Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Importancia y uso:

5.1 Corrosion of implantable medical devices can have deleterious effects on the device performance or may result in the release of corrosion products with harmful biological consequences; therefore it is important to determine the general corrosion behavior as well as the susceptibility of the devices to localized corrosion.

5.2 The forming and finishing steps used to create an implantable device may have significant effects on the corrosion resistance of the material out of which the device is fabricated. During the selection process of a material for use as an implantable device, testing the corrosion resistance of the material is an essential step; however, it does not necessarily provide critical data regarding device performance.

5.3 To accommodate the wide variety of device shapes and sizes encountered, a variety of holding devices can be used.

5.4 Note that the method is intentionally designed to reach conditions that are sufficiently severe to cause breakdown and deterioration of the medical devices and that these conditions may not necessarily be encountered in vivo. The results of this corrosion test conducted in artificial physiological electrolytes can provide useful data for comparison of different device materials, designs, or manufacturing processes. However, note that this test method does not take into account the effects of cells, proteins, and so forth, on the corrosion behavior in vivo.

Subcomité:

F04.15

Referida por:

F1357-23, G0215-17R24, F3306-19, F0746-04R21, F3268-18A, F3718-24, F3044-20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

corrosion; cyclic polarization; medical device testing; pitting potential; protection potential; rest potential;