F6: Why a standard for usability? IEC 60601-1-6/62366: Usability & Human Factors Part 1 of 2 - Schmidt – (Intermediate)
A background and overview of the IEC 60601‐1‐6 and 62366 Usability standards for medical devices. This two part session addresses how the combined application of the IEC Usability Engineering Standards (IEC/EN 60601-1-6 in combination with IEC/EN 62366) are required in order to demonstrate compliance with IEC/EN 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (both the 2nd and 3rd Editions) as well as collateral standards in the 60601-1 series.
The participant will gain and understanding of how the usability engineering process is a critical element in controlling risks associated with labeling, accompanying documents, training and alarms as well as the operator/device interface. They will also learn how implementation of the Usability Engineering Process will assure the compliance of new devices and understand how to retrospectively assess legacy devices.