KNEE PROSTHESIS TESTS

Total knee replacements consist of three parts, and for product safety, mechanical testing must be performed in accordance with international standards. The main parts of a total knee replacement can be tested individually, or all parts can be tested simultaneously.

Our main testing methods, which are included in our accreditation scope and ensure the safety of your prostheses, are as follows:

  • Tibial Tray Fatigue Test: ASTM F1800 / ISO 14879
  • Unicondylar Tibia Test: ASTM F3140
  • Insert Wear and Movement Tests: ASTM F2777
  • Mobile Bearing Mechanical Tests: ASTM F2722 / F2723 / F2724
  • Total Knee Implant Tests: ASTM F1223 / ISO 7207-2
  • Femoral Component Fatigue Test: ASTM F3210-22e1
  • Knee Prosthesis Wear Test: ISO 14242-2
  • Knee Prosthesis Wear Test (Parameters): ISO 14242-3
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SAMPLE STANDARD EXPLANATION
KNEE PROSTHESIS TIBIAL TRAY ASTM F1800 Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
KNEE PROSTHESIS UNICONDULARY TIBIA ASTM F3140 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
KNEE PROSTHESIS INSERT ASTM F2777 Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
KNEE PROSTHESIS MOBILE BEARING ASTM F2722 Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
KNEE PROSTHESIS MOBILE BEARING ASTM F2723 Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
KNEE PROSTHESIS MOBILE BEARING ASTM F2724 Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
TOTAL KNEE IMPLANT ASTM F1223 Standard Test Method for Determination of Total Knee Replacement Constraint
TOTAL KNEE IMPLANT ISO 7207-2 Implants for surgery — Components for partial and total knee joint prostheses Part 2
TOTAL KNEE FEMORAL COMPONENT ASTM F3210 Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
TOTAL KNEE JOINT PROSTHESIS ISO 14242-2 Implants for surgery — Wear of total knee-joint prostheses
TOTAL KNEE JOINT PROSTHESIS ISO 14242-3 Implants for surgery — Wear of total knee-joint prostheses Part 3
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Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

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For details about our management systems processes and corporate consulting services, please contact us.

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