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【英文标准名称】:StandardGuideforCharacterizationandTestingofAlginatesasStartingMaterialsIntendedforUseinBiomedicalandTissue-EngineeredMedicalProductsApplication
【原文标准名称】:生物医学和组织工程医学产品用的作为原材料的藻酸盐的特性和测试的标准指南
【标准号】:ASTMF2064-2000(2006)e1
【标准状态】:现行
【国别】:美国
【发布日期】:2000
【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】:alginates;biomedicallyengineered;tissue-engineeredmedicalproducts;Chemicalcharacterization;Degradation--surgicaldevices/applications;Depolymerization;Engineeredmedicalproducts;Functionality;Impurities--medical/surgicalmaterials/application
【摘要】:Thisguidecontainsalistingofthosecharacterizationparametersthataredirectlyrelatedtothefunctionalityofalginate.Thisguidecanbeusedasanaidintheselectionandcharacterizationoftheappropriatealginateforaparticularapplication.Thisguideisintendedtogiveguidanceinthemethodsandtypesoftestingnecessarytoproperlycharacterize,assess,andensureconsistencyintheperformanceofaparticularalginate.Itmayhaveuseintheregulationofthesedevicesbyappropriateauthorities.Thealginatecoveredbythisguidemaybegelled,extruded,orotherwiseformulatedintobiomedicaldevicesforuseintissue-engineeredmedicalproductsordrugdeliverydevicesforimplantationasdeterminedtobeappropriate,basedonsupportingbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissueengineeredmedicalproductordrugdeliveryapplication.ToensurethatthematerialsuppliedsatisfiesrequirementsforuseinTEMPS,severalgeneralareasofcharacterizationshouldbeconsidered.Theseare:identityofalginate,physicalandchemicalcharacterizationandtesting,impuritiesprofile,andperformance-relatedtests.1.1Thisguidecoverstheevaluationofalginatessuitableforuseinbiomedicalorpharmaceuticalapplications,orboth,including,butnotlimitedto,tissue-engineeredmedicalproducts(TEMPS).1.2Thisguideaddresseskeyparametersrelevantforthefunctionality,characterization,andpurityofalginates.1.3Aswithanymaterial,somecharacteristicsofalginatesmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthispolymershouldbeevaluatedusingtestmethodsthatareappropriatetoensuresafetyandefficacyandarenotaddressedinthisguide.1.4Warningx2014;MercuryhasbeendesignatedbyEPAandmanystateagenciesasahazardousmaterialthatcancausecentralnervoussystem,kidney,andliverdamage.Mercury,oritsvapor,maybehazardoustohealthandcorrosivetomaterials.Cautionshouldbetakenwhenhandlingmercuryandmercury-containingproducts.SeetheapplicableproductMaterialSafetyDataSheet(MSDS)fordetailsandEPAx2019;swebsite(http://www.epa.gov/mercury/faq.htm)foradditionalinformation.Usersshouldbeawarethatsellingmercuryormercury-containingproducts,orboth,inyourstatemaybeprohibitedbystatelaw.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C10
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】:英语