Tabla de contenido
Publicidad
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, 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
EN 12182:2012
EN 980:2004
EN 1041:2000
ISO 9999:2002
ISO 7176-1:1999
ISO 7176-3: 2012
ISO 7176-5: 2008
ISO 7176-7:1998
ISO 7176-8:1998
ISO 7176-11:2012
ISO 7176-15:1996
ISO 7176-19: 2008
ISO 7176-22:2000
Foligno,
November 13th, 2017
BUG SEAT UNIT WITH
4 WHEEL BASE 869,
INDOOR BASES 850, 851 and 856
Medical Devi
e c
- s
Technical aids for disabled person - s general requirements and test
methods
Graphical symbols for use in the labelling of med
Information supplied by the manufacture with med
Technical aids for person
terminology
Wheelcha
r i
- s
part 1: determination
Wheelcha
r i
- s
part 3: determination of effectiveness
Wheelchairs - part 5: determination of overall dimensions, mass and
turning space
Wheelcha
r i
- s
part 7: meas urement of seating and wheel dimensions
Wheelchairs - part 8: requirements and test methods for static, impact
and fatigue streng s h
Wheelcha
r i
- s
part 11: test du
Wheelchairs - part 15: requiremen
documentation and labelli g
Wheelchairs - part 19: wheeled mobility devices for use in motor
vehicles
Wheelcha
r i
- s
part 22: set - up procedures
A
p
l p
ication of risk management to med
s
i w
h t
d
f o
s
t
m
i m
s e
s t
n
10/104
i
a c
c i
l a
d
v e
c i
s e
c i
l a
d
v e
c i
s i
b a
l i
i t i
- s e
c
a l
s s
i f i
a c
i t
a t
c i t
t s
b a
i l i
y t
f o
r b
k a
s e
r o f
i
f n
r o
m
a
i t
on disclosure,
d l
v e
c i
s e
s e
on and
Publicidad
Tabla de contenido
