【英文标准名称】:StandardSpecificationforTotalKneeProsthesis
【原文标准名称】:全膝关节置换标准规范
【标准号】:ASTMF2083-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:arthroplasty;contactarea;contactpressure;fatigue;knee;kneeconstraint;kneeprosthesis;kneewear;particles;surfaceroughness;totalkneereplacement;TKR;UHMWPE;Kneereplacementprosthesis--specifications;Medicalmaterials/applications--spec
【摘要】:1.1Thisspecificationcoverstotalkneereplacement(TKR)prosthesesusedtoprovidefunctioningarticulationbyemployingfemoralandtibialcomponents,allowingaminimumof110x00B0;offlexiontohighflexion.AlthoughapatellarcomponentmaybeconsideredanintegralpartofaTKR,thedetaileddescriptionofthiscomponentisexcludedheresinceitisprovidedinSpecificationF1672.1.2Includedwithinthescopeofthisspecificationarereplaceablecomponentsofmodulardesigns,forexample,tibialarticulatingsurfacesandallcomponentslabeledfor,orcapableof,beingusedwithcement,regardlessofwhetherthesamecomponentscanalsobeusedwithoutcement.Thisincludesprimaryandrevisionprosthesesandalsocoversfixedandmobilebearingkneedesigns.1.3Thisspecificationisintendedtoprovidebasicdescriptionsofmaterialandprosthesisgeometry.Additionally,thosecharacteristicsdeterminedtobeimportanttoinvivoperformanceoftheprosthesisaredefined.However,compliancewiththisspecificationdoesnotitselfdefineadevicethatwillprovideadequateclinicalperformance.1.4Excludedfromthescopearehemiarthroplastydevicesthatreplaceonlythefemoralortibialsurface,butnotboth;unicompartmentaldesigns,whichreplacethearticulatingsurfacesofonlyonecondyle;andpatellofemoralprostheses.Alsoexcludedaredevicesdesignedforcustomapplications.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:9P.;A4
【正文语种】:英语