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.
Visual designation refers to the graphic symbols on the packaging, as well as within the material that makes up the accompanying documentation. It is very important that these symbols are clear and easy to understand for each user. In the latest version of ISO 15223-1, the changes relate to the improvement of some definitions and descriptions, as well as to the addition of symbols.
ISO 15223-1 is particularly useful to the manufacturers of medical devices who trade with other countries, so as to ensure consistency and eliminate any ambiguities when portraying information. By fulfilling the requirements of this standard, they ensure compliance with legal regulations and uniform labeling at the global level, thus removing language and trade barriers. Also, being informed referring to the guidelines of this standard helps users of medical devices in understanding and recognizing the products they need.