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The objective of this study was to evaluate the electrical safety and essential performance of external cardiac pacemakers in continuous clinical use. The testing methodology was based on the standards: ABNT IEC 62353: 2019 (Recurrent test and test after repair of medical electrical equipment), ABNT NBR IEC 60601-2-31: 2023 (External cardiac pacemakers with internal power source), and ABNT NBR ISO 14708-2: 2016 (Active implantable medical devices). The evaluation included testing electrical safety and verifying the accuracy of sensitivity, pulse frequency, duration, and amplitude. These tests were performed with both fully charged and partially charged batteries. Out of the tested samples, only three devices were found compliant with functionality standards. This study highlights the importance of healthcare providers establishing a regular testing schedule to verify the functionality of medical devices. Additionally, it’s crucial to educate healthcare professionals on safety protocols and usage details to maintain optimal product performance.

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Post-market Recurrent Testing of Electrical Safety and Performance in External Cardiac Pacemakers

  • 会议论文

  • 发表日期：

    2025年

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  • M. R. Nunes,
  • Felipe Fava de Lima,
  • E. S. Filho,
  • D. A. O. Rosa,
  • D. M. Nascimento,
  • P. M. Zanuzzio,
  • H. T. Moriya

摘要

The objective of this study was to evaluate the electrical safety and essential performance of external cardiac pacemakers in continuous clinical use. The testing methodology was based on the standards: ABNT IEC 62353: 2019 (Recurrent test and test after repair of medical electrical equipment), ABNT NBR IEC 60601-2-31: 2023 (External cardiac pacemakers with internal power source), and ABNT NBR ISO 14708-2: 2016 (Active implantable medical devices). The evaluation included testing electrical safety and verifying the accuracy of sensitivity, pulse frequency, duration, and amplitude. These tests were performed with both fully charged and partially charged batteries. Out of the tested samples, only three devices were found compliant with functionality standards. This study highlights the importance of healthcare providers establishing a regular testing schedule to verify the functionality of medical devices. Additionally, it’s crucial to educate healthcare professionals on safety protocols and usage details to maintain optimal product performance.