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Scope

1.1 This practice covers a method for the fatigue testing of metallic stemmed femoral components used in hip arthroplasty. The described method is intended to be used for evaluation in comparisons of various designs and materials used for stemmed femoral components used in the arthroplasty. This practice covers procedures for the performance of fatigue tests using (as a forcing function) a periodic constant amplitude force.

1.2 This practice applies primarily to one-piece prostheses and femoral stems with modular heads, with the head in place. Such prostheses should not have an anterior-posterior A-P bow or a medial-lateral M-L bow, and they should have a nearly straight section on the distal 50 mm of the stem. This practice may require modifications to accommodate other femoral stem designs.

1.3 The values stated in SI units are to be regarded as the standard.

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

This practice can be used to describe the effects of materials, manufacturing, and design variables on the fatigue resistance of metallic stemmed femoral components subjected to cyclic loading for relatively large numbers of cycles. The recommended test assumes a worst case situation in which proximal support for the stem has been lost. It is also recognized that, for some materials, the environment has an effect on the response to cyclic loading (see 12.7). The test environment used and rationale for the choice of that environment should be described in the test report.

It is recognized that actual in vivo loading conditions are not constant amplitude. However, sufficient information is not available to create standard load spectrums for metallic stemmed femoral components. A simple periodic constant amplitude force is accordingly recommended.

Keywords

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 77.040.10 (Mechanical testing of metals)

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)

77.040.10 (Mechanical testing of metals Mechanical testing in general, see 19.060 Mechanical testing of welded joints, see 25.160.40)

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