What is BS EN 15223-1:2012?

BS EN ISO 15223-1 is a revision of ISO 15223-1:2007 and replaces BS EN 980:2008 (symbols for use in the labelling of medical devices). Developed by experts this new revision provides internationally recognized symbols with precisely defined descriptions.

It identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of ISO 15223.

What are the benefits?

• This standard outlines best practice as considered by the regulatory authorities for the essential, safe and proper use of medical devices
• Reduces the need for multiple languages to be included on a single label, as well as delays in production
• Recognises that not all symbols are appropriate for all medical devices, and outlines how to apply each correctly and in line with the European Directive requirements
• Explains the meaning of the symbols required for medical device labelling
• Outlines new symbols that manufacturers or medical professionals may be unfamiliar with
• Can help simplify labelling and help prevent separate development of different symbols
• Using the appropriate symbols can be an important element in risk reduction, a key part of risk management for medical devices

Who should buy it?

• Medical device manufacturers
• Companies distributing medical devices
• Organisations purchasing medical devices
• Health and medical professionals

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