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    Hazard, Hazardous Situation, and Harm

    ISO 14971 distinction underpinning all medical-device risk analysis.

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

    Definition

    A hazard is a potential source of harm. A hazardous situation occurs when people, property, or the environment are exposed to a hazard. Harm is injury or damage to health that results from exposure during a hazardous situation.

    What this means in practice

    Many risk tables conflate these terms. Correctly modeling the chain hazard → sequence of events → hazardous situation → harm is essential for defensible risk control decisions.

    Cross-references

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2AAMI·1
    1. 1
      ISO 14971:2019
      Verified
      ISOiso.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org

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