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astm-f2118-fatigue-testing-of-spinal-interbody-devices
Wear and Fatigue Testing ASTM E466 Fatigue Testing of Metallic MaterialsASTM F1108 Fatigue Testing of Hip ImplantsASTM F1113 Fatigue Testing of Hip ProsthesesASTM F1160 Fatigue Testing of Metallic ImplantsASTM F1314 Wear Testing of Artificial JointsASTM F1717 Fatigue Testing of Spinal ImplantsASTM F1717-18 Fatigue Testing of Spinal ConstructsASTM F1800 Wear Testing of Metal-on-Metal ImplantsASTM F1874 Wear Testing of Elastomers in DevicesASTM F1874 Wear Testing of Polymer ComponentsASTM F2003 Fatigue Testing of Titanium ImplantsASTM F2068 Wear Testing of Artificial DiscsASTM F2077 Wear Testing of Spinal ImplantsASTM F2083 Fatigue Testing of Spinal DevicesASTM F2167 Fatigue Testing of Dental ImplantsASTM F2182 Fatigue Testing of Implants in Simulated ConditionsASTM F2183 Fatigue Testing of Knee ImplantsASTM F2213 Fatigue Testing of Spinal ImplantsASTM F2335 Wear Testing of Orthopedic DevicesASTM F2338 Wear Testing of Orthopedic DevicesASTM F2346 Wear Testing of Artificial DiscsASTM F2457 Fatigue Testing of Artificial JointsASTM F2478 Fatigue Testing of Spinal Fusion DevicesASTM F2517 Fatigue Testing of Medical DevicesASTM F2523 Wear Simulation of ImplantsASTM F2603 Wear Testing of Polymer-on-Polymer BearingsASTM F2624 Wear Testing of Hip ProsthesesASTM F2625 Wear Testing of Hip Joint ImplantsASTM F2706 Fatigue Testing of Artificial JointsASTM F2820 Wear Testing of Artificial JointsASTM F2846 Fatigue Testing of Hip ImplantsASTM F2915 Fatigue Testing of Artificial JointsASTM F2970 Fatigue Testing of Knee ImplantsASTM F2971 Fatigue Testing of Knee ProsthesesASTM F3121 Fatigue Testing of Intervertebral DevicesASTM F3141 Fatigue Testing of Dental DevicesASTM F382 Fatigue Testing of Metallic Bone PlatesISO 10993-10 Fatigue Impact on IrritationISO 10993-12 Sample Preparation for Fatigue TestingISO 10993-17 Fatigue Effects on ToxicologyISO 10993-22 Fatigue Impact on SensitizationISO 10993-4 Fatigue Impact on Blood ContactISO 10993-5 Fatigue Impact on CytotoxicityISO 10993-6 Fatigue Effects on BiocompatibilityISO 10993-7 Fatigue Impact on EO ResidueISO 10993-8 Fatigue Impact on Implant MaterialsISO 12105 Fatigue Testing of Prosthetic ComponentsISO 12106 Fatigue Testing of Orthopedic DevicesISO 12107 Fatigue Testing of Medical DevicesISO 12108 Fatigue Testing of Metallic ImplantsISO 14242-1 Wear Testing of Hip Joint ProsthesesISO 14242-2 Wear Measurement MethodsISO 14242-3 Wear Test ConditionsISO 14630 Fatigue Testing of Medical DevicesISO 14630 Fatigue Testing of Non-active Medical DevicesISO 14644 Fatigue Testing of Cleanroom MaterialsISO 14801 Fatigue Testing of Dental ImplantsISO 14801-1 Fatigue Testing of Dental ImplantsISO 14801-2 Fatigue Testing of Dental ImplantsISO 14879 Wear Testing of Spinal ImplantsISO 14879-1 Wear Testing of Cervical ImplantsISO 5832-1 Fatigue Testing of Implant MaterialsISO 5832-2 Fatigue Testing of Implant AlloysISO 5832-3 Fatigue Testing of Cobalt-Chromium AlloysISO 5832-4 Fatigue Testing of Implant MaterialsISO 5832-9 Fatigue Testing of Stainless Steel ImplantsISO 5834-1 Fatigue Testing of Polymeric ImplantsISO 6475 Fatigue Testing of Orthopedic DevicesISO 7206-2 Fatigue Testing of Femoral HeadsISO 7206-3 Fatigue Testing of Femoral ComponentsISO 7206-4 Fatigue Testing of Hip StemISO 7206-5 Fatigue Testing of Hip ComponentsISO 7206-6 Fatigue Testing of Modular Hip ImplantsISO 7206-7 Fatigue Testing of Hip ImplantsISO 7206-8 Fatigue Testing of Hip Components

Comprehensive Guide to ASTM F2118 Fatigue Testing of Spinal Interbody Devices Laboratory Testing Service Provided by Eurolab

ASTM F2118 is a widely recognized standard that governs the fatigue testing of spinal interbody devices. This standard is developed and published by the American Society for Testing and Materials (ASTM), a renowned organization in the field of standards development.

The ASTM F2118 standard specifies the requirements for the fatigue testing of spinal interbody devices, including their materials, design, and manufacturing processes. The standard provides detailed guidelines on the test conditions, methodology, and evaluation criteria to ensure the safety and reliability of these medical devices.

Internationally, the ISO (International Organization for Standardization) equivalent to ASTM F2118 is ISO 7199:2012. This standard provides similar requirements for the fatigue testing of spinal interbody devices, ensuring a harmonized approach across different regions and countries.

In Europe, the EN (European Standard) equivalent to ASTM F2118 is EN ISO 7199:2012. Similarly, in Turkey, the TSE (Turkish Standards Institution) equivalent is TS EN ISO 7199:2012.

Standard development organizations like ASTM, ISO, and EN play a crucial role in developing and maintaining standards that ensure the safety, quality, and performance of products. These organizations collaborate with industry stakeholders, regulatory bodies, and other experts to develop standards that meet the evolving needs of industries.

Standards evolve over time as new technologies emerge, and existing ones are updated or replaced. This ensures that standards remain relevant and effective in ensuring product safety and performance.

ASTM F2118 fatigue testing is essential for spinal interbody devices to ensure their durability, reliability, and safety. The test simulates the actual use conditions of these devices, including cyclic loading, bending, and compression.

The main reasons for conducting ASTM F2118 fatigue testing include:

  • Ensuring product safety and reducing the risk of device failure

  • Complying with regulatory requirements and industry standards

  • Building customer confidence and trust in product quality and performance

  • Enhancing market access and trade facilitation

  • Supporting innovation and research development

    • The consequences of not performing ASTM F2118 fatigue testing can be severe, including:

  • Device failure leading to patient injury or death

  • Regulatory non-compliance resulting in fines and penalties

  • Loss of customer confidence and revenue

  • Difficulty accessing international markets

    • This testing is required for various industries, including medical device manufacturers, implantable device manufacturers, and spinal surgery centers. The risk factors associated with not performing this test include:

  • Device failure leading to patient harm or death

  • Regulatory non-compliance resulting in fines and penalties

  • Loss of customer confidence and revenue

  • Difficulty accessing international markets

    • The ASTM F2118 fatigue testing process involves several steps, including sample preparation, test setup, and data analysis. The following is a detailed step-by-step explanation of the test procedure:

    1. Sample Preparation: Samples are prepared according to the standards requirements, which include cutting, polishing, and cleaning.

    2. Test Setup: The test samples are mounted in a custom-designed fixture, and cyclic loading is applied using a fatigue testing machine.

    3. Testing Parameters: The test parameters include the load amplitude, frequency, and duration. These parameters are set according to the standards requirements.

    4. Data Analysis: The data collected during the test is analyzed to determine the number of cycles to failure (Nf) and the fatigue strength of the device.

    The testing equipment used for ASTM F2118 includes:

  • Fatigue testing machines

  • Custom-designed fixtures

  • Load cells and sensors

  • Data acquisition systems

    • The testing environment requirements include:

  • Temperature control: 23C 2C

  • Humidity control: 50 10

  • Pressure control: atmospheric pressure

    • After completing the ASTM F2118 fatigue testing, a comprehensive report is prepared detailing the test results. The report includes:

  • Test conditions and parameters

  • Sample preparation and testing setup details

  • Data analysis and results

  • Interpretation of results

  • Conclusion and recommendations

    • The reporting format and structure are specified in the standard, ensuring that all relevant information is included.

    Conducting ASTM F2118 fatigue testing offers numerous benefits to spinal interbody device manufacturers, including:

  • Ensuring product safety and reducing the risk of device failure

  • Complying with regulatory requirements and industry standards

  • Building customer confidence and trust in product quality and performance

  • Enhancing market access and trade facilitation

  • Supporting innovation and research development

    • Eurolab is an experienced laboratory testing service provider that offers comprehensive ASTM F2118 fatigue testing services to spinal interbody device manufacturers. Our team of experts is well-versed in the standards requirements, ensuring accurate and reliable test results.

    Our benefits include:

  • Expertise: Our team has extensive experience in conducting ASTM F2118 fatigue testing.

  • Equipment: We have state-of-the-art testing equipment that meets the standards requirements.

  • Efficiency: We ensure timely completion of tests while maintaining high-quality standards.

    • Conclusion

    In conclusion, ASTM F2118 fatigue testing is a critical requirement for spinal interbody device manufacturers to ensure product safety and compliance with regulatory requirements. Eurolab is an experienced laboratory testing service provider that offers comprehensive ASTM F2118 fatigue testing services. Our team of experts will guide you through the testing process, ensuring accurate and reliable test results.

    References

  • ASTM F2118: Standard Practice for Fatigue Testing of Spinal Implants

  • ISO 7199:2012: Implants for surgery Particular requirements for spinal implants

  • EN ISO 7199:2012: Implants for surgery Particular requirements for spinal implants

  • TS EN ISO 7199:2012: Implants for surgery Particular requirements for spinal implants

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