PPE

  • About PPE
  • Certification procedure
  • Technical regulations
PPE

The PPE Regulation (EU) 2016/425 is a conformity assessment for the freedom of distribution of personal protective equipment within the EU.

Harmonized Standards
  • Product to be certified shall be in EU Harmonized Standards list
  • https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/personal-protective-equipment_en
Applicable Products
Product category Products
Equipment providing respiratory system protection Emergency escape respirator, air respirator, mask
Specialized areas of competence : Firemen suits fireproof garb
Equipment providing hand and arm protection protective gloves
Equipment providing head protection fireproof helmet
Equipment providing foot, leg and anti-slip protection safety footwear
Protective equipment against falls from a height safety block, safety belt, connector
Equipment providing eye and face protection welding mask
Protective equipment against chemical agents chemical protective suit
PPE Category
  • Category I : Minimal risk to atmospheric conditions
  • Category II : Includes any risk not mentioned in Category I or Category III
  • Category III : Risks that may cause very serious consequences such as death or irreversible damage
Preparation of Technical documents
  • Prepare technical documentation of the designs, manual, and specifications in accordance with the harmonized standards suggested in the PPE Regulation and the Official Journal of the EU
Conformity Assessment
  • Module A : Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations such as technical documentation, manufacturing process, CE marking, and DoC issuance, and ensures and declares sole responsibility for the fact that the concerned PPE satisfies the applicable requirements of this regulation.
  • Module B : A conformity assessment procedure in which a notified body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of the applicable regulations.
  • Module C : Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations such as the manufacturing process, CE marking, and DoC issuance, and ensures and declares sole responsibility for the fact that the PPE concerned is in conformity with the type described in the EU type-examination certification and satisfies the applicable requirements of this regulation.
  • Module C2 : Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure.
  • Module D : Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure.
Declaration of Conformity (DoC)
  • A self-declaration of conformity issued by specifying the essential characteristics for each lot or individual product when a manufacturer produces certified products after conformity assessment
CE Marking
  • For Category III products, the CE marking shall include the number of the notified body that conducted Module C2 or D.
PPE Regulation (EU) 2016/425 Guidelines
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PPE Horizontal Recommendation for Use sheets (RfUs)
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PPE Vertical Recommendation for Use sheets (RfUs)
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PPE Harmonized Standard List
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