Ankle - Wear and Fatigue Testing
Questmed GmbH offers testing for wear of ankle endoprosthesis according to ISO 22622.
Moreover we offer wear testing in compliance ASTM F3141.
Furthermore we offer fatigue testing as per ASTM F2665.
The ISO 22622 is a crucial standard to ensure the durability and performance of ankle joint replacements through rigorous testing.
It specifies the wear testing of total ankle-joint prostheses with the relative angular movement, pattern of applied force, speed and duration of testing, sample configuration, and test environment for wear-testing machines with either load or displacement control.
Ankle - Wear Test ISO 22622 / ISO 14243-2
Parameters of the Wear Test ISO 22622
The tests will be conducted load controlled so that the flexion and loads specified in ISO 22622
will be applied to the test samples. The axial force specified in ISO 22622 will be applied to the
active load soak sample.
• axial force: 191 N to 2 366 N (gait cycle)
• flexion angle: -15 degree to 15 degree (gait cycle)
• anterior posterior: -124 N to 257 N or -1.55 mm to 1.45 mm (gait cycle)
• tibial rotation: -5.83 Nm to 0.25 Nm or -2.45 degree to 8.02 degree (gait cycle)
• test frequency: 1 Hz
• test temperature: 37°C +/- 2
• test medium: calf serum (protein content 20 g/l)
• cycles: 5 000 000
Wear Measurement ISO 14243-2
The wear of the polyethylene components will be determined by the net mass loss WN according to
ISO 14243-2.
The polyethylene components will be weighted before and after the wear test as well as during the wear test
overall seven times. The inspections will be determined after 500 000 cycles, 1 million cycles and every
following 1 million cycles.
Test Preconditions
The components shall be sterilized in the same way as for clinical use.
The polyethylene components have to be soaked before the test for at least 11 days. We advise the pre-soak
conditioning in calf serum for at least 20 days including gravimetric measurements.
Test Samples
Three test specimens (three stations) and one loaded control specimen shall be tested (complete ankle joint
prosthesis).
Ankle - PE artifical aging ASTM F2003
The conditioning will be performed according ASTM F2003 and ISO 5834-3.
• test medium: oxygen
• 70 °C
• 503 kPa, 73 psi, 5.03 bar
• duration: 14 days
|
|