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    IEC 82304-1

    Standard for health software products - covering general requirements for product safety.

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

    Definition

    IEC 82304-1 complements IEC 62304 by addressing health software products as standalone products, with requirements covering identification, requirements, validation, accompanying information, and post-market activities.

    What this means in practice

    Particularly relevant for SaMD distributed independently of any specific hardware (mobile apps, web platforms, cloud services).

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    IEC·1FDA·1ISO·1
    1. 1
      IEC 82304-1
      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.