IEC/EN 60601-1-6 Standard for General Requirements for Medical Electrical Equipment, Essential Safety and Essential Performance

In medical practice, medical electrical equipment is increasingly used for the observation and treatment of patients. Operating errors due to inadequate medical electrical equipment availability have become a growing concern. Most of the medical electronic equipment developed without applying the usability engineering process is not intuitive and difficult to learn and use. As healthcare improves, less skilled operators, including patients themselves, now use medical electrical equipment, while medical electrical equipment itself is becoming more complex. In simpler times, the operator of medical electrical equipment can deal with an ambiguous, difficult-to-use operator-equipment interface. The design of usable medical electrical equipment is a challenging endeavor.

The first and second editions of IEC 60601-1-6 and EN 60601-1-6 defined a usability engineering process tailored to the needs of medical electrical equipment manufacturers. They provided guidance on how to implement and execute the process to improve the safety of medical electrical equipment.

The IEC/EN 60601-1-6 test is intended to be useful not only for manufacturers of medical electrical equipment, but also for technical committees responsible for the preparation of specific medical electrical equipment standards. It should be noted that clinical trials conducted according to ISO 14155-1 and usability testing for verification or validation according to this standard are two fundamentally different activities and should not be confused.

EUROLAB assists manufacturers with IEC 60601-1-6 and EN 60601-1-6 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories.