Conformity Declaration - Ormesa Juditta B30 Use And Maintenance Handbook

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
medical devices Directive 93/42/EEC and subsequent amendments and additions,
according to which this device is class 1 and has been designed in observance of the
following standards:
CEI EN ISO 14971:2012
UNI EN 12183:2014
EN 12182:2012
EN 980:2004
ISO 9999:2011
EN 1041:2013
ISO 7176-1:2014
ISO 7176-3:2012
ISO 7176-5: 2008
ISO 7176-7: 1998
ISO 7176-8: 2014
ISO 7176-11:2012
ISO 7176-15:1996
ISO 7176-22:2014
ISO 7176-19: 2008
WC 19: Wheelchair
ANSI/RESNA
WC:4 2012 –Section 19
January 7th, 2016
Medical Devices - Application of risk management to
medical devices
Manual Wheelchairs - Requirements and Test Methods
Technical aids for disabled persons - general requirements
and test methods
Graphical symbols for use in the labelling of medical
devices
Technical aids for persons with disabilities - classification
and terminology
Information supplied by the manufacture with medical
devices
Wheelchairs - Part 1: determination of static stability
Wheelchairs - Part 3: Determination of effectiveness of
brakes
Wheelchairs - Part 5: Determination of dimensions, mass
and manoeuvring space
Wheelchairs - Part 7: Measurement of seating and wheel
dimensions
Wheelchairs - Part 8: Requirements and test methods for
static, impact and fatigue strengths
Wheelchairs - Part 11: Test dummies
Wheelchairs - Part 15: Requirements for information
disclosure, documentation and labelling
Wheelchairs – Part 22: Set-up Procedure
Wheelchairs – Part 19: Wheeled mobility devices for use
as seats in motor vehicles, only for B30 – B60 versions
Wheelchairs Used as Seats in Motor Vehicles, only for B30
– B60 versions
17/86
The Legal Representative
Luigi Menichini