Harmonizing Medical Device Package Labeling Across Markets

Common Symbols and What They Mean

A picture is worth a thousand words. This is especially true in the Medical Device Packaging and Labeling industry. Symbols are an important tool to harmonize medical device packaging labels across markets worldwide, save valuable space while sharing important information and guidelines, and save in translating costs. In order to minimize misinterpretation across markets, symbols have standards in different regions. This graphic shows some of the most common symbols under ISO 15223 and EN 980.

There are seven main symbol categories- Manufacturer Symbols, Storage Symbols, Safe Use Symbols, Sterility Symbols, IVD Specific Symbols, Transfusion Symbols and Others.


Manufacturer Symbols

This category includes any symbol with the product’s manufacturing. It can include when it was made, where, and any product identification data, fall into this category.

 

Storage Symbols

When storing medical devices, elements such as temperature, humidly, and exposure must be considered. These symbols are extremely important to maintain the integrity of the device.

 

Safe Use Symbols

Safe use symbols are warnings to reduce risk to the users. These symbols can significantly reduce the risk associated with many medical devices.

 

Sterility Symbols category

Sterility symbols communicate important information pertaining to the sterile conditions of the product. This could mean how they were sterilized, or warning about conditional use.

 

IVD Symbols

IVD symbols are specifically used on in vitro diagnostic devices and communicate information germane to those product types.

 

Transfusion Symbols

Used on devices that are involved in the transporting of fluids from one place to another.

 

Others

The patient number is the only symbol that falls into the other category.

 

 

Check out our upcoming DEVICE AND DIAGNOSTIC LABELING CONFERENCE and our 6TH SEMI-ANNUAL MEDICAL DEVICE PACKAGING CONFERENCE for a comprehensive and interactive program through a series of case studies, panels and group discussions facilitated by industry, regulatory and end-user perspectives.