ISO 15223-
1:2016 Refer-
ence no.
5.2.8. (ISO
7000-2606)
Medical devices —Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.
Do not use if pack-
age is damaged
Indicates a medical device
that should not be used if
the package has been dam-
aged or opened and that
the user should consult
the instructions for use for
additional information
ISO 15223-
1:2016
Reference
no. 5.4.2.
(ISO 7000-
1051)
Medical devices — Symbols to
be used with medical device
labels, labeling, and inform-
ation to be supplied – Part 1:
General requirements.
Do not re-use
Indicates a medical device
that is intended for one
single use only
NOTE: Synonyms for “Do
not reuse” are “single
use” and “use only once”.
ISO 15223-
1:2016 Refer-
ence no.
5.4.3. (ISO
7000-1641)
Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.
Consult instruc-
tions for use Oper-
ator's manual;
operating instruc-
tions
Indicates the need for the
user to consult the instruc-
tions for use
ISO 15223-1,
Clause 5.4.4
ISO 60601-1
Table D.1
symbol 10
Medical devices — Symbols to
be used with medical device
labels, labelling and inform-
ation to be supplied.
Medical electrical equipment
— Part 1: General require-
ments for basic safety and
essential performance.
Caution: Read all
warnings and pre-
cautions in instruc-
tions for use
Indicates the need for the
user to consult the instruc-
tions for use for important
cautionary information
such as warnings and pre-
cautions that cannot, for a
variety of reasons, be
presented on the medical
device itself.
IEC 60601-1,
Table D.2
symbol 2
Medical electrical equipment
— Part 1: General require-
ments for basic safety and
essential performance.
General warning
sign
Indicates the need for the
user to consult the instruc-
tions for use for important
cautionary information
such as warnings and pre-
cautions that cannot, for a
variety of reasons, be
presented on the medical
device itself.
Madsen A450
87
11 Standards and Safety
