Effectiveness

In usability engineering this is about the user interface, not about clinical effectiveness. A device can treat well and still be hard to use correctly, and the standard keeps the two ideas apart.

accuracy and completeness with which USERS achieve specified goals Note 1 to entry: This is a different concept than 'clinical effectiveness'. [SOURCE: ISO 9241-11:1998, 3.2, modified – Added the note to entry.]

IEC 62366-1:2015+AMD1:2020, clause 3.4

achievement of a clinically significant intended result in a defined portion of the target population when the investigational medical device (3.29) is used within its intended uses and according to its instructions for use, the investigator’s brochure (3.31) and the CIP (3.9), as determined by documented scientific evidence

ISO 14155:2020, clause 3.20

extent to which planned activities are realized and planned results achieved [SOURCE: ISO 9000:2015, 3.7.11, modified — Note 1 to entry has been deleted]

ISO 19011:2018, clause 3.26