Tag: Standards and Guidelines Committee of the Federation of European Ergonomics Societies

Legal status of exoskeletons

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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

Gyula Szabó

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 on PPE Working group meeting April 2015.

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EU

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.

EU

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.

Report PPE Working group meeting April 2015.

Gyula Szabó

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.

Societal Stakeholders’ Toolbox at CEN and CENELEC

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CEN and CENELEC have launched a new section on their website as part of their ongoing efforts to encourage the widest possible range of stakeholders to get involved in standardization activities and help shape the content of European Standards. 


The ‘Societal Stakeholders’ Toolbox’ is aimed in particular at supporting the participation of organizations that are concerned with defending the interests of consumers, protecting the environment, and promoting the health and safety of workers.

Standards, which are documents that set out specifications and other technical information with regard to various kinds of products, materials, services and processes, can have significant impacts on the safety and well-being of consumers and workers, as well as on the wider society and the environment. Enabling organizations representing societal stakeholders to participate in the development of standards helps to ensure that all relevant concerns can be taken into account during the drafting process.

The ‘Societal Stakeholders’ Toolbox’ can be accessed directly from the homepage of the CEN-CENELEC website. It provides practical advice to organizations representing consumers, workers and environmental interests on where to find information about ongoing standardization activities and how they can contribute to the standards development process at national, European and international levels.

The toolbox has been developed by CEN and CENELEC in the framework of their ongoing collaboration with three umbrella organizations that represent the interests of specific interest groups within the European Standardization System.  These organizations are: ANEC (the European consumer voice in standardisation), ECOS (European Environmental Citizens Organisation for Standardisation), and ETUI(European Trade Union Institute – Health and Safety Department).

At national level, many members of CEN and CENELEC are also cooperating with societal stakeholders organizations. Based on existing examples of good practice, CEN and CENELEC are encouraging all of their members (in 33 European countries) to support the active involvement of societal stakeholders in standardization activities and to facilitate this by providing relevant information on their respective websites.

The ‘Societal Stakeholders’ Toolbox’ was officially presented at the CEN-CENELEC New Year Cocktail Reception, which took place in Brussels on 22 January 2014.

Short report meeting about EU directive 89/686/EEC “Personal Protective Equipment (PPE)” Working Group (WG) PPE in Brussels, 11th November 2013

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This meeting was chaired by the
European Commission (DG Enterprise and Industry).

This meeting was chaired by the
European Commission (DG Enterprise and Industry).

On behalf of the Federation of the European Ergonomics Societies Reinier
Hoftijzer attended “EU directive 89/686/EEC “Personal Protective Equipment
(PPE)” Working Group (WG)” working Group (WG). The members of this WG are
experts of national authorities (member states) and representatives of European
standardisation organisations (CEN and Cenelec). Also representatives of branch
organisations (ESF and FEES) and testing institutes are member of this
WG.

As example for this discussion at
this meeting concerns personal fall protection. In particular is an anchor
device, which is an essential part of the PPE, a part of this PPE or is it a
construction part of a building, where this fall protection is used. The
European Directive (89/686) and the European standard (EN 795:2012) are not
clear in this point. Consequently also in the Member States this is treated
different. Most representatives are in favour of a proposal of ESF (European
Safety Federation) that anchor device is a part of personal fall protection
equipment. In the next meeting of this WG the European Commission will give its
opinion on this point.

Another important point on the
agenda was the revision of the PPE directive 89/686/EEC. The impact assessment
report was finished and approved by the European Commission. The new proposal
will be published in December 2013 and it will be a regulation on PPE and not a
new directive. A regulation has a lot of advantages over a directive for the
Member States and the European Commission. The major difference between a
regulation and a directive is that the regulation has no transposition time and
becomes, after adapting by Council and Parliament, straight away national
legislation. So the member states do not have to transpose this European
legislation. The proposal for a regulation on PPE will be put forward to the
Council and the European Parliament. It will be probably on the agenda of the
Greek presidency in the first half of 2014. It will be discussed only at Council
level and in this WG there will be no longer discussion about this new
legislation.

Always a point on the agenda is
the intended use of the PPE. In the past most PPE were for professional use only
but the scope over the last years is extended to non-professional use and also
private use, like bicycle helmets for children. Also the industry places more
and more private and non-professional use PPE’s on the market. It is their
responsibility to put CE marked products on the market. But there always will be
a discussion if it is PPE or another product that is not under this scope of
this WG.

The next meeting of this WG in
2014 will probably be on 8th of April and 18th of September.

CEN-CLC BT WG8 Protective textiles and protective clothing and equipment

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The programming mandate M/509 was adressed by the European Commission to CEN, CENELEC and ETSI on the 18th of September 2012. CEN/CENELEC accepted the mandate on the 8th of November 2012. 

CEN and CENELEC created the Working Group “CEN/CLC BT WG 8 “Protective textiles and personal protective clothing and equipment” with the objective to develop a work programme in response to the mandate. Mr. Henk Vanhoutte (ESF), rapporteur for the PPE sector, was appointed as convenor for this BT WG.

The programming mandate M/509 was adressed by the European Commission to CEN, CENELEC and ETSI on the 18th of September 2012. CEN/CENELEC accepted the mandate on the 8th of November 2012. 

CEN and CENELEC created the Working Group “CEN/CLC BT WG 8 “Protective textiles and personal protective clothing and equipment” with the objective to develop a work programme in response to the mandate. Mr. Henk Vanhoutte (ESF), rapporteur for the PPE sector, was appointed as convenor for this BT WG.
On the 17th of January 2013 a kick off meeting of BT WG 8 was organised at CEN/CENELEC meeting centre in Brussels. Four Tasks Groups were created. The descriptions of the assigned tasks to the different groups are:
Task Group 1: Compatibility of different elements – Technology
Task Group 2: Compatibility of different elements – Integration of the complete system
Task Group 3: Comfort and ergonomics
– Explore existing standards in the field of ergonomics and comfort in order to identify whether recent technology developments and smart integrated protection systems would require further standarisation in this field
Task Group 4: Environmental sustainability and total cost of ownership
On behalf of FEES Mr. R. Hoftijzer participated at the meetings and was secretary of Task Group 3.
Dowload the final report from attachment area below.