Orthotek Laboratory

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HIP JOINT IMPLANTS

Many advances have been made in the field of hip joint replacement devices over the last 50 years, allowing hundreds of thousands of patients to lead normal and active lives.

The technical documentation for hip joint implants requires the verification of device characteristics on the basis of standardized test procedures.

Orthotek can conduct these tests with high precesion for both modular and non-modular hip implant systems.

Wear, fatigue and impringement tests on hip joint implants

Test standard overview in the field of hip joint implant

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.

ASTM F3047M: Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

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.

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

Femoral Head Compresion/Tosion/Impact/Pull-off 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.

ISO 7206-13: Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components

ISO 11491:Implants for surgery - Determination of impact resistence of ceramic femoral heads for hip joint prostheses
ASTM F 2345: Standard test methods for determination of static and cyclic fatigue strength of ceramic modular femoral heads.

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

ISO 7206-12

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Acetabular Device Test

ISO 7206-12: Implants for surgery- Partial and total hip joint prostheses-Part12:Deformation test method for acetabular shells

ASTM F1820: Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

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.

Impingement Test

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

Range of Motion Test

ISO 21535:Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants.

Hip Joint Prostheses Requirements

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.