【英文标准名称】:StandardGuideforCharacterizationandTestingofHyaluronanasStartingMaterialsIntendedforUseinBiomedicalandTissueEngineeredMedicalProductApplications
【原文标准名称】:生物医疗和组织工程医疗产品中使用的作为初始材料的透明质酸盐的表征和试验标准指南
【标准号】:ASTMF2347-2003
【标准状态】:现行
【国别】:
【发布日期】:2003
【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】:
【英文主题词】:biomaterials;biopolymer;hyaluronan;polysaccharide;TEMPs
【摘要】:Thisguidecontainsalistingofthosecharacterizationparametersthataredirectlyrelatedtothefunctionalityofhyaluronan.Thisguidecanbeusedasanaidintheselectionandcharacterizationoftheappropriatehyaluronanforaparticularapplication.Thisguideisintendedtogiveguidanceinthemethodsandtypesoftestingnecessarytoproperlycharacterize,assess,andensureconsistencyintheperformanceofaparticularhyaluronan.Itmayhaveuseintheregulationofthesedevicesbyappropriateauthorities.Thehyaluronancoveredbythisguidemaybegelled,cross-linked,extruded,orotherwiseformulatedintobiomedicaldevicesforuseintissueengineeredmedicalproductsordrugdeliverydevicesforimplantationasdeterminedtobeappropriate,basedonsupportingbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissueengineeredmedicalproductordrugdeliveryapplication.ToensurethatthematerialsuppliedsatisfiesrequirementsforuseinTEMPs,severalgeneralareasofcharacterizationshouldbeconsidered.Theseare:identityofhyaluronan,physicalandchemicalcharacterizationandtesting,impuritiesprofile,andperformance-relatedtests.1.1Thisguidecoverstheevaluationofhyaluronansuitableforuseinbiomedicalorpharmaceuticalapplications,orboth,including,butnotlimitedto,TissueEngineeredMedicalProducts(TEMPs).1.2Thisguideaddresseskeyparametersrelevanttothecharacterizationandpurityofhyaluronan.1.3Aswithanymaterial,somecharacteristicsofhyaluronanmaybealteredbyprocessingtechniques,suchascross-linkingandsterilization,requiredfortheproductionofaspecificformulationordevice.Therefore,propertiesoffabricatedformsofthispolymershouldbeevaluatedusingtestmethodsthatareappropriatetoensuresafetyandefficacyandarenotaddressedinthisguide.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_120_99
【页数】:9P.;A4
【正文语种】: