Symbols

According to the EU Medical Devices Regulation, users / patients are obliged to report serious events with a
medical device to the manufacturer and to the competent authority of the country in which they occurred.

Symbol

Symbol Title

Symbol Description

Standard Reference

Standard Title

Manufacturer

Indicates the medical device
manufacturer (as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

5.1.1

ISO 15223-1:2016 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

Indicates the authorized
representative in the  European Community.

5.1.2

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Date of manufacture

Indicates the date when the medical device was manufactured.

5.1.3

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Use-by date

Indicates the date after which the medical device is not to be used.

5.1.4

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Batch code

Indicates the manufacturer's batch code so that the batch or lot can be identified.

5.1.5

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Catalogue number

Indicates the manufacturer's catalogue number so that the medical device can be identified.

5.1.6

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Serial number

Indicates the manufacturer’s serial number so that a specific medical device can be identified.

5.1.7

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterile

Indicates a medical device that has been subjected to a sterilization process.

5.2.1

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterilized using aspectic
processing techniques

Indicates a medical device that has been manufactured using accepted aseptic techniques.

5.2.2

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterilized using ethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide.

5.2.3

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

5.2.4

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterilized using steam or dry
heat

Indicates a medical device that has been sterilized using steam or dry heat.

5.2.5

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Do not resterilize

Indicates a medical device that is not to be resterilized.

5.2.6

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Non-sterile

Indicates a medical device that has not been subjected to a sterilization process.

5.2.7

ISO 15223-1:2016 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

Indicates a medical device that should not be used if the package has been damaged or opened.

5.2.8

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sterile fluid path

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.

5.2.9

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Fragile, handle with care

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

5.3.1

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Keep away from sunlight

Indicates a medical device that needs protection from light sources.

5.3.2

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Protect from heat and radioactive sources

Indicates a medical device that needs protection from heat and radioactive sources.

5.3.3

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Keep dry

Indicates a medical device that needs to be protected from moisture.

5.3.4

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Lower limit of temperature

Indicates the lower limit of
temperature to which the medical device can be safely exposed.

5.3.5

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Upper limit of temperature

Indicates the upper limit of
temperature to which the medical device can be safely exposed.

5.3.6

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Temperature limits

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

5.3.7

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Humidity limitation

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

5.3.8

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Atmospheric pressure limit

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

5.3.9

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Biological risks

Indicates that there are potential biological risks associated with the medical device.

5.4.1

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

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.

5.4.2

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Consult instructions for use

Indicates the need for the user to consult the instructions for use

5.4.3

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

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.

5.4.4

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Contains presence of natural rubber latex

Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device

5.4.5

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Sampling site

Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container

5.6.1

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Fluid path

Indicates the presence of a fluid path.

5.6.2

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Non-pyrogenic

Indicates a medical device that is nonpyrogenic

5.6.3

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Drops per millilitre

Indicates the number of drops per millilitre.

5.6.4

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Liquid filter with pore size

Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal
pore size.

5.6.5

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

One-way valve

Indicates a medical device with a valve that allows flow in only one direction.

5.6.6

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Importer

To indicate the entity importing the medical device into the locale.

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Patient number

Indicates a unique number associated with an individual patient.

5.7.1

ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General Requirements

Single patient multiple use

To indicate that the medical device may be used multiple times (multiple procedures) on a single patient

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-

Contains human blood or plasma derivatives

To indicate that the medical device contains or incorporates human blood or plasma derivatives

5.4.6

ISO 15223-1:2021 Medical Devices - symbols to be used with information to be supplied by the manufacturer - Part 1: General Requirements

Unique Device Identifier

The UDI symbol is optional. When multiple data carrier are present on the label, the symbol may be used.

5.7.1

ISO 15223-1:2021 Medical Devices - symbols to be used with information to be supplied by the manufacturer - Part 1: General Requirements

Medical device

Indicates that a given product is a medical device.

5.7.7

ISO 15223-1:2021 Medical Devices - symbols to be used with information to be supplied by the manufacturer - Part 1: General Requirements

N/A

An indication placed at the title of a section within the IFU that information has changed.

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Prescription only

Caution: Federal (US) law restricts this device to sale by or on the order of a physician.

-

Requirement for medical products sold in the U.S.

European conformity

CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.

-

Required for products manufactured anywhere in the world that are then marketed in the EU.