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