ISO 16428-2005 外科植入物.可植入物质和医疗器械的静态和动态腐蚀试验用试验溶液和环境条件

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【英文标准名称】:Implantsforsurgery-Testsolutionsandenvironmentalconditionsforstaticanddynamiccorrosiontestsonimplantablematerialsandmedicaldevices
【原文标准名称】:外科植入物.可植入物质和医疗器械的静态和动态腐蚀试验用试验溶液和环境条件
【标准号】:ISO16428-2005
【标准状态】:现行
【国别】:国际
【发布日期】:2005-04
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:磨蚀试验;腐蚀;腐蚀试验;定义;动态试验;环境条件;外科植入物;医疗器械;医疗设备;医学科学;修复装置;外科学;测试;磨损;磨损试验
【英文主题词】:Abrasiontests;Corrosion;Corrosiontests;Definition;Definitions;Dynamictesting;Environmentalconditions;Implants(surgical);Medicaldevices;Medicalequipment;Medicalsciences;Prostheticdevices;Surgery;Surgicalimplants;Testing;Wear;Weartests
【摘要】:ThisInternationalStandardspecifiesstandardenvironmentalconditionsforthetestingofmetallicmaterialsintendedforimplantation,surgicalimplants,andmedicaldevices.Thetestconditionsdescribedsimulatephysiologicalconditionsinasimplifiedmannercontrollingthetestsolution,thetemperature,thegaseousatmosphereandtheproportionsofsamplesizeandvolumeofsolution.Theseenvironmentaltestingconditionscanbeemployedwherenecessaryincombinationwithvariousstaticordynamictestswheretheeffectofthephysiologicalenvironmentistobeconsidered.Typicalapplicationsarecorrosionfatiguetestsandselectedfrettingandweartests,aswellasgeneralelectrochemicaltests.TypicalarticulatingjointsimulatortestsandaspectsparticulartothedentalfieldarenotconsideredbythisInternationalStandard.Solutionsthatattempttoreplicatethetribologicalpropertiesofbodyfluids,suchasthoseusedinwearstudies,areoutsidethescopeofthisInternationalStandard.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:8P.;A4
【正文语种】:英语