Accredited Testing Laboratory – Mechanical Testing of Medical Devices

Thanks to their electromagnetic drives, the testing machines operate with almost no wear, allowing us to achieve high forces at high frequencies. Our eight testing machines from TA Instruments / Electroforce operate with forces up to +/- 7.5 kN and frequencies up to 100 Hz. For lower force ranges, additional electrodynamic testing machines from the manufacturer Instron have been acquired.

With the Dyna5dent, we can test up to five dental implants simultaneously according to ISO 14801. Each station is individually controlled, allowing different load levels to be applied under load control. Whether using an S-N curve or staircase method, testing dry at room temperature or in saline solution at 37°C, load and temperature values are continuously recorded during the tests.

Our equipment includes two electromechanical testing machines from Zwick. These machines allow for compression and tensile tests, one in the range up to 5 kN and the other up to 50 kN. For our standardized test methods, these machines are used, for example, in rupture tests of breast implants, tensile strength and shear strength tests of coatings, and pull-off tests of conical connections.

At INNOPROOF, breast implants are tested according to ISO 14607:2024 Annex C.1 on four test stands, each equipped with 12 stations. Under a static load of 50 N, shear stresses are applied to the implants using an electrically driven moving plate over more than 6,500,000 cycles. The test stands operate in accordance with the standard at a frequency of 3.3 Hz.

With our digital microscope from Keyence, we can generate depth-of-field sharp images of samples, for example, before and after testing. Depending on the chosen objective lens, magnifications of up to 200x or up to 5000x are possible. The 3D depth of field allows consistently sharp imaging of curved samples or samples viewed at an angle.