Information on the most widely used ASTM standards within the materials testing industry
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.
The mechanical strength (fatigue test ISO 7206-4, ISO 7206-6, shear strength test ASTM F1044, tensile test ASTM F1147, abrasion resistance test ASTM F1978), corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.
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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).
ASTM F2068 Test methods detail guides and introduction:
| Fatigue test of the femoral hip components | ISO 7206-4 | Specifies the cyclic load and number of cycles to determine the endurance properties of the femoral stem. A minimum of six femoral stems must withstand five million load cycles at a maximum load of 2300 N and a minimum load of 300 N. |
| Fatigue test of the head and neck of the stemmed femoral | ISO 7206-6 | Simulates a well ingrown femoral stem. According to the standard, at least six femoral stems must withstand ten million load cycles with a load of 5340N (R=0.1) |
| Shear Strength | ASTM F1044 | When tested in accordance with Test Method F1044, the average shear strength of the surface/ substrate interface shall equal or exceed 20 MPa (2900 psi).
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| Tensile Strength | ASTM F1147 | When tested in accordance with Test Method F1147, the average tensile strength of the surface/substrate interface shall equal or exceed 20 MPa (2900 psi).
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| Abrasion Resistance of Plasma Spray Thermal Coatings | ASTM F1978 | Samples fabricated and coated using this process shall not have an average mass of liberated porous coating material in excess of 65 mg/100 cycles. Test with Taber abrasion resistance tester.
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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. | |
Related products and device
Related Standard
ISO 7206‑4 and ISO 7206‑6 are key international standards defining fatigue endurance tests for stemmed femoral components of partial and total hip joint prostheses. ISO 7206‑4 evaluates the femoral stem under simulated proximal loosening; ISO 7206‑6 evaluates the femoral neck under well‑fixed, normal in‑vivo loading.
ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings.
ASTM F1044 is a standard test method developed to evaluate the shear strength of coatings on metallic substrates, specifically targeting continuous calcium phosphate coatings (like hydroxyapatite) and metallic coatings. Its primary purpose is to measure either the adhesive strength between the coating and substrate or the cohesive strength within the coating itself when subjected to a force parallel to the coating plane.
ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1044 is a standard procedure for determining the tensile adhesion or cohesion strength of coatings on metallic substrates. It is specifically designed for continuous calcium phosphate coatings (e.g., hydroxyapatite) and metallic porous coatings bonded to dense metal substrates. The test applies a uniaxial tensile load perpendicular (normal) to the coating plane to evaluate the integrity of the bond between the coating and substrate (adhesion) or the strength within the coating material itself (cohesion).
ASTM F1160 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings;
Rotating beam fatigue testing generates higher frequencies than traditional high cycle fatigue (HCF) methods. UnitedTest testing services provide critical data about coatings and metallic surface treatments to ISO 1143, ASTM F1160 standards.
Rotating beam fatigue testing, Shear and Bending Fatigue testing.
Rotating beam fatigue testing is a mechanical test method used to evaluate the fatigue properties of materials. In this test, a beam specimen is subjected to cyclic loading, which induces repeated bending causing failure over time. The specimen is mounted on a rotating apparatus, which allows for the cyclic load to be applied at constant amplitude and frequency.
During the test, the beam specimen is rotated at a constant speed while a loading force is applied to it. The force causes the beam to bend, and as the beam rotates, it undergoes cyclic bending stress that can induce fatigue failure.
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