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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

Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068

Normative References  



ASTM F2068: Standard Specification for Femoral Prostheses - Metallic Implants
ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
ISO 7206-6: Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
ASTM F1044: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
ASTM F1147: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
ASTM F1978: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

The standard describes four different types of femoral stems and summarizes several considerations concerning the fatigue performance of femoral hip components and their metallic coating integrity.

Fatigue performance can be assessed using following standards:
ISO 7206-4: Femoral stem fatigue test
ISO 7206-6: Femoral neck fatigue test

Coating integrity can be investigated regarding shear and tensile strength and abrasion resistance of plasma sprayed thermal coatings. Standards and minimum acceptance criteria as below:
ASTM F1044 – Shear strength – equal or exceed 20 MPa
ASTM F1147 – Tensile strength – equal or exceed 20 MPa
ASTM F1978 – Abrasion resistance – ≤ 65 mg/100 cycles

 


Implant Testing - Requirements for Femoral Prostheses - Metallic Implants - ASTM F2068