ASTM F2345-03 - 1.11.2003
 
1. Scope

1.1 These test methods cover the evaluation of the static and cyclic fatigue strength of ceramic modular femoral heads, mounted on a cone as used on the femoral stem of the total hip arthroplasty.

1.2 These test methods were primarily developed for evaluation of ceramic (Specifications F 603 and F 1873) head designs on metal cones but may have application to other materials.

1.3 The values stated in SI units are to be regarded as the 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 and health practices and determine the applicability of regulatory limitations prior to use.

 
2. Referenced Documents

FDA Guidance Document

for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems (draft Jan. 10, 1995) Available from Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857.

DIN 4768

Determination of Surface Roughness Ra, R z, and Rmax with Electric Stylus Instruments; Basic Data Available from Beuth Verlag GmbH (DIN--DIN Deutsches Institut fur Normung e.V.), Burggrafenstrasse 6, 10787, Berlin, Germany.

E4-21

Standard Practices for Force Calibration and Verification of Testing Machines

F603-12(2020)

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

F1873-98

Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)

F1875-98(2022)

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface