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 standards.
Replaces
SSH EN 60601-1-6:2004
WITHDRAWN
SSH EN 60601-1-6:2007
95.99
Withdrawal of Standard
Mar 3, 2014
PUBLISHED
SSH EN 60601-1-6:2010
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Shqip