IEC62366-1:2015isaninternationalstandardthatspecifiesaprocessforamanufacturertoanalyze,specify,design,verify,andvalidateusabilityasitrelatestothesafetyofmedicaldevices.Thisprocessisintendedtoachievesafeandeffectiveusabilitybyreducinguseerrorsandminimizingrisksassociatedwiththeuseofthedevice.Thestandardemphasizestheimportanceofuserinterfacedesignandhumanfactorsengineeringinthedevelopmentofmedicaldevicestoensuretheymeettheneedsofuserswhilemaintainingsafetyandperformance.Itappliestoalltypesofmedicaldevicesandprovidesaframeworkforintegratingusabilityintotheoverallproductdevelopmentlifecycle.CompliancewithIEC62366-1:2015helpsmanufacturersmeetregulatoryrequirementsandimprovetheoverallqualityoftheirmedicaldevices.
