SYMBOL GLOSSARY DEFINITIONS
| SYMBOL | SYMBOL TITLE | DESCRIPTION | STANDARD REFERENCE | STANDARD TITLE |
|---|---|---|---|---|
 | Manufacturer | Indicates the medical device manufacturer | ISO 15223-1 Reference no. 5.1.1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Authorized Representative in the European Community/ European Union | Indicates the authorized representative in the European Community / European Union | ISO 15223-1 Reference no. 5.1.2 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Authorized Representative in Switzerland | Indicates the authorized representative in Switzerland | ISO 20417 Reference no. 6.1.2 (d) | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Importer | Indicates the entity importing the medical device into the locale | ISO 15223-1 Reference no. 5.1.8 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Distributor | Indicates the entity distributing the medical device into the locale | ISO 15223-1 Reference no. 5.1.9 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Country of Manufacture | To identify the country of manufacture of products | ISO 15223-1 Reference no. 5.1.11 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. 5.4.2 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Date of Manufacture | Indicates the date when the medical device was manufactured | ISO 15223-1 Reference no. 5.1.3 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Use-by Date | Indicates the date after which the medical device is not to be used | ISO 15223-1 Reference no. 5.1.4 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. 5.1.5 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Unique Device Identifier | Indicates a carrier that contains unique device identifier information | ISO15223-1 Reference no. 5.7.10 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Medical Device | Indicates the item is a medical device | ISO15223-1 Reference no. 5.7.7 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Catalogue number | Indicates the manufacturer’s catalog number so that the medical device can be identified | ISO 15223-1 Reference no. 5.1.6 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Model Number | Indicates the model number or type number of a product | ISO 15223-1 Reference no. 5.1.10 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Serial Number | Indicates the manufacturer’s serial number so that a specific medical device can be identified | ISO 15223-1 Reference no. 5.1.7 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. A.16 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. 5.4.3 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. 5.4.5 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. Annex B (b.2) | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. 5.2.8 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Sterile | Indicates a medical device that has been subjected to a sterilization process | ISO 15223-1 Reference no. 5.2.1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Sterilized Using Irradiation | Indicates a medical device that has been sterilized using irradiation | ISO 15223-1 Reference 5.2.4 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Non-Sterile | Indicates a medical device that has not been subjected to a sterilization process | ISO 15223-1 Reference no. 5.2.7 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Single Sterile Barrier System with Protective Packaging Inside | Indicates a single sterile barrier system with protective packaging inside | ISO 15223-1 Reference no. 5.2.13 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Single Sterile Barrier System with Protective Packaging Outside | Indicates a single sterile barrier system with protective packaging outside | ISO 15223-1 Reference no. 5.2.14 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Keep Away from Sunlight | Indicates a medical device that needs protection from light sources | ISO 15223-1 Reference no. 5.3.2 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Keep Dry | Indicates a medical device that needs protection from moisture | ISO 15223-1 Reference no. 5.3.4 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | Temperature Limit | Indicates the temperature limits to which the medical device can be safely exposed | ISO 15223-1 Reference no. 5.3.7 | Medical devices — Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements |
 | 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 Reference no. Annex V | REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
 | 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 | 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) Reference no. Annex 5 | Medical Devices Ordinance (MedDO) |
 | 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 Reference no 4.6 (b) | Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |