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New International Standards Boon to Personal Care Robotics

Will early certification boost mainstream acceptance or breed false confidence?
By Emmet Cole
14 9 0 3
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January 09, 2014

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, its 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, thats 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 Japans 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.

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If investors dont 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 standardsand this is quite anecdotalwhat Ive 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 Rajans 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 dont have a clear understanding of the basic science behind the human-robot interaction,
explains Scassellati.

Roboticists and other stakeholders dont 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. Its both where the money is and its what
some of these corporate entities would like to orient themselves toward. Its a rapidly growing and very expensive market.

But as robots move from industrial settings into our homes, weve 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 theres 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, thats because we dont have too many things that fall into those consumer electronics categories that arent already automobiles or medical

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devices or airplanes, all of which have their own specific regulatory processes, explains Scassellati.

We dont know what to do with them, to be honest. We dont 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 isnt 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 weve all been very much bullish about. The future in which this type of technology really has a market. All told, I think
its a really good thing, says Osborn.

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

Regarding Scassellatis 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. Its 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

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About the author

Emmet Cole
Emmet Cole has been writing about robots since 2006. Formerly Wired UK's robotics expert,
Emmet's bylines include Wired News, The Economist, BBC Future, and Robotics Trends. He is
particularly interested in commercialization of research and in the ethical, legal, and regulatory
implications of emerging robotic and cyborg technology. Twitter: @emmetcole

Article topics
Consumer & Household Healthcare Medical & Assistive Service Robots News
Technology Healthcare ISO Personal Care Robotics Regulations Robot Law Service
Robotics Technology View all topics

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