【英文标准名称】:Biologicalevaluationofmedicaldevices-Part19:Physico-chemical,morphologicalandtopographicalcharacterizationofmaterials
【原文标准名称】:医疗设备的生物评定.第19部分:材料的物理化学、形态学和地形学特点
【标准号】:ISO/TS10993-19-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-06
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:生物试验;定义;牙科设备;牙科器械;评定;医疗设备;医疗产品;微观结构;形态学;物理化学;物理性能;物理化学法;特性;参考材料;规范(验收);试样制备;表面;外科设备;外科植入物;手术器械;试验;地形学
【英文主题词】:Biologicaltests;Definitions;Dentalequipment;Dentalinstruments;Evaluations;Medicaldevices;Medicalequipment;Medicalproducts;Microstructure;Morphology;Physicalchemistry;Physicalproperties;Physico-chemicalmethods;Properties;Referencematerials;Specification(approval);Specimenpreparation;Surfaces;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing;Topography
【摘要】:ThisTechnicalSpecificationprovidesacompilationofparametersandtestmethodsthatcanbeusefulfortheidentificationandevaluationofthephysico-chemical,morphologicalandtopographical(PMT)propertiesofmaterialsinfinishedmedicaldevices.Suchanassessmentislimitedtothosepropertiesthatarerelevanttobiologicalevaluationandthemedicaldevice'sintendeduse(clinicalapplicationanddurationofuse)evenifsuchpropertiesoverlapwithclinicaleffectiveness.ThispartofISO10993doesnotaddresstheidentificationorquantificationofdegradationproducts,whicharecoveredinISO10993-9,ISO10993-13,ISO10993-14andISO10993-15.ChemicalcharacterizationofmaterialsiscoveredbyISO10993-18.TheISO10993seriesofInternationalStandardsisnotapplicablewhenthematerialordevicedoesnotcontactthebodydirectlyorindirectly(seeISO10993-1:2003,4.2).
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:15P.;A4
【正文语种】:英语