Symbol Glossary
Explanation of Symbols
The following symbols may appear on the packaging, labelling or instructions for use of medical devices.
| Symbol | Title | Description | Standard / Reference |
|---|---|---|---|
| Manufacturer | Indicates the medical device manufacturer | ISO 15223-1, 5.1.1 (ISO 7000-3082) | |
| Authorized Representative in the European Community/ European Union | Indicates the authorized representative in the European Community / European Union | ISO 15223-1, 5.1.2 | |
| Authorized Representative in Switzerland | Indicates the authorized representative in Switzerland | ISO 20417, 6.1.2 (d) | |
| Importer | Indicates the entity importing the medical device into the locale | ISO 15223-1, 5.1.8 (ISO 7000-3725) | |
| Distributor | Indicates the entity distributing the medical device into the locale | ISO 15223-1, 5.1.9 (ISO 7000-3724) | |
| Country of Manufacture | To identify the country of manufacture of products | ISO 15223-1, 5.1.11 (IEC 60417-6049) | |
| Do Not Re-use | Indicates a medical device that is intended for one single use only NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”. | ISO 15223-1, 5.4.2 (ISO 7000-1051) | |
| Date of Manufacture | Indicates the date when the medical device was manufactured | ISO 15223-1, 5.1.3 (ISO 7000-2497) | |
| Use-by Date | Indicates the date after which the medical device is not to be used | ISO 15223-1, 5.1.4 (ISO 7000-2607) | |
| Batch Code | Indicates the manufacturer's batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”. | ISO 15223-1, 5.1.5 (ISO 7000-2492) | |
| Unique Device Identifier | Indicates a carrier that contains unique device identifier information | ISO 15223-1, 5.7.10 | |
| Medical Device | Indicates the item is a medical device | ISO 15223-1, 5.7.7 | |
| Catalogue number | Indicates the manufacturer's catalog number so that the medical device can be identified | ISO 15223-1, 5.1.6 (ISO 7000-2493) | |
| Model Number | Indicates the model number or type number of a product | ISO 15223-1, 5.1.10 (IEC 60417-6050) | |
| Serial Number | Indicates the manufacturer's serial number so that a specific medical device can be identified | ISO 15223-1, 5.1.7 (ISO 7000-2498) | |
| Consult Instructions for Use or Consult Electronic Instructions for Use | Indicates the need for the user to consult the instructions for use | ISO 15223-1, A.16 | |
| Consult Instructions for Use or Consult Electronic Instructions for Use | Indicates the need for the user to consult the instructions for use | ISO 15223-1, 5.4.3 (ISO 7000-1641) | |
| Contains or Presence of Natural Rubber Latex | Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device | ISO 15223-1, 5.4.5 (ISO 7000, Symbol 2725) | |
| Not Made with or Absence of Natural Rubber Latex | Indicates the absence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device | ISO 15223-1, Annex B (b.2) | |
| 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 and that the user should consult the instructions for use for additional information | ISO 15223-1, 5.2.8 (ISO 7000-2606) | |
| Sterile | Indicates a medical device that has been subjected to a sterilization process | ISO 15223-1, 5.2.1 (ISO 7000-2499) | |
| Sterilized Using Irradiation | Indicates a medical device that has been sterilized using irradiation | ISO 15223-1, 5.2.4 (ISO 7000-2502) | |
| Non-Sterile | Indicates a medical device that has not been subjected to a sterilization process | ISO 15223-1, 5.2.7 (ISO 7000-2609) | |
| Single Sterile Barrier System with Protective Packaging Inside | Indicates a single sterile barrier system with protective packaging inside | ISO 15223-1, 5.2.13 (ISO 7000-3708) | |
| Single Sterile Barrier System with Protective Packaging Outside | Indicates a single sterile barrier system with protective packaging outside | ISO 15223-1, 5.2.14 (ISO 7000-3709) | |
| Keep Away from Sunlight | Indicates a medical device that needs protection from light sources | ISO 15223-1, 5.3.2 (ISO 7000-0624) | |
| Keep Dry | Indicates a medical device that needs protection from moisture | ISO 15223-1, 5.3.4 (ISO 7000-0626) | |
| Temperature Limit | Indicates the temperature limits to which the medical device can be safely exposed | ISO 15223-1, 5.3.7 (ISO 7000-0632) | |
| CE Marking | CE marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing | Regulation (EU) 2017/745, Annex V | |
| UKCA Marking | UKCA marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Great Britain | The Medical Devices Regulations 2002 | |
| Swiss MD Marking | Swiss MD marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Switzerland | Medical Devices Ordinance (MedDO), Annex 5 | |
| Contains potential Type IV chemical allergens | For any medical glove where chemical ingredients such as accelerators, antioxidants and biocides are added during the manufacturing or already known to be present in the product and there is a residual risk of causing Type IV allergy | BS EN 455-3, 4.6 (b) |
Note: not all symbols necessarily appear on every product. The information on the respective product packaging and in the accompanying instructions for use always prevails.