Hazard

A hazard does not cause harm on its own; a sequence of events has to expose someone to it first. Mixing up hazards, hazardous situations and harms is one of the most common problems in risk files.

potential source of harm (3.3) [SOURCE: ISO/IEC Guide 63:2019, 3.2]

ISO 14971:2019, clause 3.4

potential source of HARM Note 1 to entry: Potential sources of HARM include breach of SECURITY and reduction of effectiveness. [SOURCE: ISO/IEC Guide 51:2014, 3.2, modified – Note 1 to entry has been added.]

IEC 82304-1:2016, clause 3.4

potential source of HARM [ISO 14971:2007, 2.3]

IEC 62304:2006+AMD1:2015, clause 3.9

Potential source of harm.

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

Potential source of harm.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology