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© ROPOX 2013
EU
– Declaration of Conformity
The undersigned hereby declares that the following products:
Ropox Support Washbasin
Item numbers: 40-44010, Ropox Support Washbasin, Fixed (left)
40-44011, Ropox Support Washbasin, Fixed (right)
40-44012, Ropox Support Washbasin, Basic (left)
40-44013, Ropox Support Washbasin, Basic (right)
40-44014, Ropox Support Washbasin, Manual (left)
40-44015, Ropox Support Washbasin, Manual (right)
are in accordance with the following Directives and Standards:
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: 09-12-13
ROPOX A/S
Ringstedgade 221
DK-4700 Naestved Denmark
Tel. (+45) 55 75 05 00 Fax (+45) 55 75 05 50
e-mail:[email protected]
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