CE MARKING - EU 2016/425 Personal Protective Equipment
Certification of Personal Protective Equipment, CE Marking and Regulation EU 2016/425
The requirements for Personal Protective Equipment are classified based on the risks identified for the intended protection of the equipment. Annex I of the regulation identifies the categories of the PPE based on these risks.
Category I
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
For CE marking no Notified Body service is necessary. The manufacturer can fix CE mark to the product by fulfilling requirements of the PPE regulation for Category I products, implementing an internal production control system as defined in Module A (Annex IV) of the regulation and issuing an EU Declaration of Conformity as described in Annex IX of the regulation.
Category II
Category II includes risks other than those listed in Categories I and III;
For CE marking, manufacturers shall apply a Notified Body to get an EU Type Examination Certificate based on Annex V (Module B). The manufacturer can fix CE mark to the product by after getting an EU Type Certificate from a Notified Body and fulfilling requirements of the PPE regulation for Category II products, ensuring conformity to type (Module B) based on internal production control system as defined in Module C (Annex VI) of the regulation and issuing an EU Declaration of Conformity as described in Annex IX of the regulation.
Category 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.
For CE marking, manufacturers shall apply a Notified Body to get an EU Type Examination Certificate based on Annex V (Module B). After getting the EU Type Examination Certificate the manufacturer shall apply a Notified Body for either conformity to type based on internal production control plus supervised product checks at random intervals (Module C2 – Annex VII of PPE regulation) or conformity to type based on quality assurance of the production process (Module D – Annex VIII of PPE regulation). The manufacturer can fix CE mark to the product followed by the Notified Body identification number chosen for Module C2 or Module D service. The manufacturer shall fulfil requirements of the PPE regulation for Category III products and issue an EU Declaration of Conformity as described in Annex IX of the regulation.
Universal Certification provides certification services for the following Category II or Category III PPE based on the guidance of the EN harmonised standards.
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| Regulation (EU) 2016/425 Personal protective equipment Last approval date : .../.../.... (Waiting for an renewal of the accreditation cycle) |
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