Symbols Glossary

SymbolStandard Title and Designation NumberSymbol TitleSymbol Reference  NumberSymbol Description
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsManufacturer5.1.1Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Authorized representative in the European Community

5.1.2

Indicates the Authorized representative in the European Community.

 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsDate of Manufacture5.13Indicates the date when the medical device was manufactured.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsUse-by date5.1.4Indicates the date after which the medical device is not to be used.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsBatch code5.1.5Indicates the manufacturer’s batch code so that the batch or lot can be identified.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Catalogue number

5.1.6Indicates the manufacturer’s catalogue number so that the medical device can be identified.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Sterilized using ethylene oxide

5.2.3Indicates a medical device that has been sterilized using ethylene oxide.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Sterilized using irradiation

5.2.4Indicates a medical device that has been sterilized using irradiation.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Do not use if package is damaged

5.2.8Indicates a medical device that should not be used if the package has been damaged or opened.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsSterile fluid path5.2.9Indicates 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.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Fragile, handle with care

5.3.1

Indicates a medical device that can be broken or damaged if not handled carefully.

 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Keep away from sunlight

5.3.2

Indicates a medical device that needs protection from light sources.

 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsTemperature limit5.3.7

Indicates the temperature limits to which the medical device can be safely exposed.

 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsHumidity limitation5.3.8

Indicates the range of humidity to which the medical device can be safely exposed.

 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsDo not re-use5.4.2Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsConsult instructions for use5.4.3Indicates the need for the user to consult the instructions for use.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsCaution5.4.4Indicates 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.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsNon-pyrogenic5.6.3Indicates a medical device that is non-pyrogenic.
 ISO 15223-1:2016(E): Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsDrops per milliliter5.6.4Indicates the number of drops per milliliter.

Symbols Glossary RG-SYM-Rev 0