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    IEC 60825

    Standard for safety of laser products, including laser-based medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    IEC 60825-1 classifies laser products (Classes 1, 1M, 2, 2M, 3R, 3B, 4) and specifies labeling and protective measures. Medical-laser-specific requirements appear in collateral standards and product-specific particular standards.

    What this means in practice

    Critical for surgical, ophthalmic, and aesthetic laser devices; also referenced for high-intensity LED products.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    IEC·1FDA·1ISO·1
    1. 1
      IEC 60825-1
      Verified
      IECwebstore.iec.ch
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.