The table of symbols shown below comes from the following standard: Designation Number: ISO 15223-1:2016
Title: Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied – Part 1: General Requirements
Symbol |
The title of the symbol and its reference number |
The meaning or explanatory text or the symbol as provided in the standard |
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5.1.1 Manufacturer |
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42EEC and 98/79/EC. |
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5.1.2 Authorized representative in the European Community |
Indicates the authorized representative in the European Community. |
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5.1.3 Date of manufacture |
Indicates the date when the medical device was manufactured. |
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5.1.4 Use by date |
Indicates the date after which the medical device is not to be used. |
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5.1.5 Batch code |
Indicates the manufacturer’s batch code so that the batch or lot can be identified. |
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5.1.6 Catalogue number |
Indicates the manufacturer’s catalogue number so that the medical device can be identified. |
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5.2.3 Sterilised using ethylene oxide |
Indicates a medical device that has been sterilised using ethylene oxide. |
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5.2.4 Sterilised using irradiation |
Indicates a medical device that has been sterilised using irradiation. |
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5.2.5 Sterilised using steam or dry heat |
Indicates a medical device that has been sterilised using steam or dry heat. |
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5.2.6 Do not resterilise |
Indicates a medical device that is not to be resterilised. |
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5.2.8 Do not use if packaging is damaged |
Indicates a medical device that should not be used if the package has been damaged or opened. |
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5.3.2 Keep away from sunlight |
Indicates a medical device that needs protection from light sources. |
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5.3.4 Keep dry |
Indicates a medical device that needs to be protected from moisture. |
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5.3.7 Temperature limit |
Indicates the temperature limits to which the medical device can safely be exposed. |
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5.4.2 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. |
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5.4.3 Consult instructions for use |
Indicates the need for the user to consult the instructions for use. |
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5.4.3 Consult instructions for use |
Indicates the need for the user to consult the electronic instructions for use. |
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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. |