FEM used in improvement of quality of medical devices

Purpose: The fundamental aim of this research was to determine the biomechanical characteristics of the medical bed made of carbon steel and an assessment of its stability. To define the biomechanical characteristics of the bed design, the finite element method (FEM) was applied. Additionally, the risk analysis was conducted according to the directives of ISO 14971 standard. Design/methodology/approach: The research was carried out on the typical rehabilitation bed. To define the biomechanical characteristics of this equipment, the finite element method was applied. Geometric model of medical bed, was discretized by means of SOLID 95 element. Appropriate boundary conditions imitating phenomena in the real system with appropriate accuracy were established. The aim of biomechanical analysis was calculation of displacements and stresses in the bed’s construction elements in a function of the applied loading. In order to carry out calculations, 3 models of diverse variants of loading were selected – safe working load model 1, transverse stability model 2 and longitudinal stability model 3. Findings: The analyses showed the difference in displacements, strains and stresses in the characteristic points depending on the selected loading. That also helped to determine maximal loading causing the exceeding of the yield stress of the bed’s components. Research limitations/implications: The limitations were connected with simplification of numerical model of femur as well as with the selected boundary conditions. Practical implications: The obtained results can be useful in the designing process (modification of requirements regarding design and construction, as well as materials used in the production of the device, and reduction of risk as far as possible to the patient). They prove that 3D geometrical analysis works quite well for assistive medical devices design. Originality/value: Stress-strain-displacement characteristics of the medical bed’s elements, obtained from the numerical analysis were presented in the work.