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    ISO 15223-1 Symbols

    Recognized graphical symbols for labels, labeling, and information supplied with medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    ISO 15223-1 specifies symbols that express information about a medical device - such as manufacturer, lot number, sterilization method, and use-by date - supporting global label harmonization. The 2021 edition added symbols needed by the EU MDR and IVDR, such as the 'medical device' (MD) symbol, UDI and importer and distributor symbols. Using symbols from the standard is a way to show conformity with labeling requirements without translating text into every language, but some symbols must be explained in the IFU or accompanying documents. FDA allows standard symbols without adjacent text under 21 CFR 801.15.
    What the regulation says
    Regulators like the FDA and those operating under the EU MDR recognize ISO 15223-1 symbols as an alternative to written text on medical device labeling, provided certain conditions are met, to streamline global market access and ensure clear communication of critical information. The standard helps fulfill essential requirements regarding information supplied by the manufacturer, as detailed in EU MDR Annex I, Chapter III, Section 23.

    What this means in practice

    Both EU MDR/IVDR and FDA recognize ISO 15223-1 symbols in lieu of explanatory text under specified conditions, simplifying multi-region labeling.

    Examples

    • A manufacturer uses the "LOT" symbol followed by a unique alphanumeric code to indicate the batch number on a sterile surgical instrument package.
    • The "Do Not Reuse" symbol, as defined in ISO 15223-1, is prominently displayed on single-use catheters to prevent re-sterilization and potential patient harm.
    • A medical device company includes the "Manufacturer" symbol next to its corporate logo on the device packaging to clearly identify the responsible entity.
    Common pitfalls
    • •Failing to provide definitions for symbols in accompanying documentation (e.g., Instructions For Use) can lead to non-compliance.
    • •Using symbols inconsistently across different product lines or regions creates confusion and potential regulatory issues.
    • •Assuming all symbols are universally understood without considering country-specific regulations or user demographics is a common mistake.
    • •Neglecting to keep symbol usage updated with the latest revisions of ISO 15223-1 can result in outdated labeling.
    • •Poor legibility or incorrect placement of symbols on the label can render them ineffective or misleading.

    Frequently asked questions

    While not always strictly mandatory for all products, ISO 15223-1 symbols are widely adopted and recognized by regulatory bodies worldwide, including the FDA and those overseeing the EU MDR. Their use often simplifies compliance and improves global market acceptance.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    ISO·2FDA·1
    1. 1
      ISO 15223-1:2021
      Tier 1 Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Tier 2 Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Tier 1 Verified
      ISOiso.org

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