CEI EN 60601-1-6/A1 PDF

INTRODUCTION TO THE AMENDMENT

The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process elements that are inconsistent with a TYPE TEST. This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that are required for compliance with the IEC 60601 series.