ASTM F1814-1997a(2009) Standard Guide for Evaluating Modular Hip and Knee Joint Components《评价髋部和膝关节连接部件模数的标准指南》.pdf

1、Designation: F 1814 97a (Reapproved 2009)Standard Guide forEvaluating Modular Hip and Knee Joint Components1This standard is issued under the fixed designation F 1814; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of las

2、t revision. 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

3、 tests and evaluations 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

4、 loads.1.4 This 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. Refer

5、enced Documents2.1 ASTM Standards:2F 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plantsF 897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and ScrewsF 1440 Practice for Cyclic Fatigue Testing of MetallicStemmed Hip

6、 Arthroplasty Femoral Components WithoutTorsionF 1800 Test Method for Cyclic Fatigue Testing of MetalTibial Tray Components of Total Knee Joint Replacements2.2 ISO Standard:3ISO 7206 Implants for Surgery-Partial and Total Hip JointProsthesisPart 4 Determination of Endurance Properties of StemmedFemo

7、ral Components 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 mod

8、ular femoral hip implantany device, con-structed of two or more mating parts intended for implantationinto the femur for the purpose of replacing the femoral hipjoint.3.1.1.1 bolts/screwsa fastener used to secure modularpieces of a femoral component.3.1.1.2 bullets/distal sleevesmodular accessories

9、for in-creasing 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 coup

10、lebetween the 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 oftwo or more mating

11、parts intended for implantation into thefemur or 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 componen

12、t secured to theproximal 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 thefemo

13、ral or tibial component by a variety of means including ataper, screw, etc.3.1.2.4 tibial inserta modular bearing member of a tibialcomponent, usually made in accordance with SpecificationF 648, that is secured to a knee tibial tray by means of a lockingmechanism.1This guide is under the jurisdictio

14、n 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 F 1814 97a(2003).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact AS

15、TM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM

16、International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.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 g

17、uide cover manydifferent, but not all possible, areas of research and concernwith regard to modular hip stems and modular knee compo-nents.4.2 Due to the unlimited possible modular designs, thisguide should be utilized as a guide for what should beconsidered with regard to device safety testing. The

18、re may becircumstances where alternative test methods may be useful. Itis still the responsibility of the investigator to address all safetyconcerns that are inherent to individual modular designs.4.3 The tests suggested herein should be utilized in such away that the results reflect the effects of

19、modularity, if any.4.4 Tests that are checked in Fig. 1 or Fig. 2 or indicated inthis guide as a possible test to consider may not be applicableto every implant design.5. Testing5.1 AssemblyStatic assembly parameters should be evalu-ated to determine the minimum required loads (axial ortorsional) th

20、at ensure adequate assembly strengths. This testingcan be performed in conjunction with 5.2. Disassembly, toascertain how various assembly loads affect disassembly5.1.1 Axial Engagement ForceThe force required to con-nect the components (for example, to engage a tapered con-nection). Consider the fo

21、llowing:5.1.1.1 The procedure for applying the engagement force(clinical relevance), and5.1.1.2 The environment in which the components areconnected (contamination).5.1.2 TorsionalThe torque required to connect the com-ponents (for example, bolt or screw). This may only beapplicable for threaded con

22、nections. Consider the following:5.1.2.1 The procedure for applying the torsional force (clini-cal relevance).5.2 DisassemblyStatic disassembly parameters should beevaluated to assess minimum design requirements for prevent-ing unintentional in vivo disassembly.5.2.1 AxialThe axial force required to

23、 disassemble matingcomponents (for example, the force required to disassociate atapered junction).5.2.2 ShearThe shear force required to disassemble mat-ing components (for example, the force required to shear awedge from a tray).5.2.3 BendingThe possibility of static disassociation un-der combined

24、loading. Consider the following:5.2.3.1 Reporting a load-versus-deflection curve.5.2.4 TorsionThe torque required to disconnect the com-ponents (for example, bolt or screw). This may only beapplicable for threaded connections.5.3 Cyclic Fatigue PropertiesThe nature of in vivo load-ing generates the

25、need for cyclic fatigue evaluation. Testsshould be designed to examine pre-cycle and post-cycleproperties to gain an understanding of how the design with-stands, and is affected by, cyclic loading.5.3.1 FractureThe possibility of fracture of either amodular construct or the connections under fatigue

26、 loading.Consider the following:5.3.1.1 Loading that represents that applied to the compo-nent in vivo,5.3.1.2 An P-N curve to determine the load levels at whichthe construct can withstand cyclic loading without fracture, and5.3.1.3 Test Method F 1440, Test Method F 1800, andISO 7206-4,6, 8.5.3.2 Di

27、sassemblyThe possibility of disassembly of themodular components under fatigue loading. Consider thefollowing:5.3.2.1 Loading that represents that applied to the compo-nent in vivo, and5.3.2.2 Measuring the disassembly force after fatigue load-ing and comparing it to static values.5.3.3 Sterilizatio

28、nThe effects of sterilization on the fa-tigue integrity of the modular connection. Sterilization maycause material changes which could affect the performance ofthe modular connection. Sterilization should be performedaccording to the manufacturers specifications. Consider thefollowing:5.3.3.1 The ef

29、fect of sterilization of plastic components.5.3.4 CorrosionThe environment in which the modularconnection will be used may affect the ability of the connectionto resist disassociation or fracture. Consider the following:5.3.4.1 Corrosion of similar metal connections,5.3.4.2 Corrosion of dissimilar m

30、etal connections,5.3.4.3 The fluid environment,5.3.4.4 The temperature,5.3.4.5 The frequency, and5.3.4.6 See Test Method F 897.5.3.5 FrettingMicromotion between two components of amodular connection may produce adverse effects (that is, weardebris, increased risk for disassociation). Consider the fo

31、llow-ing:5.3.5.1 Fretting of taper junctions5.3.5.2 Fretting of mating, non-articulating surfaces5.3.5.3 Environmental test, and5.3.5.4 See Test Method F 897.6. Keywords6.1 arthroplasty; disassembly; hip arthroplasty; knee arthro-plasty; modular; orthopaedic medical devicesF 1814 97a (2009)2FIG. 1 T

32、otal Hip ImplantsF181497a(2009)3FIG. 2 Total Knee ImplantF181497a(2009)4APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This guide is intended to be used to direct the readerto some of the most common areas of concern for modular hipand knee prosthetic implants. For each area of concern, there i

33、sa checklist of possible junctions to evaluate with appropriatetopics to consider for each test. This guide is not intended to beall inclusive of the potential areas of concern or tests that canbe performed for modular implants but is meant to cover someof the more common topics of modular implants.

34、 It is felt thatthis document will be particularly useful to the novice inves-tigator in directing their efforts in the investigation of safetyand efficacy of a modular hip or knee implant, or both.X1.2 Assembly and disassembly may be useful to theinvestigator in determining the strength of a modula

35、r connec-tion. The strength of the modular connection may be deter-mined as a ratio if disassembly force to assembly force. Thisnumber may also provide information as to the strength of themodular connection over time.ASTM International takes no position respecting the validity of any patent rights

36、asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any tim

37、e by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will r

38、eceive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM I

39、nternational, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 1814 97a (2009)5