Harm

Harm is the end of the chain that starts with a hazard, which is why risk is defined from the probability and severity of harm. Many risk files focus on harm to patients and forget users, bystanders and property.

injury or damage to the health of people, or damage to property or the environment [SOURCE: ISO/IEC Guide 63:2019, 3.1]

ISO 14971:2019, clause 3.3

injury or damage to the health of people, or damage to property or the environment [SOURCE: ISO/IEC Guide 51:2014, 3.1]

IEC 82304-1:2016, clause 3.3

physical injury, damage, or both to the health of people or damage to property or the environment [ISO 14971:2007, 2.2]

IEC 62304:2006+AMD1:2015, clause 3.8

Injury or damage to the health of people, or damage to property or the environment.

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

Physical injury or damage to the health of people.

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

The human factors guidance includes damage to property or the environment. The 510(k) change guidance limits harm to physical injury or damage to the health of people.