ISO 15223-1:2021—Medical Devices Symbols
Symbols on medical devices are crucial for patient safety, regulatory compliance, and effective communication, allowing for clear and concise information across different languages and cultures. ISO 15223-1:2021—Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements covers the internationally recognized symbols used to express information on medical devices.
Symbols on Medical Devices
Medical device manufacturers and others in the supply chain must provide specific information on the medical deviceitself, as part of the packaging, or in the accompanying information. This information can be provided as symbolsthat have a specific meaning to convey essential information about the device, such as warnings, precautions, manufacturing date, batch code, catalog number, expiry date, unique device identifiers, and usage details. This information is critical not only for the safety of the user but also for legal compliance.
ISO 15223-1:2021 specifies internationally recognized symbols for the provision of this specific information.
What Is ISO 15223-1?
ISO 15223-1:2021 specifies symbols used to express information supplied for a medical device. This international standard is applicable to symbols used in a broad spectrum of medical devices that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The use of symbols allows for a consistent portrayal of information.
ISO 15223-1:2021 is intended to be used by manufacturers of medical devices who market products in countries where there are specific language requirements; the document can also be used by consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.
The requirements of ISO 15223-1:2021 are not intended to apply to symbols specified in other standards.
Amendment 1 to ISO 15223-1:2021
ISO 15223-1:2021/Amd1:2025 specifies the “addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific.”
The First Medical Device Symbol
The caduceus, a staff with two snakes coiled around it, probably was first used as a medical emblem in the 16th century. In its earliest form, the caduceus appeared as a forked rod with its prongs knotted or crossing to form a loop. Later, the rod was entwined by two snakes with their heads meeting at the top. This symbol originated when Mercury once attempted to stop a fight between two snakes by throwing his rod at them, whereupon they twined themselves around the rod, and the symbol was born.
Today, this symbol has been frequently used as a pharmacy or healthcare company crest. In fact, the caduceus (a staff with two snakes coiled around it) is the official insignia of the United States Medical Corps, Navy Pharmacy Division, and the Public Health Service.
ISO 15223-1:2021—Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements is available on the ANSI Webstore.
