V Congreso Latinoamericano de Ingeniería Biomédica (CLAIB2011)

Electromedical Certification Laboratories on the Perspective of the ABNT NBR IEC 60601-1 New Edition
Icaro dos Santos, Inajara Hayata de Azevedo

##manager.scheduler.building##: Palacio de Convenciones de La Habana
##manager.scheduler.room##: Sala 7
Fecha: 2011-05-19 08:30  – 08:45
Última modificación: 2011-04-15 05:59


This article describes the difference between the current and the new version of IEC 60601-1 from the aspect of the certification laboratories. With the paradigm of the risk management included in the third edition of this standard, certification laboratories 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.