ASTM F2315-2010 褐藻酸盐胶丸中的活细胞或组织的固定或封包的标准指南

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【英文标准名称】:StandardGuideforImmobilizationorEncapsulationofLivingCellsorTissueinAlginateGels
【原文标准名称】:褐藻酸盐胶丸中的活细胞或组织的固定或封包的标准指南
【标准号】:ASTMF2315-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:F04.43
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:Beadformation;Compositionanalysis;Alginates;Encapsulants/encapsulation;Gelationanalysis;Immobilization;Ionconcentration;Matrixdata/programs;Microencapsulatedcells;Painanalysis/reduction;Parkinson'sdisease;TEMPs(tissueengineeredm
【摘要】:Themainuseistoimmobilize,support,orsuspendlivingcellsortissueinamatrix.Theuseofanencapsulation/immobilizationsystemmayprotectcellsortissuesfromimmunerejection.Whenimmobilizingbiologicalmaterialinalginategels,therearenumerousparametersthatmustbecontrolled.Thisguidecontainsalistoftheseparametersanddescribesthemethodsandtypesoftestingnecessarytoproperlycharacterize,assess,andensureconsistencyintheperformanceofanencapsulationsystemusingalginate.Thisguideonlycoverssinglegelledbeads,coatedornot,andnotdoublecapsulesorotherconstructs.Thealginategelationtechnologycoveredbythisguidemayallowtheformulationofcellsandtissuesintobiomedicaldevicesforuseastissueengineeredmedicalproductsordrugdeliverydevices.Theseproductsmaybeappropriateforimplantationbasedonsupportingbiocompatibilityandphysicaltestdata.Recommendationsinthisguideshouldnotbeinterpretedasaguaranteeofclinicalsuccessinanytissueengineeredmedicalproductordrugdeliveryapplication.1.1Thisguidediscussesinformationrelevanttotheimmobilizationorencapsulationoflivingcellsortissueinalginategels.Immobilizedorencapsulatedcellsaresuitableforuseinbiomedicalandpharmaceuticalapplications,orboth,including,butnotlimitedto,TissueEngineeredMedicalProducts(TEMPs).1.2Thisguideaddresseskeyparametersrelevantforsuccessfulimmobilizationandencapsulationinalginategels.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatoryrequirementspriortouse.
【中国标准分类号】:C10
【国际标准分类号】:11_120_99
【页数】:8P.;A4
【正文语种】:英语