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