Symbols Glossary

The following symbols may be used in Acumed labeling:

  • Manufacturer

    Indicates the medical device manufacturer, as defined by EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. (reference 5.1.1*)

  • Date of Manufacture

    Indicates the date when the medical device was manufactured. (reference 5.1.3*)

  • Use-by date

    Indicates the date after which the medical device is not to be used. (reference 5.1.4*)

  • Authorized representative in the European Community

    Indicates the authorized representative in the European Community. (reference 5.1.2*)

  • Batch Code

    Indicates the manufacturer’s batch code so that the batch or lot can be identified. (reference 5.1.5*)

  • Catalogue number

    Indicates the manufacturer’s catalogue number so that the medical device can be identified. (reference 5.1.6*)

  • Sterilized using ethylene oxide

    Indicates a medical device that has been sterilized using ethylene oxide. (reference 5.2.3*)

  • Sterilized using irradiation

    Indicates a medical device that has been sterilized using irradiation. (reference 5.2.4*)

  • Do not resterilize

    Indicates a medical device that is not to be resterilized. (reference 5.2.6*)

  • Non-sterile

    Indicates a medical device that has not been subjected to a sterilization process. (reference 5.2.7*)

  • Do not use if package is damaged

    Indicates a medical device that should not be used if the package has been damaged or opened. (reference 5.2.8*)

  • Upper limit of temperature

    Indicates the upper limit of temperature to which the medical device can be safely exposed. (reference 5.3.6*)

  • Do not re-use

    Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. (reference 5.4.2*)

  • Consult instructions for use

    Indicates the need for the user to consult the instructions for use. (reference 5.4.3**)

  • Caution

    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. (reference 5.4.4*)

* ISO 15223-1 2nd Ed. 2012-07-01, Medical Devices - Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements

** An eIFU indicator below symbol 5.4.3 indicates the website URL where instructions for use are made available in electronic format.