The PPE Directive (EU) 2016/425 intends to help ensure the free movement of personal protective equipment (PPE) in Europe by laying down all essential safety requirements that PPE must fulfil so that users’ health protection and safety is ensured. Gloves, face masks or shields, laboratory coats, safety goggles, and another similar protective gear fall under the scope of this directive. Furthermore, the PPE included is further categorised into three groups concerning the level and type of protection. Each category determines the extent of control on the manufacturer’s production and quality system, as well as the level of involvement of a notified body.
Category I – Simple PPE
The PPE, classified as category I, intends to protect users against minimal risks and doesn’t provide protection against severe hazards, such as ionising radiation or harmful biological elements. Due to that, the conformity assessment procedure doesn’t include Notified body testing and evaluation. On the contrary, manufacturers can self-declare compliance with the respective legislation.
As examples of minimal risks, the following can be mentioned:
- superficial mechanical injury
- interaction with hot surfaces which temperature doesn’t exceed 50°C
- damage caused to the visual organs as a result of abnormal sunlight exposure
- atmospheric circumstances that are not extreme.
Category II – Intermediate PPE
This category includes medium-risk PPE, such as safety spectacles and goggles, high-visibility clothing, bump caps and industrial helmets. The conformity procedure required for Intermediate PPE involves Notified body assessment which usually complicates and prolongs the certification process of PPE.
Category III – Complex PPE
PPE of complex design intended to protect the user against any risks with very severe consequences. Such risks may cause serious and irreversible harm to the user’s health and the immediate effects of which the user, presumably, cannot identify in time. High-level risks are, for example:
- Hazardous substances and mixtures
- Environments, where can be observed oxygen deficiency
- Harmful biological elements
- High-pressure jets
- Drowning
- Ionising radiation
- Electric shock
- High-temperature environments (+100 °C)
- Low-temperature environments (– 50 °C or less)
- Harmful noise
- Falling from a height.
The compliance process of complex PPE includes Notified body assessment (EC-type examination) and either on-going surveillance through testing or on-going inspection through factory auditing.