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DÉCLARATION de CONFORMITÉ
ORMESA S.r.l. guarantees and declares , under its own exclusive responsibility, that the
La
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 I risk class and has been designed in
observance to the following standards
CEI EN ISO 14971
EN 12182
EN ISO 15223-1
EN 1041
ISO 9999
CEI EN 60601-1-2
EN 61000 – 4 – 2
EN 61000 – 4 – 4
EN 61000 – 4 – 5
September 16, 2015
STANDY ELECTRO WING
STANDING FRAME FOR AN UPRIGHT POSITION
Medical Devices - Application of risk management to
medical
Products designed to assist people with disabilities -
General re-quirements and test methods
Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:
General requirements
Information supplied by the manufacture with medical
devices
Technical aids for persons with disabilities - Classification
and terminology
General requirements for basic safety and essential
performance
compatibility – Requirements and tests
(EMC) immunity test static electricity discharge
(EMC) immunity test transients, bursts of pulses fast
Electric
(EMC) immunity test pulse
p. 11 de 40
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Collateral
standard:
The Legal Representative
Luigi Menichini
Electromagnetic
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