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
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
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
