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which this declaration refers to, conforms with the general requirements
provided in the Directive 93/42/EEC and subsequent amendments and
additions, concerning the medical devices, according to which this aid belongs
to the I risk class and has been designed in observance to the following
standards:
CEI EN ISO 14971:2012
EN 12182:2012
EN 980:2009
EN 1041:2009
ISO 9999:2011
EN 1985 :2001
EN ISO ISO 11199-3:2005
Foligno
June 21st, 2018
CE DECLARATION
DYNAMICO walker
for INDOOR and OUTDOOR USE
Medical Devices - Application of risk
management to medical
technical aids for disabled persons - general
requirements and test methods
Graphical symbols for use in the labelling of
medical devices
Information supplied by the manufacture with
medical devices
Technical aids for persons with disabilities -
Classification and terminology
Walking aids. General requirements and test
methods
Walking aids manipulated by both arms -
Requirements and test methods – Part 3:
Walking tables
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