Symbol glossary
Explanations of the standardized symbols on medical device packaging and labels, per ISO 15223-1.
Manufacturer information
Identifies the manufacturer, date of manufacture and identifying codes.
- Manufacturer ISO reference: ISO 15223-1, 5.1.1
- Indicates the medical device manufacturer as defined in the applicable EU directives.
- Authorized representative in the European Community ISO reference: ISO 15223-1, 5.1.2
- Indicates the authorized representative in the European Community.
- Date of manufacture ISO reference: ISO 15223-1, 5.1.3
- Date on which the medical device was manufactured.
- Batch code ISO reference: ISO 15223-1, 5.1.5
- Indicates the manufacturer's batch code so the batch can be identified.
- Catalogue number ISO reference: ISO 15223-1, 5.1.6
- Indicates the manufacturer's catalogue number so the medical device can be identified.
- Serial number ISO reference: ISO 15223-1, 5.1.7
- Indicates the manufacturer's serial number so a specific medical device can be identified.
Storage and handling
Conditions for safe storage and transport of the medical device.
- Temperature limit ISO reference: ISO 15223-1, 5.3.7
- Indicates the temperature limits to which the medical device can be safely exposed.
- Upper limit of temperature ISO reference: ISO 15223-1, 5.3.6
- Indicates the upper temperature limit to which the medical device can be safely exposed.
- Keep dry ISO reference: ISO 15223-1, 5.3.4
- Indicates a medical device that needs to be protected from moisture.
- Humidity limitation ISO reference: ISO 15223-1, 5.3.8
- Indicates the humidity limits to which the medical device can be safely exposed.
- Fragile, handle with care ISO reference: ISO 15223-1, 5.3.1
- Indicates a medical device that can be broken or damaged if not handled carefully.
- Keep away from sunlight ISO reference: ISO 15223-1, 5.3.2
- Indicates a medical device that needs to be protected from light sources.
Sterilization
Information on sterilization method and protection of the sterile barrier.
- Sterilized using ethylene oxide ISO reference: ISO 15223-1, 5.2.3
- Indicates a medical device that has been sterilized using ethylene oxide.
- Sterilized using irradiation ISO reference: ISO 15223-1, 5.2.4
- Indicates a medical device that has been sterilized using irradiation.
- Sterilized using steam or dry heat ISO reference: ISO 15223-1, 5.2.6
- Indicates a medical device that has been sterilized using steam or dry heat.
- Do not use if package is damaged ISO reference: ISO 15223-1, 5.2.8
- Indicates a medical device that should not be used if the package has been damaged or opened.
- Sterile fluid path ISO reference: ISO 15223-1, 5.2.10
- Indicates the presence of a sterile fluid path within the medical device, in cases where other parts of the device, including the exterior, may not be supplied sterile.
Usage warnings
Important notices for the safe use of the medical device.
- Consult instructions for use ISO reference: ISO 15223-1, 5.4.3
- Indicates the need for the user to consult the instructions for use.
- Do not reuse ISO reference: ISO 15223-1, 5.4.2
- Indicates a medical device that is intended for one single use only.
- Caution ISO reference: ISO 15223-1, 5.4.4
- Indicates the need for the user to consult the instructions for use for important cautionary information.
- Contains or presence of natural rubber latex ISO reference: ISO 15223-1, 5.4.5
- Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging.
MDR identifiers
Identifiers per the EU Medical Device Regulation (MDR) and IVDR.
- Medical device ISO reference: ISO 15223-1, 5.7.7
- Indicates the item is a medical device.
- Unique Device Identifier (UDI) ISO reference: ISO 15223-1, 5.7.10
- Indicates a carrier that contains Unique Device Identifier (UDI) information.
- In vitro diagnostic medical device ISO reference: ISO 15223-1, 5.5.1
- Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.