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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

Particular requirements for joint replacement implants - ISO 21534

Normative References  



ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters
ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral components
ISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests
ISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurement
ISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
ISO 14630: Non-active surgical implants - General requirements
ISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
 


The standard provides particular requirements for joint replacement implants. Amongst others, test services evaluating the geometrical, fatigue and wear properties of joint replacement implants are provided by EndoLab®.  

Implant Testing - Particular requirements for joint replacement implants - ISO 21534


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