EN – ENGLISH
11
Symbol Title of Symbol Meaning of Symbol Standard
Reference
Number
Manufacturer
Indicates the medical device manufacturer,
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
medical device labels, labelling and information to be
supplied
5.1.1
Authorized representative in the
European Community
Indicates the authorized representative in
the European Community
5.1.2
Date of manufacture
(YYYY-MM-DD)
Indicates the date when the medical device
was manufactured.
5.1.3
Batch code
Indicates the manufacturer’s batch code so
that the batch or lot can be identified.
Catalogue Number
Indicates the manufacturer’s catalogue
number so that the medical device can be
identified.
5.1.6
Non-sterile
Indicates a medical device that has not
been subjected to a sterilization process.
5.2.7
Do not use if package is damaged
Indicates a medical device that should not
be used if the package has been damaged
or opened.
5.2.8
Consult instructions for use
Indicates the need for the user 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 that cannot, for a variety
of reasons, be presented on the medical
device itself.
5.4.4
Refer to instruction
manual / booklet
To signify that the instruction manual/
booklet must be read.
ISO 7010 – Graphical symbols – Safety colors and safety
signs – Registered safety signs
M002
Prescription Use Only
Caution: Federal (US) law restricts
this device to sale by or on the order
of a physician or licensed healthcare
practitioner.
Guidance for Industry: Alternative to Certain Prescription
Device Labeling Requirements, dated January 21, 2000
N/A
Magnetic Resonance (MR)
conditional
An Item with demonstrated safety in
the MR environment within defined
conditions.
ASTM F2503 – Marking Medical Devices and Other Items
for Safety in the Magnetic Resonance Environment
N/A
Waste Electrical and Electronic
Equipment Symbol
Dispose of in accordance with WEEE
regulations.
BS EN 50419:2006 – Marking of electrical and electronic
equipment in accordance with Article 11(2) of Directive
2002/96/EC (WEEE)
N/A
Quantity
To indicate the number of devices per
package
Proprietary N/A
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