ASTM F2150-2007 组织工程医疗产品中使用的生物材料支架的表征和试验用标准指南

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【英文标准名称】:StandardGuideforCharacterizationandTestingofBiomaterialScaffoldsUsedinTissue-EngineeredMedicalProducts
【原文标准名称】:组织工程医疗产品中使用的生物材料支架的表征和试验用标准指南
【标准号】:ASTMF2150-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:F04.42
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:生物技术;医疗产品;医疗技术学;脚手架;测试;组织
【英文主题词】:absorption;bioabsorption;biomaterials;biomedicalmaterial;bioresorption;cellseeding;matrix;porometry;porosimetry;porosity;scaffold;tissueengineering;Biomedicalmaterials/applications;Cellseeding;Impurities--medical/surgicalmaterials/appl
【摘要】:Scaffoldspotentiallymaybemetallic,ceramic,polymeric,natural,orcompositematerials.Scaffoldsareusuallyporoustosomedegree,butmaybesolid.Scaffoldscanrangefrommechanicallyrigidtogelatinousandcanbeeitherabsorbable/degradableornonresorbable/nondegradable.Thescaffoldmayormaynothaveasurfacetreatment.Becauseofthislargebreadthofpossiblestartingmaterialsandscaffoldconstructions,thisguidecannotbeconsideredasexhaustiveinitslistingofpotentiallyapplicabletests.Avoluntaryguidanceforthedevelopmentoftissue-engineeredproductscanbefoundinOmstead,etal(1).GuideF2027containsalistingofpotentiallyapplicabletestmethodsspecifictovariousstartingmaterials.EachTEMPscaffoldproductisuniqueandmayrequiretestingnotwithinthescopeofthisguideorotherguidancedocuments.UsersofthisguideareencouragedtoexaminethereferenceslistedhereinandpertinentFDAorotherregulatoryguidelinesorpractices,andconductaliteraturesearchtoidentifyotherproceduresparticularlypertinentforevaluationoftheirspecificscaffoldmaterial(2,3,4).ItistheultimateresponsibilityoftheTEMPscaffolddesignertodeterminetheappropriatetesting,whetherornotitisdescribedinthisguide.AlistingofpotentiallyapplicabletestsforcharacterizingandanalyzingthematerialsutilizedtofabricatethescaffoldmaybefoundinGuideF2027.However,conformanceofarawmaterialtothisand/oranyothercompendialstandard(s)doesnot,initself,ensurethattheselectedmaterialissuitableorthattheprovidedqualityisadequatetomeettheneedsofaparticularapplication.Thus,othercharacterizationproceduresmayalsoberelevantandnotcoveredbythisguide.ThefollowingprovidesalistingoflinkstoU.S.Foodx0026;DrugAdministration(FDA)x2014;CenterforDevicesx0026;RadiologicHealth(CDRH)websitesthatmaypotentiallycontainadditionalguidancerelevanttobiomaterialscaffoldscoveredwithinthisdocument.RecognizedFDA-CDRHConsensusStandardsDatabase:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfmThisdatabaseprovidesaresourceforlocatingFDArecognizedconsensusstandardsformedicalproducts.FDA-CDRHGoodGuidancePractice(GGP)Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfmThisdatabaseprovidesaresourceforlocatingnon-bindingFDAguidancedocumentsintendedforCDRHstaff,regulatedindustryandthepublicthatrelatetotheprocessing,content,andevaluationofregulatorysubmissions,thedesign,production,manufacturing,andtestingofregulatedproducts,andFDAinspectionandenforcementprocedures.AdocumentwithinthisdatabasepossessingcontentthatwarrantsparticularconsiderationforitspotentialapplicabilityfortissueengineeringscaffoldsisGuidanceforthePreparationofaPremarketNotificationApplicationforaSurgicalMesh;Final.FDA-CDRHPremarketApproval(PMA)Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfmFDA-CDRH510(k)(PremarketNotification)Database:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm1.1Thisguideisaresourceofcurrentlyavailabletestmethodsforthecharacterizationofthecompositionalandstructuralaspectsofbiomaterialscaf......
【中国标准分类号】:C47
【国际标准分类号】:11_020
【页数】:10P.;A4
【正文语种】: