Regulatory issues for exoskeletons
The chapter presents the safety standards which apply to wearable exoskeleton robots. Wearable robots are either regulated as machines or as medical electrical equipment. The machine regulations are formulated to comply with the Machinery Directive and the harmonised ISO 13482 safety standard has been recently published to present the safety requirements for personal care robots and which includes physical assistant robots. Medical exoskeletons are regulated under the Medical Device Directive and apply to patients needing medical help in carrying out human motion tasks. Both machine and medical regulations of wearable robots are described.
Regulatory issues for exoskeletons, Page 1 of 2
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