natus Quantum Mode D'emploi page 6

Standard
Symbol
Reference
ISO 15223-1
Symbol 5.1.6
ISO 15223-1
Symbol 5.4.3
Annex A
#A.15
IEC 60601-1
Table D.2 #10
ISO 15223-1
Symbol 5.4.4
IEC 60601-1
Table D.1 #10
IEC 60601-1
Table D.2 #2
MDR
2017/745
ISO 15223-1
Symbol 5.3.7
ISO 15223-1
Symbol 5.3.8
ISO 15223-1
Symbol 5.3.9
Standard Title
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
essential performance
Medical electrical
equipment — Part 1:
General requirements
for basic safety and
Essential performance
EU Medical Device
Regulation
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be
supplied
6 / 94
Symbol Title
Catalogue number Indicates the manufacturer's
catalogue number so that the
medical device can be identified.
Consult instructions for Indicates an instruction to consult
use an electronic instructions for use
(eIFU).
Follow instructions for Refer to instruction manual/
use booklet.
NOTE on ME EQUIPMENT
"Follow instructions for use"
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.
General warning sign Indicates a hazard of potential
personal injury to patient or
operator.
CE marking Signifies European technical
conformity.
Temperature limit Indicates the (storage)
temperature limits to which the
medical device can be safely
exposed.
Humidity limitation Indicates the range of (storage)
humidity to which the medical
device can be safely exposed.
Atmospheric pressure Indicates the acceptable upper and
limitation lower limits of atmospheric
pressure for transport and storage.
Explanation