Healthcare Robotics Safety Standards
The International Electrotechnical Commission (IEC) has now published a standard to address the specific performance and safety characteristics of robotically assisted equipment. The standard, IEC 80601-2-77, Medical Electrical Equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment - bridges an important gap in previously available medical device standards.
IEC 80601-2-77 is expected to be adopted in the near future by regulatory authorities in most international medical markets for use in assessing the safety of advanced robotic systems and devices used in surgery.
Our white paper, Safety Testing in Healthcare Robotics, provides an in-depth view of IEC 80601-2-77.