Medical devices — Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015)

Summary

The International Electrotechnical Commission (IEC) is a worldwide organisation for standardisation comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardisation in the electrical and electronic fields.

This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks 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.