Normal use

Human factors work looks beyond normal use. Use errors can happen during normal use, and abnormal use and reasonably foreseeable misuse are handled separately in the risk analysis.

operation, including routine inspection and adjustments by any USER, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those MEDICAL DEVICES provided without instructions for use Note 1 to entry: NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, but maintenance, transport, etc. as well. Note 2 to entry: USE ERROR can occur in NORMAL USE. Note 3 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by some authorities with jurisdiction. Note 4 to entry: Figure 1 shows the relationships of the types of use. [SOURCE: IEC 60601-1:2005, 3.71, modified – Notes 2, 3 and 4 to entry have been added, and in the definition ‘OPERATOR’ has been replaced with ‘USER’ and the entire phrase after "instructions for use" has been added.]

IEC 62366-1:2015+AMD1:2020, clause 3.9

Operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use or in accordance with generally accepted practice for those medical devices provided without instructions for use.

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