The emergence of personal care and medical robots?

Industrial Robot

ISSN: 0143-991x

Article publication date: 3 May 2011

1179

Citation

Virk, G.S. (2011), "The emergence of personal care and medical robots?", Industrial Robot, Vol. 38 No. 3. https://doi.org/10.1108/ir.2011.04938caa.002

Publisher

:

Emerald Group Publishing Limited

Copyright © 2011, Emerald Group Publishing Limited


The emergence of personal care and medical robots?

Article Type: Viewpoint From: Industrial Robot: An International Journal, Volume 38, Issue 3

The author

Gurvinder S. Virk is the Chairman of CLAWAR Association Limited, Sheffield, UK

Robotic research in widening applications has been growing since the 1990s yet the robot market has remained firmly focussed on industrial robots. International trade for these “machines” has been facilitated by the development of ISO standards for safety and performance complying with the Machinery Directive (MD: 2006/42/EC) in Europe and corresponding regulations in other regions, with ISO 8373, ISO 9283, ISO 9409, ISO 9787, ISO 9946, ISO 10218-2 being some of the key documents. Since the late 1990s/early 2000s many countries and organisations have switched their focus to developing new robotic markets for “non-industrial robots”, with the term “service robotics” emerging as the collective term for these new types of robots. From around 2005, major efforts have been initiated to facilitate the commercialisation of the new types of robots. The main issue is that the “intended use” as generally accepted for industrial robots, namely to carry out manufacturing tasks in industrial environments, has changed in order to provide services to humans in “any environment”. As industrial robots tend to be large powerful machines they are deemed to be dangerous and so ISO ensures basic safety by physically separating humans from the industrial robot during operation, although the recently revised ISO 10218-1 includes a collaborative mode clause.

Although many research innovations in service robots are being made, there are no internationally agreed basic safety requirements for the situations in which these new robots make physical contact with humans, or for the robots to apply any appreciable force to humans in order to perform their intended use (e.g. to assist a person in lifting a load). In addition, there are no agreed protocols for robots to perform invasive operations needed in carrying out medical procedures. In order for robot manufacturers to produce and commercialise the new types of non-industrial robots currently being prototyped, it is essential for the development and adoption of an international basic safety standard allowing robots and humans to closely interact safely with each other. ISO TC 184/SC 2/WG 7 (personal care safety), chaired by myself, is studying the emerging area of personal care robots (currently defined to be a service robot with the purpose of aiding actions or performing actions that contribute directly towards improving quality of life for individuals). Three types of personal care robot have been defined, namely, mobile servant robot, person carrier robot, and personal assistant robot. The main work has been in developing an appropriate risk-assessment process for the various personal care robots. These new robots will be still governed under the MD, and the work is progressing well with the basic safety requirement expected to be published as ISO 13482, in 2012. This essential work will extend the basic safety to personal care robots, consistent with the Machinery Directive, and paves the way for developing the standardization documents for medical robots.

A study group on medical care robots was set up by WG 7 in October 2009, and this has been working closely with IEC TC 62 (electrical equipment in medical practice), which formulated most of the international standardization documents for electrical medical equipment with IEC 60601-1 being the key document complying with the Medical Device Directive (MDD: 2007/47/EC). It is clear that medical robots will need to comply with IEC 60601-1 and hence it is essential to identify which clauses will apply and which will not. There is much work still to do for this but it is important to realise is that compliance will need to be under the MDD rather than the MD; meaning that basic and essential performance requirements need to be formulated for medical robots. The work is in its early phases and it is expected that the standardization documents for medical robots will fit the IEC 60601 family of standards. These standards are of two types; generic (or collateral) and particular. It is not clear if there will be a collateral standard for medical robots that will be applicable to all types. To date, a number of different types of medical robots have been defined including surgical, diagnostic, treatment, and rehabilitation robots.

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?

I believe it is vitally important that all the relevant stakeholders be fully engaged in this standardization work to facilitate the development and international market for medical robots. Normally, it is the industrial partners directly affected who collaborate to develop the international standards required for a particular sector, but the industrial critical mass is insufficient to do the work for medical robots. Hence, a much wider range of stakeholders is needed, namely, researchers, clinicians, regulatory and government bodies, to work with industry to produce the basic safety and essential performance document for medical robots.

We can all assist in these endeavours, as IEC SC 62A (common aspects of electrical equipment used in medical practice) and ISO TC 184/SC 2 (robots and robotic devices) is currently proposing to establish a new Joint Working Group (JWG) on safety for medical devices using robotic technology with me as the convener. The JWG will develop general requirements and guidance related to the safety of medical electrical equipment and systems that utilize robotic technology. National committees are being asked to indicate their support for the formation of the JWG by 22 April 2011, and if they agree, to nominate their national experts to join the JWG. We as individuals can all get involved in this important work and I urge you to express your interest to your national ISO/IEC bodies by this date so that the results produced will be as complete and robust as possible.

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