1、Designation:F181497a(Reapproved 2009)Standard Guide forEvaluating Modular Hip and Knee Joint Components1This standard is issued under the fixed designation F1814;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revisi
2、on.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide covers a procedure to assist the developer ofa modular joint replacement implant in the choice of appropri-ate tests and ev
3、aluations to determine device safety.1.2 This guide does not attempt to define all test methodsassociated with modular device evaluation.1.3 This guide does not cover intentional intraoperativedisassembly but is meant only to suggest testing necessary todetermine inadvertent disassembly loads.1.4 Th
4、is standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.
5、1 ASTM Standards:2F648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and ScrewsF1440 Practice for Cyclic Fatigue Testing of MetallicStemmed Hip Arthroplasty Femora
6、l Components WithoutTorsion(Withdrawn 2012)3F1800 Practice for Cyclic Fatigue Testing of Metal TibialTray Components of Total Knee Joint Replacements2.2 ISO Standard:4ISO 7206 Implants for Surgery-Partial and Total Hip JointProsthesisPart 4 Determination of Endurance Properties of StemmedFemoral Com
7、ponents With Application of TorsionPart 6 Determination of Endurance Properties of Head andNeck Region of Stemmed Femoral ComponentsPart 8 Endurance Performance of Stemmed Femoral Com-ponents With Application of Torsion3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 modular fem
8、oral hip implantany device,constructedof two or more mating parts intended for implantation into thefemur for the purpose of replacing the femoral hip joint.3.1.1.1 bolts/screwsa fastener used to secure modularpieces of a femoral component.3.1.1.2 bullets/distal sleevesmodular accessories for in-cre
9、asing the length or distal diameter of the femoral compo-nent.3.1.1.3 collarsa medial platform located immediately dis-tal to the femoral neck.3.1.1.4 femoral heada modular bearing,spherical inshape,that mates with the femoral component.3.1.1.5 neck extensionsan intermediate modular couplebetween th
10、e femoral component and the femoral head.Attach-ment can vary(for example,threads,tapers).3.1.1.6 proximal sleeves/padsmodular accessories forvarying the geometry of the femoral component in the meta-physeal area.3.1.2 modular knee implantany device,constructed of twoor more mating parts intended fo
11、r implantation into the femuror tibia for the purpose of replacing the knee joint.3.1.2.1 metal backed patellaa modular patellar replace-ment consisting of an articular piece which is secured to ametal backing by means of a locking mechanism.3.1.2.2 metal tibial traya metal component secured to thep
12、roximal tibia which provides mechanical support to andcouples directly with the modular tibial inserts.3.1.2.3 stem extension or sleeveany modular extension toeither a knee femoral or tibial component which extends intothe medullary canal.A stem extension may be attached to thefemoral or tibial comp
13、onent by a variety of means including ataper,screw,etc.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices.Current edition approved Feb.1,2009.Published March 2009.Originallyapproved in 1997.Last previous edition approved in 2003 as F1814 97a(2003
14、).DOI:10.1520/F1814-97AR09.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this hist
15、orical standard is referenced onwww.astm.org.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.2.4 tibial inserta m
16、odular bearing member of a tibialcomponent,usually made in accordance with SpecificationF648,that is secured to a knee tibial tray by means of a lockingmechanism.3.1.2.5 wedgea modular addition to a total knee replace-ment that serves the function of filling voids left by deficient orabsent bone stock.4.Significance and Use4.1 The tests suggested within this guide cover manydifferent,but not all possible,areas of research and concernwith regard to modular hip stems and modular knee compo-nents.4