Medical practice is increasingly using MEDICAL DEVICES for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL DEVICE USABILITY have become an increasing cause for concern. Many of the MEDICAL DEVICES developed without applying a USABILITY ENGINEERING (HUMAN FACTORS ENGINEERING) PROCESS are non-intuitive, difficult to learn and difficult to use. As healthcare evolves, less skilled USERS including PATIENTS themselves are now using MEDICAL DEVICES and MEDICAL DEVICES are becoming more complicated. The design of the USER INTERFACE to achieve adequate USABILITY requires a different PROCESS and skill set than that of the technical implementation of the USER INTERFACE.
The USABILITY ENGINEERING PROCESS is intended to identify and minimize USE ERRORS and thereby reduce use-associated RISKS. Some, but not all, forms of incorrect use are suited to control by the MANUFACTURER.
The main standard of usability to be used for medical devices intended to be sold to the European market is EN 62366 (Medical devices-Application of usability engineering in medical devices) which is the European harmonized standard adopted from the international standard, IEC 62366.
For medical electrical equipment, there is also the collateral standard EN 60601-1-6. However edition 2010 of this standard (clause 4.2) states that “usability engineering process complying with the IEC 62366 shall be performed”; therefore EN 62366 is adopted as the main standard for demonstration of usability of all medical devices.
The requirements of the standards are the same in the IEC and EN versions, therefore when IEC 62366 is used in the following section; it also applies to EN 62366.
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