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Biomedical Engineering

Vol. 41 No. 01 (2026): Proceedings of the Faculty of Technical Sciences

ELECTRICAL SAFETY OF MEDICAL DEVICES

  • Danijel Vasiljevic
DOI:
https://doi.org/10.24867/33RB01Vasiljevic
Submitted
August 23, 2026
Published
2026-08-23

Abstract

This paper describes various methods for testing medical devices. The standards IEC 60601 and ISO 13485, which define the manufacturing process and use of medical devices, as well as testing and calibration procedures that ensure their proper functioning, are discussed. Attention is also given to the calibration of medical devices, upon which the lives of patients may depend

References

  1. [1] https://www.renewsolar.co.uk/companyinformation/
  2. blog/electrical-regulations-history-andcause/
  3. [2] https://www.iso.org/obp/ui/en/#iso:std:59752:en
  4. [3] Achin Jain, “ QUALITY STANDARDS FOR
  5. MEDICAL DEVICES ”, 2014.
  6. [4] Christopher Kitcher, “ Practical Guide to Inspection,
  7. Testing and Certification of Electrical Installations ”,
  8. 2013.
  9. [5] Operating Instructions, “ SECULIFE HITAM HITMD
  10. METRAHIT X-TRA OUTDOOR TECH PRO BASE”
  11. [6] https://uk.rs-online.com/web/content/discovery/ideasand-
  12. advice/insulation-resistance-testing
  13. [7] https://www.fluke.com/en/learn/blog/clamps/leakagecurrent-
  14. measurement-basics
  15. [8] https://www.gossenmetrawatt.de/mpim/doku/allg/fach
  16. artikel/fa-pm220509-pruefen-vondefibrillatoren_
  17. gb.pdf
  18. [9] https://www.gossenmetrawatt.de/media/doku/pm/secu
  19. life-dfbase/seculife-dfbase-qsg_gb.pdf
  20. [10] https://www.gossenmetrawatt.de/mpim/doku/allg/
  21. fach artikel/fa-pm220201-pruefen-von
  22. infusionspumpen_gb.pdf
  23. [11] https://www.gossenmetrawatt.de/mpim/doku/allg/
  24. fachartikel/fa-pm230214-pruefen-von-teesonden_
  25. gb.pdf
  26. [12] Rupesh Kumar, Ram Kumar Choudhary, Archana,
  27. and Nitish Kumar Yadav, “Calibration of Medical
  28. Devices: Method and Impact on Operation Quality ”,
  29. 15 Sep 2023.