ISO 14607:2024 Annex C.3 and the document Docket No. 2004D-0124 from the U.S. Food and Drug Administration (FDA) describe fatigue tests on breast implants aimed at developing a Wöhler (S–N) curve. Unlike the fatigue tests under shear stress according to ISO 14607, the implants in the FDA guideline Docket No. 2004D-0124 are subjected to cyclic compressive loading. Sinusoidal load cycles with defined upper and lower loads are applied up to a run-out level of 6.5 million cycles. We offer this test together with static rupture tests according to ISO 14607:2007.

For the impact test according to ISO 14607:2024 Annex C.2, INNOPROOF has developed and built a custom drop rig that ensures a standard-compliant test. Depending on the mass and projection height of the breast implant, the required drop height is calculated. A weight of 4.4 kg is held by an electromagnet, and the drop height is set using a measuring device. The test specimen is placed centrally on the test table. When the electromagnet is switched off, the weight is released, initiating the impact.

After the impact test, the breast implant undergoes a visual inspection. To pass the test, no damage to the shell may be visible.

ISO 14607:2024 describes in Annex C.1 the fatigue testing of breast implants under shear stress. The implant is placed between two horizontally arranged plates, and a static load of 50 N per implant is applied. Using an eccentric drive, one of the plates is moved back and forth, applying shear stress to the implant. The test is conducted over 6.5 million cycles at a frequency of 3.33 Hz. Afterwards, an optical rupture inspection is performed.

We offer this test as a service and can test six breast implants of various sizes simultaneously on our test rig. We would be happy to provide you with a quote.

As part of our testing services for breast implants, we offer, among other things, tests to assess the integrity of the shell in accordance with ISO 14607:2024, Annex B. These include tests of the shell’s elongation, measurement of tensile set after sustained elongation, and testing of seam strength.

For the shell tests mentioned above, specimens are first prepared using a standardized die. INNOPROOF has a corresponding cutting die in accordance with ISO 37:2017, Type 2, enabling us to obtain specimens directly from the breast implants. All tests are performed under tensile loading using our Zwick universal testing machine. We would be pleased to provide you with a quotation for these testing services.