ASTM-F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components

Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Standard Guide for Evaluating Modular Hip and Knee Joint Components



Want this as a site license?

Changes from the previous issue

A redline edition is available for this document, with all changes visible. Ask Document Center Inc. for more information.


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 disassembly 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.

Significance and Use

4.1 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.

4.2 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.

4.3 The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.

4.4 Tests that are checked in Table 1 or Table 2 or indicated in this guide as a possible test to consider may not be applicable to every implant design.


arthroplasty; disassembly; hip arthroplasty; knee arthroplasty; modular; orthopaedic medical devices;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

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)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.


Customers who bought this document also bought:

Standard Test Methods for Rockwell Hardness of Metallic Materials

Standard Specification for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels

Standard Specification for Stainless Steel Bars and Shapes

Document Number


Revision Level




Modification Type


Publication Date

Dec. 31, 2015

Document Type


Page Count

5 pages

Committee Number