2ad89664-e5f4-4907-bab1-9f7c76e7d9ef / DP10.0 / 2016-07-04
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Eurolyser Diagnostica GmbH
DECLARATION OF CONFORMITY
C
The Eurolyser CUBE-S/CUBE Analyser consisting of the CUBE-S/CUBE Instrument and the CUBE-
S/CUBE Tablet PC is in conformity with the directive
2004/108/EC
of the European Parliament and the
Council of 15 December 2004 on the approximation of the laws of the Member States relating to
electromagnetic compatibility and repealing Directive 89/336/EEC.
The standards
“
EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices
”,
“
IEC 61010-1:2001 - Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements
“,
“
IEC 61010-2-101:2002 - Safety requirements for electrical equipment for measurement, control,
and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
“,
and the standards referenced below were taken in consideration:
EN 55011:2009 Class B;
EN 61000-4-2:2009;
EN 61000-4-3:2009;
EN 61000-4-4:2009;
EN 61000-4-5:2009;
EN 61000-4-6:2009;
EN 61000-4-11:2009;
EN 61326-1:2006-05-01;
ISO 14971:2007-10-01.
