Legal status of exoskeletons

On the Personal Protected Equipment (PPE) working group meeting 2019 October in Brussels Reinier Hoftijzer on behalf of FEES and Henk Vanhoutte ESF (European Safety Federation) raised the issue of the legal status of exoskeletons. 

Due to functionality, there are three types of exoskeletons:

  • Supportive: redistributing forces on the body or correcting posture to avoid injuries or stress;
  • Reinforcing: adding strength (+ redistribution of forces);
  • Medical/curative: replacing or reinforcing bodily functions.

Due to power, there are two types of exoskeletons:

  • Active exoskeletons include actuators:
    • Electrical motor
    • Hydraulic
    • Pneumatic
  • In passive types, the energy only generated by the movement of the user:
    • Springs
    • Dampers

European Legal framework contains several applicable but not always obligatory reference:

  • Machinery Directive: critical words in definition: “fitted with a drive system other than directly applied by human or animal effort.”
  • Medical Device regulation: critical words in definition: “to be used for diagnostic and/or therapeutic purposes.”
  • Personal Protective Regulation: critical words in definition: “to be worn or held by a person for protection against one or more risks to that person’s health or safety.”

All the skeletons that are at the European Market in use at the workplace are certified (CE-mark) under Medical device regulation. But by definition, it should be under the PPE regulation. Because this presentation was the first about this problem of legislation, we expect more information and discussion soon.

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