ISO 15223-1
ISO 15223-1 specifies symbols used to communicate information supplied with medical devices, including symbols placed on devices, packaging, labels, and accompanying information.
Global · ISO 15223-1
ISO 15223-1: What Device Labels Need to Say
The standard specifies symbols for information supplied with medical devices.
Open the video guideWhat you’ll learn
- The standard specifies symbols for information supplied with medical devices.
- A standardized symbol does not automatically remove local wording requirements.
- Before releasing artwork, verify the edition, the intended meaning and the market requirements.
Read the video transcript
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.
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.
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