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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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