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 (as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. | 5.1.1 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Authorized representative in the European Community | Indicates the authorized representative in the European Community. | 5.1.2 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Date of manufacture | Indicates the date when the medical device was manufactured. | 5.1.3 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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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 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Sterile fluid path | Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile. | 5.2.9 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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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. | 5.4.2 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Consult instructions for use | Indicates the need for the user to consult the instructions for use | 5.4.3 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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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 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Contains 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 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Sampling site | Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container | 5.6.1 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Fluid path | Indicates the presence of a fluid path. | 5.6.2 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Non-pyrogenic | Indicates a medical device that is nonpyrogenic | 5.6.3 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Drops per millilitre | Indicates the number of drops per millilitre. | 5.6.4 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Liquid filter with pore size | Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size. | 5.6.6 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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One-way valve | Indicates a medical device with a valve that allows flow in only one direction. | 5.6.6 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Importer | To indicate the entity importing the medical device into the locale. | – | – |
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Patient number | Indicates a unique number associated with an individual patient. | 5.7.1 | ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements |
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Single patient multiple use | To indicate that the medical device may be used multiple times (multiple procedures) on a single patient | – | – |
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Contains human blood or plasma derivatives | To indicate that the medical device contains or incorporates human blood or plasma derivatives | 5.4.6 | 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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Unique Device Identifier | The UDI symbol is optional. When multiple data carrier are present on the label, the symbol may be used. | 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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Medical device | Indicates that a given product 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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N/A | An indication placed at the title of a section within the IFU that information has changed. | – | – |
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Prescription only | Caution: Federal (US) law restricts this device to sale by or on the order of a physician. | – | Requirement for medical products sold in the U.S. |
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European conformity | CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. | – | Required for products manufactured anywhere in the world that are then marketed in the EU. |