ASTM-F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

ASTM-F2009 - 2020 EDITION - CURRENT
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Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
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Scope

1.1 This test method establishes a standard methodology for determining the force required, under laboratory conditions, to disassemble tapers of implants that are otherwise not intended to release. Some examples are the femoral components of a total or partial hip replacement or shoulder in which the head and base component are secured together by a self-locking taper.

1.2 This test method has been developed primarily for evaluation of metal and ceramic head designs on metal tapers but may have application to other materials and designs.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Significance and Use

4.1 This test method helps to assess the axial locking force of a modular taper. Some types of devices that may utilize this type of connection are the modular shoulder and modular hip prostheses. Additional means of evaluating the locking mechanisms of tapers may be appropriate, depending upon the design of the device.

4.2 This test method may not be appropriate for all implant applications. The user is cautioned to consider the appropriateness of the practice in view of the materials and design being tested and their potential application.

4.3 While this test method may be used to measure the force required to disengage tapers, any comparison of such data for various component designs must take into consideration the size of the implant and the type of locking mechanism evaluated.

Keywords

arthroplasty; assembly; disassembly; heads; hip prosthesis; modular; shoulder prosthesis; tapers;

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F2009-20

Revision Level

2020 EDITION

Status

Current

Modification Type

Revision

Publication Date

May 18, 2020

Document Type

Test Method

Page Count

4 pages

Committee Number

F04.22