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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 the regulation says
    IEC 82304-1 specifies requirements for the safety, effectiveness, and security of health software products, particularly those that operate independently of a specific medical device. It emphasizes aspects such as validation, risk management, and the provision of adequate accompanying information to users, aligning with principles found in regulations like the EU MDR and FDA guidance on medical software.

    What this means in practice

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

    Examples

    • A mobile application intended for diagnosing skin conditions using image analysis would fall under IEC 82304-1 as standalone health software.
    • A web-based platform providing dosage calculations for medication, used independently by healthcare professionals, is an example of health software addressed by this standard.
    • Cloud-based software for managing patient records and providing clinical decision support, not tied to a specific hardware device, exemplifies the application of IEC 82304-1.
    Common pitfalls
    • •A common pitfall is assuming compliance with IEC 62304 alone is sufficient for standalone health software, neglecting the broader lifecycle requirements introduced by IEC 82304-1.
    • •Manufacturers often err by not adequately defining the intended use and user profiles for their health software, leading to validation shortcomings.
    • •Another mistake is overlooking the critical post-market surveillance activities specifically for standalone software, which differ from hardware-integrated software.
    • •Underestimating the cybersecurity risks inherent in standalone health software, especially for products connected to networks or cloud services, is a significant pitfall.

    Frequently asked questions

    IEC 62304 primarily focuses on software as part of a medical device, whereas IEC 82304-1 specifically addresses health software that functions as a standalone product, often independent of any particular hardware, extending the scope to a broader range of digital health solutions.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.