17
5. S
ymb
ols
Symbol
Standard/Law
Reference
Standard/Law Title
Symbol Title/
Text Reference
Explanatory Text
ISO 15223-1,
Clause 5.5.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
In Vitro
Diagnostic
Medical Device
Indicates that a medical
device is intended to be
used as an
in vitro
diagnostic medical device.
IEC 60601-1, Table
D.1, Symbol 10
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
Caution
Indicates the need for the
user to consult the
instructions for use for
important cautionary
information such as
warnings and precautions
that cannot, for a variety of
reasons, be presented on
the medical device itself.
ISO 7000-0434
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.7
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Temperature Limit
Indicates the temperature
limits to which the medical
device can be safely
exposed.
ISO 7000-0632
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.8
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Humidity Limitation
Indicates the range of
humidity to which the
medical device can be
safely exposed.
ISO 7000-2620
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.4
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Keep Dry
Indicates a medical device
that needs to be protected
from moisture.
ISO 7000-0626
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.3.1
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Fragile,
Handle with Care
Indicates a medical device
that can be broken or
damaged if not handled
carefully.
ISO 7000-0621
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.4.2
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Do Not Reuse
Indicates a medical device
that is intended for one
use or for use on a single
patient during
a single procedure.
ISO 7000-1051
Graphical symbols for use on equipment
ISO 15223-1,
Clause 5.2.6
Medical devices - Symbols to be used
with medical device labels, labeling and
information to be supplied
Do Not Resterilize
Indicates that a medical
device should not be
resterilized.
ISO 7000-2608
Graphical symbols for use on equipment