Designation:F2451−05(Reapproved2010)StandardGuideforinvivoAssessmentofImplantableDevicesIntendedtoRepairorRegenerateArticularCartilage1ThisstandardisissuedunderthefixeddesignationF2451;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoversgeneralguidelinesfortheinvivoassessmentofimplantabledevicesintendedtorepairorregen-eratearticularcartilage.Devicesincludedinthisguidemaybecomposedofnaturalorsyntheticbiomaterials(biocompatibleandbiodegradable)orcompositesthereofandmaycontaincellsorbiologicallyactiveagentssuchasgrowthfactors,syntheticpeptides,plasmids,orcDNA.1.2Guidelinesincludeadescriptionandrationaleofvariousanimalmodelsutilizingarangeofspeciessuchasrabbit(lupine),dog(canine),pig(porcine),goat(caprine),sheep(ovine),andhorse(equine).Outcomemeasuresbasedonhistologic,biochemical,andmechanicalanalysesarebrieflydescribedandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetail.1.3Thisguideisnotintendedtoincludethetestingofrawmaterials,preparationofbiomaterials,sterilization,orpackag-ingofproduct.ASTMstandardsforthesestepsareavailableinReferenceDocuments.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatoryrequirementspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F561PracticeforRetrievalandAnalysisofMedicalDevices,andAssociatedTissuesandFluidsF565PracticeforCareandHandlingofOrthopedicImplantsandInstrumentsF895TestMethodforAgarDiffusionCellCultureScreeningforCytotoxicityF981PracticeforAssessmentofCompatibilityofBiomate-rialsforSurgicalImplantswithRespecttoEff...
