Safety of Surgical Robots and IEC 80601-2-77: The First International Standard for Surgical Robots

Abstract

A new standard IEC 80601-2-77 will be issued to establish safety requirements for surgical robots under regulatory control. A new term Robotically Assisted Surgical Equipment (RASE) is introduced to cover a wide variety of mechanical structures, control algorithms, human-machine interface and intended surgical procedures. This article is to introduce the key ideas of this standard, the scope, to what extent this standard will be applicable and some of the specific requirements. The future of surgical robot safety, including the emerging autonomy is also mentioned.