ASU Baltic

Product certification

Regulation No. 2016/425

Scope:

• a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
• b) interchangeable components for equipment referred to in point a) which are essential for its protective function;
• c) connexons systems for equipment referred to in point a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.

PPE is classified according to risk categories:

• Category I includes exclusively the following minimal risks:
  • a) superficial mechanical injury;
  • b) contact with cleaning materials of weak action or prolonged contact with water;
  • c) contact with hot surfaces not exceeding 50 °C;
  • d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
  • e) atmospheric conditions that are not of an extreme nature.
• 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:
  • a) substances and mixtures which are hazardous to health;
  • b) atmospheres with oxygen deficiency;
  • c) harmful biological agents;
  • d) ionising radiation;
  • e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
  • f) low-temperature environments the effects of which are comparable to those of an air temperature of -50 °C or less;
  • g) falling from a height;
  • h) electric shock and live working;
  • i) drowning;
  • j) cuts by hand-held chainsaws;
  • k) high-pressure jets;
  • l) bullet wounds or knife stabs;
  • m) harmful noise.

Conformity assessment procedures:

• Category I: internal production control (module A) set out in Annex IV;
• Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;
• Category III: EU type-examination (module B) set out in Annex V, and either of the following:
  • conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;
  • conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.
• For PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point b) may be followed.

Directive 2014/34/EU (ATEX)

Scope:

Directive shall apply to the following:

• a) equipment and protective systems intended for use in potentially explosive atmospheres;
• b) safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion;
• c) components intended to be incorporated into equipment and protective systems referred to in point (a).

Conformity assessment procedures:

• a) for equipment-groups I and II, equipment-categories M 1 and 1, the EU-type examination set out in Annex III, in conjunction with either of the following:
  • Conformity to type based on quality assurance of the production process set out in Annex IV,
  • Conformity to type based on product verification set out in Annex V;
• b) for equipment-groups I and II, equipment categories M 2 and 2:
  • i) in the case of internal combustion engines and electrical equipment in these groups and categories, the EU-type examination set out in Annex III, in conjunction with either of the following:
    • Conformity to type based on internal production control plus supervised product testing set out in Annex VI,
    • Conformity to type based on product quality assurance set out in Annex VII;
  • ii) in the case of other equipment in these groups and categories, internal production control set out in Annex VIII and the communication of the technical documentation provided for in Annex VIII, point 2, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it;
• c) for equipment-group II, equipment category 3, internal production control set out in Annex VIII;
• d) for equipment-groups I and II, in addition to the procedures referred to in points (a), (b) and (c) of this paragraph, conformity based on unit verification set out in Annex IX may also be followed.