>> Implant test

Hip joint prostheses testing measures how your product will withstand different levels of fatigue, compression, torsion, and bending over an extended period of time. 

Befitlab performs a variety of testing for partial and total hip joint prostheses, including those outlined in by the ISO 7206 specification. Our medical device testing experts work diligently to help you bring safe products to patients around the world. 

Our ISO 7206 testing services

ISO 7206 provides industry guidance for the classification, dimensions, and test methods for partial and total hip joint prostheses. Befitlab’s orthopedic device experts specialize in evaluating the endurance properties of hip joint replacements and are ready to assist with your testing needs. 

Hip stem fatigue testing (ISO 7206-4)

Hip stem fatigue testing, governed by ISO 7206-4, applies an axial load to an implant that has been potted in such a way as to represent the loosening of the implant proximally. The orientation translates axial load into a combination of compression, torsion, and bending stresses on the stem of the specimen. Tests typically run to 5,000,000 cycles and must meet the load requirement of 2,300 N (517 lbs).

Femoral neck fatigue testing (ISO 7206-6)

Whereas stem fatigue testing simulates a loosened implant, femoral neck fatigue testing per ISO 7206-6 simulates loads experienced by a properly fixed implant during gait. Hip prostheses are expected to run out to 10,000,000 cycles without failure and tested at 5,340 N (1,200 lbs).

Femoral head compression testing (ISO 7206-10)

Femoral head testing applies static axial forces to ensure the prosthesis withstands the forces it’s exposed to while in use. Testing according to ISO 7206-10 helps determine the static compressive or tension loads that cause failure of the femoral neck and head assembly.

Fatigue Test

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

ISO 7206-6: Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components.

ISO 7206-8: Implants for surgery -- Partial and total hip joint prostheses -- Part 8: Endurance performance of stemmed femoral components with application of torsion.

Femoral Head Test

ISO 7206-9: Implants for surgery - Partial and total hip joint prostheses - Part 9: Determination of resistance to torque of head fixation of stemmed femoral components.  

ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of femoral heads.

ASTM F 2345: Standard test methods for determination of static and cyclic fatigue strength of ceramic modular femoral heads.  

Ball Pull-off Test

ASTM F 2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.

Hip Geometry
ISO 7206-1: Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions.
ISO 7206-2: Implants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials.
ASTM F 1814: Standard Guide for Evaluating Modular Hip and Knee Joint Components.
ASTM F 2033: Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials.
ASTM F 2068: Standard Specification for Femoral Prostheses—Metallic Implants.

ASTM F 2091: Standard Specification for Acetabular Prostheses.

Hip Simulator Test

ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.

ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.

Insert push-in/out Test 

ASTM F 1820: Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device.

Hip Stem Corrosion Test

ASTM F 1875: Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface.

Hip Range of Motion

ISO 21535：

Fatigue Test

ASTM F 2580: Standard test method for evaluation of modular connection of proximally fixed femoral hip prosthesis.

Impingement Test

ASTM F 2582: Standard test method for impingement of acetabular prostheses.

Hip Joint Wear Test
ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests.

ISO 14242-2: Implants for surgery - wear of total hip prostheses Part 2: Methods of measurement.

ISO 14242-3: Implants for surgery - wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test.