Safety Priority Strategies

CE marking for personal protective equipment

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The use of personal protection equipment (PPE) should always be viewed as a complement to the adoption of collective preventative measures. With a focus on protective clothing, fabrics and fibres, this article looks at the CE marking for PPE.

PPE refers to any device or measure designed to be used or be available to protect against one or more risks that may threaten the health and safety of an employee.

The use of PPE should act as a guarantee of the effectiveness of preventive measures of a general or planned nature, coupled with established protection protocols and guidelines, since its purpose is not to carry out an activity, but to offer protection against the risks inherent in that activity.

The use of non-certified PPE, which has been modified in a manner not foreseen by the manufacturer, or by an article that has expired or deteriorated, is equivalent to not wearing any protection and being totally exposed to the risk.

Characteristics and conditions of use of PPE

PPE items must be adapted to the conditions in the workplace (prevailing temperature and humidity, concentration of oxygen in the air, etc.), as well as the conditions of the operator (anatomy, physiology, health, etc.) to reduce the element of risk.

When PPE items are sold or available, it is necessary to verify that the instruction manual has been included and that its contents are fully understood in detail and applied.

Remember that the effectiveness of PPE depends in a large part on its proper use and maintenance; therefore, the information leaflet that must be presented by the manufacturer is a fundamental component of the use of PPE, and should include:

  • Name and address of the manufacturer and/or its agent in the European Economic Community
  • Instructions for storage, use, cleaning, maintenance, inspection and disinfection
  • The PPE technical rating, to verify the degrees or classes of protection it offers
  • Accessories that can be used with the PPE and features of suitable spare parts
  • Protection classes appropriate to the different levels of risk and corresponding limits of use
  • Expiration date or shelf life of the PPE or any of its components
  • Type of packaging suitable for transporting the PPE
  • Explanation of the marks, if any
  • Name, address and identification number of the notified control bodies involved in the design of the PPE

Furthermore, this information booklet must be written in clear, precise language and at least in the official language(s) of the destination Member State. In addition, the cleaning, repair and maintenance of PPE must be carried out following the instructions provided by the manufacturer. In the case of deterioration or alterations affecting the instructions, the responsible person must be informed.

After using an item of PPE, follow the advice below:

  • Check that the PPE is in perfect condition
  • Keep in mind its useful life
  • Check before use to detect any faults
  • Study the area where the PPE is to be used to identify any situation that may reduce the effectiveness of its protection
  • Adjust the PPE following the instructions provided by the manufacturer

PPE should only be used for its intended purpose. If several PPE items are used simultaneously, they must be compatible with each other and not interfere with the protection provided individually.

PPE must be used for as long as the wearer is exposed to the risk that required its use.

When there is a risk, the following measures should be taken, according to the Occupational Risk Prevention Law (LPRL) in its article 15 (Principles of Preventive Action):

  • Avoid the risk
  • Evaluate the risk that cannot be avoided
  • Combat the risk at source
  • Adapt the job to the person
  • Replace the danger
  • Plan prevention
  • Place collective protection over and above individual protection
  • Give instructions to staff

The decision to use protective clothing or other protective equipment must be preceded by a risk-assessment process and justification that there is no alternative to avoid it.

PPE is the first line of defence between the person and the risk. PPE does not act on the origin of the risk but on the person exposed to it. It does not eliminate the risks, but is designed to minimise the consequences.

Comprehensive Certification services

Since 1995, AITEX has been a European Notified Body No. 0161 for the application of Directive 89/686/EEC, (now EU Regulation 2016/425), which establishes the essential minimum requirements that must be met by Personal Protective Equipment.Since 1995, AITEX has been a European Notified Body No. 0161 for the application of Directive 89/686/EEC, (now EU Regulation 2016/425), which establishes the essential minimum requirements that must be met by Personal Protective Equipment.

EU Regulation 2016/425 deals with the legal provision that replaces the previous Directive 89/686/EEC, and like it, establishes the minimum health and safety requirements that must be met by the Personal Protective Equipment (PPE) before it can be sold in the European Union.

“PPE does not act on the origin of the risk but on the person exposed to it. It does not eliminate the risks, but is designed to minimise the consequences”

The Regulation categorises PPE according to the type of risk against which it offers protection, according to the following criteria:

  • Category I PPE – Simple design. To protect against a low level of risk
  • Category III PPE – Complex design. To protect against a fatal risk or one that may seriously and irreversibly affects the user’s health
  • Category II PPE – Does not meet any of the above criteria

One of AITEX’s core missions is to guarantee the CE marking for Personal Protective Equipment. The CE marking indicates a product’s conformity and is the visible result of an entire process that includes conformity assessment in a broader sense. The general principles governing the CE marking are set out in Regulation (EC) No 765/2008. This marking indicates that the manufacturer of the product has submitted it to all the procedures that the EU has established with the sole purpose being that it can circulate throughout the EU, guaranteeing the user’s complete safety in any of the 28 EU Member States and Iceland, Norway and Liechtenstein.

The CE marking must be displayed permanently on each item of PPE manufactured in a visible, legible and indelible manner, for the foreseeable duration of its useful life.

Only PPE that guarantees the health and safety of users can be imported, marketed and put into service without endangering the health or safety of other people, pets or goods, when properly maintained and used according to its purpose.

Regulation (EU) 2016/425

As a PPE Certification Body accredited by the National Accreditation Entity (ENAC), AITEX performs quality controls to ensure compliance with the requirements required according to ISO / IEC 17065: 2012 and under Regulation (EU) 2016/425 according to the following Modules.

Module A

Module A internal production control. (Category I). The manufacturer guarantees and declares under its sole responsibility that the PPE satisfies the applicable requirements of EU Regulation 2016/425.

Module B

Module B EU type exam (Category II). It is part of a conformity assessment procedure whereby a notified body examines the technical design of PPE and verifies and certifies that said technical design complies with the requirements of applicable regulations.

Module C2

Module C2 compliance with type based on internal production control in addition to supervised product sampling at random intervals (Category III). The manufacturer guarantees and declares under its sole responsibility that the PPE to which the product control provisions have been applied, complies with the type described in the EU type examination and meets the applicable EU regulation requirements.

Module D

Module D compliance with type based on the quality assurance of the production process. The manufacturer guarantees and declares under its sole responsibility that the PPE in question complies with the type described in the EU type certificate and meets the applicable requirements of the EU Regulation.

As a Notified Body, AITEX certifies that the tested product meets the essential health and safety requirements. The certificate is issued after the corresponding request to the Notified Body by the manufacturer or their authorised representative in the EU.

Electrical risk

Next we will address the evaluation of equipment designed to protect the wearer from the risk of electric shock.

“of all the types of PPE available, the most frequently used are dielectric insulating gloves”

Electricity plays a vital role in our lives. It is present in nearly every work environment and often we forget how dangerous it is and the consequences of a moment’s lack of concentration:

  • •Electric shock and electrocution is when a charge runs through the body, a charge of only 10 milliamps (mA) has a certain degree of risk, and 60 to 75 mA can be fatal
  • After electrocution, the victim may suffer a fatal fall
  • Electricity may cause the ignition of flammable or explosive gases
  • A spark from a short circuit may result in a fire

Two conditions need to be present for electrocution to occur:

  1. A closed conducting circuit
  2. A difference in voltage

Therefore, for a current to flow through the body, the body needs to form part of the circuit and that between the point of entry and exit of the electrical current, there must be a voltage difference.

Body protection

The physical effects of electric shock range in seriousness for an unprotected victim.

Direct physiological effects

These are the immediate consequences of electric shock. The seriousness depends largely on the intensity of the charge and the time of contact. The effects vary from a slight feeling of discomfort at intensities of 1-3 mA to ventricular fibrillation (rapid contraction and relaxation of the heart chambers) at intensities of between 60 and 75 mA. There are many other effects which depend on the intensity of the shock, from burns to cramps and breathing arrest, etc.

Indirect physiological effects

Indirect physiological effects are disorders accompanied by an electric shock and which affect the heart and other organs, produce internal burns or problems with the liver or the nervous system, and which may prove fatal.

Secondary effects

Secondary effects are caused by the involuntary reaction of the shock victim and the work environment. A fall from a height, impact with objects, objects being thrown by the charge, fires or explosions.

Any work which may result in exposure to the risk of electric shock must be identified and the appropriate preventative measures taken. The measures will include the use of different types of PPE against electrical hazards.

PPEs states that any PPE designed to protect against electrical hazards must provide the wearer with adequate insulation against the voltages present in a worst-case scenario for where they will be working.

All materials and components must be selected so that the escaping current, measured through the protective layer at voltages similar to those which may be present in situ, is as low as possible and always below the conventional maximum admissible value.

Further to this, the manufacturer is legally obliged to supply an informative leaflet with every PPE sold, in the language spoken in the country where the item is sold, and which must display the following:

  • The manufacturer’s name and address
  • Storage, use, cleaning, maintenance, inspection and disinfection instructions
  • Performance achieved in the technical testing to verify the degree or class of protection
  • Accessories which can be used and the characteristics of the appropriate replacement parts
  • Appropriate class of protection for different levels of risk and limits of use
  • Date or period of expiry of the equipment or any of its components
  • Type of appropriate packaging for transporting the article
  • Explanation of any marks or symbols the article bears

Of all the types of PPE available, the most frequently used are dielectric insulating gloves, and these must bear a specific label or symbol indicating that they comply with the following, according to IEC 60903:2003:

The equipment available at AITEX to perform this type of evaluation. Two methods are used to study the behaviour of materials and garments for workers at risk of exposure to an electric arc:

  • Open arc method: EN 61482-1-1; ASTM F 2621; ASTM F 1959
  • “Box test” method: EN 61482-1-2

Both methods quantify the damage to the material, caused by the effects of an electric arc, to ensure that the consequences for an operator will not be aggravated by their clothing. The tests evaluate the transmission of heat flow through the material to measure the thermal protection provided by the material. Likewise, the protection of gloves, face shields and harnesses is determined, in this case performing the drop tower test after exposure to the electric arc.

Protection against thermal risks

The device is a life-size mannequin equipped with 131 thermal flow sensors, which is dressed in thermal flow garments and protective clothing to be tested. It is then exposed to an instant flare with a temperature that simulates real conditions in the extreme case of the user. The sensors record the temperature reached on the surface of the dummy, while a computer calculates the expected percentage of pain from first, second and third-degree burns that a person would suffer under similar conditions.

Protection against chemical hazards

Protection against chemical hazards comes from the Man-In-Simulant Test (MIST), according to ASTM F2588-07. With this method, the entry of chemical agents in the form of vapour is evaluated, using Metyl Salicylate (MeS), a mustard gas simulator, through the protective clothing consisting of suits, gloves, shoes and respiratory and interconnection devices, when worn. Evaluation and certification of protective gear against:

  • Chemical liquids (type 6, 4 and 3)
  • Solid particles (type 5)
  • Chemical liquids and gases, including aerosols and particles (types 2 and 1)

Protection against falls from a height

AITEX is certified by the UIAA (International Climbing and Mountaineering Federation), and is an active member of the European Co-ordination of Notified Bodies, Vertical Group No. 11 (Protection against falls from heights).

The Institute tests ropes, harnesses, climbing harnesses, anchor device type A, B, C and D. Anchoring components, flat belts, mooring elements, connectors, carabiners and energy absorbers, among others. Of particular importance is the Institute’s large 18 horizontal dynamometer and the fall tower.

Protection against cold and cool environments

Certification of protective clothing and gloves according to EN 342 and EN 511, and evaluation against inclement weather according to EN 14058. The tests include both structural characteristics, as well as general and specific requirements:

  • Thermal insulation
  • Water penetration
  • Air permeability
  • Water vapour resistance

Ballistic protection

AITEX has ballistic and stab test laboratory, certified by ENAC (file 12LE / 025) which is capable of testing bulletproof vests, helmets, vehicle armour, bulletproof glass etc. Tests to be carried out according to international regulations and to the conditions that the client specifies.

The laboratory has a high-speed camera to view the behaviour of the material when the projectile hits. In addition, a yaw angle-measuring device verifies the angle of the projectile at the moment of impact and a scanner takes precise measurements of the traumas produced.

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AITEX

The Textile Industry Research Association – AITEX, is a private research association which performs characterisation trials and certification of textile materials and articles for a wide range of sectors including interior design, fashion, work wear, healthcare, sports and leisure, land and sea transport, aerospace and sports surfaces. The AITEX’s core objective is to create and transfer knowledge of textiles to the private sector, making the textile industry more competitive and opening up doors to new opportunities with a high added-value factor. The Institute promotes modernisation and the introduction of emerging technologies through its on-going R+D activities and other projects which contribute to the evolution of the textile industry, and issues the most appropriate product certifications to allow an article to compete in the international marketplace and facilitate its introduction into high-end niche markets.
AITEX is Spain’s leading research and innovation centre and provider of advanced technical services to the textile industry. The Institute has a network of nine international offices providing cover for its associates and clients in fifty countries, and this has led to the Institute becoming one of Europe’s leading research centres. AITEX research work has culminated in the signing of several bilateral agreements with centres from around the world to exchange experiences, participate in international R+D projects and generate know-how to provide the private sector with a value-added factor for their products.
The Institute’s laboratory service offers its members the most up-to-date equipment and infrastructure for the characterisation of products, QA and certification to the most demanding international standards and regulations and AITEX is one of Europe’s best equipped centres, with the widest scope of technical accreditation facilities with ENAC – ILAC approval, the national and European accreditation bodies.

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