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14 • Symbols
80114-770_V23802
2021-01
Chapter 14
Symbols
Individual details of the symbols in this chapter may deviate from your product. Not all
symbols may necessarily appear on your device or its packaging.
Standard Ref. no. Symbol Title Explanation
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.4.4 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.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.1.6 Catalogue num-
ber
Indicates the manufacturer’s catalogue
number so that the medical device can be
identified.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.1.7 Serial number Indicates the manufacturer’s serial num-
ber so that a specific medical device can
be identified.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.1.1 Manufacturer Indicates the medical device manufac-
turer, as defined in EU Directives 90/
385/EEC, 93/42/EEC and 98/79/EC.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.1.3 Date of manufac-
ture
Indicates the date when the medical
device was manufactured.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.3.2 Keep away from
sunlight
Indicates a medical device that needs
protection from light sources.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.3.4 Keep dry Indicates a medical device that needs to
be protected from moisture.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.3.7 Temperature limit Indicates the temperature limits to which
the medical device can be safely exposed.
ISO 15223-1 Medical devices –
Symbols to be used with medi
-
cal device labels, labelling and
information to be supplied
5.3.8 Humidity limita-
tion
Indicates the range of humidity to which
the medical device can be safely exposed.
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