2016/425

Depending on the risk category, an appropriate conformity assessment procedure is applied

CATEGORY I

• Low Risk Products - includes PPE designed to protect against minimal risk, that is not associated with a risk to life or health (e.g. gardening gloves,
  a) superficial mechanical injuries;
  b) contact with weak cleaning agents or long-term contact with water;
  c) contact with hot surfaces with a temperature not exceeding 50 °C;
  d) eye damage due to exposure to sunlight (other than when observing the sun);
  e) weather conditions that are not extreme. Rainfall, splashes and low winter temperatures that can be expected when engaging in outdoor activities such as snow shoveling, sports, sailing and construction.

• internal production control (module A)

CATEGORY II

• Medium Risk Products - includes PPE designed to protect against moderate to significant risks,  but not extreme risks (e.g. safety glasses, construction helmets).

• EU type examination (module B) followed by conformity to type examination based on internal production control (module C)

CATEGORY III

• High-risk products - includes only hazards that may cause very serious consequences, such as death or irreversible damage to health, regarding:
  a) substances and mixtures hazardous to health;
  b) oxygen deficient atmospheres;
  c) harmful biological agents;
  d) ionizing radiation;
  e) high temperature environments whose effects are comparable to those of an air temperature of at least 100 °C;
  f) low temperature environments whose effects are comparable to those of an air temperature of –50 °C or less;
  g) fall from a height;
  h) electric shock and working under voltage;
  i) drowning;
  j) cutting with hand chain saws;
  k) high pressure nozzles;
  l) gunshot or stabbing wounds;
  m) harmful noise.

• EU type examination (module B) and one of the following modules:                                         
  a) conformity to type based on internal production control and supervised product inspections at random intervals (module C2),
  b) Conformity to type based on process quality assurance production (module D)

Protective Equipment EU Regulation 2016/425 provides requirements for the design    and production of protective gloves. Describes essential health and safety requirements and sets regulations on for introducing a product on the market in the EU. The  CE  marking indicates that the PPE meets the requirements of the EU harmonization legislation.