Designation:F2383−11StandardGuideforAssessmentofAdventitiousAgentsinTissueEngineeredMedicalProducts(TEMPs)1ThisstandardisissuedunderthefixeddesignationF2383;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguideisintendedasaresourceforindividualsandorganizationsinvolvedintheproduction,delivery,andregula-tionoftissueengineeredmedicalproducts(TEMPs).Thesafetyfromcontaminationbypotentiallyinfectiousadventi-tiousagentsisimportantinthedevelopmentofallTEMPsaswellastheircomponents.Thisguideaddresseshowtoassesssafetyrisksassociatedwithadventitiousagentsandtheirbyproducts.Theseagentscurrentlyincludebacteria,fungi,mycoplasma,viruses,endotoxins,transmissiblespongiformencephalopathies(TSEs),andparasiticorganisms.ThisguidedoesnotaddressTEMPswithliveanimalcells,tissuesororgans,orhumancells,includingstemcells,grownonanyanimalfeedercells.Alsoexcludedispatientfollow-uptesting.1.2ThisguidedoesnotapplytoanymedicalproductsofhumanoriginregulatedbytheU.S.FoodandDrugAdminis-trationunder21CFRParts16and1270and21CFRParts207,807and1271.ThisguidedoesapplytocellulartherapiesregulatedunderthePHS(PublicHealthService)act.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E1873GuideforDetectionofNucleicAcidSequencesbythePolymeraseChainReactionTechniqueF2210GuideforProcessingCells,Tissues,andOrgansforUseinTissueEngineeredMedicalProductsF2211ClassificationforTissueEngineeredMedicalProd-ucts(TEMPs)F2312TerminologyRelatingtoTissueEngineeredMedicalProdu...
