Masterclass with Kiyoyuki Chinzei

28 October, 2019,
Institute of Advanced Studies, UWA
Postgraduate Students, Early Career Researchers, Academics, Professional Researchers


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The 101 of IEC 60601s: Safety of medical electrical equipment for university researchers and ‘Makers’

An IAS masterclass with Kiyoyuki Chinzei, Deputy Director of Health Research, National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan and 2019 UWA Robert and Maude Gledden Senior Visiting Fellow.

IEC 60601 series standards define requirements that all medical electrical equipment must comply with to be sold on the market. From a digital thermometer for the home, to a heavy particle accelerator facility, manufacturers must design, maintain, and manage their products to fulfill IEC 60601s. But IEC 60601s are not just for companies. Knowing IEC 60601s are useful for university researchers who develop research tools and students who love to ‘Make’ electric gadgets that can be applied to human or animal bodies.

In this masterclass we will discuss the following:

  • Safety: Definition of ‘safety’, ‘risk’, ‘hazard’ etc.
  • Medical device safety: types of hazards, biological, electrical, mechanical, other physical, human factors.
  • Standards for medical device safety.IEC 60601 series: safety of medical electrical equipment (MEE).
  • Single fault safety: some fault (failure, malfunction) conditions are assumed to happen.
  • Patient environment: Most likely MEE are not used alone.
  • How safety is affected when two MEE are simultaneously connected to a patient?
  • Leak current: for MEE, current matters, not voltage.
  • Mechanical, thermal and other safety issues.Human factors, software factors.

This masterclass is aimed at researchers in the area biomedical engineering, ergonomics, veterinary science, who develop or apply research tools to be used on human or animals.The masterclass will  not focus on spefcific clauses of IEC 60601-1, but will instead examine the ideas behind it, its history and its rationale.

Kiyoyuki Chinzei has been the deputy director of Health Research Institute of AIST (National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan) since 2015. He is also adjunct professor of Tokyo Denki University, and guest professor at the University of Tokyo between 2014 and 2016. He served as project leader of IEC TC 62/SD 62D/JWG 35 (medical robot for surgery) since 2015 and lead the development of IEC 80601-2-77:2019, the safety standard for medical robot for surgery.

Professor Chinzei’s main research accomplishments have been in the fields of biomedical engineering including surgical robotics, MR (magnetic resonance) robotics, biomechanics for surgical assistance, and regulatory science for medical devices. His two early works are still in the interests of many researchers – biomechanics of soft tissues for surgical assistance and MR robotics. He has collaborated with Professor Karol Miller at UWA since the mid-90s and published several papers on biomechanics for surgical simulation, which has over 1500 citations. MR robotics is about the design and control of robot within MRI room, which is quite restricted and ‘unfriendly’ environment for a robot. Chinzei developed the first prototype robot and demonstrated the MR compatibility, that the motion and imaging did not adversely affect each other. His methods to demonstrate the compatibility is still used by researchers.