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Purpose <p>Electrical safety is a fundamental requirement for electromedical equipment (EME), as insulation failure, degraded protective earthing, or excessive leakage currents can expose patients and healthcare workers to electric shock and other adverse events. IEC 62353:2014 was established to provide standardized, reproducible, and non-destructive procedures for recurrent testing and testing after repair throughout the in-service life of EME, complementing the design-oriented requirements of IEC 60601-1. Despite its relevance, practical evidence on its routine application in large healthcare institutions, particularly regarding failure detection rates and the operational time required for implementation, remains scarce in the literature.</p> Methods <p>This study addresses this gap by systematically implementing the recurrent and post-repair tests prescribed by IEC 62353:2014 in a large public hospital in Curitiba, Paraná, Brazil, and by quantifying both the nonconformities detected and the time demanded by the protocol. A total of 393 EME tests were performed in routine clinical use.</p> Results <p>The overall failure rate was 9.3%, predominantly due to protective earth bond resistance (primarily power cords) and applied-part leakage current in CF-type defibrillator paddles. Post-repair tests had the highest failure rate (23.7%), underscoring the importance of testing after any invasive technical intervention. The mean time required to perform each test was 5.34&#xa0;min (standard deviation of 1.71&#xa0;min), confirming the operational feasibility of incorporating these procedures into clinical engineering routines without significantly affecting productivity.</p> Conclusion <p>These findings demonstrate the effectiveness of the standard in detecting critical EME failures and support its adoption as a routine practice in healthcare institutions.</p>

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Implementation of IEC 62353:2014: The importance of recurrent and post-repair testing in electromedical equipment

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月8日

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  • André Felipe Brescovici Nunes,
  • Frieda Saicla Barros,
  • Henrique Cunha Carvalho

摘要

Purpose

Electrical safety is a fundamental requirement for electromedical equipment (EME), as insulation failure, degraded protective earthing, or excessive leakage currents can expose patients and healthcare workers to electric shock and other adverse events. IEC 62353:2014 was established to provide standardized, reproducible, and non-destructive procedures for recurrent testing and testing after repair throughout the in-service life of EME, complementing the design-oriented requirements of IEC 60601-1. Despite its relevance, practical evidence on its routine application in large healthcare institutions, particularly regarding failure detection rates and the operational time required for implementation, remains scarce in the literature.

Methods

This study addresses this gap by systematically implementing the recurrent and post-repair tests prescribed by IEC 62353:2014 in a large public hospital in Curitiba, Paraná, Brazil, and by quantifying both the nonconformities detected and the time demanded by the protocol. A total of 393 EME tests were performed in routine clinical use.

Results

The overall failure rate was 9.3%, predominantly due to protective earth bond resistance (primarily power cords) and applied-part leakage current in CF-type defibrillator paddles. Post-repair tests had the highest failure rate (23.7%), underscoring the importance of testing after any invasive technical intervention. The mean time required to perform each test was 5.34 min (standard deviation of 1.71 min), confirming the operational feasibility of incorporating these procedures into clinical engineering routines without significantly affecting productivity.

Conclusion

These findings demonstrate the effectiveness of the standard in detecting critical EME failures and support its adoption as a routine practice in healthcare institutions.