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