Medical Device Symbol, Definition and Relevant Standard

Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1:2012. 5.1.1

ISO 7000 reg. no. 3082

Authorized representative in the European Community.

Indicates the Authorized representative in the European Community.

ISO 1552-1:2012. 5.1.2

Date of manufacture.

Indicates the date when the medical device was manufactured.

ISO 15223-1:2012. 5.1.3

ISO 7000 reg. no. 2497

Use-by date.

Indicates the date after which the medical device is not to be used.

ISO 15223-1:2012. 5.1.4

ISO 7000 reg. no. 2607

Batch code.

Indicates the manufacturer's batch code so that the batch or lot can be identified.

ISO 15223-1:2012. 5.1.5

ISO 7000 reg. no. 2492

Catalogue number.

Indicates the manufacturer's catalogue number so that the medical device can be identified.

ISO 15223-1:2012. 5.1.6

ISO 7000 reg. no. 2493

Serial number.

Indicates the manufacturer's serial number so that a specific medical device can be identified.

ISO 15223-1:2012. 5.1.7

ISO 7000 reg. no. 2498

Sterile.

Indicates a medical device that has been subjected to a sterilization process.

ISO 15223-1:2012. 5.2.1

ISO 7000 reg. no. 2499

Non-Sterile.

Indicates a medical device that has not been subjected to a sterilization process.

ISO 15223-1:2012. 5.2.7

ISO 7000 reg. no. 2609

Do not use if package is damaged.

Indicates a medical device that should not be used if the package has been damaged or opened.

ISO 15223-1:2012. 5.2.8

ISO 7000 reg. no. 2606

Fragile, handle with care.

Indicates a medical device that can be broken or damaged if not handled carefully.

ISO 15223-1:2012. 5.3.1

ISO 7000 reg. no. 0621

Keep away from sunlight.

Indicates a medical device that needs protection from light sources.

ISO 15223-1:2012. 5.3.2

ISO 7000 reg. no. 0624

Keep dry.

Indicates a medical device that needs to be protected from moisture.

ISO 15223-1:2012. 5.3.4

ISO 7000 reg. no. 0626

Lower limit of temperature.

Indicates the lower limit of temperature to which the medical device can be safely exposed.

ISO 15223-1:2012. 5.3.5

ISO 7000 reg. no. 0534

Upper limit of temperature.

Indicates the upper limit of temperature to which the medical device can be safely exposed.

ISO 15223-1:2012. 5.3.6

ISO 7000 reg. no. 0533

Temperature limit.

Indicates the temperature limits to which the medical device can be safely exposed.

ISO 15223-1:2012. 5.3.7

ISO 7000 reg. no. 0632

Humidity limitation.

Indicates the range of humidity to which the medical device can be safely exposed.

ISO 15223-1:2012. 5.3.8

ISO 7000 reg. no. 2620

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.

ISO 15223-1:2012. 5.4.2

ISO 7000 reg. no. 2621

Consult instructions for use.

Indicates the need for the user to consult the instructions for use.

ISO 15223-1:2012. 5.4.3

ISO 7000 reg. no. 2621

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 15223-1:2012. 5.4.4

ISO 7000 reg. no. 0434A

Contains or presence of natural rubber latex.

Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

ISO 15223-1:2012. 5.4.5