MedTech Terms
    The authoritative reference
    All terms

    Software Safety Classification

    IEC 62304 classes A, B, C reflecting potential harm from software failure.

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

    Definition

    Per IEC 62304, software is assigned to Class A (no injury possible), Class B (non-serious injury possible), or Class C (death or serious injury possible). The class determines the rigor of required lifecycle activities.

    What this means in practice

    Classification is risk-based and may be reduced by external risk controls. Misclassification (especially under-classification) is a common audit finding.

    Cross-references

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1MDCG·1FDA·1
    1. 1
      IEC 62304
      Verified
      ISOiso.org
    2. 2
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu
    3. 3
      FDA - Software as a Medical Device (SaMD)
      Verified
      FDAfda.gov

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