PERSONAL
PROTECTIVE
EQUIPMENT (PPE)
CERTIFICATION
CE MARKING
PERSONAL PROTECTIVE EQUIPMENT (PPE) CERTIFICATION
WHAT IS THE PERSONAL PROTECTIVE EQUIPMENT (PPE) CERTIFICATION?
The commercialization of Personal Protective Equipment (PPE) must meet the technical criteria contained in EU Regulation 2016/425 on Personal Protective Equipment.
The CE marking and the EU Declaration of Conformity ensure the free movement of Personal Protective Equipment, PPE, in the European Market. In addition, the CE marking assures users of Personal Protective Equipment that the product does not compromise their safety and guarantees common protection levels in the Member States of the European Union.
WHO CAN CERTIFY PERSONAL PROTECTIVE EQUIPMENT?
The conformity assessment of PPE must be carried out by a Notified Body.
AITEX is a Notified Body No. 0161, for Regulation (EU) 2016/425 on Personal Protective Equipment, which establishes the essential health and safety requirements that personal protective equipment must comply with.
The accreditation covers:
> EU type examination certificates (Module B)
> Conformity to type based on internal production control plus supervised control of the product at random intervals (module C2)
> Conformity to type based on quality assurance of the production process (module D)
REGULATION (EU) 2016/425 ON PERSONAL PROTECTIVE EQUIPMENT
REGULATION (EU) 2016/425 ON PERSONAL PROTECTIVE EQUIPMENT
The Regulation (UE) 2016/425 lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.
CE MARKING
‘CE marking’ means a marking by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.
Rules and conditions for affixing the CE marking:
> The CE marking shall be affixed before the PPE is placed on the market.
> For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
RISK CATEGORIES OF PERSONAL PROTECTIVE EQUIPMENT
> Category I
Category I includes exclusively the following minimal risks: (a)superficial mechanical injury; (b)contact with cleaning materials of weak action or prolonged contact with water; (c) contact with hot surfaces not exceeding 50 °C; (d)damage to the eyes due to exposure to sunlight (other than during observation of the sun); (e)atmospheric conditions that are not of an extreme nature.
> Category II
Category II includes risks other than those listed in Categories I and III;.
> Category III
Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following: (a) substances and mixtures which are hazardous to health; (b) atmospheres with oxygen deficiency; (c) harmful biological agents; (d)ionising radiation; (e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C; (f) low-temperature environments the effects of which are comparable to those of an air temperature of – 50 °C or less; (g) falling from a height; (h) electric shock and live working; (i) drowning; (j) cuts by hand-held chainsaws; (k) high-pressure jets; (l) bullet wounds or knife stabs; (m) harmful noise.
CONFORMITY ASSESSMENT PROCEDURES
The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:
> Category I: internal production control (module A)
> Category II: EU type-examination (module B), followed by conformity to type based on internal production control (module C),
> Category III: EU type-examination (module B), and either of the following:
(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2).
(ii) conformity to type based on quality assurance of the production process (module D).
Applicants for certifications of this type of products commit themselves to the signing of the formal application for certification to comply with the obligations that apply within their activities and are found both in current legislation, as in ISO / IEC 17065:2012, which are detailed in the document:
AITEX, NOTIFIED BODY FOR THE CERTIFICATION OF PERSONAL PROTECTIVE EQUIPMENT (PPE)
PERSONAL PROTECTIVE EQUIPMENT (PPE)
PROTECTIVE
CLOTHING
HEAD
PROTECTION
HAND AND ARM
PROTECTION
EYE AND FACE
PROTECTION
RESPIRATORY
PROTECTION
PROTECTION AGAINST
FALLS FROM A HEIGHT
LEADERS CERTIFYING
PERSONAL PROTECTIVE
EQUIPMENT (PPE)
NOTIFIED BODY
No 0161
AITEX is the Notified Body number 0161 assigned by the European Commission for the conformity assessment procedures of certain products: CE marking
OTHER AREAS OF AITEX
AITEX provides different types of services for companies that develop products for the markets in the different textile application areas. Our services fall within the following areas.