【英文标准名称】:StandardGuideforInterpretingImagesofPolymericTissueScaffolds
【原文标准名称】:聚合物组织假体释图的标准指南
【标准号】:ASTMF2603-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:图像;医用设备;医疗技术;摄影;聚合物;骨架;外科学;组织
【英文主题词】:biomaterials;imageanalysis;matrix,scaffold;polymeric;segmentation;stereologicalanalysis;thresholding;tissuescaffolds
【摘要】:Thisdocumentprovidesguidanceforuserswhowishtoobtainquantifiabledatafromimagesoftissuescaffoldsmanufacturedfrompolymersthatincludebothhighwatercontentgelsandwoventextiles.Informationderivedfromtissuescaffoldimagescanbeusedtooptimizethestructuralcharacteristicsofthematrixforaparticularapplication,todevelopbettermanufacturingproceduresortoprovideameasureofqualityassuranceandproducttraceability.Fig.1providesasummaryofthekeystagesofimagecaptureandanalysis.ThereisasynergybetweentheanalysisofporesintissuescaffoldsandthatofparticlesthatisreflectedinstandardscitedandintheanalysisdescribedinSection9.GuideE1919providesacompendiumofstandardsforparticleanalysisthatincludesmeasurementtechniques,dataanalyticalandsamplingmethodologies.FIG.1KeyStagesinImageCapture,Storage,andAnalysis1.1Thisguidecoversthefactorsthatneedtobeconsideredinobtainingandinterpretingimagesoftissuescaffoldsincludingtechniqueselection,instrumentresolutionandimagequality,quantificationandsamplepreparation.1.2Theinformationinthisguideisintendedtobeapplicabletoporouspolymer-basedtissuescaffolds,includingnaturallyderivedmaterialssuchascollagen.However,somematerials(bothsyntheticandnatural)mayrequireuniqueorvariedsamplepreparationmethodsthatarenotspecificallycoveredinthisguide.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesandtodeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35;C04
【国际标准分类号】:11_040_40;37_040_99
【页数】:9P.;A4
【正文语种】: