TS EN ISO 15223-1

TS EN ISO 15223-1 is the general-requirements standard for the symbols used on medical device labels, labelling, and information supplied with the device. Its focus is the controlled use of symbols that communicate information needed for the safe and effective use of medical devices, together with a list of symbols that meet those requirements.

Why medical device symbols matter

In medical device communication, symbols help reduce language dependence and make essential information easier to recognise at a glance. They are commonly used to convey handling instructions, storage conditions, traceability details, warnings, and other product-specific information. In practice, well-defined symbols support consistency across markets and help limit the risk of misinterpretation when products are distributed internationally.

What this standard covers

• General requirements for symbols used in medical device labelling
• Symbols that communicate information related to safe and effective use
• A listing of symbols that satisfy the document’s requirements

As general technical context, symbols in this field are typically built on widely recognised graphical conventions and are expected to carry a stable meaning. That stability matters because a symbol is not just a graphic mark; it is a compact information carrier that must be interpreted consistently by manufacturers, users, and other stakeholders. This standard provides the common framework for that shared interpretation.

This record refers to the corrected version of the 2016 edition and is now withdrawn, but it remains relevant as a reference point for understanding the structured use of symbols in medical device labelling.