Hazardous situation

In ISO 14971 thinking, a sequence of events turns a hazard into a hazardous situation, and only some hazardous situations lead to harm. Estimating the probability of each step separately makes the risk estimate easier to defend.

circumstance in which people, property or the environment is/are exposed to one or more HAZARDS [SOURCE: ISO/IEC Guide 51:2014, 3.4]

IEC 82304-1:2016, clause 3.5

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.4) Note 1 to entry: See Annex C for an explanation of the relationship between hazard and hazardous situation. [SOURCE: ISO/IEC Guide 63:2019, 3.3, modified — Note 1 to entry added.]

ISO 14971:2019, clause 3.5

circumstance in which people, property or the environment are exposed to one or more HAZARD(S) [SOURCE: ISO 14971:2007, 2.4]

IEC 62304:2006+AMD1:2015, clause 3.35

Circumstance in which people, property or the environment is/are exposed to one or more hazards.

FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices (August 2026), Section 3, Definitions