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FEM used in improvement of quality of medical devices

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Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
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.
Rocznik
Strony
172--179
Opis fizyczny
Bibliogr. 34 poz., rys., tabl.
Twórcy
autor
  • Division of Materials Processing Technology, Management and Computer Techniques in Materials Science, Institute of Engineering Materials and Biomaterials, Silesian University of Technology, ul. Konarskiego 18a, 44-100 Gliwice, Poland, boguslaw.ziebowicz@polsl.pl
Bibliografia
  • [1] ISO 8402: 1994, Quality management and quality assurance - Vocabulary.
  • [2] Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 93/42/EEC concerning medical devices.
  • [3] B. Jacobson, A. Murray, Medical devices: use and safety, Churchill Livingstone, 2007.
  • [4] J. D. Bronzino, Medical devices and systems, The Biomedical Engineering Handbook, Third Edition, CRC Taylor & Francis Group, USA, 2006.
  • [5] M. Cheng, Medical devices regulations - global overview and guiding principles, World Health Organization, Geneva, 2003.
  • [6] ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes.
  • [7] ISO 14971:2009, Medical devices - Application of risk management to medical devices.
  • [8] V. P. Gundarov, Standardization and testing of medical equipment, Biomedical Engineering 37 (2003) 51-58.
  • [9] IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
  • [10] IEC 60812, Analysis techniques for system reliability - Procedures for failure mode and effects analysis (FMEA).
  • [11] IEC 61025, Fault tree analysis (FTA).
  • [12] J. Szkodny, An application and the functional criteria of the selected rehabilitation equipment, Master's thesis, Gliwice, 2009.
  • [13] R. F. Fries, Reliable design of medical devices, Second Edition, CRC Taylor & Francis Group, USA, 2006.
  • [14] D. Prutchi, M. Norris, Design and development of medical electronic instrumentation. A practical perspective of the design, construction and test of medical devices, Wiley - Interscience, Canada, 2005.
  • [15] S. Shrivastawa, Medical device materials, Proceedings of the Materials and Processes for Medical Devices Conference, ASM International, USA, 2004.
  • [16] D. Y. Taeseung, K. Eunyoung, D. K. Bogen, J. H. Han, Geometrical analysis for assistive medical device design, Computational and Information Science 3314 (2005) 916-921.
  • [17] N. Rebelo, M. Perry, Finite element analysis for the design of Nitinol medical devices, Minimally Invasive Therapy and Allied Technologies 9/2 (2000) 75-80.
  • [18] M. Ken-ichiro, Simulation of materials processing: theory, methods and application, Proceedings of the 7th International Conference NUMIFORM, Taylor and Francis, Japan, 2001, 1073-1078.
  • [19] O. Goksel, S. E. Salcudean, High - quality model generation for finite element simulation of tissue deformation, Medical Image Computing and Computer - Assited Intervention - MICCAI 5762, Springer, London, 2009.
  • [20] W. Walke, J. Marciniak, Z. Paszenda, M. Kaczmarek, J. Cieplak, Biomechanical behaviour of double threaded screw in tibia fixation, Information Technologies in Biomedicine, vol. 47, Springer, Berlin – Heidelberg, 2008, 521-528.
  • [21] J. Marciniak, M. Kaczmarek, W. Walke, J. Cieplak, Biomechanical analysis of plate for corrective osteotomy of tibia, Information Technologies in Biomedicine, vol. 47, Springer, Berlin – Heidelberg, 2008, 545-550.
  • [22] J. Marciniak, J. Szewczenko, W. Walke, M. Basiaga, M. Kiel, I. Mańka, Biomechanical analysis of lumbar spine stabilization by means of transpedicular stabilizer, Information Technologies in Biomedicine, vol. 47, Springer, Berlin – Heidelberg, 2008, 529-536.
  • [23] J. Żmudzki, W. Walke, W. Chladek, Influence of model discretization density in fem numerical analysis on the determined stress level in bone surrounding dental implants, Information Technologies in Biomedicine, vol. 47, Springer, Berlin – Heidelberg, 2008, 559-567.
  • [24] R. Będziński, Engineering biomechanics, Selected issues, Publishing House of Wroclaw Technical University, Wroclaw, 1997 (in Polish).
  • [25] W. Kajzer, A. Krauze, M. Kaczmarek, J. Marciniak, FEM analysis of the expandable intramedullary nail, Information Technologies in Biomedicine, vol. 47, Springer, Berlin – Heidelberg, 2008, 537-544.
  • [26] A. Krauze, W. Kajzer, W. Walke, J. Dzielicki, Physicochemical properties of fixation plates used in pectus excavatum treatment, International Journal of Computational Materials Science and Surface Engineering 1/3 (2007) 351-365.
  • [27] A. Krauze, M. Kaczmarek, J. Marciniak, Numerical analysis of femur in living and dead phase, Proceedings of the 16th International Scientific Conference “Achievements in Materials and Mechanical Engineering” AMME’2008, Gliwice - Ryn, Poland, 2008.
  • [28] A. Krauze, J. Marciniak, Numerical method in biomechanical analysis of intramedullary osteosynthesis in children, Journal of Achievements in Material and Manufacturing Engineering 15 (2006) 120-126.
  • [29] W. Walke, Z. Paszenda, J. Filipiak, Experimental and numerical biomechanical analysis of vascular stent, Proceedings of the 13th International Scientific Conference “Achievements in Materials and Mechanical Engineering” AMME'2005, Gliwice - Wisła, 2005, 699-702.
  • [30] W. Walke, Z. Paszenda, J. Filipiak, Experimental and numerical biomechanical analysis of vascular stent, Journal of Materials Processing Technology 164-165 (2005) 1263-1268.
  • [31] W. Chrzanowski, J. Marciniak, Biomechanical and biomaterial conditions in intramedullar osteosynthesis, Proceedings of the 3rd Scientific Conference “Materials, Mechanical and Manufacturing Engineering” MMME’2005, Gliwice - Wisła, 2005, 319-324.
  • [32] M. Kaczmarek, J. Marciniak, Issues of plate stabilizers for osteosynthesis, Proceedings of the 3rd Scientific Conference “Materials, Mechanical and Manufacturing Engineering” MMME’2005, Gliwice - Wisła, 2005, 325-334.
  • [33] J. Okrajni, M. Plaza, S. Ziemba, Validation of computer models of an artificial hip joint, Archives of Materials Science and Engineering 28/5 (2007) 305-308.
  • [34] W. Walke, Z. Paszenda, W. Jurkiewicz, Biomechanical behaviour of coronary stent design with OCC Technology, Journal of Achievements in Materials and Manufacturing Engineering 20 (2007) 199-202.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BOS2-0022-0096
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