【英文标准名称】:StandardGuideforPre-clinicalinvivoEvaluationinCriticalSizeSegmentalBoneDefects
【原文标准名称】:节段性骨缺损临界粒度的活体潜伏期评定的标准指南
【标准号】:ASTMF2721-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.44
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:animalmodels;biomaterials;bone;boneregeneration;bonerepair;defectgeneration;devices;implants;invivo;mechanicaltesting;syntheticbiomaterials;TEMPs(TissueEngineeredMedicalProducts);Animalexperimentation;
【摘要】:Thisguideisaimedatprovidingarangeofinvivomodelstoaidinpreclinicalresearchanddevelopmentoftissue-engineeredmedicalproducts(TEMPs)intendedfortheclinicalrepairorregenerationofbone.Thisguideincludesadescriptionoftheanimalmodels,surgicalconsiderations,andtissueprocessingaswellasthequalitativeandquantitativeanalysisoftissuespecimens.TheuserisencouragedtouseappropriateASTMandotherguidelinestoconductcytotoxicityandbiocompatibilitytestsonmaterials,TEMPs,orboth,priortoassessmentoftheinvivomodelsdescribedherein.ItisrecommendedthatsafetytestingbeinaccordancewiththeprovisionsoftheFDAGoodLaboratoryPracticesRegulations21CFR58.Safetyandeffectivenessstudiestosupportregulatorysubmissions(forexample,InvestigationalDeviceExemption(IDE)),PremarketApproval(PMA),510K,InvestigationalNewDrug(IND),orBiologicsLicenseApplication(BLA)submissionsintheU.S.)shouldconformtoappropriateguidelinesoftheregulatorybodiesfordevelopmentofmedicaldevices,biologics,ordrugs,respectively.Animalmodeloutcomesarenotnecessarilypredictiveofhumanresultsandshould,therefore,beinterpretedcautiouslywithrespecttopotentialapplicabilitytohumanconditions.1.1Thisguidecoversgeneralguidelinesfortheinvivoassessmentoftissueengineeredmedicalproducts(TEMPs)intendedtorepairorregeneratebone.TEMPsincludedinthisguidemaybecomposedofnaturalorsyntheticbiomaterials(biocompatibleandbiodegradable)orcompositesthereof,andmaycontaincellsorbiologicallyactiveagentssuchasgrowthfactors,syntheticpeptides,plasmids,orcDNA.Themodelsdescribedinthisguidearesegmentalcriticalsizedefectswhich,bydefinition,willnotfillwithviabletissuewithouttreatment.Thus,thesemodelsrepresentastringenttestofamaterialx2019;sabilitytoinduceoraugmentbonegrowth.1.2Guidelinesincludeadescriptionandrationaleofvariousanimalmodelsincludingrat(murine),rabbit(leporine),dog(canine),goat(caprine),andsheep(ovine).Outcomemeasuresbasedonradiographic,histologic,andmechanicalanalysesaredescribedbrieflyandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetail.1.3Thisguideisnotintendedtoincludethetestingofrawmaterials,preparationofbiomaterials,sterilization,orpackagingoftheproduct.ASTMstandardsforthesestepsareavailableintheReferencedDocuments(Section2).1.4Theuseofanyofthemethodsincludedinthisguidemaynotproducearesultthatisconsistentwithclinicalperformanceinoneormorespecificapplications.1.5Otherpre-clinicalmethodsmayalsobeappropriateandthisguideisnotmeanttoexcludesuchmethods.Thematerialmustbesuitableforitsintendedpurpose.Additionalbiologicaltestinginthisregardwouldberequired.1.6ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.7Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_100_10
【页数】:13P.;A4
【正文语种】:英语