Reasonably foreseeable misuse

Manufacturers are expected to identify and control it in risk management and usability engineering, so it cannot be dismissed as the user's fault. It differs from abnormal use, which is a conscious act against normal use that lies beyond reasonable risk control by the manufacturer.

use of a product or system in a way not intended by the manufacturer (3.9), but which can result from readily predictable human behaviour Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and professional users. Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional. [SOURCE: ISO/IEC Guide 63:2019, 3.8]

ISO 14971:2019, clause 3.15

Abnormal use should be distinguished from reasonably foreseeable misuse, which is defined as the use of a product or system in a manner not intended by the manufacturer, but which can result from readily predictable human behavior (ISO 14971:2019(EN)).

MDCG 2023-3 Rev.2, Question 5, footnote 17 (citing ISO 14971:2019)

use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior.

FDA guidance: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026), Appendix 5, Terminology