ABSTRACT
Increasingly, robotic devices are used in the field of neurorehabilitation; these so-called rehabilitation robots are used to provide motor training and physical therapy. In the context of regulation, these are medical devices, and among others, the standards for Medical Electrical Equipment apply (the IEC 60601 series of standards). Due to the medical applications, the connection of such robots with the patient, and the exchange of mechanical power between robot and human, the formal safety of such robots is a complex issue. This chapter tries to clarify the basics of this regulatory environment. It also reports on the newly expected standard that specifically applies to such devices: the IEC 80601-2-78 on RACA robots: Robots for Rehabilitation, Assessment, Compensation, or Alleviation, related to the patient’s movement functions following an impairment.
