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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • White Paper

Safety Standards in Healthcare Robotics

This white paper summarizes the key aspects of the IEC 80601-2-77, Medical Electrical Equipment standard and provides information on the anticipated adoption of the standard by regulators.

Medical robots on an operating table

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.

Related offerings
Medical Devices and Products
  • Capability

Medical Device Performance and Safety Testing
Two men work on robot.
  • Service

Medical Device EMC Testing and Certification