Analysis and Validation of Electrical Safety Procedures for Biomedical Devices

Abstract

Monitoring electrical failures in biomedical devices makes it possible to ensure patient’s safety. While assessing risk in medical equipment, we observed that electrical failures are one of the adverse events detected. Biomedical laboratories include procedures and design devices for testing electrical safety. In this work, we develop procedures to perform electrical safety test based on national and international standards. One of them is the Protective Earth Resistance test. Currently, the main standard applied to medical equipment tests is IEC 62353: 2014 “Medical electrical Equipment - recurrent test and test after repair of medical electrical equipment”. Specifically, this standard is a guideline that describes the requirements to ensure the electrical safety through comparable and reproducible tests. To ensure technical competence, laboratories must validate their testing procedures following the standard ISO/IEC 17025: 2017 “General requirements for the competence of testing and calibration laboratories”. This standard comprises all the requirements that laboratories must achieve to demonstrate that they (i) apply a quality management system, (ii) are technically competent and (iii) they may obtain valid technical results.