ASTM F2345-03
Historical Standard: ASTM F2345-03 Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
SUPERSEDED (see Active link, below)
ASTM F2345
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
E4 Practices for Force Verification of Testing Machines
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F1873 Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications
F1875 Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
Other Documents
FDAGuidanceDocument 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.Keywords
bore; ceramic; cone; fatigue; modular head; static; strength;
ICS Code
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
DOI: 10.1520/F2345-03
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