The information provided on medical devices must be correctly understood by every player in the supply chain, whatever language they may speak. For this reason, a range of internationally agreed graphical symbols are used. The standard that defines those symbols has just been updated.
ISO 15223-1, Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements, is a globally adopted document applicable to symbols used across a wide range of medical devices, both on their packaging and within accompanying information. It has recently been updated to improve definitions and descriptions and include new symbols to align with various regulatory requirements.
The standard is designed to be used by manufacturers of medical devices who trade with other countries, so as to ensure consistency and eliminate any ambiguities when portraying information. It can also be useful for consumers of such products, to improve their understanding and allow for more informed product choice.
ISO 15223-1 was developed by ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, whose secretariat is held by ANSI, ISO’s member for the USA. It can be purchased from your national ISO member or the ISO Store.