This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.
Risk categories of PPE
Category I includes exclusively the following minimal risks:
- superficial mechanical injury;
- contact with cleaning materials of weak action or prolonged contact with water;
- contact with hot surfaces not exceeding 50 °C
Category II includes risks other than those listed in Categories I and III.
Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:
- substances and mixtures which are hazardous to health;
- harmful biological agents;
- high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
- low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less; cuts by hand-held chainsaws;
- bullet wounds or knife stabs
Conformity assessment procedures
Category I: internal production control
Category II: EU type-examination, followed by conformity to type based on internal production control
Category III: EU type-examination, followed by conformity to type based on internal production control + conformity to type based on quality assurance of the production process (module D)