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 mitigateRISKS 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.
