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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 May 5, 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.

    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.

    Cross-references

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 15223-1:2021
      Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

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