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DECLARACIÓN DE CONFORMIDAD
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, is manufactured by Ormesa srl in conformity 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:
DIRETTIVA 2014/30/EU
UNI CEI EN ISO 14971:2012
UNI EN 12182:2012
ISO 9999:2011
UNI EN 1041:2013
UNI CEI EN ISO 15223-1:2012
CEI EN 60601-1-2:2010
CEI EN 61000-3-2:2007
CEI EN 61000-3-3:2014
CEI EN 61000-4-4:2013
CEI EN 61000-4-2:2011
CEI EN 61000-4-11:2006
CEI EN 61000-4-3:2007
CEI EN 61000-4-5:2007
CEI EN 61000-4-6:2011
CEI EN 55011:2013
CEI EN 60335-1
Foligno, 25.10.2016
APP MULTISENSORIAL STANDING
Harmonization of the Member States relating to electromagnetic
compatibility
Medical devices - Application of risk management to medical devices
Products designed to assist people with disabilities -
General requirements and test methods
Technical aids for disabled persons - Classification
Information supplied by the manufacturer with medical devices
Symbols for use in the medical device labels, labeling
and information to be supplied - Part 1: General requirements
General requirements for basic safety and essential performance.
Collateral standard. Prescription electromagnetic compatibility
and tests.
(EMC) Limits for harmonic current emissions
(EMC) Limits for voltage fluctuations of voltage fluctuations flicker
in low voltage supply systems for equipment with rated current <=
16A
(EMC) immunity test transients, bursts of pulses fast Electric
(EMC) immunity test static electricity discharge
(EMC) immunity test voltage dips, short interruptions and voltage
variations
(EMC) Immunity to radio frequency electromagnetic fields radiated
(EMC) immunity test pulse
(EMC) Testing and measurement techniques - Immunity to
conducted disturbances, induced by RF fields
Industrial, scientific and medical. radio disturbance characteristics.
Limits and methods of measurement
Safety of household and similar electrical appliances di'uso.
General rules
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The Legal Rapresentative
Luigi Menichini
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