Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.
Directives related to this standard.
SRPS EN 60601-1-6:2009
95.99 Withdrawal of Standard
Mar 31, 2011
SRPS EN 60601-1-6:2011