Personal protective equipment (PPE)
CE MARKING PERSONAL PROTECTIVE EQUIPMENT
Regulation (EU) 2016/425 (as well as Directive 89/686) applies to 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 and establish the essential requirements they shall meet.
The Regulation does not apply to PPE:
- specifically designed for use by the armed forces or in the maintenance of law and order;
- designed to be used for self-defence, with the exception of PPE intended for sporting activities;
- designed for private use to protect against: atmospheric conditions that are not of an extreme nature and damp and water during dishwashing;
- for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States
- for head, face or eye protection of drivers and passengers of motorcycles and mopeds.
PPE are divided in three categories (I, II e III) that require a different conformity assessment according to the risk.
CATEGORY I (minimal risks): the manufacturer ensures and declares on his sole responsibility that the PPE concerned satisfies the applicable requirements of this Regulation (he shall establish the technical documentation and take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the PPE)
CATEGORY II (PPE protecting from neither from minimal risks nor causing very serious consequences such as death): a notified body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it through examination of the technical documentation, plus examination of a specimen, representative of the production envisaged.
CATEGORY III (risks with very serious consequences): the conformity assessment is the same as category II, adding periodic surveillance in order to verify the conformity of the PPE based on supervised product checks at random intervals or on quality assurance of the production process.
CSI, Notified Body No. 0497, is notified for the followng Personal Protective Equipment.
- Equipment providing head protection
- Equipment providing eye and face protection
- Equipment providing hand and arm protection
- Equipment providing general body protection (clothing)
- Equipment providing buoyancy aid
- Protective Equipment against drowning
- Protective Equipment against substances and mixtures which are hazardous to health
CSI is accredited laboratory according to UNI EN ISO/IEC 17025 as well for several harmonised standards, such as:
EN 397: Industrial safety helmets
EN 443: Helmets for firefighting in buildings and other structures
EN 1077: Helmets for alpine skiers and snowboarders
EN 1078: Helmets for pedal cyclists and for users of skateboards and roller skates
EN 12492: Mountaineering equipment - Helmets for mountaineers
Complete list of accredited tests: https://www.accredia.it/
Directive 89/686/EEC is repealed with effect from 21st April 2018 but there is a transition period until 20th April 2019 in which making available on the market of products is covered by both Directive and Regulation is possible.
EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.
Since 19th April 2018, the issue of new certificates or updates of already issued certificates, will be possible only according to regulation (EU) 2016/425.