Electronic medical devices must comply with the stringent requirements of the IEC 60601-
1:2005 + AMD1:2012 + AMD2:2020 standard (in the following text, IEC 60601-1). When
testing the safety conditions of medical devices according to the IEC 60601-1 standard, non-conformities may occur, which, if not addressed, can compromise the safety of both the operator and the patient and negatively impact the effectiveness of the device itself. It is crucial to identify the causes of these non-conformities and eliminate them accordingly.
The purpose of this work is to analyze the most common non-conformities according to the IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 standard, identify their causes, and find practical solutions. Special emphasis is placed on the requirements of the standard, non-conformities in the minimum required distances, and the development of a tool for automatic calculation of these distances. The tool, designed in Excel, allows for easy data entry and parameter selection, and ensures quick and accurate determination of the minimum required distances. The developed tool has been validated in accordance with the requirements of the ISO/IEC 17025:2017 standard.
The tool significantly reduces calculation time, reduces the possibility of errors, and improves efficiency in testing medical devices. The results of the research show that significant improvements can be achieved in practice by analyzing non-conformities and automating the distance calculation process. This work contributes to better compliance of medical devices with the standard and provides a practical solution to common technical challenges. In this way, it can help the industry identify and eliminate potential problems and achieve a higher level of safety and quality.
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