Electrical Safety of Medical Equipment in the Post-Market Context - a Practical Approach in Cardiac Defibrillators Based on ABNT NBR IEC62353:2019 Standard

Sep 8, 2026

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Ensuring electrical safety in medical equipment is crucial for effective patient treatment and protects both the operator and the patient. This paper discusses the electrical safety of external cardiac defibrillators in the post-market context, focusing on the ABNT NBR IEC 62353:2019 standard. Through a systematic approach, the study addresses the technical criteria prescribed in the standard, highlighting key tests such as protective earth resistance, insulation resistance, and leakage current. Results from tests on two defibrillators reveal one unit failing protective earth resistance limits and the other showing insulation values near the established threshold.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages1

Reading Time3 min

AccessFree to download

Abstract

Electrical safety focus

Standard-based tests

Practical results and compliance

FAQs

What standard guides the electrical safety evaluation in this study?

The study focuses on ABNT NBR IEC 62353:2019 and uses its technical criteria for assessing electrical safety in external cardiac defibrillators.

Which electrical tests are emphasized for the defibrillators?

Key tests include protective earth resistance, insulation resistance, and leakage current, as prescribed by the standard.

What were the main findings from testing two different defibrillator models?

One defibrillator failed to meet the normative limit for protective earth resistance, while the other produced insulation resistance values very close to the established limit.

Sep 8, 2026

Upload by Ezra