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.

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.

CEN PPE Sector forum and TC meetings

On behalf of the Federation of the European Ergonomics Societies Reinier Hoftijzer atteneded the CEN PPE Sector forum held in Brussels at 16th of February 2016 and CEN TC/122 WG 14 PPE and Ergonomics meetings in Zoetermeer (NL) last year, and on 21 and 22 of March in Brussels.

Ergonomics, safety and comfort are the three main considerations when designing new Personal Protective Equipment (PPE). PPE mean all the PPE may be worn for Occupational Health and Safety purposes, as well as sports or other recreational activities.

The PPE Sector Forum coordinates European standardization in the PPE field. At the meeting there were 20 persons attending from PPE Industry, PPE testing organization, National Standardization Bodies, CEN and the European Commission (DG Grow and DG Social Affairs and Employment). The role of FEES is to represent the ergonomic aspect of the design and the use of PPE.

The new PPE regulation in replacing the directive 89/686 was approved by the European Parliament on 20th January of 2016. The Council of the European Union adopted, on 12 February 2016, the comprise text on the proposal for Regulation of the European Parliament and of the Council on personal protective equipment and repealing Directive 1989/686/EEC. The next steps should be the signature of the text by the Dutch Presidency of the Council of the European Union and the President of the European Parliament. After approval in March there will be a transition period of two years.

Report PPE Working group meeting April 2015.

The Federation of European
Ergonomics Societies
was represented at the Directive 89/686/EEC
Working group meeting in Brussels, 21 April 2015, by Reinier
Hoftijzer as member of the S&G working group.

The Federation of European
Ergonomics Societies
was represented at the Directive 89/686/EEC
Working group meeting in Brussels, 21 April 2015, by Reinier
Hoftijzer as member of the S&G working group.

To represent ergonomics in European
level is extremely important because the existing PPE Directive will
be replaced by a European PPE regulation. Besides up to date changes
in the legislation it also means that this new regulation has not to
be transformed into national legislation of the European Member
States. By the end of 2014 there was a common Council position. The
final voting in the European Parliament will very soon. It is
expected that the final decision between EU/Commission/Parliament and
final version agreement will be available before summer 2015. There
will be a transition period of at three years (2018).

The Federation of European
Ergonomics Societies
can give opinion regarding the part of the
guidelines concerning Ergonomics. All decisions regarding the new
guidelines have to be taken before the end of 2015.

On behalf of CEN there was also
announced that there will a new proposal for a horizontal TC
(Technical Committee) of CEN and CENELEC under Dutch secretariat
(NNI) about horizontal subjects regarding “Personal Protective
Ensembles and Systems” (also Ergonomics). Also under CEN TC 122
Ergonomics at the meeting in Prague (4 and 5 May) was a decision on a
new WG (Working group) “Ergonomics design and evaluation of
integrated PPE systems”, also under Dutch secretariat (NNI) and
Dutch convenor.

The next meeting will be on 17 November
2015.

PPE – From protection against risks to hazards through protective equipment

3 October 2013 Fribourg/Freiburg, Switzerland
Organisers: Swiss Ergonomics Society (SwissErgo) and the Swiss Occupational Hygiene Association (SOHA)

All ergonomists, occupational hygienist, occupational safety specialists and other
interested persons are invited to actively join our event and submit their proposals.

3 October 2013 Fribourg/Freiburg, Switzerland
Organisers: Swiss Ergonomics Society (SwissErgo) and the Swiss Occupational Hygiene Association (SOHA)

All ergonomists, occupational hygienist, occupational safety specialists and other
interested persons are invited to actively join our event and submit their proposals.

The origin of this meeting was the programming mandate of the EC to CEN CLC BT “in the area of protective textiles and personal protective clothing (PPC) and equipment (PPE), including revision of existing European standards and other standardisation deliverables as appropriate”, where the mandate also includes the “exploring of existing standards in the field of ergonomics and comfort”.