EUROLAB
iso-6475-fatigue-testing-of-orthopedic-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 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 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

ISO 6475 Fatigue Testing of Orthopedic Devices: Eurolabs Laboratory Testing Service

1. STANDARD-RELATED INFORMATION

The ISO 6475 standard is a widely accepted international standard for fatigue testing of orthopedic devices. The standard specifies the requirements and procedures for conducting fatigue tests on orthopedic implants, such as hip, knee, and shoulder prostheses.

1.1 International Standards

  • ISO 6475:2016(E): This is the current version of the ISO 6475 standard, published in 2016.

  • ASTM F1804-19: This is an equivalent American Standard for fatigue testing of orthopedic implants.

  • EN 13001-3-2:2017: This is a European Standard for the design and verification of lifting appliances, including orthopedic devices.

    • 1.2 Standard Development Organizations

    The ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) are the primary standard development organizations responsible for developing and maintaining international and national standards for fatigue testing of orthopedic devices.

    1.3 Evolution of Standards

    Standards evolve over time to reflect changes in technology, materials, and regulatory requirements. New versions of standards are developed to incorporate updates and revisions.

    Key Takeaways:

  • The ISO 6475 standard is widely accepted internationally for fatigue testing of orthopedic devices.

  • Equivalent American and European standards exist (ASTM F1804-19 and EN 13001-3-2:2017).

  • Standard development organizations, such as ISO and ASTM, are responsible for updating and maintaining standards.

    • Standard Numbers and Scope:

    Standard Number Title

    --- ---

    ISO 6475:2016(E) Fatigue testing of orthopedic implants General requirements

    ASTM F1804-19 Standard Test Method for Determining the Fatigue Life of Orthopaedic Implants

    Industry-Specific Requirements:

  • Compliance with relevant standards is a requirement for regulatory approval and certification.

  • Industry-specific regulations, such as those in the medical device industry, may require adherence to specific standards.

    • Standard Compliance Requirements:

    Industry Relevant Standard

    --- ---

    Medical Device Industry ISO 6475:2016(E)

    Orthopedic Implant Manufacturers ASTM F1804-19

    ---

    2. STANDARD REQUIREMENTS AND NEEDS

    Fatigue testing is a critical requirement for ensuring the safety and reliability of orthopedic devices.

    2.1 Why Fatigue Testing is Needed

  • Product Safety: Fatigue testing helps ensure that orthopedic implants can withstand repetitive loads without failing.

  • Regulatory Compliance: Regulatory bodies require manufacturers to demonstrate compliance with relevant standards, including fatigue testing.

    • 2.2 Business and Technical Reasons for Conducting ISO 6475 Fatigue Testing

  • Reduced Liability: Manufacturers can reduce liability by demonstrating that their products meet regulatory requirements.

  • Increased Confidence in Product Safety: Fatigue testing provides assurance that orthopedic implants are safe for use.

    • Consequences of Not Performing Fatigue Testing:

  • Non-Compliance with Regulations: Manufacturers may face fines, penalties, or even product recalls if they fail to comply with regulatory requirements.

  • Loss of Customer Confidence: Failure to demonstrate product safety can lead to a loss of customer confidence and reputation damage.

    • Quality Assurance and Quality Control Aspects:

  • Manufacturing Process Controls: Manufacturers must implement quality control measures throughout the manufacturing process.

  • Testing and Inspection: Regular testing and inspection are necessary to ensure compliance with regulatory requirements.

    • ---

    3. TEST CONDITIONS AND METHODOLOGY

    Fatigue testing involves subjecting orthopedic implants to repetitive loads until failure occurs.

    3.1 Testing Equipment and Instruments

  • Testing Machines: Fatigue testing machines, such as servohydraulic or electro-hydraulic systems.

  • Sensors and Data Acquisition Systems: Sensors and data acquisition systems are used to measure and record load, displacement, and other parameters during testing.

    • 3.2 Testing Environment Requirements

  • Temperature: The testing environment should be controlled within a specified temperature range (usually between 20C and 25C).

  • Humidity: The relative humidity should be maintained at a level that does not affect the test results (usually between 30 and 70).

    • Sample Preparation Procedures:

    1. Implant Selection: Select representative samples of orthopedic implants for testing.

    2. Surface Preparation: Clean and prepare the implant surface to simulate real-world conditions.

    ---

    This is a general outline, but please let me know if you want me to continue with the rest of the article.

    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