Integra CereLink Bedienungsanleitung Seite 6

EN – ENGLISH
Symbol
Manufacturer
Prescription
Use Only
Temperature
Humidity
limitation
Title of Meaning of
Symbol
Indicates the
medical device
manufacturer,
as defined in
EU Directives
90/385/EEC,
93/42/EEC and
Federal (US)
law restricts
this device to
sale by or on
the order of
a physician
or licensed
healthcare
practitioner
Indicates the
limit temperature
limits to which
the medical
device can be
safely exposed
Indicates
the range of
humidity to
which the
medical device
can be safely
Symbol
Medical Devices
– Symbols to
be used with
medical device
labels, labelling
and information
98/79/EC to be supplied
Caution:
for Industry:
Prescription
Device Labeling
Requirements,
dated January
with medical
device labels,
labelling and
information to
be supplied
with medical
exposed device labels,
labelling and
information to
be supplied
5
Standard Reference
ISO 15223-1
Guidance
Alternative
to Certain
21, 2000
ISO 15223-1
Medical
Devices –
Symbols
to be used
ISO 15223-1
Medical
Devices –
Symbols
to be used
Number
5.1.1
N/A
5.3.7
5.3.8