Radiancy FSD+ Manuel d'utilisateur télécharger pdf (Page 21)

8. Standards, Safety and Speciﬁcations

Design and technical speciﬁcations are subject to change without notice�

International Standards

FSD Plus complies with the following international standards and directives:

Electrical Safety

Medical Electrical Equipment – Part 1: General Requirements for

Basic Safety and Essential Performance, 3rd Ed: IEC60601-1:2005/

EN60601-1:2006

Electromagnetic Compatibility

IEC 60601-1-2:2007

EU Directive:

Low Voltage Directive 2006/95/EC

Electromagnetic Compatibility Directive 2004/108/EC

The CE mark represents the compliance to the European Low Voltage Directive

2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC�

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Radiancy FSD+ Manuel d'utilisateur Page 21