ASTM F1814-1997a(2003) 评价髋部和膝关节连接部件模数的标准指南

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【英文标准名称】:StandardGuideforEvaluatingModularHipandKneeJointComponents
【原文标准名称】:评价髋部和膝关节连接部件模数的标准指南
【标准号】:ASTMF1814-1997a(2003)
【标准状态】:现行
【国别】:
【发布日期】:1997
【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】:F04.22
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:膝关节成形术;髋关节成形术;关节成形术;整形外科医疗设备;模数;分解
【英文主题词】:arthroplasty;disassembly;hiparthroplasty;kneearthroplasty;modular;orthopaedicmedicaldevices
【摘要】:Thetestssuggestedwithinthisguidecovermanydifferent,butnotallpossible,areasofresearchandconcernwithregardtomodularhipstemsandmodularkneecomponents.Duetotheunlimitedpossiblemodulardesigns,thisguideshouldbeutilizedasaguideforwhatshouldbeconsideredwithregardtodevicesafetytesting.Theremaybecircumstanceswherealternativetestmethodsmaybeuseful.Itisstilltheresponsibilityoftheinvestigatortoaddressallsafetyconcernsthatareinherenttoindividualmodulardesigns.Thetestssuggestedhereinshouldbeutilizedinsuchawaythattheresultsreflecttheeffectsofmodularity,ifany.TeststhatarecheckedinFig.1orFig.2orindicatedinthisguideasapossibletesttoconsidermaynotbeapplicabletoeveryimplantdesign.FIG.1TotalHipImplantsFIG.2TotalKneeImplant1.1Thisguidecoversaproceduretoassistthedeveloperofamodularjointreplacementimplantinthechoiceofappropriatetestsandevaluationstodeterminedevicesafety.1.2Thisguidedoesnotattempttodefinealltestmethodsassociatedwithmodulardeviceevaluation.1.3Thisguidedoesnotcoverintentionalintraoperativediassemblybutismeantonlytosuggesttestingnecessarytodetermineinadvertentdisassemblyloads.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】: