Symbols Glossary

Symbol Standard Title and Designation Number Symbol Title Symbol Reference  Number Symbol 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 requirements Manufacturer 5.1.1 Indicates 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 requirements Date of Manufacture 5.13 Indicates 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 requirements Use-by date 5.1.4 Indicates 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 requirements Batch code 5.1.5 Indicates 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

5.1.6 Indicates 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

5.2.3 Indicates 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

5.2.4 Indicates 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

5.2.8 Indicates 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 requirements Sterile fluid path 5.2.9 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.
  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 requirements Temperature limit 5.3.7

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 requirements Humidity limitation 5.3.8

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 requirements Do not re-use 5.4.2 Indicates 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 requirements Consult instructions for use 5.4.3 Indicates 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 requirements Caution 5.4.4 Indicates 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 requirements Non-pyrogenic 5.6.3 Indicates 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 requirements Drops per milliliter 5.6.4 Indicates the number of drops per milliliter.

Symbols Glossary RG-SYM-Rev 0