Page
9
CE-marking
EU
–
Declaration of Conformity
Ropox hereby declares that the following products
40-41145
Ropox Storage Modules for Swing Wash basin
40-41146
Ropox Tray for Swing Wash Basin
40-40935
Ropox Stopper with Overflow
have been classified as Class I and conform to the following directive and standard:
Directives
Directive No. 93/42/EEC concerning Medical Devices (risk class 1)
Machinery Directive No. 2006/42/EC, amended by Directive No. 98/37/EC.
Standards
DS/EN 12182: 2012:
Assistive devices for persons with functional disabilities -
General requirements and test methods
DS/EN 14971: 2012:
Medical devices -
Application of risk management to medical devices
DS/EN 9999: 2011:
Assistive devices for persons with functional disabilities -
Classification and terminology
Date:
15-09-2012
