Medical Product Safety and Reliability Enhanced Through Innovative Testing Technology
Fatigue tests are an essential element in the development of durable, safe, and reliable implants. Prototypes undergo extensive testing before entering the validation process. Based in Lemgo, Komet Medical uses a Zwick testing machine with linear drive for these tests.
Komet Medical’s core area of expertise lies in developing and manufacturing motor-powered precision tools for use in surgical drive systems. These include saw-blades, drills, and high-speed milling cutters. This extensive know-how is now being channeled into Komet Medical’s current implant development project.
Using a Zwick LTM linear testing machine (Fmax 5 kN), prototypes are checked in the Komet testing laboratory before moving on to the validation process. Dynamic tests are performed under cyclic loading and are used for determination of fatigue-limit values and for durability forecasts for the implants. Komet’s testing requirements cover various standards.
Tests carried out with the LTM include fatigue tests on spinal implants to ASTM F1717, dental implants to ISO 14801 and bone-screws to ASTM F1264.
The LTM is operated solely by electricity, no hydraulic or compressed air supplies are therefore needed in the laboratory. The testing machine can also be used for static tests.
The LTM will also be joined in the Komet laboratory by a zwickiLine materials testing machine (Fmax 5 kN) incorporating a torsion drive (Nmax 20 Nm). This will allow the maximum fracture torques and insertion properties of bone-screws to be determined in accordance with ASTM F453.
These two testing machines will enable a wide range of relevant biomechanical and endoprosthetic test standards to be covered.