natus Aurical HIT, User Manual, Page: 23 / 28

ISO 15223-
1:2016 Refer-
ence no.
5.4.5. (ISO
7000, symbol
2025) Medical devices —
Symbols to be used
with medical device
labels, labelling and
information to be sup-
plied. Not made with
Natural Rubber
Latex Indicates a medical device that is
not made with dry natural rubber
or natural rubber latex as a mater-
ial of construction within the med-
ical device or the packaging of a
medical device
ISO 7000
Reference no.
0623
Graphical symbols for
use on equipment -
registered symbols This way up N/A
Directive
2012/19/EU Waste Electrical and
Electronic Equipment
(WEEE) Disposal at end of
operating life
instructions Indicates that electrical and elec-
tronic waste equipment waste
should not be discarded together
with unseparated waste but must
be collected separately.
21 CFR Part
801.109(b)(1) Labeling-Prescription
devices. Prescription only Indicates the product is authorized
for sale by or on the order of a
licensed healthcare practitioner.
UL Listing N/A N/A Nationally Recognized Testing Lab-
oratories (NRTL) certifications
INMETRO in
conjunction
with UL for
Latin America InMetro and
UL marking of con-
formity MEDICAL - Gen-
eral Medical
Equipment as to
electrical shock,
fire and mech-
anical hazards
only in accord-
ance with:
ANSI/AAMI
ES60601-1:2005/
(R)2012
IEC 60601-1-6
CAN/CSA-C22.2
No. 60601-1:14
CAN/CSA-C22.2
No. 60601-1-6
INMETRO in conjunction with the
Mark of the National Institute of
Metrology, Standardization and
Industrial Quality in Brazil
Aurical HIT 23
9 Definition of symbols