Specifications
Users Manual: MD-CP42AUPG-MED
© 2011 Richardson Electronics GmbH
Division Canvys
10
Manufacturer’s declaration of compliance with standards and
directives
EG Declaration of Conformity
Manufacturer Richardson Electronics GmbH
Division Canvys
Raiffeisenstraße 5 Tel.: +49 (0) 771 / 8300-0
D-78166 Donaueschingen Fax: +49 (0) 771 / 8300-80
Product: Medical Monitor (product group 1)
MD-CP42AUPG-MED
MD-CP42AUxx-MEDX (chassis without front bezel)
Classification: I
(Directive 93/42/EWG)
We declare in own responsibility, that the above named products correspond to relevant
regulations according to the following EG guidelines and standards.
Directive:
Directive 93/42/EWG of the Council of 14. Jun. 1993
Standards:
DIN EN 13485: 2009 Medical Products-Quality management system
IEC 60601-1 : 2007 General Requirements Of Basic Safety and Essential
Performance
EN 60601-1-2: 2007 EMC-Directive
2002/95/EG:2003-01 RoHS
93/68/EWG:1993-07 CE-Marking
EMC-Tests have been carried out using standard cables with cables length of up to 2,5
meters. If longer cables are used, additional tests might be necessary to prove
compliance with the EMC-directive.
93/68/EWG:1993-07 CE-Kennzeichnung