By Dean Hooper, Principal Human Factors Scientist
FDA Standard: 62366, Medical devices - Application of usability engineering to medical devices
ISO/IEC 62366 lays out a user-centered standard process that may ultimately help medical device manufacturers avoid user errors and maximize usability. Also included in the standard is a framework for the training of intended users and for the device’s accompanying documentation. It has expanded the scope of its preceding standard, which was solely for electrical medical devices (ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability), to include all medical devices. The 62366 standard is often used when applying for a product’s CE marking.