Standard Historical Last Updated: Aug 16, 2017 Track Document
ASTM F1814-97a

Standard Guide for Evaluating Modular Hip and Knee Joint Components

Standard Guide for Evaluating Modular Hip and Knee Joint Components F1814-97A ASTM|F1814-97A|en-US Standard Guide for Evaluating Modular Hip and Knee Joint Components Standard new BOS Vol. 13.01 Committee F04
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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.

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Details
Book of Standards Volume: 13.01
Developed by Subcommittee: F04.22
Pages: 5
DOI: 10.1520/F1814-97A