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15. CE-marking
The undersigned hereby declares that the following products:
Flexi, electrical with 1 motor and 2 legs 60
– 104 cm
Flexi, electrical with 2 motors and 2 legs 105
– 204 cm
Flexi, electrical with 2 motors and 3 legs 205
– 300 cm
all belong to risk class I and conform to the Directives and Standards mentioned below:
DIRECTIVES
The Machinery Directive 2006/42/EC
STANDARDS
DS/EN 12182: 2012
Assistive products for functionally disabled persons -
General requirements and test methods
DS/EN 14971: 2012
Medical devices
– Application of risk management to medical devices
Risk analyses according to the Machinery Directive 2006/42/EC
DS/EN 60335-1: 2012
Household and similar electrical appliances -
Safety
– Part 1: General requirements
DS/EN 9999: 2011:
Assistive products for functionally disabled persons -
Classification and terminology
DS/EN 1041+A1: 2013:
Information supplied by the manufacturer of medical devices
Dato: ___01-12-2016_____
