EVS-EN 60601-1-6:2010/A1:2015

IEC 60601-1-6 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. IEC 60601-1-6:2010/A1:2013 is intended to clarify the elements of the usability engineering process that are required for compliance with the IEC 60601 series.

The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. EN 60601-1-6:2010/A1:2015 modifies the European standard EN 60601-1-6:2010.