CONFORMITY DECLARATION
Foligno,
November 13th, 2017
ORMESA S.r.l. GUARANTEES AND DECLARES, under its own exclusive responsibility, that
the following Medical Device, technical aid for rehabilitation:
BUG SEAT UNIT WITH
4 WHEEL BASE 869,
INDOOR BASES 850, 851 and 856
which this declaration refers to, conforms with the general requirements provided in the
medical devices Directive 93/42/EEC and subsequent amendments and additions, according
to which this device is class I and has been designed in observance of the following
standards:
CEI EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices
EN 12182:2012 Technical aids for disabled persons - general requirements and test
methods
EN 980:2004 Graphical symbols for use in the labelling of medical devices
EN 1041:2000 Information supplied by the manufacture with medical devices
ISO 9999:2002 Technical aids for persons with disabilities - classification and
terminology
ISO 7176-1:1999 Wheelcha
irs - part 1: determination of static stability
ISO 7176-3: 2012 Wheelchairs - part 3: determination of effectiveness of brakes
ISO 7176-5: 2008 Wheelchairs - part 5: determination of overall dimensions, mass and
turning space
ISO 7176-7:1998 Wheelchairs - part 7: measurement of seating and wheel dimensions
ISO 7176-8:1998 Wheelchairs - part 8: requirements and test methods for static, impact
and fatigue strengths
ISO 7176-11:2012 Wheelchairs - part 11: test dummies
ISO 7176-15:1996 Wheelchairs - part 15: requirements for information disclosure,
documentation and labelling
ISO 7176-19: 2008 Wheelchairs - part 19: wheeled mobility devices for use in motor
vehicles
ISO 7176-22:2000 Wheelchairs - part 22: set-up procedures
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