Designation:F2312−11StandardTerminologyRelatingtoTissueEngineeredMedicalProducts1ThisstandardisissuedunderthefixeddesignationF2312;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1ThisterminologydefinesbasictermsandpresentstherelationshipsofthescientificfieldsrelatedtoTissueEngi-neeredMedicalProducts(TEMPs).CommitteeF04hasde-finedthesetermsforthespecificpurposeofunifyingthelanguageusedinstandardsforTEMPs.1.2ThetermsandrelationshipsdefinedherearelimitedtoTEMPs.TheydonotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdministrationunder21CFRParts16and1270and21CFRParts207,807,and1271.1.3ThetermsandnomenclaturepresentedinthisstandardareforthespecificpurposesofunifyingthelanguageusedinTEMPstandardsandarenotintendedforlabelingofregulatedmedicalproducts.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1GovernmentDocuments:221CFRParts16and1270HumanTissues,IntendedforTransplantation(July29,1997)21CFRParts207,807,and1271HumanCells,Tissues,andCellularandTissue-BasedProducts;EstablishmentReg-istrationandListing(January19,2001)3.SignificanceandUse3.1TheneedforstandardsregardingTEMPshasalsopromptedaneedfordefinitions.ThisterminologysetsforthdefinitionsofthemostcommonlyusedtermsandspecifiestherelationshipamongthesciencesandcomponentsappliedintissueengineeringtodevelopTEMPs.UseofthesetermsandanunderstandingoftheserelationshipswillunifytheASTMTEMPsstandardswithacommonlanguagesuchthattheusersofthesestandardscanunderstandandinterpretthestandardsmoreprecisely.TermsspecifictoaTEMPstandardwillalsobedefinedwithintherespectivestandardasappro...
