ASTM F2665-2009 全踝关节置换假体的标准规范

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【英文标准名称】:StandardSpecificationforTotalAnkleReplacementProsthesis
【原文标准名称】:全踝关节置换假体的标准规范
【标准号】:ASTMF2665-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:ankle;ankleconstraint;ankleprosthesis;arthroplasty;anklewear;contactarea;contactpressure;fatigue;particles;surfaceroughness;totalanklereplacement(TAR);UHMWPE
【摘要】:1.1Thisspecificationcoverstotalanklereplacement(TAR)prosthesesusedtoprovidefunctioningarticulationbyemployingtalarandtibialcomponentsthatallowforaminimumof15x00B0;ofdorsiflexionand15to25x00B0;(1)ofplantarflexion,asdeterminedbynon-clinicaltesting.1.2Includedwithinthescopeofthisspecificationareanklecomponentsforprimaryandrevisionsurgerywithmodularandnon-modulardesigns,bearingcomponentswithfixedormobilebearingdesigns,andcomponentsforcementedand/orcementlessuse.1.3Thisspecificationisintendedtoprovidebasicdescriptionsofmaterialandprosthesisgeometry.Inaddition,thosecharacteristicsdeterminedtobeimportanttoinvivoperformanceoftheprosthesisaredefined.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_180_10
【页数】:7P.;A4
【正文语种】:英语