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Symbol
Standard
Reference
Standard Title
Symbol Title
Explanation
IEC 60601-1
Table D.2
#10
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
Follow instructions for
use
Refer to instruction manual/
Booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use”
ISO 15223-1
Symbol 5.4.4
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
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.
IEC 60601-1
Table D.1
#10
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
IEC 60601-1
Table D.2 #2
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
Essential performance
General warning sign Indicates a hazard of potential
personal injury to patient or
operator.
MDR
2017/745
EU Medical Device
Regulation
CE marking
Signifies European technical
conformity.
ISO 15223-1
Symbol 5.2.8
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Do not use if package
is damaged
Indicates a medical device that
should not be used if the package
has been damaged or opened.
ISO 15223-1
Symbol 5.3.7
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Temperature limit
Indicates the (storage)
temperature limits to which the
medical device can be safely
exposed.
ISO 15223-1
Symbol 5.3.8
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Humidity limitation
Indicates the range of (storage)
humidity to which the medical
device can be safely exposed.
033125_03 02/2021
