ASTM F2345-03

Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

STANDARD published on 1.11.2003

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The information about the standard:

Designation standards: ASTM F2345-03
Note: WITHDRAWN
Publication date standards: 1.11.2003
SKU: NS-53623
The number of pages: 8
Approximate weight : 24 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F2345-03 :

Keywords:

bore, ceramic, cone, fatigue, modular head, static, strength, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

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for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications (Withdrawn 2007)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

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