Ion Release and Corrosion Test

Corrosion and Ion Release of medical implants like stent, occluder, hip implants and dental implants can be performed by Questmed GmbH.
We are capable of testing implants to analyse the ion release according to ASTM F3306, ASTM F1875, ASTM F1877 and ISO 10271.
The nickel leaching of stents is determined in compliance with ASTM F3306.
We also perform electrochemical corrosion tests of implants according ASTM F2129 and ASTM F3044.

ASTM F3306 - Ion Release - Nickel Leaching

ASTM F3306 is a test method utilized for evaluating the ion release - nickel leaching of medical implants, e.g:

  • cardiovascular devices,
  • endovascular devices,
  • orthopedic implants,
  • and more.
The device gets tested by simulating the in-vivo situation. To achieve that environment the implant gets exposed to different solutions and will be heated to the in-vivo temperature for a predetermined time frame with regular sampling at adequate intervals as described in ASTM F3306-19. We are also able to create a testing setup that differs from the ASTM standard if you wish so. To discuss the best testing situation for you feel free to contact us.

According to ASTM F3306 the test should run at 37°C in bufferd saline solution with a pH-value of 7.4 (corresponding to the pH-value of blood).
It is possible to test in other test solutions like artificial salvia, bile, or urea too.
For devices containing nickel-rich alloys the FDA recommends measuring concentrations of nickel leached from the device into a fluid at physiologic temperature and pH.
Concentration measurements by ICP-MS are ordinarily taken at 1, 2, 4, 7, 14, 21, 28, 39, 50 and up to 60 days.
Test results are typicly reported as total cumulative release per device in micrograms and as a per day release (μg/day).
These 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.

ISO 10271 - Corrosion Test of Dental Implants

Questmed executes different tests on corrosion according to ISO 10271. These tests are utilized to determine the behavior of metallic implants in the oral cavity. This determination is a step of an approval process.

Static immersion test

When performing the static immersion corrosion testing of dental implants according to ISO 10271, two sets of test samples will be placed in a aqueous solution constisting of 0.1 mol/l lactic acid and 0.1 mol/l sodium chloride with a pH-value of 2.3 and a temperature of 37 degree for 7 days. Afterwards 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

Static Immersion Test with Periodic Analysis

The test procedure of this examination is very similar to the static immersion test with the difference that after a fixed amount of days a probe needs do be taken. Sampling occurs after: 1, 4, (7, 14, 21, 28, 35 (recommended)), 42 days.

Sulfid Tarnish Test (cyclic immersion)

In this test two sample devides get dipped for 10-15 seconds once a minute into an aquetic solution of sodium sulfite hydrate. This procedure is repeated for 72 hours. After that timespan we report any surface deteriotation to you.

Sulfid Tarnish test (static immersion)

Like the above, this test procedure tests the implant on sulfide tarnish too. In difference to the cyclic immersion test the two samples get immersed fully in the test solution of dissolved sodium sulfide nonahydrate for the whole 72 hours at 37 degree.
Similar to the above decribed procedure we report any surface deteriotation to you.

ASTM F2129 - Cyclic Potentiodynamic Polarization

Questmed determines the corrosion susceptibility of small, metallic, implant medical devices (vascular stents, ureteral stents, vena cava filters, endovascular grafts, cardiac occluders, aneurysm or ligation clips, medical staples), using cyclic potentiodynamic polarization. The corrosion susceptibility will be determined according ASTM F2129: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices.

ASTM F3044 - Galvanic Corrosion

Questmed executes galvanic corrosion tests of implants (stent, occluder) contains more than one type of metal, such as a base stent material with added markers, to demonstrate the design’s resistance to galvanic corrosion.
If stents will be overlapped during clinical procedures, and these implants are made of different materials, the potential for galvanic corrosion should be determined according ASTM F3044: Standard test method for evaluating the potential for galvanic corrosion for medical implants.
Orthopedic plate and screws, hip stem and head, external fixation devices which are of a different alloy may also be evaluated using ASTM F3044.

Test Setup and Customization

Currently we have 10 test setups for metal ion emission and dental corrosion testing and one test system for electrochemical corrosion testing.
If you need a customized test procedure feel free to contact us. With more than 14 years of experience we will be able to assist and support on your path to an FDA approval.