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Conformity assessment of PERSONAL PROTECTIVE EQUIPMENT - Regulation 2016/425

Contact

Products and Persons Certification Bureau
Polish Register of Shipping
al. gen. Józefa Hallera 126
80-416 Gdańsk, Poland

tel:.  +48 58 75 11 273
        +48 58 75 11 287
        +48 58 75 11 119
fax: +48 58 34 17 769
e-mail: dc@prs.pl

       

 





Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC, in short PPER (Personal Protective Equipment Regulation), sets the requirements for the design and manufacture of personal protective equipment that is to be made available on the market to ensure health and safety of users and defines the rules for a free movement of PPE in the European Union.

Personal protective equipment is, according to the a.m. Regulation, equipment intended for carrying or holding by its user to protect him against risk to that person’s health or safety. Such equipment is protective helmets, gloves, clothing, footwear, masks, hearing protection or other equipment protecting against external factors. Personal protective equipment also includes spare parts installed within the equipment, e.g. filters for dust masks and connection systems like safety belts.

The Regulation divides personal protective equipment into three categories, depending on its type, complexity of construction and the level of risk it protects against and on this basis determines the mode of conformity assessment. There are 4 ways to assess/certify personal protective equipment, depending on the risk category of given PPE:

  • category I - module A,
  • category II - module B + C,
  • category III - module B + C2 or module B + D.

For categories II and III of PPE a notified body have to participate in the conformity assessment process of PPE. The NB issues a conformity certificate proving that assessed PPE and its manufacture process comply with essential requirements of the PPER.

Manufacturers have to carry out a full conformity assessment procedure based on legal and regulatory acts. It is required for each PPE, introduced to the market or made available for use,  to meet the requirements, including:
- be marked with CE mark,
- have appropriate technical documentation,
- have a declaration of conformity.

Polish Register of Shipping as a notified body number 1463 carry out processes of conformity assessment with PPER for the following PPE groups:

  Personal protective means protecting against drowning (e.g. life jackets, immersion suits),
    Buoyancy clothing (e.g. personal buoyancy aids, armbands),
    Personal Protective Equipment for body protection against cold (> –50oC),
    Personal Protective Equipment for protection against fall from height,
    Diving equipment (e.g. dry and wet diving suits, buoyancy compensators),
   Respiratory equipment in diving equipment (e.g. demand valves, cylinder valves),
    Equipment providing chest and groin protection against risks arising from sports activity,
    Equipment providing foot and leg protection against risks arising from sports activity,
    Equipment providing general body protection (clothing),
    Equipment providing general body protection (clothing) against chemical agents,
    Equipment providing hand and arm protection against [heat < 100oC], [heat > 100oC and fire and flame],
    Equipment providing hand protection against biological agents,
    Equipment providing hand protection against chemical agents,
   
Equipment providing hand protection against cold risks [cold > -50oC], [extreme cold < -50oC],
    Equipment providing hand protection against electrical risks,
    Equipment providing head protection,
    Equipment providing head protection against [heat < 100oC], [heat > 100oC and fire and flame],
    Equipment providing head protection against risks arising from sports activity,
    Equipment providing respiratory protection,
    Protective equipment against chemical agents,
    Protective equipment against cold [cold > -50oC],
    Protective clothing for firemen.

We invite you to carry out the conformity assessment of your PPE with the participation of PRS as an authorized notified body. CE certificate issued by PRS is a document recognized throughout the European Union and EFTA countries, equal with these issued by other EU notified bodies and it enables legal introduction of a positively assessed PPE to European markets.

A price calculation of our services does not involve any costs on the part of the client, so if you want to know the offer for the assessment of the conformity of your products with PPER, just send us a completed Application for product conformity assessment (available to download in the panel on the right or at the bottom of the page). The application does not put an obligation to use our services. It is only a basis for preparing an offer for you.

If you have doubts which module of the conformity assessment applies to your PPE or if you require more information about our services, you are welcomed to call as directly or send an email.  We will provide the necessary information and indicate the procedures that apply when assigning the CE marking.

The CE conformity assessment process with our participation runs smoothly and can cover all applied requirements (including necessary PPE tests), while maintaining a reasonable price for the service.


We invite you to assess the conformity of products with the participation of PRS!