A new ISO safety standard for manufacturers of personal care robots set for publication in 2014 could lead to a rapid rise in sales for low-cost exoskeletons and personal assistant robots in Europe and elsewhere.

ISO 13482 applies to manufacturers of “personal care robots” which allow close robot-human interaction and even robot-human contact.

Currently in the final balloting phase, ISO 13482 was developed by a team of more than 50 nominated experts and observers from 12 countries, and lays out certain safety requirements for manufacturers of robot assistants, personal carriers, and exoskeletons.

The single most important thing required for the widespread expansion of the [personal robotics] market is the development of standards,” says Gurvindar Virk, convenor of ISO TC184/SC2/WG7, the group responsible for ISO 13482 project. (Read our in depth-interview with Virk.)

“The lack of safety standards has prevented small companies from innovating and taking the risk that an accident may occur with their new robotic product. If such an accident did happen, it’s up to the company to prove to a court of law that they have carried out the risk assessment for their product in a sufficiently logical and thorough way. For a small company with limited resources, that’s quite difficult to prove without an ISO standard,” says Virk.

ISO Blueprint Sets Regulatory Tone

The economic effect of ISO 13482 will be felt most in the E.U., where it will be deemed to comply with the E.U.’s Machinery Directive.

In fact, the impact of the new ISO standard, which makes certain safety and design demands of manufacturers, is already being felt elsewhere.

In February, Cyberdyne received a safety certificate for its HAL exoskeleton from Japanese regulators on the basis of its compliance with a draft version of ISO 13482. According to Japan’s Ministry for the Economy Trade and Industry, HAL is the first exoskeleton to receive such certification and other organisations are going through the certification process at present.

Internationally-agreed standards provide companies with roadmaps towards commercialization and inspire confidence in investors, says Venkat Rajan, advanced medical technologies industry manager at analyst firm Frost & Sullivan.

“If investors don’t know exactly what the regulatory standards are going to be, there is going to be uncertainty about making that investment. But if the standards are set in place companies and investors know what is allowed and what is not allowed and can act accordingly,” explains Rajan.

Companies that plan to sell personal care robots globally are likely to default to the most stringent available international standards in their designs, says Rajan.

“In terms of safety standards –and this is quite anecdotal– what I’ve seen is that companies default to the strictest regulation in an established market, whether it be Japan, Europe or the U.S.”

There is some precedent for Rajan’s claim. The European Union for example, restricts the use of certain substances, such as lead, in some electronics devices.

Despite there being no such requirement regarding the use of lead-free electronic components in medical products in the U.S., American companies have defaulted to the more stringent European standard.

“The device manufacturers have found that since all your suppliers and everyone else is switching to lead free, you almost have no choice but to adopt the standard so that you can be joined in with their operations,” explains Rajan.

Although ISO 13482 is aimed at machinery and not medical devices (it applies to personal care robots designed to the quality of life of humans, excluding medical applications), compliance with international and overseas guidelines and standards will remain a pre-requisite of entering foreign markets.

Industry vs. Society

The creation of ISO 13482 standard is “a great start,” but it may give the false impression that care robots are ready for the mainstream, says Brian Scassellati, an associate professor of computer science at Yale and an expert on socially-assistive robotics and human-robot interaction (HRI).

“The impact of stroke rehabilitation robots and our understanding of how these robots can provide support and care is reasonably well understood. There are other areas and populations however, where we don’t have a clear understanding of the basic science behind the human-robot interaction,” explains Scassellati.

Roboticists and other stakeholders don’t have a clear understanding of the roles that care robots should play, the kind of support the robots should or should not provide, and the impact that robot care will have on their users, says Scassellati.

“These are issues we know relatively little about. For this reason, I think early certification could send the message that these areas are ready for wide scale industry development, and this may provide more harm than good,” warns Scassellati, who is involved with the ‘Socially Assistive Robotics’ project, a National Science Foundation funded initiative designed to improve the performance of child-centered care robots.

“Industry has a very clear idea that serving these populations is something that they want to be able to do. It’s both where the money is and it’s what some of these corporate entities would like to orient themselves toward. It’s a rapidly growing and very expensive market.”

“But as robots move from industrial settings into our homes, we’ve become concerned much more with supporting individuals in terms of psychological, cognitive and social tasks. I think they have a great start here for a very specific set of cases which I think are likely to be some of the first ones that industry adopt. I think that there’s a lot of work out there still to do, though.”

While the U.S. has very clear regulatory processes for medical devices and industrial robots, the environment is very different for consumer electronic products, says Scassellati.

“In part, that’s because we don’t have too many things that fall into those consumer electronics categories that aren’t already automobiles or medical devices or airplanes, all of which have their own specific regulatory processes,” explains Scassellati.

“We don’t know what to do with them, to be honest. We don’t have an existing regulatory infrastructure that deals with personal care robots. You can get UL certified, pass a minimum set of electrical certifications, and meet any additional certification standards for toys for example.”

“But there isn’t really an equivalent regulatory standard for these devices in the US right now. There certainly needs to be some regulatory processes put in place.”

Clearing the Way for Innovation

The symbolism of creating a standard for personal care robots is a positive thing, says Jim “Oz” Osborn, executive director and co-founder of the Quality of Life Technology Center at Carnegie Mellon University.

“It validates the future that we’ve all been very much bullish about. The future in which this type of technology really has a market. All told, I think it’s a really good thing,” says Osborn.

“The standard could also help ensure sure that people bring these [safety] issues into consciousness as they’re doing R&D,” explains Osborn.

Regarding Scassellati’s concerns, Osborn believes the positives outweigh the negatives.

“Scassellati is right on both counts. You have to ask ‘Are people really jumping the gun here?’ The technology of the robots and our understanding of HRI both have some way to go before these applications become real. So, I can see where one could say ‘It seems kind of early to be doing a standard.'”

“However, I think that the existence of the standard is a good thing. The value of that affirmation transcends the possible negative effects and could lead to very tangible positive effects both in terms of raising that awareness and keeping people honest respecting issues of safety. It’s a net positive,” says Osborn, who notes that many medical robotics companies that started out in Carnegie Mellon start their clinical trials in Europe because of the less stringent regulatory environment.

ISO 13482 is due to be published in January or February 2014.

Also read: Exclusive Interview: Gurvinder Virk Explains Brand New ISO 13482