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Last updated on 07 Sep, 2020

Personal Protective Equipment (PPE)

 

What it is Personal Protective Equipment?

Personal Protective Equipment, or PPE, is any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. 

PPEs belonging to Category I PPE are the ones that protect against superficial mechanical injuries, protecting against weak cleaning materials or water, hot surfaces bellow 50⁰C, sunlight protection, and regular weather protection.

PPEs belonging to Category III PPE are the ones that cover against, substances dangerous to health, oxygen deficiency, biological agents, ionizing radiation, temp above 100⁰C  or below -50⁰C  or comparable effects, height falls, electric shocks, drowning, chainsaws cuts, high pressure jets, bullet wounds or knife stabs and harmful noise.

PPEs belonging to Category II PPE are the ones that do not fit in any of the other categories.

Are excluded from this directive: PPE used by the armed forces or law enforcement, non-sport self-defense PPEs, regular weather protection clothing, marine or aircraft PPE covered by international treaties, and helmets for motorcycles and mopeds

 

Legislation

Subsidiary legislation S.L. 427.95

Regulation 2016/425/EU on Personal Protective Equipment

 

Documents

Guideline on the application of the PPE regulation

List of Harmonized Standards

List of Notified Bodies

 

Placing on the market

To place a PPE in the market, it needs to bear the CE marking, and be accompanied by the EC declaration of conformity. To draw the declaration of conformity a process called conformity assessment needs to be followed.

PPEs manufactured following the Harmonized Standards, bearing the CE marking and accompanied by the EC declaration of conformity will be regarded as complying with the provisions of the directive.

 

To asses the conformity of a PPE the first step is to check which categories of the Annex I the PPE belongs to. When the PPE is classified one of the following methods needs to be followed:

  • 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

 

Contact Us

Need further information or assistance?

Feel free to send us an email - rad@mccaa.org.mt or give us a call at +356 23952000.

 

More information

Information about CE marking

Guidance on CE marking for professionals

The ‘Blue Guide’ on the implementation of EU product rules

Maltese Harmonised Standards - distributed for free during the COVID-19 crisis

 

 

 

 

 

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