Ion Release and Corrosion test

Corrosion and Ion Release of medical implants like Stent, Occluder, Hip implants and dental implants is performed by Questmed GmbH.
We are testing implants with the analysis of Ion Release according ASTM F3306, ASTM F1875, ASTM F1877 and ISO 10271.
Nickel leaching for stents is determined according ASTM F3306.

Ion Release test ASTM F3306

Test Method for Ion Release Evaluation of Medical Implants (cardiovascular devices, endovascular devices, and orthopedic implants), by exposing the device to solutions simulating the in-vivo environment and temperature for a predetermined time frame with regular sampling at adequate intervals is described in ASTM F3306-19.

The test should run at 37°C in bufferd saline solution with pH 7.4 (blood).
Other test solutions like artificial salvia, bile, or urea are also available.
For devices containing nickel-rich alloys FDA recommend measuring concentrations of nickel leached from the device into a fluid at physiologic temperature and pH.
Measurements by ICP-MS are taken at 1, 2, 4, 7, 14, 21, 28, 39, 50 up to 60 days.
Test results are reported as total cumulative release per device in micrograms and as a per day release (μg/day).
Test reports will be accepted by FDA.

Stent Nickel Ion Release test ASTM F3306 principle Release of metal ions
Ion release of medical implants is also assessed for orthopedic implants like hip implants.

Corrosion test dental implants ISO 10271

For example, the static immersion corrosion testing of dental implants according ISO 10271, two test samples were placed at 0.1 mol/l lactic acid and 0.1 mol/l sodium chloride with pH value 2.3 and 37 degree for 7 days and then the medium is analysed by ICP-MS for:

  • Aluminium
  • Beryllium
  • Cadmium
  • Chromium
  • Cobalt
  • Iron
  • Lead
  • Manganese
  • Molybdenum
  • Nickel
  • Titanium
  • Tungsten
  • Vanadium

Dental implant corrosion test ISO 10271
Currently we have 10 test setups for metal ion emission and corrosion testing.