ABSTRACT
In this chapter, we discuss the safety of medical robots, mainly of surgical and rehabilitation robots. The regulatory system and international standards for these robots are explained.
Unlike other robots, medical robots are under regulatory control as medical devices. Although the regulation systems differ by nations and regions, the regulatory bodies in the world aim to harmonize and converge their requirements. IMDRF (International Medical Device Regulators Forum) and the preceding GHTF (Global Harmonization Task Force) have issued key documents, which also define the key technical terms, the Essential Principles, and the role of the safety standards for medical devices.
There are two different sets of safety standards for medical and other robots. We discuss the method to determine which set of standards to apply. Then the forthcoming new standards, IEC 80601-2-77 and 78, are introduced, which are particularly applicable to surgical robots and rehabilitation robots. Since regulation for medical devices precedes over requirements for robots, these particular standards are written as part of the IEC 60601 series for medical electrical equipment. We also discuss the future of medical robot safety on the autonomy, artificial intelligence, and situational awareness.
