According to the EU Medical Devices Regulation, users / patients are obliged to report serious events with a
medical device to the manufacturer and to the competent authority of the country in which they occurred.
| Symbol | Symbol Title | Symbol Description | Standard Reference | Standard Title |
|---|---|---|---|---|
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Manufacturer | Indicates the medical device manufacturer. | 5.1.1 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Date of manufacture | Indicates the date when the medical device was manufactured. | 5.1.3 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Authorized representative in the European Community / European Union |
Indicates the authorized representative in the European Community / European Union. |
5.1.2 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Use-by date | Indicates the date after which the medical device is not to be used. | 5.1.4 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Batch code | Indicates the manufacturer’s batch code so that the batch or lot can be identified. | 5.1.5 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Catalogue number | Indicates the manufacturer’s catalogue number so that the medical device can be identified. | 5.1.6 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Serial number | Indicates the manufacturer’s serial number so that a specific medical device can be identified. | 5.1.7 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer -Part 1: General requirements |
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Sterile | Indicates a medical device that has been subjected to a sterilization process. | 5.2.1 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Sterilized using aspectic processing techniques | Indicates a medical device that has been manufactured using accepted aseptic techniques. | 5.2.2 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Sterilized using ethylene oxide | Indicates a medical device that has been sterilized using ethylene oxide. | 5.2.3 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Sterilized using irradiation | Indicates a medical device that has been sterilized using irradiation. | 5.2.4 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Sterilized using steam or dry heat | Indicates a medical device that has been sterilized using steam or dry heat. | 5.2.5 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Do not resterilize | Indicates a medical device that is not to be resterilized. | 5.2.6 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Non-sterile | Indicates a medical device that has not been subjected to a sterilization process. | 5.2.7 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Do not use if package is damaged and consult instructions for use | Indicates a medical device that should not be used if the package has been damaged or opened. | 5.2.8 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Fragile, handle with care | Indicates a medical device that can be broken or damaged if not handled carefully. | 5.3.1 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Keep away from sunlight | Indicates a medical device that needs protection from light sources. | 5.3.2 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Protect from heat and radioactive sources | Indicates a medical device that needs protection from heat and radioactive sources. | 5.3.3 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Keep dry | Indicates a medical device that needs to be protected from moisture. | 5.3.4 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Lower limit of temperature | Indicates the lower limit of temperature to which the medical device can be safely exposed. | 5.3.5 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Upper limit of temperature | Indicates the upper limit of temperature to which the medical device can be safely exposed. | 5.3.6 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Temperature limits | Indicates the temperature limits to which the medical device can be safely exposed. | 5.3.7 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Humidity limitation | Indicates the range of humanity to which the medical device can be safely exposed. | 5.3.8 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Atmospheric pressure limit | Indicates the range of humidity to which the medical device can be safely exposed. | 5.3.9 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Biological risks | Indicates that there are potential biological risks associated with the medical device. | 5.4.1 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Do not re-use | Indicates a medical device that is intended for one single use only. | 5.4.2 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Consult instructions for use or consult electronic instructions for use | Indicates the need for the user to consult the instructions for use | 5.4.3 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Caution | Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. | 5.4.4 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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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 | 5.4.5 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Not made with natural rubber latex | Not made with natural rubber latex. | Annex B | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Importer | Indicates the entity importing the medical device into the locale. |
5.1.8 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Patient number | Indicates a unique number associated with an individual patient. | 5.7.1 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Single patient multiple use | Indicates a medical device that may be used multiple times (multiple procedures) on a single patient | 5.4.12 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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Medical device | Indicates the item is a medical device. | 5.7.7 | ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
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MR Unsafe | An item which poses unacceptable risks to the patient, medical staff, or other persons within the MR environment. |
Fig. 10 | ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
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Change identifier | Indicates changes to a section in the Instructions for Use since previous revision. |
Annex I, Chapter III, 23.4(y) | EU MDR 2017/745 |
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Prescription only | Caution: Federal (US) law restricts this device to sale by or on the order of a physician. | (b)(1) | 21 CFR 801.109 |
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European conformity | CE mark indicates that a product has been assessed to meet EEA safety, health and environmental protection requirements. |
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