ISO/IEC for a standard on medical robots

Back in February, I took part in the ISO/TC 184/SC 2/JWG 9 work as a national deleguate. This is the standing joint committee of the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC) aiming to develop a new collateral standard for medical robot safety. The rest stands for: 

• TC 184: Technical Committee on Automation Systems and Integration
• SC 2: Sub-Committee on Robots and Robotic Devices
• JWG 9: Joint Work Group on Standard for Medical Robots (with WG 7 & IEC/SC 62A).

Here is the official introduction to the group's intention:

"First, we need to understand what additional hazard a medical robot can give and what is not yet covered within IEC 60601. Currently addressed by IEC 60601 are the mechanical hazards, including the trapping zones such as pinching or guards, the electrical hazards, temperature and other hazards, like disinfection, sterilization and biocompatibility, and software reliability, handled within the overall term of the PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).
The potential missing parts discovered within IEC 60601 are common measures for the accuracy and
repeatability of medical robots. Furthermore, safety factors might be either too restrictive or are missing for dynamic motions and the contact with humans, such as operators or patients, is unique for medical robots compared to industrial robots. Also, medical robots can require a continuous activation for operation but not in any case. Emergency situations and its countermeasures would also be part of the new standard.

The new collateral standard should give guidance with the risk assessment for the above specific topics. The basic safety and essential performance of a medical robot have to be understood.

At the present stage, there are more questions than answers with the following being some of the key issues:

• What are the differences between a robot as a machine or a medical device?
• What are the differences between medical robots and other medical devices?
• How can the risk-benefit balance for patients, versus the risk to operators/third parties in using medical robots to perform intended tasks, be defined?"

The February meeting (at Disney's military resort Shades of Green) was focusing on the proper definitions of automation vs automated function vs autonomy. We tried to keep our focus on the ALFUS concept, developed by an NIST committee. Eventually, we also incorporated in the recommendation an evalobarated version from Kabe and Endslay (2004). Will report here on later advances.
The next round will be in July, Milan. Parallel, a surgical robotics workshop will be orgnaized.