ISO 15223-1: What Device Labels Need to Say

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Can a symbol replace words on a medical-device label? Sometimes, but that is not a shortcut to one label for every country. This is where ISO fifteen two two three, part one, helps.

The standard specifies symbols for information supplied with medical devices. Those symbols can appear on the device, its packaging or accompanying information, within the standard’s scope.

In practice, bring the label artwork and product documentation together. Identify the information you need to communicate, then confirm that a chosen symbol actually expresses that meaning.

The current base edition is from twenty twenty-one. Amendment one, published in twenty twenty-five, updates the authorized-representative definition and symbol. Keep your artwork library’s version under control.

A standardized symbol does not automatically remove local wording requirements. Acceptance, required languages and supplementary information still depend on the target market and the particular device.

Inspect the actual printed label, not only the design file. Size, contrast, placement and nearby text can change whether important information is easy to find and understand.

Before releasing artwork, verify the edition, the intended meaning and the market requirements. If a representative is identified, the accompanying details must match the properly appointed entity.

Use the standard alongside your product and market requirements. Our glossary explains its role and links to the official edition, amendment and related labeling guidance.

Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.