FDA Docket No. 2004D-0002 Fatigue test*

The American Food and Drug Administration (FDA) has published a method for fatigue testing of breast implants in Docket No. 2004D-0002. Aim of this test standard is development of a Woehler diagram resp. to generate an applied force versus number of cycles to failure (AF/N) curve in order to estimate fatigue strength. Unlike the ISO 14607 fatigue tests under shear stress, the fatigue test covered by FDA directive Docket no. 2004D-0002 are subjected to cyclic compressive stress. With defined upper and lower loads, sinusoidal load cycles are driven up to a run-out level of 6.5 million cycles.

We offer this fatigue test in combination with static rupture testing according to ISO 14607:2007.

*We offer this testing service as part of our accredited scope.