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ASTM F2068 Fatigue test system of Femoral Prostheses Implants, Hip Implants Testing

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ASTM F2068: Standard Specification for Femoral Prostheses – Metallic Implants


ASTM F2068 covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.

ASTM F2068 Fatigue test system of Femoral Prostheses Implants, Hip Implants Testing

ASTM F2068 specification for fatigue testing and determining coating integrity of femoral THR stems. Fatigue testing can be performed according to ISO 7206-4 and ISO 7206-6. 

Samples are tested for 10 million cycles. 

Coating integrity can be assessed according to ASTM F1044 (shear strength), ASTM F1147 (tensile strength) and ASTM F1978 (abrasion resistance).


Related standard introduction:

ISO 7206-4                   Implants for surgery: Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components

Specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses, and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. 

It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing. the test parameters and the requirements for the endurance limit of stemmed femoral components tested in accordance with this document. 

The value of the endurance limit test forces and the corresponding number of load cycles are specified.


In the ISO 7206-4 standard, the dynamic load of the hip prosthesis rod during the movement of a loosened implant was simulated to test the service life of the rod. 

ISO 7206-4 specifies the cyclic load and number of cycles to determine the durability characteristics of femoral rods. 

At least six femoral rods must withstand five million load cycles, with a maximum load of 2300 N and a minimum load of 300 N.

ISO 7206-6:  Implants for surgery: Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components

ISO 7206-6:2013 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of the neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. 

It is applicable to modular and non-modular designs made of metallic or non-metallic materials.

It also specifies the test conditions so that the important parameters that affect the hip femoral components are taken into account and describes how the specimen is set up for testing.

The standards ISO 7206-4 and ISO 7206-6 describe durability/fatigue testing of the rod and neck regions of femoral components with rods for hip implants. 

During testing, the hip joint prosthesis is fixed in the corresponding testing fixture with cement and subjected to cyclic loading through a dynamic testing machine. 

According to the design and length of the hip joint prosthesis, as well as the part to be tested according to the standards, the embedding depth, oscillation load, and number of cycles.



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