Regulatory issues for exoskeletons

Regulatory issues for exoskeletons

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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.

Chapter Contents:

  • Abstract
  • 12.1 Introduction
  • 12.1.1 Exoskeletons: medical–non-medical applications
  • 12.1.2 Machinery exoskeletons
  • 12.1.3 Medical exoskeletons
  • 12.2 Legislation applicable for wearable exoskeletons (medical/non-medical)
  • 12.2.1 In Europe
  • What are directives?
  • 12.2.2 In other parts of the world
  • 12.3 The European directives: application on exoskeletons (non-medical)
  • 12.3.1 The Machinery Directive (2006/42/E)
  • Scope of the Machinery Directive
  • Application of the directive machines on exoskeletons
  • Excluded or not?
  • What if the exoskeleton is considered as a medical device?
  • Division in risk-categories – Annex IV
  • Conformity procedures
  • 12.3.2 The Low Voltage Directive (2014/35/EU)
  • Scope of Low Voltage Directive
  • Conformity procedures
  • 12.3.3 The EMC Directive (2014/30/EU)
  • Scope of EMC Directive
  • Conformity procedures
  • 12.4 Regulation for medical exoskeletons
  • 12.4.1 Standards for medical devices
  • Product standards
  • Process standards
  • Installation and environmental standards
  • In-process standards
  • Safety standards
  • 12.4.2 IEC 60601 standards series
  • Electromagnetic disturbances
  • 12.4.3 Quality management system standards
  • 12.4.4 Programmable electrical medical systems
  • 12.4.5 Biocompatibility
  • 12.4.6 Usability engineering
  • 12.4.7 Recurrent test and test after repair
  • 12.4.8 Home healthcare environment
  • 12.5 New and future standards for medical electrical devices
  • 12.6 Safety aspects for medical electrical devices
  • 12.6.1 Safety aspects of wearable medical electrical devices
  • 12.7 Conclusions
  • References

Inspec keywords: service robots; safety; medical robotics; wearable robots; ISO standards; patient rehabilitation; biomedical equipment

Other keywords: physical assistant robots; medical help; machine regulations; personal care robots; Machinery Directive; harmonised ISO 13482 safety standard; regulatory issues; medical regulations; Medical exoskeletons; wearable exoskeleton robots; motion tasks; Medical Device Directive; medical electrical equipment; safety requirements; safety standards

Subjects: Robotics; Prosthetic and orthotic control systems; Patient care and treatment

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