ISO 15223-1

What is ISO 15223-1?

ISO 15223-1:2021 specifies symbols used to express information supplied for medical devices across different regulatory environments. The symbols may appear on the device, its packaging, or accompanying information.

The standard helps manufacturers communicate recurring concepts consistently, but its scope does not extend to symbols governed by other standards. It should be used together with the product-specific and market-specific requirements that apply to the device.

What is the current version of ISO 15223-1?

The current base edition is ISO 15223-1:2021. Amendment 1:2025 adds a definition for “authorized representative” and modifies the authorized representative symbol so it is not specific to one country or region.

Artwork libraries, labeling specifications, and controlled templates should identify both the 2021 base edition and the 2025 amendment where applicable.

Can ISO 15223-1 symbols replace written label text?

Not automatically. Whether a symbol is accepted without explanatory text depends on applicable regulations, recognized standards, product requirements, and the target market. Required languages, label content, importer or representative details, and instructions for use remain jurisdiction-specific.

For example, manufacturers should separately assess Brazil ANVISA labeling, Mexico COFEPRIS labeling, and Singapore HSA labeling rather than assuming one global label is sufficient.

How does ISO 15223-1 relate to ISO 20417?

ISO 15223-1 provides standardized graphical symbols. ISO 20417 addresses the broader information manufacturers supply, including identification, labels, packaging information, markings, and accompanying documentation. A labeling program may use symbols from ISO 15223-1 to communicate information required under ISO 20417 or applicable regulation, but the standards are not interchangeable.

What should manufacturers verify before using a symbol?

Confirm that the symbol’s meaning matches the intended information, that the current artwork is used, and that its size, placement, contrast, and surrounding context remain legible. The manufacturer should also verify regional recognition and determine whether supplementary wording is required.

When an authorized representative symbol is used, the accompanying name and address must correspond to the properly appointed entity. See Pure Global’s EU Authorized Representative guidance for the related EU role.