF2808;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1TheBehind-the-Knee(BTK)method,usingthepoplitealfossaofhumanvolunteersasatestsite,simultane-ouslyevaluatestheinherentchemicalirritation,andthepoten-tialformechanicalirritationofsubstratesandproductsthataredesignedtocomeintorepeatedorextendedclosecontactwiththeskin(seevalidationreferences1-7).2Thisisabilateraltestcomparingatestmaterialtoareferencematerialwithaknownsafetyprofile.1.2Thistestmethodshallbeusedbyqualifiedhealthcareprofessionalsexperiencedingoodclinicalpractice(GCP)procedures.1.3Thistestmethodcanbeperformedusinghumansub-jectsoneitherintactorcompromisedskin.Testingshouldbeperformedonintactskinfortestsubstratesorproductsex-pectedtohavecontactwithnormal,intactskin,orfordirectcomparisontoproductswithaknownskinirritationprofile.Testingcanbeperformedoncompromisedskinfortestsubstratesorproductsthatmaycommonlycomeintocontactwithdamagedskin(forexample,skinwithdiaperrash,orchappedskin)orskinthatisexpectedtobehydrated.1.4Visualscoringoferythemaanddrynessisperformedbyatrainedskingraderonapre-definedscale.1.5Priortouseinthistest,materialsshallundergooverallfavorablebiocompatibilitytestingconsistentwiththeapproachoutlinedinprotocolPracticeF748orISO10993-1:2009.Asapartofthisseriesoftesting,irritationperPracticeF719orISO10993-10shallbeconducted.1.6Thevaluesstatedininch-poundunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandar...
