Ormesa Grillo, Use And Maintenance Handbook

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CONFORMITY DECLARATION
ORMESA S.r.l. GUARANTEES AND DECLARES, under its own exclusive
responsibility, that the following medical device, technical aid for
rehabilitation:
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 risk class I and has
been designed in observance to the following standards:
CEI EN ISO 14971:2012 Medical Devices - Application of risk
management to medical
EN 12182:2012 technical aids for disabled persons - general
requirements and test methods
EN 980:2009 Graphical symbols for use in the labelling of
medical devices
EN 1041:2009 Information supplied by the manufacture with
medical devices
ISO 9999:2011 Technical aids for persons with disabilities -
Classification and terminology
EN 1985 :2001 Walking aids. General requirements and test
methods
EN ISO ISO 11199-3:2005 Walking aids manipulated by both arms -
Requirements and test methods – Part 3:
Walking tables
EN UNI EN ISO11199-2:2005 Walking aids manipulated by both arms.
Requirements and test methods. Rollators
October 14, 2014 the Legal Representative
Luigi Menichini
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