AAMI News January 2020

Standards Spotlight: U.S. Adopts Two Medical Robotics Standards

Medical Robotic Equipment
The U.S. adopts two international standards directed at medical robotic equipment.

2018 BIT March/AprilEnhancing Medical Robot Safety with Standards

To learn more about how standards developers work to enhance the safety of medical robots, see the Setting Standards column in the March/April 2018 issue of BI&T (Biomedical Instrumentation & Technology) titled “Emergence of Medical Robots and Autonomy in Medical Electrical Equipment.”

Two international standards for medical robots are being adopted as American National Standards:

  • ANSI/AAMI/IEC 80601-2-77, Medical electrical equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment.
  • ANSI/AAMI/IEC 80601-2-78, Medical electrical equipment—Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.

These are the first standards that are directed at robotic equipment in the medical/health sector. The International Electrotechnical Commission (IEC) published the international standards in July.

Part 2-77 applies to the basic safety and essential performance of robotically assisted surgical equipment and robotically assisted surgical systems, together with their interaction conditions and interface conditions. Part 2-78 includes the general requirements for basic safety and essential performance of medical robots that physically interact with a patient to support or perform rehabilitation, assessment, compensation, or alleviation related to the patient’s movement functions following an impairment, as intended by the manufacturer.

The growing demand for robotic surgical procedures is expected to lead to growth opportunities for manufacturers of medical robots. Therefore, it is important for manufacturers to comply with regulatory requirements and standards in order to claim their piece of this growing market and to ensure the safety and performance of their cutting-edge products.

AAMI administers the secretariats for the International Electrotechnical Commission (IEC) working groups IEC/SC 62A and IEC/SC 62D, which helped to coordinate the medical/health side of robotic standardization.

Members of two joint working groups with IEC/SC 62D, JWG 35 (medical robots for surgery) and JWG 36 (medical robots for rehabilitation), developed the international standards that are being adopted as American National Standards. U.S. experts, nominated through the AAMI committees, played an important part in the development of these standards.

Pamela Gwynn, a U.S. expert in the JWG 36 working group and principal engineer at Underwriters Laboratories in Raleigh-Durham, NC, said of the two medical robotics standards: “Their adoption and final approval should allow for a consistent global approach for medical robot evaluation and increase patient safety.”

The adopted American National Standards are anticipated to achieve final approval in early 2020.