PPE protects its intended user against one or more hazards.
Exposure to hazards may lead to injury. 3 Categories have been defined, depending on the degree of the risk
- category I = less serious injuries
- category II = summarising the remaining degrees of seriousness of injuries. (so no Cat I or III)
- category III = very serious injuries leading to irreversible harm to health and/or death)
In function of those categories, the manufacturers or their legal representative in the EU have to follow a strick prodecure to put into the European market their PPE
- category I = simple design : declaration of conformity by the manufacturer on his own responsibility. So he has to confirm 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.
- category II = declaration of conformity by the manufacturer after a notified body has drawn up an EC type-examination certificate for a PPE model
- category III = declaration of conformity by the manufacturer after a notified body has drawn up an EC type-examination certificate for a PPE model and after a notified body (either the same one that drew up the EC type-examination certificate or another one) has carried out the quality control of the PPE manufactured
- 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 Notified Body.
- Secondly, the manufacturer must choose between:
- either the ‘EC quality control system for the final product
- or the ‘system for ensuring EC quality of production by means of monitoring’.
Only after having completed the appropriate certification process, the manufacturer (or his authorised representative in the EU) must affix the CE marking to the PPE (or a shortage of place ). The CE marking must be ‘visible, legible and indelible’ throughout the expected life of the PPE.