EUROLAB
astm-f1717-18-fatigue-testing-of-spinal-constructs
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 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 F2118 Fatigue Testing of Spinal Interbody 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 F1717-18 Fatigue Testing of Spinal Constructs Laboratory Testing Service Provided by Eurolab

ASTM F1717-18 is a widely recognized standard for fatigue testing of spinal constructs, which is essential for ensuring the safety and reliability of spinal implants. The standard provides guidelines for conducting cyclic loading tests to evaluate the durability of spinal implants under repetitive stress.

The legal and regulatory framework surrounding this testing service is governed by various international and national standards, including:

  • ISO 5842-1:2018 (Cyclic fatigue testing of spinal implants)

  • ASTM F1717-18 (Fatigue testing of spinal constructs)

  • EN 14230:2019 (Spinal systems for intervertebral fusion Requirements)

    • These standards are developed by standard development organizations such as the American Society for Testing and Materials (ASTM), International Organization for Standardization (ISO), and European Committee for Standardization (CEN).

    Standard evolution is an ongoing process, with new versions being released to reflect advancements in technology and emerging trends. For instance, ASTM F1717-18 was revised in 2018 to include updated requirements for testing spinal constructs under various loading conditions.

    The scope of ASTM F1717-18 includes:

  • Cyclic loading tests

  • Static compressive strength tests

  • Torsional stiffness tests

    • Compliance with these standards is mandatory for industries such as medical device manufacturers, orthopedic implant manufacturers, and regulatory bodies. Failure to comply can result in product recalls, fines, or even litigation.

    ASTM F1717-18 fatigue testing of spinal constructs is necessary to ensure the durability and reliability of spinal implants. The test evaluates the ability of the implant to withstand repetitive stress without failing or causing harm to the patient.

    Business and technical reasons for conducting this test include:

  • Ensuring compliance with regulatory requirements

  • Demonstrating product safety and efficacy

  • Reducing product liability risks

  • Enhancing customer confidence and trust

    • Consequences of not performing this test can be severe, including:

  • Product recalls and financial losses

  • Regulatory non-compliance and fines

  • Loss of market share and reputation

  • Increased risk of patient harm and litigation

    • Industries and sectors that require ASTM F1717-18 fatigue testing include:

  • Medical device manufacturers

  • Orthopedic implant manufacturers

  • Spine surgeons and hospitals

  • Regulatory bodies (e.g., FDA, CE Marking)

    • Risk factors and safety implications associated with non-compliance are significant. For instance, failure to test spinal constructs can result in implant failure, patient injury, or even death.

    Quality assurance and quality control aspects of ASTM F1717-18 testing include:

  • Ensuring calibration and validation of testing equipment

  • Maintaining accurate records and documentation

  • Conducting regular audits and assessments

    • This test contributes significantly to product safety and reliability by:

  • Evaluating the durability of spinal implants under repetitive stress

  • Identifying potential design flaws or material weaknesses

  • Informing product improvement and optimization efforts

    • Competitive advantages of having this testing performed include:

  • Demonstrated compliance with regulatory requirements

  • Enhanced customer confidence and trust

  • Reduced risk of product liability and recalls

  • Improved product safety and efficacy

    • Cost-benefit analysis of performing this test reveals significant savings in the long run, including reduced costs associated with product recalls, litigation, and reputational damage.

    Conducting ASTM F1717-18 fatigue testing involves several steps:

    1. Sample preparation: Selecting and preparing spinal constructs for testing

    2. Equipment setup: Calibrating and validating testing equipment

    3. Testing parameters: Setting up loading conditions, frequency, and duration

    4. Data collection: Recording and analyzing test results

    5. Reporting: Documenting and interpreting test results

    Testing equipment used includes:

  • Cyclic loading machines (e.g., Instron, MTS)

  • Static compressive strength testing machines (e.g., Instron, MTS)

  • Torsional stiffness testing machines (e.g., Instron, MTS)

    • Testing environment requirements include:

  • Temperature control (22C 2C)

  • Humidity control (50 5)

  • Pressure control (1 atm 0.01 atm)

    • Sample preparation procedures involve:

  • Selecting spinal constructs from various manufacturers

  • Cleaning and preparing samples for testing

    • Testing parameters and conditions include:

  • Loading frequency (1-100 Hz)

  • Loading amplitude (1-10 mm)

  • Duration (10,000-100,000 cycles)

    • Measurement and analysis methods involve:

  • Recording displacement and force data

  • Calculating stiffness and fatigue life

  • Analyzing test results using statistical software

    • Calibration and validation procedures ensure the accuracy of testing equipment.

    Quality control measures during testing include:

  • Regular calibration checks

  • Equipment maintenance and repair

  • Auditing and assessing testing protocols

    • Reporting requirements for ASTM F1717-18 fatigue testing include:

    1. Test summary: Brief overview of test conditions and results

    2. Test data: Detailed records of displacement, force, and stiffness data

    3. Analysis: Calculation of fatigue life and stiffness

    4. Conclusion: Interpretation of test results and recommendations

    Test reports should include:

  • Sample identification and description

  • Testing equipment used

  • Loading conditions and parameters

  • Data analysis and interpretation

  • Recommendations for product improvement or optimization

    • Conclusion

    ASTM F1717-18 fatigue testing of spinal constructs is a critical requirement for ensuring the safety and reliability of spinal implants. Compliance with this standard requires careful attention to detail, accurate documentation, and rigorous testing protocols.

    Eurolab provides comprehensive ASTM F1717-18 fatigue testing services, including sample preparation, equipment setup, data collection, and reporting. Our experienced team ensures that all testing is conducted in accordance with the latest standards and regulatory requirements.

    By choosing Eurolab for your ASTM F1717-18 fatigue testing needs, you can ensure compliance with regulatory requirements, enhance product safety and efficacy, and reduce risk of product liability and recalls.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers