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Standard /
Symbol
Regulation*
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
IFU 5686 AE, 2024-04
Graphic Symbols on Packaging
Standard Reference No. /
Symbol Title
5.1.1 / Manufacturer
5.1.3 / Date of
Manufacture & 5.1.11 /
Country of Manufacture
5.1.2 / Authorised
representative in the
European Community
5.1.4 / Use-By Date
5.1.5 / Batch Code
5.1.6 / Catalogue number
5.1.8 / Importer
5.1.10 / Model number
5.2.4 / Sterilised by
irradiation
5.2.6 / Do not re-sterilise
5.2.8 / Do not use if
packaging is damaged
5.2.12 / Double sterile
barrier system
5.3.4 / Keep dry
5.3.7 / Temperature limit
5.4.2 / Do not reuse
5.4.3 / Read instructions
for use or electronic
instructions for use
5.4.4 / Caution
Definition
Medical device manufacturer.
Indicates the date when the medical device was
manufactured / to identify the country of manufacture of
products (MX = Mexico).
Authorised representative in the European Community.
Date after which the medical device is not to be used.
Manufacturer's batch code so that the batch or lot can be
identified.
Manufacturer's catalogue number so that the medical
device can be identified.
Entity importing the medical device into the locale.
Model number or type number of a product.
Medical device that has been sterilised by irradiation.
Medical device that is not to be re-sterilised.
Medical device that should not be used if the packaging
has been damaged or opened.
Indicates two sterile barrier systems.
Medical device that needs to be protected from moisture.
Temperature limits to which the medical device can be
safely exposed.
Medical device intended for one use or for use on a single
patient during a single procedure.
Need for the user to consult the instructions for use.
Caution is necessary when operating the device or control
close to where the symbol is placed or the current
situation needs operator awareness or operator action in
order to avoid undesirable consequences.
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