Detalhes do Artigo
[303744] A Case Study on Post-Market Safety Verification of Electromedical Equipment: Evaluating ABNT NBR IEC 62353 Standard Testing in Real-World and Lab Settings
Autores: Gilberto Balby Araujo Filho, Edison Silva Filho, Miguel Rosa Nunes, Diego Antonio Oliveira Rosa, Sara Gomes Mello Santiago, Gustavo Yeh Fuzinato, Paulo Malusa Zanuzzio, Henrique Takachi Moriya, Felipe Fava de Lima
Resumo: This preliminary study investigates the role of testing environments in the post-market safety verification of electromedical devices, particularly electrocardiographs, using the ABNT NBR IEC 62353 Standard. Electrical tests were conducted in two distinct scenarios: a well-controlled laboratory and a typical hospital environment, focusing on two tests, insulation resistance and leakage current evaluations. Some variations were observed in the insulation resistance test outcomes within the hospital setting, specifically on accessible parts and applied parts, potentially reflecting the inherent complexities of real-world testing environments. Nevertheless, all tests confirmed the compliance of the equipment with the ABNT NBR IEC 62353 Standard requirements. These findings underscore the importance of robust testing protocols that account for environmental factors, ensuring the reliable and comprehensive safety assessment of electromedical devices across diverse real-world healthcare settings.