TS EN ISO 15223-1

TS EN ISO 15223-1 is a core standard for symbols used to present information supplied by the manufacturer for a medical device. It supports consistent, language-independent communication on the device itself, on packaging, and in accompanying information, helping the same message remain understandable across different markets and regulatory settings.

Why symbols matter in medical device information

In general technical terms, symbols are compact visual carriers of meaning. They are especially useful where label space is limited, where products move across languages, or where information must remain legible and uniform across a global supply chain. Their value lies not in decoration, but in reducing ambiguity: a well-chosen symbol can communicate a status, instruction, or handling note more efficiently than text alone. This standard family addresses that communication need for manufacturer-supplied information.

What this part covers

According to the scope, this document applies to symbols used for a broad spectrum of medical devices and to products that need to satisfy different regulatory requirements worldwide. The symbols may appear on the medical device itself, on its packaging, or in the accompanying information. The scope also makes clear that symbols defined in other standards are not intended to fall under this document’s requirements simply by association; the origin and intended use of each symbol remain important.

For users, this means the standard sits at the intersection of labeling practice, product identification, and regulatory communication. It helps establish a common visual vocabulary for manufacturer information while preserving the distinction between symbols standardized here and symbols governed elsewhere.

• Addresses symbols for information supplied by the manufacturer.
• Applies to symbols on the device, its packaging, or accompanying information.
• Intended for a broad range of medical devices.
• Relevant to products distributed globally under differing regulatory requirements.
• Does not intend to cover symbols specified in other standards.