Medical devices – Part 1 Application of usability engineering to medical devices

1 * Scope

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.

NOTE 1 SAFETY is freedom from unacceptable RISK. Unacceptable RISK can arise from USE ERROR, which can lead

to exposure to direct physical HAZARDS or loss or degradation of clinical functionality.

NOTE 2 Guidance on the application of USABILITY ENGINEERING to MEDICAL DEVICES is available in IEC 62366-22,

which addresses not only SAFETY but also aspects of USABILITY not related to SAFETY.

If the USABILITY ENGINEERING PROCESS detailed in this International Standard has been

complied with, then the USABILITY of a MEDICAL DEVICE as it relates to SAFETY is presumed to be

acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.

NOTE 3 Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.