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【英文标准名称】:StandardGuideforCharacterizationandTestingofChitosanSaltsasStartingMaterialsIntendedforUseinBiomedicalandTissue-EngineeredMedicalProductApplications
【原文标准名称】:作物生物化学和组织工程医疗产品原材料的脱乙酰壳多糖盐的表征和试验标准指南
【标准号】:ASTMF2103-2001(2007)e2
【标准状态】:现行
【国别】:美国
【发布日期】:2001
【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】:biomedical;chitosansalts;tissue-engineeredmedicalproductapplications(TEMPs);Biomedicalmaterials/applications;Characteristics/characterization--surgicalimplants/applications;Chitosansalts;Salts;TEMPs(tissueengineeredmedicalproducts)
【摘要】:Thisguidecontainsalistingofthosecharacterizationparametersthataredirectlyrelatedtothefunctionalityofchitosan.Thisguidecanbeusedasanaidintheselectionandcharacterizationoftheappropriatechitosanorchitosansaltforaparticularapplication.Thisstandardisintendedtogiveguidanceinthemethodsandtypesoftestingnecessarytoproperlycharacterize,assess,andensureconsistencyintheperformanceofaparticularchitosan.Itmayhaveuseintheregulationofdevicescontainingchitosanbyappropriateauthorities.Thechitosansaltscoveredbythisguidemaybegelled,extruded,orotherwiseformulatedintobiomedicaldevicesforuseastissue-engineeredmedicalproductsordrugdeliverydevicesforimplantationasdeterminedtobeappropriate,basedonsupportingbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissue-engineeredmedicalproductordrugdeliveryapplication.ToensurethatthematerialsuppliedsatisfiesrequirementsforuseinTEMPs,severalgeneralareasofcharacterizationshouldbeconsidered.Theseincludeidentityofchitosan,physicalandchemicalcharacterizationandtesting,impuritiesprofile,andperformance-relatedtests.1.1Thisguidecoverstheevaluationofchitosansaltssuitableforuseinbiomedicalorpharmaceuticalapplications,orboth,including,butnotlimitedto,tissue-engineeredmedicalproducts(TEMPS).1.2Thisguideaddresseskeyparametersrelevantforthefunctionality,characterization,andpurityofchitosansalts.1.3Aswithanymaterial,somecharacteristicsofchitosanmaybealteredbyprocessingtechniques(suchasmolding,extrusion,machining,assembly,sterilization,andsoforth)requiredfortheproductionofaspecificpartordevice.Therefore,propertiesoffabricatedformsofthispolymershouldbeevaluatedusingtestmethodsthatareappropriatetoensuresafetyandefficacy.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_100_99
【页数】:8P.;A4
【正文语种】:英语