November 3, 2020
Clearing global market pathways through the IECEE CB Scheme
With the benefits of robotically assisted surgical procedures, more medical manufacturers are producing surgical assist robots for multiple purposes. These surgeries can include cardiac, endoscopic, spinal, prostate and others. As the usage becomes more widely accepted, the safety and compliance of these devices becomes imperative.
The IEC (International Electrotechnical Commission) recognized the potential risks associated with these products and published a standard to address the basic safety and essential performance requirement for surgical assist robots in 2019. The standard is IEC 80601-2-77:2019, medical electrical equipment — robotically assisted surgical equipment.
UL’s active participation
UL experts actively participated in the IEC Working Group when developing this standard. In October 2020, UL RTP, North Carolina and Fremont, California locations became the first (and to date only) two labs With recognized as CB Testing Laboratories (CBTL) in the US to perform testing under the IECEE CB Scheme for this standard.
UL has been collaborating with several manufacturers of these on medical robotics for many years and has extensive knowledge of both the requirements in IEC 80601-2-77, and equally important understands the “why” behind the requirements.
The US national standard was also published by AAMI in August 2020, with no national deviations for this particular standard.