The European directive regulating PPE products

Personal protective equipment is equipment protecting the wearer against one or several health- or safety risks. To be able to sell personal protective equipment within the EU you need to follow directive 89/686/EEC, which is the European directive regulating PPE products. The directive regulates requirements regarding function, marking, technical documentation and the CE marking process.

Personal protective equipment is divided, according to the directive, into three categories:

Category I – Protective equipment of simple design protecting against minimal risks where the user himself can assess level of protection. Products from Blåkläder: Rainwear.

Category II – Neither simple nor complex design protecting against intermediate risks. Products from Blåkläder: High visibility garments, protective shoes, protective gloves, kneepads, garments protecting against heat and flame, saw protection.

Category III – Protective equipment of complex design protecting the wearer against mortal danger or serious and irreversible injuries where the user himself cannot identify the risks in sufficient time. Products from Blåkläder: Filter respiratory devices, garments protecting against electric arcs.

Category II and III products are type examined by a notified body and conforms with several different harmonizing standards.

PPE products shall be CE marked to be able to sell them. The CE mark means that a product is type examined and conforms with the requirements for the protective equipment set in the directive 89/686/EC. Consequently, the protective equipment can be sold in all EU and EES countries.

All PPE-products by Blåkläder conforms with the requirements set in directive 89/686/EC.


Standards defining test methods and other requirements are used to verify that a PPE product provides proper protection and can thus be placed on the European market. These standards are developed with the participation of national committees that are co-ordinated by a central organisation. The central organisation for standardisation in Europe is Comité Européen de Normalisation (CEN). Standards developed by or included under CEN are prefixed with “EN”. There are other standardisation organisations, for example, the International Organization for Standardization (ISO). Standards that have been developed by ISO and then adopted as a European standard are prefixed with “EN ISO”.

Personal protective equipment is labelled to show which standard has been used to demonstrate the protective performance of the products. Pictograms are also used on personal protective equipment to provide visual information about the type of protection afforded by the equipment. If there are varying levels of protection against a hazard, the equipment’s labelling will indicate which level of protection it provides.

EN 342

Protective clothing – Ensembles and garments for protection against cold

EN 343

Protective clothing – protection against rain


High-visibility clothing

Personal protective equipment in Category I can be verified using standards, but does not have to be certified by a third party. Personal protective equipment in Categories II and III must, however, be certified by a third party. An accredited test facility, a so-called “notified body”, must test and approve Category II and III products and issue an EU type examination certificate. In addition, an annual quality assurance audit of the manufacturing process for Category III products is required.

All PPE must be correctly labelled, delivered with user instructions, and carry the CE mark.

A manufacturer of PPE must ensure that the products it brings to the market comply with relevant requirements. This is done by issuing a Declaration of Conformity for all personal protective equipment. A Declaration of Conformity is a legally binding document that the manufacturer may be asked to submit to verify that the personal protective equipment complies with all relevant legal requirements.

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