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Hip implants
all procedures accredited

Fatigue Test - ISO 7206-4, ISO 7206-6 and PI-58 (ISO 7206-8)Fatigue Test - ISO 7206-4, ISO 7206-6 and PI-58 (ISO 7206-8) Femoral head torsion test - ISO 7206-13Femoral head torsion test - ISO 7206-13 Femoral Head Compression Test - ISO 7206-10/ ASTM F2345/ PI-14Femoral Head Compression Test - ISO 7206-10/ ASTM F2345/ PI-14 Femoral Head pull-off test - ASTM F 2009Femoral Head pull-off test - ASTM F 2009 Luxation test - PI-3Luxation test - PI-3 Hip surface analysis - ISO 7206-2Hip surface analysis - ISO 7206-2 Hip Wear Test - ISO 14242-1Hip Wear Test - ISO 14242-1 Disassembly Forces of Modular Acetabular Devices - ASTM F1820Disassembly Forces of Modular Acetabular Devices - ASTM F1820 Fretting Corrosion Testing of Modular Implants – Femoral Stem-Head Interface - ASTM F1875Fretting Corrosion Testing of Modular Implants – Femoral Stem-Head Interface - ASTM F1875 Hip Range of Motion – ISO 21535Hip Range of Motion – ISO 21535 Fatigue test - ASTM F 2580Fatigue test - ASTM F 2580 Impingement Test - ASTM F2582Impingement Test - ASTM F2582 Insert Compression Test - PI-11Insert Compression Test - PI-11 Microseparation test - PI-78 (ISO 14242-4)Microseparation test - PI-78 (ISO 14242-4) Third body wear test based on - ISO 14242-1Third body wear test based on - ISO 14242-1 High demand hip wear testing - ASTM F3047MHigh demand hip wear testing - ASTM F3047M Deformation test for acetabular shells - ISO 7206-12Deformation test for acetabular shells - ISO 7206-12 3D Frictional torque measurement of total hip joint prostheses - PI-643D Frictional torque measurement of total hip joint prostheses - PI-64 Guide for assessment of hard-on-hard articulation THR devices - ASTM F3018Guide for assessment of hard-on-hard articulation THR devices - ASTM F3018 Impact Resistance Femoral Heads - ISO 11491Impact Resistance Femoral Heads - ISO 11491 FEA Non-modular Hip Femoral Stem - ASTM F2996FEA Non-modular Hip Femoral Stem - ASTM F2996 Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068 Bearing surface characterization of retrieved hard-on-hard hip prostheses - ...Bearing surface characterization of retrieved hard-on-hard hip prostheses - ASTM F2979 Specific Requirements for Hip-joint Replacement Implants - ISO 21535Specific Requirements for Hip-joint Replacement Implants - ISO 21535 Particular requirements for joint replacement implants - ISO 21534Particular requirements for joint replacement implants - ISO 21534 Fatigue Test of Acetabular Devices - ASTM F3090Fatigue Test of Acetabular Devices - ASTM F3090 Classification and Designation of Dimensions - ISO 7206-1Classification and Designation of Dimensions - ISO 7206-1

Specific Requirements for Hip-joint Replacement Implants - ISO 21535

Normative References  



ISO 21535: Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint implants  


ISO 21535 has been fundamentally revised. It now references all testing standards for hip implants, including the relevant ASTM procedures. In addition, it describes how the test results are to be evaluated in a multi-stage procedure. In particular, the described use of a reference implant presents manufacturers with fundamentally new requirements.
Our specialists will be happy to assist you in selecting the worst-case products to be tested and in developing a test plan that meets the requirements of ISO 21535.  

Implant Testing - Specific Requirements for Hip-joint Replacement Implants - ISO 21535


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