Sioen Professional Protective Clothing - 2016

Category 1 : P.P.E. of ‘simple design’
This P.P.E. protects the wearer against minor risks
which are defined by the exhaustive list at Art. 8(3).
A typical example is rainwear. The manufacturer
declares conformity by means of an EC Declaration of
Conformity only, without having to pass by a
Notified Body. This so called «auto-certification» does
not discharge the manufacturer from the obligation
to make a technical file which demonstrates the
compliance.
Category 2: ‘Neither simple nor complex design’
P.P.E. not defined by the exhaustive list at Article 8(3)
(a) and Article 8(4)(a) from the Directive; meaning that
this category contains all P.P.E. which are not explicitly
mentioned in category 1 or 3. Typical examples of
category 2 P.P.E. are: high visibility garments,
freezerwear, ... . These P.P.E. are subject to an EC-
Type examination procedure by an independent
Notified Body and an EC Declaration of Conformity is
produced by the manufacturer.
Category 3: P.P.E. of so-called ‘complex design’
This P.P.E. - defined by the exhaustive list at Article 8 (4)
(a) from the Directive - are intended to protect against
mortal danger or against dangers that may seriously and
irreversibly harm the health of the user. Typical examples
are firefighting clothing and chemical protective clothing.
These P.P.E. are subject to an EC-type examination
procedure by an independent Notified Body and to one
of the two Quality Assurance Procedures as described in
Article 11A and 11B of the Directive. An EC Declaration of
Conformity is produced by the Manufacturer.
SIOEN has chosen for the 11B procedure. This yearly
compulsory quality assurance assessment - in addition to
EC-type examination and in addition to the compulsory
ISO 9001 audits - is an additional guarantee to prove
the quality of the produced P.P.E. is constant and in
correspondence with the certification file.
EN ISO 13688:
Protective Clothing: General requirements
This international standard specifies general performance requirements including:
• Innocuousness of the materials to the user
• Design requirements
• Comfort requirements
• Performance requirements after ageing
• Sizing specifications
• Labeling
• Information to be supplied by the manufacturer
This standard is only intended to be used in combination with other standards containing requirements for
specific protective performance.
(EN 13688 Supersedes EN 340)
NORMS
GENERAL NORMS & STANDARDS 367