Medical Device Testing Services
Medical Device Testing Services
 

Corrosion Testing

Implantable Medical Devices 

Scope:

This benchtop test provides empirical evidence of the ability of metals to resist corrosion when subjected to cyclic potentiodynamic polarization voltages. The test is conducted in body temperature water (37°C) using a Princeton Applied Research 273A Potentiostat.

Standards:

ASTM F2129: Standard Test Methods for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices.

ASTM G59-97 (2014): Standard Test Method for Conducting Potentiodynamic Polarization Resistance Measurements

ASTM G31-12a: Standard Guide for Laboratory Immersion Corrosion Testing of Metals

ASTM G71: Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes.

Additional Testing Capabilities: MDT can also develop test protocols and environmental sampling systems for the measurement of nickel leaching and ion release.

Equipment:

MDT has two Princeton Applied Research 273A Potentiostats that include:

Inspection Services Offered:

MDT offers several inspection and monitoring methods.  The two methods most applicable to corrosion testing are:

Test Protocol & Setup:

Testing schedules and resource needs are determined during project kickoff meetings with MDT engineers and the customer. Services are performed in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, standard operating procedures and test protocols specific to the project are used.

Test Reports:

In compliance with ANSI/ISO/IEC 17025-2005, MDT test reports include comprehensive documentation and summary of the test protocol and results. All reports are GLP compliant and can be submitted directly to regulatory agencies. Any test method deviations, additions, or exclusions are documented and reviewed with the customer prior to beginning the test. Information within the report includes the specific test conditions, statements of compliance with test protocol, and the estimated measurement uncertainty. The reported results only relate to the items tested. Any opinions and interpretations provided by MDT are clearly marked as such. Any additional information required by customer-specific methods will also be noted. At the conclusion of the test, MDT provides the customer with a Microsoft Windows formatted CD containing copies of all raw data, inspection results, and other information collected during the test (see example test reports).

Please take a few moments to tell us more about your device and test requirements in our short questionnaire, and we will be happy to provide you with a quote.

 

Corrosion Testing
Corrosion Testing
Corrosion Testing
Corrosion Testing