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EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling
and information to be supplied - Part 1 General requirements
Symbol/
Name: Definition
number
Manufacturer: indicates the medical device manufacturer,
as defined in EU Directives 90/385/EEC, 93/42/EEC and
5.1.1
98/79/EC.
Date of manufacture: Indicates the date when the medical device was
manufactured.
5.1.3
Use-by date: Indicates the date after which the medical device is not to be
used.
5.1.4
Batch code: Indicates the manufacturer's batch code so that the batch or
lot can be identified.
5.1.5
Catalog number: indicates the manufacturer's catalog number so that the
REF
medical device can be identified.
5.1.6
Serial number: Indicates the manufacturer's serial number so that the
SN
medical device can be identified.
5.1.7
Non-Sterile: indicates a medical device that has not been subjected to a
NON
sterilization process.
STERILE
5.2.7
Fragile, handle with care: Indicates a medical device that can be broken
or damaged if not handled carefully.
5.3.1
Keep away from sunlight: Indicates a medical device that needs protec-
tion from light sources.
5.3.2
Keep dry: Indicates a medical device that needs to be protected from mois-
ture.
5.3.4
Temperature limit: Indicates the temperature limits to which the medical
device can be safely exposed.
5.3.7
Humidity limitation: Indicates the range of humidity to which the medi-
cal device can be safely exposed.
5.3.8
Atmospheric pressure limit: Indicates the range of atmospheric pressure
to which the medical device can be safely exposed.
5.3.9
Do not re-use: Indicates a medical device that is intended for one use or for
use on a single patient during a single procedure.
5.4.2
Consult instructions for use: indicates the need for the use to consult the
instructions for use.
5.4.3
Caution: Indicates the need for the user to consult the instructions for use
for important cautionary information such as warnings and precautions
5.4.4
that cannot, for a variety of reasons, be presented on the medical device
itself.
IEC 60417 Graphical symbols for use on equipment
Symbol
Name: Definition
This way up: To indicate correct upright position of the transport package.
0623
EN
How to Use this Document | 2/21

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