Standard Guide for Evaluating Modular Hip and Knee Joint Components

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-08-2022

Publisher

American Society for Testing and Materials

1.1This 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.

1.2This guide does not attempt to define all test methods associated with modular device evaluation.

1.3The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.

1.4This 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.

1.5This 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.

Committee	F 04
DocumentType	Guide
Pages	6
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM F 1814 : 2015

ASTM F 2887 : 2017	Standard Specification for Total Elbow Prostheses
ASTM F 3018 : 2017	Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
ASTM F 2068 : 2015	Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
ASTM F 2083 : 2021	Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
ASTM F 2665 : 2021	Standard Specification for Total Ankle Replacement Prosthesis
ASTM F 3047M : 2015	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

ASTM F 2580 : 2018	Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
ASTM F 1875 : 1998 : R2022	Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
ASTM F 1875 : 1998 : R2014	Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface