Standard IEC standard · IEC 62366:2007

Medical devices - Application of usability engineering to medical devices

Status: Withdrawn

· Replaced by: IEC 62366-1:2015 Amended by: IEC 62366:2007/AMD1:2014
Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary.

This International Standard does not apply to clinical decision-making relating to the use of a medical device.


Medical equipment (11.040) General (11.040.01)

Product information

Language: French English

Written by: IEC

International title:

Article no: STD-569082

Edition: 1

Approved: 10/18/2007

No of pages: 209

Replaced by: IEC 62366-1:2015