Designation:F2211−13StandardClassificationforTissueEngineeredMedicalProducts(TEMPs)1ThisstandardisissuedunderthefixeddesignationF2211;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisclassificationoutlinestheaspectsoftissueengi-neeredmedicalproductsthatwillbedevelopedasstandards.Thisclassificationexcludestraditionaltransplantationofor-gansandtissuesaswellastransplantationoflivingcellsaloneascellulartherapies.1.2Thisclassificationdoesnotapplytoanymedicalprod-uctsofhumanoriginregulatedbytheU.S.FoodandDrugAdministrationunder21CFRParts16and1270and21CFRParts207,807,and1271.1.3Thisstandarddoesnotpurporttoaddressspecificcomponentscoveredinotherstandards.Anysafetyareasassociatedwiththemedicalproduct’susewillnotbeaddressedinthisstandard.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatoryrequirementspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F2027GuideforCharacterizationandTestingofRaworStartingBiomaterialsforTissue-EngineeredMedicalProductsF2064GuideforCharacterizationandTestingofAlginatesasStartingMaterialsIntendedforUseinBiomedicalandTissueEngineeredMedicalProductApplicationsF2103GuideforCharacterizationandTestingofChitosanSaltsasStartingMaterialsIntendedforUseinBiomedicalandTissue-EngineeredMedicalProductApplicationsF2131TestMethodforInVitroBiologicalActivityofRe-combinantHumanBoneMorphogeneticProtein-2(rhBMP-2)UsingtheW-20MouseStromalCellLineF2150GuideforCharacterizationandTestingofBiomate-rialScaffoldsUsedinTissue-EngineeredMedicalProd-ucts2.2FederalDocuments:3USFDACFR21,Part3[3.2(e)]ProductJurisdiction21CFRParts16and1270HumanTissues,IntendedforTransplantation21CFRParts207,807,...
