ASTM F1814-1997a(2003) 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

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1、Designation: F 1814 97a (Reapproved 2003)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 (e) 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-at

3、e 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 disassembl

4、y 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. Refe

5、renced Documents2.1 ASTM Standards:F 648 Specification for Ultra-High-Molecular-Weight Poly-ethylene Powder and Fabricated Form for Surgical Im-plants2F 897 Test Method for Measuring Fretting Corrosion ofOsteosynthesis Plates and Screws2F 1440 Practice for Cyclic Fatigue Testing of MetallicStemmed H

6、ip Arthroplasty Femoral Components WithoutTorsion2F 1800 Test Method for Cyclic Fatigue Testing of MetalTibial Components of Total Knee Joint Replacements22.2 ISO Standard:ISO 7206 Implants for Surgery-Partial and Total Hip JointProsthesis3Part 4 Determination of Endurance Properties of StemmedFemor

7、al Components With Application of Torsion3Part 6 Determination of Endurance Properties of Head andNeck Region of Stemmed Femoral Components3Part 8 Endurance Performance of Stemmed Femoral Com-ponents With Application of Torsion33. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 m

8、odular 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 accessorie

9、s for in-creasing length or distal diameter of the femoral component.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 coupleb

10、etween 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 par

11、ts 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 component s

12、ecured to theproximal tibia which provides mechanical support to andcouples directly with the modular tibial inserts.3.1.2.3 stem extensions or sleeveany modular extensionto either a knee femoral or tibial component which extends intothe medullary canal. Stem extensions may be attached to thefemoral

13、 or tibial component by a variety of means includingtapers, screws, 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 jurisdiction o

14、f ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Apr. 10, 2003. Published June 2003. Originallyapproved in 1997. Last previous edition approved in 1997 as F 1814 97a.2Annual Book of ASTM

15、Standards, Vol 13.01.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.1Copyright ASTM 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-m

16、ent 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.4.2 Due to the un

17、limited possible modular designs, thisguide should be utilized as a guide for what should beconsidered with regard to device safety testing. There may becircumstances where alternative test methods may be useful. Itis still the responsibility of the investigator to address all safetyconcerns that ar

18、e inherent to individual modular designs.4.3 The tests suggested herein should be utilized in such away that the results reflect the effects of 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 imp

19、lant design.5. Testing5.1 AssemblyStatic assembly parameters should be evalu-ated to determine the minimum required loads (axial ortorsional) that ensure adequate assembly strengths. This testingcan be performed in conjunction with 5.2. Disassembly, toascertain how various assembly loads affect disa

20、ssembly5.1.1 Axial Engagement ForceThe force required to con-nect the components (for example, to engage a tapered con-nection consider the following:5.1.1.1 The procedure for applying the engagement force(clinical relevance), and5.1.1.2 The environment in which the components areconnected (contamin

21、ation).5.1.2 TorsionalThe torque required to connect the com-ponents (for example, bolt or screw). This may only beapplicable for threaded connections. Consider the following:5.1.2.1 The procedure for applying the torsional force (clini-cal relevance).5.2 DisassemblyStatic disassembly parameters sho

22、uld beevaluated to assess minimum design requirements for prevent-ing unintentional in vivo disassembly.5.2.1 AxialThe axial force required to disassemble matingcomponents (for example, force required to disassociate atapered junction).5.2.2 ShearThe shear force required to disassemble mat-ing compo

23、nents (for example, force required to shear a wedgefrom a tray).5.2.3 BendingThe possibility of static disassociation un-der combined 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

24、screw). This may only beapplicable for threaded connections.5.3 Cyclic Fatigue PropertiesThe nature of in vivo load-ing generates the 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

25、is affected by, cyclic loading.5.3.1 FractureThe possibility of fracture of either amodular construct or the connections under fatigue 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 c

26、onstruct 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 DisassemblyThe possibility of disassembly of themodular components under fatigue loading. Consider thefollowing:5.3.2.1 Loading that represents that applied to the comp

27、o-nent in vivo, and5.3.2.2 Measuring the disassembly force after fatigue load-ing and comparing to static values.5.3.3 SterilizationThe effects of sterilization on the fa-tigue integrity of the modular connection. Sterilization maycause material changes which could affect the performance ofthe modul

28、ar connection. Sterilization should be performedaccording to manufacturer specifications. Consider the follow-ing:5.3.3.1 The effect 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 dis

29、association or fracture. Consider the following:5.3.4.1 Corrosion of similar metal connections,5.3.4.2 Corrosion of dissimilar metal 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 compone

30、nts of amodular connection may produce adverse effects (that is, weardebris, increased risk for disassociation). Consider the follow-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

31、 arthroplasty; disassembly; hip arthroplasty; knee arthro-plasty; modular; orthopaedic medical devicesF 1814 97a (2003)2FIG.1TotalHipImplantsF 1814 97a (2003)3FIG.2TotalKneeImplantF 1814 97a (2003)4APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This guide is intended to be used to direct the re

32、aderto some of the most common areas of concern for modular hipand knee prosthetic implants. For each area of concern, there isa 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 conce

33、rn or tests that canbe performed for modular implants but is meant to cover someof the more common topics of modular implants. 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 o

34、r knee implant, or both.X1.2 Assembly and disassembly may be useful to theinvestigator in determining the strength of a modular 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

35、strength of themodular connection over time.ASTM International takes no position respecting the validity of any patent rights 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

36、 the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time 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 revisio

37、n of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive 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 sho

38、uldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 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 (2003)5