ASTM F2009-2000(2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses《测定模块化假体锥形连接的轴向拆解力的标准试验方法》.pdf
《ASTM F2009-2000(2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses《测定模块化假体锥形连接的轴向拆解力的标准试验方法》.pdf》由会员分享,可在线阅读,更多相关《ASTM F2009-2000(2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses《测定模块化假体锥形连接的轴向拆解力的标准试验方法》.pdf(4页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F2009 00 (Reapproved 2011)Standard Test Method forDetermining the Axial Disassembly Force of TaperConnections of Modular Prostheses1This standard is issued under the fixed designation F2009; the number immediately following the designation indicates the year oforiginal adoption or, in t
2、he case of revision, the year of last 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 test method establishes a standard methodology fordetermining the force required
3、, under laboratory conditions, todisassemble tapers of implants that are otherwise not intendedto release. Some examples are the femoral components of atotal or partial hip replacement or shoulder in which the headand base component are secured together by a self-lockingtaper.1.2 This test method ha
4、s been developed primarily forevaluation of metal and ceramic head designs on metal tapersbut may have application to other materials and designs.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This standard does not pur
5、port 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 Documents2.1 ASTM Standards:2E4
6、 Practices for Force Verification of Testing MachinesF1636 Specification for Bores and Cones for ModularFemoral Heads33. Summary of Test Method3.1 The axial disassembly test method provides a means tomeasure the axial locking strength of the taper connection formodular prostheses.3.2 Following assem
7、bly, an axial tensile force is applied todisassemble the taper connection and the maximum force isrecorded.4. Significance and Use4.1 This test method helps to assess the axial locking forceof a modular taper. Examples of these devices are described inSpecification F1636. Some types of devices that
8、may utilizethis type of connection are the modular shoulder and modularhip prostheses. Additional means of evaluating the lockingmechanisms of tapers may be appropriate, depending upon thedesign of the device.4.2 This test method may not be appropriate for all implantapplications. The user is cautio
9、ned to consider the appropriate-ness of the practice in view of the materials and design beingtested and their potential application.4.3 While this test method may be used to measure the forcerequired to disengage tapers, any comparison of such data forvarious component designs must take into consid
10、eration thesize of the implant and the type of locking mechanismevaluated.5. Apparatus5.1 The cone portion of the assembly shall be constrainedby suitable fixtures that can sustain high loads.5.2 The fixtures shall be constructed so that the line of loadapplication is aligned with the axes of the ma
11、le and femaletaper components within 61.5.2.1 For example, modular heads may be assembled by asolid metal 100 cone as shown in Fig. 1. The cone shouldprovide line contact around the diameter of the head.5.2.2 For example, modular heads may be disassembledwith a metal cage that surrounds the head and
12、 provides evencontact around the inferior edge of the head as shown in Fig. 2.5.3 The testing machine shall conform to the requirementsof Practices E4. The loads used to determine the attachmentstrength shall be within the range of the testing machine asdefined in Practices E4.5.4 The test machine s
13、hould be capable of delivering acompressive and tensile force at a constant displacement rate.The test machine should have a load monitoring and recordingsystem.6. Sampling and Test Specimens6.1 The male and female taper components can be finishedimplants or they can be simplified test specimens. Th
14、e testspecimens shall have tapers manufactured to the specifications1This test method is under the jurisdiction of ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved March 1, 2011. Published
15、April 2011. Originallyapproved in 2000. Last previous edition approved in 2005 as F2009 00 (2005).DOI: 10.1520/F2009-00R11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
16、fer to the standards Document Summary page onthe ASTM website.3Withdrawn.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.of a finished implant, including material, and preferablymanufactured with the same equipment.6.2 The supporting
17、 material around the female taper shall besimilar in size and shape to the finished implant.6.3 A minimum of five taper assemblies shall be tested todetermine the axial disassembly force between the taperedcomponents. Pairing of the components shall be random unlessotherwise reported. The appropriat
18、eness of performing mul-tiple tests on the same taper connection will depend on thedesign and application of the device.6.4 Sterilization of test components is not required unless ithas known effects on the parts being evaluated. Generally,sterilization does not have an effect on metallic materials.
19、7. Procedure7.1 Following normal laboratory cleaning procedures toremove any debris or other surface contaminants, the tapercomponents are assembled on a suitable test machine. Asuggested procedure for cleaning and drying of the specimensis given in Appendix X1.7.2 Each specimen should be characteri
20、zed prior to testing.This information may include, but is not limited to, thefollowing: material, hardness, bore and taper diameters, con-centricity, surface roughness, taper angle, and length of en-gagement.7.3 Tapers can be assembled using two methods. Dependingon the intended use, the user may us
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
5000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ASTMF200920002011STANDARDTESTMETHODFORDETERMININGTHEAXIALDISASSEMBLYFORCEOFTAPERCONNECTIONSOFMODULARPROSTHESES

链接地址:http://www.mydoc123.com/p-536281.html