Designation:F2450−10StandardGuideforAssessingMicrostructureofPolymericScaffoldsforUseinTissue-EngineeredMedicalProducts1ThisstandardisissuedunderthefixeddesignationF2450;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidecoversanoverviewoftestmethodsthatmaybeusedtoobtaininformationrelatingtothedimensionsofpores,theporesizedistribution,thedegreeofporosity,interconnectivity,andmeasuresofpermeabilityforporousmaterialsusedaspolymericscaffoldsinthedevelopmentandmanufactureoftissue-engineeredmedicalproducts(TEMPs).Thisinformationiskeytooptimizingthestructureforaparticularapplication,developingrobustmanufacturingroutes,andprovidingreliablequalitycontroldata.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisguidedoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesandtodeterminetheapplicabilityofregula-torylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D2873TestMethodforInteriorPorosityofPoly(VinylChloride)(PVC)ResinsbyMercuryIntrusionPorosim-etry(Withdrawn2003)3D4404TestMethodforDeterminationofPoreVolumeandPoreVolumeDistributionofSoilandRockbyMercuryIntrusionPorosimetryE128TestMethodforMaximumPoreDiameterandPerme-abilityofRigidPorousFiltersforLaboratoryUseE1294TestMethodforPoreSizeCharacteristicsofMem-braneFiltersUsingAutomatedLiquidPorosimeter(With-drawn2008)3E1441GuideforComputedTomography(CT)ImagingF316TestMethodsforPoreSizeCharacteristicsofMem-braneFiltersbyBubblePointandMeanFlowPoreTestF2150GuideforCharacterizationandTestingofBiomate-rialScaffoldsUsedinTissue-EngineeredMedicalProd-uctsF2603GuideforInterpretingImagesofPolymericTissueScaffolds3.Terminology3.1Defin...
