AAMI News June 2018

Standards Spotlight: Danger, Will Robinson! Standards Developers Work to Enhance the Safety of Medical Robots

The media and popular culture have presented robots in many creative ways, including speculation about the adverse effects on humanity if artificially intelligent robots were to “gain consciousness.” While such concerns remain the purview of science fiction, safety issues related to robots have been on the minds of standards developers for decades, culminating in two new standards for medical robots expected in 2019.

Industrial robots, which have traditionally been separated from humans by placing them in work cells, are regulated under the International Organization for Standardization (ISO) safety standards ISO 10218-1:20111 and ISO 10218-2:2011. However, during the 1990s, mobile robotics started being considered for applications when the robot was required to travel instead of being in a fixed location. However, safety considerations for these applications were not seriously considered until 2005, when ISO convened an advisory group to explore the standardization needs for these emerging “service robots.” The recommendations from the advisory group led to the creation of new working groups and several new robot safety standardization projects.

One of these activities, in 2006, was to start developing safety requirements for personal care robots where close human-robot interaction was essential. This in turn led to consideration of medical and nonmedical robot applications. During this period, the intelligence capabilities of robots started to become an important focus, to the degree that the definition of “robot” was updated to: “Programmed actuated mechanism with a degree of autonomy, moving within its environment, to perform intended tasks.”

The “degree of autonomy” is an essential attribute that all robots, including medical robots, are deemed to possess. Autonomy is further defined as the “ability to perform intended tasks based on current state and sensing, without human intervention.”

For medical robot standardization, the involvement of the International Electrotechnical Commission (IEC) was important because of the experience in medical electrical equipment standardization within IEC TC 62 (Electrical equipment in medical practice). This involvement allowed medical robot standardization issues to be integrated within the existing and evolving IEC 60601 series of medical device standards, which address the safety and essential performance of medical electrical equipment.

A joint working group (JWG 9) was formally created in 2011 between ISO TC 299 and IEC TC 62/SC 62A, in order to focus on “collateral-like” safety standardization issues for medical electrical equipment and systems using robotic technology.

Although the work started by focusing on how robotics could be adopted into medical applications, issues related to degree of autonomy are now driving standardization efforts. However, a significant group of experts still believed that robotics introduced other basic safety and performance issues, especially for particular types of medical robots. In view of this, IEC/TC 62/SC 62D and ISO/TC 299/JWG 5 decided to address the particular standardization issues for specific medical robots by focusing on surgery and rehabilitation applications.

AAMI administers the secretariats for both IEC/SC 62A and IEC/SC 62D. In this way, AAMI coordinates the medical/health side of the robotic standardization within the three areas of joint work. For the two joint working groups with IEC/SC 62D that were set up, namely JWG 35 (medical robots for surgery) and JWG 36 (medical robots for rehabilitation), their work program included the following standards:

IEC 80601-2-77: Medical Electrical Equipment—Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
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

Both standards should be finalized by the end of 2018 or early 2019. AAMI’s adoption of these two standards as American National Standards is expected in 2019.

This article was excerpted from a column by Gurvinder Singh Virk, PhD, technical director at Innovative Technology & Science Ltd. in Cambridge, UK; Kiyoyuki Chinzei, PhD, deputy director of the Health Research Institute in the National Institute of Advanced Industrial Science and Technology in Tsukuba, Japan; and Michel Brossoit, medical technical advisor at the CSA Group in Toronto, Canada that was published in the March/April 2018 issue of BI&T, www.aami.org/bit.

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