Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
(IEC 80601-2-78:2019); German version EN IEC 80601-2-78:2020 Class/Status:
VDE Art. No.: 0701309
This particular standard is written at a time when technical evolution of medical robots is in rapid progress and the scientific foundation of safe use is still being expanded. This International Standard is the result of work that began in ISO/TC 184/SC 2/WG 7 in October 2006 on personal care ROBOTS, to address an emerging type of medical robot that was used outside of an industrial environment. That group was working on a new standard, ISO 13482, which was published as an International Standard (IS) in 2014. While initially focused on non-medical applications, WG 7 recognized that work was needed on medical devices utilizing robotic technology. In October 2009, ISO/TC 184/SC 2 established a WG 7, Study Group (SG) on Medical care robots, comprised of experts from Canada, France, Germany, Japan, Korea, Romania, Switzerland, UK and USA.
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