The 6 Testing Standards to Consider when Developing & Manufacturing Hip Implants

Research and development of modular hip implants requires a substantial investment in testing the materials and the device itself. New materials and designs are constantly being evaluated. Standardization committees have established a variety of test protocols and procedures that ensure safe and effective development of these medical devices.

The test standards that you should consider in the development of hip replacements includes:

• ISO 7206 - Implants for surgery – Partial and total hip joint prostheses
• Part 4: Determination of endurance properties and performance of stemmed femoral components
• Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
• Part 8: Endurance performance of stemmed femoral components with application of torsion
• Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
• Part 10: Determination of resistance to static load of modular femoral heads
• ASTM F 1612 – 95 (2005) - Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion
•  ASTM F 1714 – 96 (2008) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
• ASTM F 1875 – 98  (2009) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone  Taper Interface
• ASTM F 2345 – 03(2008) - Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• ISO 14242 - 1: 2002-03 - Implants for Surgery - Wear of Total Hip Prostheses - Part 1: Loading and displacement parameters for wear-testing  machines and corresponding environmental conditions for tests