This Part of IEC 62366, which is a Technical Report, contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a USABILITY ENGINEERING ( HUMAN FACTORS ENGINEERING ) PROCESS both as defined in IEC 62366-1 :201 5 and as supporting goals other than SAFETY . This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.
NOTE 1 S AFETY is freedom from unacceptable RISK , which is described in ISO 1 4971 . Unacceptable RISK can arise from USE ERROR , which can lead to exposure to direct physical HAZARDS or to loss or degradation of clinical performance.
