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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