EU: International standard EN 15223-1 to replace EN 980 as Europe’s symbols standard for devices
As of 31st January 2013, the familiar and well-used horizontal EU labeling standard for medical devices, EN 980 – which applies to medical devices and in vitro diagnostics across the board – is being replaced with a globally recognized standard: EN ISO 15223-1.
EN ISO 15223-1 – Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied – Part 1: General requirements – has been adopted and published, and is just starting to become available from European standards organizations.
The Europe-adopted international standard, features internationally recognized symbols with precisely defined descriptions. These will be of considerable value to manufacturers marketing globally and of particular interest to medical device manufacturers, designers, production teams and consultants as it
• is harmonized under all three EU medical device directives
• avoids the need and costs for translation by using correct symbols.