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Last Updated: Dec 31, 2010
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ASTM F1814-97a(2003)
Standard Guide for Evaluating Modular Hip and Knee Joint Components
Standard Guide for Evaluating Modular Hip and Knee Joint Components
F1814-97AR03
ASTM|F1814-97AR03|en-US
Standard Guide for Evaluating Modular Hip and Knee Joint Components
Standard
F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components>
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BOS Vol. 13.01 Committee F04
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Significance and Use
The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip stems and modular knee components.
Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.
The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.
Tests that are checked in Fig. 1 or Fig. 2 or indicated in this guide as a possible test to consider may not be applicable to every implant design.
FIG. 1 Total Hip Implants
FIG. 2 Total Knee Implant
Scope
1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 This guide does not cover intentional intraoperative diassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.
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 and health practices and determine the applicability of regulatory limitations prior to use.