Biomaterials and Prosthetic Testing

In this article, a case is presented in which the force applied to an ankle joint during walking was actually applied to a specimen. First, the TM5135, a compact telemetry system manufactured by Toyota Technical Development Corporation shown in Fig. 1, was used to measure strain data during walking and to generate force waveforms. Next, the generated force waveforms were loaded into a fatigue testing machine, and the force was applied to a square polyethylene material (23.5×23.5×12mm) used as an artificial ankle joint material.

To guarantee the safety and efficacy of medical equipment and technologies in the wake of medical breakthroughs, more active efforts are being made to reinforce the evaluation criteria and the regulations governing the standardization of measuring instruments and test methods. Medical equipment manufacturers and research organizations around the world are conducting research and development into medical equipment based on mechanical properties evaluation and finite-element analysis. Shimadzu Corporation is applying the technical expertise cultivated through physical testing, quality control, and full-scale testing in materials development to the fields of leading-edge medicine and biomaterials evaluation.

The Aggregates Sizer aggregation analysis system enables the quantitative evaluation of particle amounts in the 0.1 μm to 10 μm range as a concentration (units: μg/mL or particles/mL). Aggregations of biopharmaceuticals can be categorized into 4 ranges: nanometer (<100 nm), submicrometer (100 nm to 1 μm), subvisible (1 to 100 μm), and visible (>100 μm), according to their particle size. Until now, particles in the submicrometer to subvisible portion of this range (100 nm to 10 μm) were generally measured by combining multiple methods.