Correct use

IEC 62366-1 splits use into correct use, use error and abnormal use. Not following the instructions counts as a use error only when the device then behaves differently than intended or expected.

NORMAL USE without USE ERROR Note 1 to entry: Deviation from instructions for use is only considered USE ERROR if it leads to a MEDICAL DEVICE response that is different than intended by the MANUFACTURER or expected by the USER. Note 2 to entry: Figure 1 shows the relationships of the types of use.

IEC 62366-1:2015+AMD1:2020, clause 3.3