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 Personal Protective Equipment (PPE)

Personal Protective Equipment (PPE)

About personal protective equipment

Personal protective equipment (PPE) aff ords the user protection from hazards encountered at work, at home or during leisure activities. In the professional context, they are instruments for achieving what the EU considers a fundamental right, that of health and safety in the workplace.

 

European Union policy with regard to PPE is aimed to defi ne the basic health and safety requirements to be fulfi lled by manufacturers and remove barriers to trade in these products within the internal market.

 

The presence of the CE marking on PPE is an indication that it meets these harmonized requirements and can be sold anywhere in the European Economic Area (made up of the EU countries plus Norway, Iceland and Liechtenstein) as well as in Turkey. This also applies to products manufactured in third countries.

 

CE marking and the Directive on Personal Protective Equipment

Directive 89/686/EEC defi nes PPE asany device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

 

The Directive makes a distinction between PPE of simple design, complex design and neither of these, the last being the third Category. Whilst the Directive does not explicitly define

these three groups as Categories, it is common practice to use the terms category I, III and II respectively. Category I is listed in Article 8.3 and consists of products designed to protect the user against gradual or unexceptional risks. They includes, among other things, sunglasses, gardening gloves and thimbles. Category III is listed in Article 8.4 and includes for example emergency equipment for use in very high or very low temperatures, respiratory devices and PPE to protect against falls from a height. Category II PPE includes PPE not defined in the above two Articles.

 

The Directive does not apply to PPE designed for use by the armed forces and police, for self-defence or for rescue operations on aircraft or ships. It also does not apply to helmets or visors intended for users of two or three-wheeled motor vehicles, or PPE for simple private use such as umbrellas or dish-washing gloves.

 

The health and safety requirements that PPE must meet in order to be sold in the EU are set out in detail in Annex II of the Directive.

 

On the road to CE markingconformity assessment

The manufacturer (or his authorised representative established in the EU) has the obligation to put together technical documentation regardless the category of PPE. The content of this documentation is prescribed in Annex III.

 

To confi rm that PPE of simple design complies with the safety requirements of the Directive, the manufacturer is required to complete the EC Declaration of Conformity only.

 

For PPE of categories II, III, a two-stage conformity assessment procedure must be followed. Firstly, the PPE must undergo the EC type-examination, which is carried out by a Notifi ed Body. Secondly, the manufacturer must choose between either the EC quality control system for the fi nal product, or the system for ensuring EC quality of production by means of monitoring. The details of these two options are set out in Article 11 of the Directive.

 

Once the appropriate certification process has been completed, the manufacturer (or his authorised representative in the EU) must affix the CE marking to the PPE. If for practical reasons the marking cannot be affixed to the PPE itself, it can appear on the packaging. Where appropriate, the CE marking must be accompanied by the identify cation number of the Notified Body involved in the conformity assessment process. The CE marking must be visible, legible and indelible throughout the expected life of the PPE.

 

Finding the relevant European Harmonised Standards

The first step a manufacturer should take to ensure that PPE will be compliant with the Directive is to check which European Harmonised Standards are applicable. A list of harmonized standards for PPE can be found on the European Commission’s Enterprise and Industry website.


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