2014-09-30
Page 32 of 34
R-Biopharm AG
Declaration of conformity
The RIDA
®
CUBE SCAN Analyser consisting of the RIDA
®
CUBE SCAN Instrument and the RIDA
®
CUBE
SCAN 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.