Tests on implants and implant materials
Testing implants and implant materials is crucial to ensure that they meet quality requirements and perform safely and effectively in the patient’s body. The mechanical properties of the material—including break resistance, hardness and elasticity—and of the surfaces must be determined. Corrosion resistance and biocompatibility are also investigated.
The implants and implant materials must comply with national and international guidelines and standards for medical products. The results derived from these tests are an important part of the documentation for approval and regulation. ASTM, ISO and the national standards derived from them define the methodology and framework conditions for testing implants and implant materials, without which it would not be possible to compare the properties.
ZwickRoell works in close partnership with implant manufacturers, accredited testing service providers and institutes and universities. Our specialists are actively involved in national and international standards committees. This allows us to be at the source of important information and understand discussions and background information in detail, which is then integrated in the development of standard-compliant and reliable testing systems and test devices.
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Here you will find an overview of the most important test standards:
Spinal column implants Hip implants Osteosynthesis/trauma implants Knee implants Transtibial prostheses Implant materials
Test standards for spinal implants
| Standard | Name | Description |
|---|---|---|
| ASTM F2193 | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System | ASTM F2193 describes test methods to determine the mechanical properties of individual components of spinal implants, such as rods, screws and plates |
| ASTM F543 | Standard Specification and Test Methods for Metallic Medical Bone Screws | ASTM F543 describes four test methods to determine the mechanical properties of metallic bone screws in simplified clinical use. These include torsional strength, insertion and removal behavior, pull-out strength and self-tapping performance. |
| ASTM F1798 | Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants | ASTM F1798 describes test methods to determine uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of screw-rod systems for the spine. |
| ASTM F1717 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model | ASTM F1717 describes static test methods for fatigue testing on spinal implant constructs in a vertebrectomy model. Spinal implant constructs—which normally consist of a screw and rod system—are mounted on two test blocks made of ultra-high molecular weight polyethylene (UHMWPE). |
| ASTM F2706 | Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model | ASTM F2706 describes static test methods for fatigue tests on occipital-cervical and occipital-cervical-thoracic spinal implant constructs in a vertebrectomy model. |
| ISO 12189 | Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support | ISO 12189 describes fatigue testing on flexible spinal implant assemblies and biomechanical fatigue testing of all types of spinal implant assemblies, especially semi-rigid and dynamic implants using an anterior supported model. |
| Standard | Name | Description |
|---|---|---|
| ASTM F2077 | Test Methods for Intervertebral Body Fusion Devices | ASTM F2077 describes a series of different quasi-static and oscillating tests to enable mechanical comparison of intervertebral body fusion devices. These include shear, compression and torsion tests, which provide a simplified in vivo simulation of the loads imposed on such components. |
| ASTM F2267 | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | ASTM F2267 describes a test method to measure the axial compressive subsidence of non-biologic intervertebral body fusion devices. |
| ASTM F2346 | Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs | ASTM F2346 describes static testing and dynamic fatigue testing of artificial intervertebral discs. |
Test standards for hip implants
| Standard | Name | Description |
|---|---|---|
| ASTM F2068 | Standard specification for femoral prostheses — metallic implants | ASTM F2068 describes the specifications for metallic femoral prostheses used to replace the natural hip joint by means of hemi-anthroplasty or total hip surgical procedures. |
| ISO 21535 | Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants | ISO 21535 contains specific requirements for hip replacement implants regarding intended performance, design features, materials, design evaluation, manufacturing, sterilization and packaging, and specifies the information and test methods to be provided by manufacturers. |
| Standard | Name | Description |
|---|---|---|
| ASTM F1820 | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices | ASTM F1820 specifies different test methods for determining the forces for disassembly between the acetabular shell and liner |
| ISO 7206-12 | Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for acetabular shells | ISO 7206-12 specifies a test method and the test conditions for determining short-term deformation of a press-fit acetabular component. |
| ASTM F3090 | Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement | ASTM F3090 describes a test method to evaluate the fatigue strength of metallic acetabular shells with hemispheric outer surfaces. |
| Standard | Name | Description |
|---|---|---|
| ISO 7206-4 | Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components | In the ISO 7206-4 standard, the dynamic load on the femoral stem while walking with an implant that is already loosening is simulated in the proximal bone bed in order to test the stem life expectancy. |
| 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 | The ISO 7206-6 standard is used to determine the finite life fatigue in the femoral neck area. This test simulates a well ingrown femoral stem. |
| ASTM F2580 | Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis | ASTM F2580 specifies a test method for fatigue testing of metallic femoral stems with metaphyseal fixation. |
| Standard | Name | Description |
|---|---|---|
| ISO 7206-10 | Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads | ISO 7206-10 specifies the requirements on the testing system for the determination of resistance to static load of modular 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 7206-13 specifies a test method for the determination of resistance to torque between the femoral head and neck, or the stem. |
| ASTM F2009 | Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses | ASTM F2009 specifies a test method for determining the required disassembly force of the taper connection between the femoral head and femoral shaft. |
| ASTM F2345 | Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads | ASTM F2345 covers determination of the static and cyclic fatigue strength of ceramic modular femoral heads. |
| ISO 11491 | Implants for surgery — Determination of impact resistance of ceramic femoral heads for hip joint prostheses | ISO 11491 specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses |
Test standards for osteosynthesis/trauma implants
| Standard | Name | Description |
|---|---|---|
| ASTM F543 | Standard specification and test methods for metallic medical bone screws | ASTM F543 describes four test methods to determine the mechanical properties of metallic bone screws. |
| ISO 6475 | Implants for surgery Metal bone screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods | ISO 6475 specifies the test methods for determining the breaking torque and the angle of rotation at break. |
| ASTM F382 | Standard specification and test method for metallic bone plates | ASTM F382 describes test methods to determine the mechanical properties of bone plates. |
| ISO 9585 | Implants for surgery - Determination of bending strength and stiffness of bone plates | ISO 9585 describes a test method to determine the bending strength and stiffness of straight bone plates. It can also be used to test plates having a small initial curvature, which are intended to create prestressing of the bone during insertion, and to test the straight part of angled plates. |
| ASTM F384 | Standard specifications and test methods for metallic angled orthopedic fracture fixation devices | ASTM F384 describes static and dynamic bend tests on angled fixation devices. |
| ASTM F2502 | Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants | ASTM F2502 addresses the special properties of absorbable materials. However, the tests are carried out in accordance with ASTM F543 and ASTM F382 |
| ASTM F1264 | Standard specification and test methods for intramedullary fixation devices | ASTM F1264 describes two static (4-point bend test / torsion test with nail) and two dynamic test methods to determine the mechanical properties of intermedullary systems. |
| Standard | Name | Description |
|---|---|---|
| ASTM F1541 | Standard specification and test methods for external skeletal fixation devices | ASTM F1541 describes different static and dynamic methods to test external skeletal fixation devices – from individual components such as pins, to subassemblies and connectors through to the complete structure. |
| Standard | Name | Description |
|---|---|---|
| ASTM F564 | Standard specification and test methods for metallic bone staples | ASTM F564 describes four test methods to determine the mechanical properties of metallic bone staples |
| ASTM F2180 | Standard Specification for Metallic Implantable Strands and Cables | ASTM F2180 describes mechanical testing of metallic strands and cables. The test procedure refers to ASTM E8. |
Test standards for knee implants
| Standard | Name | Description |
|---|---|---|
| ASTM F1800 | Standard practice for cyclic fatigue testing of metal tibial tray components of total knee joint replacements | ASTM F1800 describes a method for fatigue testing using a cyclic force with constant amplitude on metal tibial trays used in knee-joint prostheses. |
| ISO 14879-1 | Implants for surgery — Total knee-joint prostheses — Part 1: Determination of endurance properties of knee tibial tray | ISO 14879-1 describes a test method to determine the fatigue properties of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia. |
Test standards for lower-limb prostheses
| Standard | Name | Description |
|---|---|---|
| ISO 10328 | Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods | ISO 10328 specifies procedures for static and cyclic strength tests on lower limb prostheses, which typically produce compound loadings by the application of a single test force. |
| ISO 22675 | Prosthetics — Testing of ankle-foot devices and foot units — Requirements and test methods | ISO 22675 specifies static and dynamic test methods for ankle foot devices and foot units of external lower limb prostheses. |
Implant materials / materials testing
| Standard | Name | Description |
|---|---|---|
| ASTM F1044 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings | ASTM F1044 describes the determination of the static shear strength of continuous calcium phosphate coatings and metallic coatings. It assesses the degree of adhesion of coatings to substrates, or the internal cohesion of a coating in shear, parallel to the surface plane. |
| ASTM F1160 | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings | ASTM F1160 covers the test procedure for determining shear and bending fatigue performance of calcium phosphate coatings and of porous and nonporous metallic coatings and for determining the bending fatigue performance of metallic coatings over sprayed with calcium phosphate. |
| ASTM F1147 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings | ASTM F1147 describes tensile testing of calcium phosphate and metallic porous coatings. It assesses the degree of adhesion of coatings to substrates, or the internal cohesion of a coating in tension normal to the surface plane. |
| ISO 13779-4 | Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength | ISO 13779-4 specifies a test method to determine the adhesion strength of hydroxyapatite coatings on metallic substrates. |
| Standard | Name | Description |
|---|---|---|
| ASTM F2118 | Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials | ASTM F2118 describes test procedures for evaluating the fatigue strength of cylindrical waisted specimens manufactured from acrylic bone cement. |
| ISO 16402 | Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics | ISO 16402 specifies a test method to determine the fatigue strength of flat specimens of polymerized cement. |
| ASTM F451 | Standard Specification for Acrylic Bone Cement | |
| ISO 5833 | Implants for surgery — Acrylic resin cements | ISO 5833 specifies the physical, mechanical, packaging and labeling requirements for curing polymerizing radio-opaque resin cements based on poly (meathacrylic acid esters). |
