ASTM F2129: when the FDA requires

a detailed corrosion test

Philippe Marx, To launch certain orthopaedic implants on the American market, the
Manager of the AMF Company. FDA asks now, among others, for a try of corrosion following the
standard ASTM F2129. The subcontractor AMF identified the traps of
this trial type, which requires choosing his laboratory with full
knowledge of the facts.

Thus, it is recommended to contact a laboratory which is not going

to only register the curves and rule with the requirements of the
standard ASTM F2129 (entitled Test Standard Method for
Conducting Cyclic Potentiodynamic PoIarization Measurements to
Definite the Corrosion Susceptibility of Small lmplant Devices).
The laboratory may help you to understand the differences and
give you the tracks to solve them. Moreover, the situation is not
much more reassuring when the trial report is favourable; and
when we do not know why the results are good. Nowhere is safe
from a future drift not controlled in the quality of the implant.

The titles of the chapters of the standard ASTM F2129 are the
following ones: scope, reference documents, terminology, the
summary of the method of test, meaning and use, equipment, the
ways of preservation of the sample, the reactive, the specimens
of test, the procedure of the test, and the trial report. We notice
that the standard describes, technically and with accuracy, how to
lead the test, but only specialists of the corrosion are really able
to operate it and understand the phenomena.

Beyond a simple trial report

As mentioned, the success of the test is linked to a close

A corrosion test is very delicate to realize for several reasons. At first,
it is necessary to know how to interpret the curves of corrosion and
understand the phenomena. Besides, the efficiency of a test depends
many of the quality of its implementation. Properly to apply a
potential to the sample, the quality of the electric contact is a key
factor. Finally, the corrosion resistance is linked to the quality of the
state of surface of the implant. It is not enough to use a
biocompatible renowned stainless alloy to pass undoubtedly this
test. The quality of the state of surface crosses by a control of the
polishing of the sample and the thickness of the passivation layer
which we meet in many stainless materials.
When we subcontract this test in a Laboratory, a simple trial report
is not enough. Indeed, if the report is not decisive, it is necessary
to possess in house the resources to work to improve the situation,
what is particularly complicated for this kind of test.
collaboration with the laboratory. It is important to meet the
people of the laboratory, who are actually going to lead the tests
and to agree on the fact that the trial report has to:
 specify all the conditions of the test to show without ambiguity
the respect of the standard,
 explain the performances obtained in their relations with the
states of surface of the material and the quality of the
passivation layer.
It is not enough to test a manufacturing of implant. It is necessary
to give to the laboratory series of implants with several qualities
of state of surface and several thicknesses of passivation layer.
It is only with such a level of trial report that we can hope to win
the trust of an auditor of CE or FDA marking.
In France, a technical centre such as the CETIM CERMAT of
Mulhouse can bring this kind of expertise. Those who want to
integrate ways of in-house test can contact Origalys.
www.nitifrance.com

Traduction de l’article DeviceMed, page 26, November/December 2016