This glossary provides clear explanations of standardized symbols used on medical device labels, packaging, and documentation. These symbols are essential for ensuring safety, compliance, and effective communication across global markets.
ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
| Symbol | Description of symbol | Reference number and title of symbol |
|---|---|---|
 | Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. | 5.1.1 |
 | Indicates the authorized representative in the European Community. | 5.1.2 |
 | Indicates the date when the medical device was manufactured. | 5.1.3 |
 | Indicates the date after which the medical device is not to be used. | 5.1.4 |
 | Indicates the manufacturer's batch code so that the batch or lot can be identified. | 5.1.5 |
 | Indicates the manufacturer's catalogue number so that the medical device can be identified. | 5.1.6 |
| Indicates the manufacturer’s serial number so that a specific medical device can be identified. | 5.1.7 |
 | Indicates a medical device that has been sterilized using ethylene oxide. | 5.2.3 |
 | Indicates a medical device that has been sterilized using irradiation. | 5.2.4 |
 | Indicates a medical device that should not be used if the package has been damaged or opened. | 5.2.8 |
 | 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 |
 | Indicates a single sterile barrier system | 5.2.11 |
 | Indicates a medical device that can be broken or damaged if not handled carefully. | 5.3.1 |
 | Indicates a medical device that needs protection from light sources. | 5.3.2 |
 | Indicates a medical device that needs to be protected from moisture | 5.3.4 |
 | Indicates the temperature limits to which the medical device can be safely exposed. | 5.3.7 |
 | Indicates the range of humidity to which the medical device can be safely exposed. | 5.3.8 |
 | Indicates a medical device that is intended for one single use only | 5.4.2 |
 | Indicates the need for the user to consult the instructions for use. | 5.4.3 |
 | 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 |
 | Indicates a medical device that is non-pyrogenic. | 5.6.3 |
 | Indicates the number of drops per milliliter. | 5.6.4 |
 | Indicates the item is a medical device | 5.7.7 |
ISO 7000 Graphical symbols for use on equipment - Registered symbols
| Symbol | Description of symbol | Reference number and title of symbol |
 | To indicate that hooks shall not be used for handling the transport package. | 0622 |
 | To indicate correct upright position of the transport package | 0623 |
| To indicate that the items shall not be vertically stacked, either because of the nature of the transport packaging or because of the nature of the items themselves. | 2402 |
 | To indicate that the items shall not be vertically stacked beyond the specified number, either because of the nature of the transport packaging or because of the nature of the items themselves. | 2403 |
 | To indicate that the transport package shall not be rolled or turned over but shall remain in the upright position. | 2405 |
Symbols not from Standards
| Symbol | Description of symbol | Reference number and title of symbol |
|---|---|---|
 | Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. | FDA Quality System Regulation – Labeling requirements 21 CFR Part 801.109: Prescription use only |
 | Not made with natural rubber latex | NA |
 | Not made with di(2- ethylhexyl) phthalate | NA |
 | Not made with Bisphenol-A | NA |
 | Not for use with Hemodiafiltration | NA |
 | This device must be used on dialysis machines with an ultrafiltration controller or accurate fluid balancing system. | NA |
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