Laboratorio de Certificacao de Equipamentos Eletromedicos sob a Perspectiva da Nova Edicao da ABNT NBRIEC60601-1

摘要

This article describes the difference between the current and the new version of IEC 60601-1 from the aspect of the certification Iaboratories [1]. With the paradigm of the risk management included in the third edition of this standard, certification Iaboratories were forced to change their way to conduct their tests. It also has to invest in training people certified to analyze a qualitative risk matrix and a risk chart, not forgetting the tools used to estimate risk. This article will also shows an exemplification of certification for an ECG machine following the second and the third edition of this standard, so that the differences between the new and the current versions will be clearer.