EC declaration of conformance:
EC 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-DFM24-ENDO
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: 2003 + AC2007
Medical Products-Quality management system
IEC 60601-1 3rd Edition: 2005 = EN 60601-1:2007
General Requirements Of Basic Safety and Essential Performance
EN 60601-1-2: 2007
EMC-Directive
EMC – Emission
EMC – Immunity
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.
Conformity assessment procedure:
Annex VII
Name:
Bernhard Zimmermann
Position:
Director of European Sales
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