User Manual

Page 21
© ROPOX 2014
CE-marking
EU – Declaration of Conformity
Ropox hereby declares that the following product
40-40069-4 Ropox Dock-in
is classified as Class I and conforms 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/ISO 17966: 2016: Assistive products for personal hygiene that support users –
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: 24-07-2019