What is BS EN ISO 15223-1:2021 about?

When medical device information is conveyed in multiple languages it can cause confusion and delays locating the right version; problems with translation, design and logistics; and additional costs for manufacturers.

As an alternative, BS EN ISO 15223-1:2021 is a well-established international standard that supplies precisely defined and internationally recognized symbols that convey the necessary information and are for use on or with medical devices.

Who is BS EN ISO 15223-1:2021 for?

• Medical device manufacturers
• Healthcare professionals and institutions needing to familiarize themselves with the meaning of specific symbols
• Distributors of medical devices or other representatives of manufacturers
• Healthcare providers responsible for training, as well as those being trained
• Healthcare regulatory authorities, testing organizations, certification bodies and other organizations responsible for implementing regulations affecting medical devices and with responsibility for post-market surveillance and vigilance

Why should you use BS EN ISO 15223-1:2021?

Medical device manufacturers and others in the supply chain must provide specific information that's essential to the safe and proper use of the medical device. Symbols can be used to convey that information without the need to translate text into multiple languages. BS EN ISO 15223-1:2021 provides internationally recognized symbols for this purpose.

The standard provides clear, validated symbols. Its use can save significant costs and labelling space, and prevent the need for costly translations or labelling changes. As the symbols are recognized internationally, a single symbol should be accepted in all regions. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.

NOTE: The requirements in this standard are not intended to apply to symbols specified in other standards.

What's new about BS EN ISO 15223-1:2021?

This is a revision of BS EN ISO 15223-1:2016. Several new symbols have been added to BS EN ISO 15223-1:2021 and the definition of existing symbols updated, taking into account manufacturer and user needs and the evolving regulation of medical devices.

BS EN ISO 15223-1:2021 contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages because it supports the safe use of medical devices.