General conditions : storage of technical documentation
(non electrical equipment of category 2)
according to the Article 13 1) b) ii) of the 2014/34/EU directive
1.
SUBJECT AND BACKGROUND
The present offer is established for storage of technical documentation (non electrical
equipment of category 2) according to the Article 13 1) b) ii) of the 2014/34/EU directive.
The deposit file contents is defined in the appendix VIII of the 2014/34/EU directive (see annex).
2.
NATURE OF THE SERVICE PROVIDED
Our service will include :
- The storage of the technical file deposited by the applicant for ten years.
- The establishment of an acknowledgement of delivery of file deposit.
INERIS will not read this file.
You can find the deposit file contents - send to an notified body for an electrical equipment
placed in zones 1 or/and 21 – in the appendix VIII of the 2014/34/EU directive (see annex) :
marking
general description of the equipment
drawings
components description (including certificates)
instructions (according to annex II of Directive 2014/34/EU)
risks analysis showing the conformity of the equipment to the essential requirements of the
directive (examples given in the standard EN 13463-1 : 2009 or EN 80079-36).
Two equipment of different designs, will be the subject of two different files, while several
materials of identical design but of different size represent the same range and will thus be the
subject of only one file.
A new deposit file will follow any engineering change of the equipment, indeed an addition
deposit does not exist.
3.
IMPLEMENTATION CONDITIONS
3.1.
Reception of your file
The file has to be send :
-
Paper format : a specimen in closed fold of your file. The file format has to be no more
than 34 x 25 and variable thickness.
-
Or CD/DVD format : two specimens.
To avoid the misunderstanding, the word “ATEX” must not be used for the name of your file
One month after the receipt of the following documents : form for order, technical form,
check and file, we will send you an acknowledgement of the deposit of your file as well as a
settled invoice.
3.2.
Storage of your file
INERIS will preserve the technical file for 10 years (taking to account the acknowledgement
date). Beyond this period the file will be destroyed. If you wish to continue the storage of your
file, you should let us know by letter three months before the previous destruction date.
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Directive 2014/34/EU Extract
ANNEX VIII
MODULE A: INTERNAL PRODUCTION CONTROL
1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the
products concerned satisfy the requirements of this Directive that apply to them.
2.Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible
to assess the product’s conformity to the relevant requirements, and shall include an adequate analysis
and assessment of the risk(s).
The technical documentation shall specify the applicable requirements and cover, as far as relevant for
the assessment, the design, manufacture and operation of the product. The technical documentation shall
contain at least the following elements:
(a) a general description of the product,
(b)
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.
(c)
descriptions and explanations necessary for the understanding of those drawings and schemes and the
operation of the product,
(d)
a list of the harmonised standards applied in full or in part the references of which have been
published in the Official Journal of the European Union and, where those harmonised standards have
not been applied, descriptions of the solutions adopted to meet the essential health and safety
requirements of this Directive, including a list of other relevant technical specifications applied. In
the event of partly applied harmonised standards, the technical documentation shall specify the parts
which have been applied,
(e)
reresults of design calculations made, examinations carried out, etc., and
(f)
test reports.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring
ensure compliance of the manufactured products with the technical documentation referred to in point 2
and with the requirements of this Directive that apply to them.
4. CE marking, EU declaration of conformity and attestation of conformity
4.1. The manufacturer shall affix the CE marking to each individual product other than a component that
satisfies the applicable requirements of this Directive.
4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model other
than a component and keep it together with the technical documentation at the disposal of the
national authorities for 10 years after the product, other than a component, has been placed on the
market. The EU declaration of conformity shall identify such product model for which it has been
drawn up.
A copy of the EU declaration of conformity shall accompany every product other than a component.
4.3. The manufacturer shall draw up a written attestation of conformity for each component model and
keep it together with the technical documentation at the disposal of the national authorities for 10
years after the component has been placed on the market. The attestation of conformity shall
identify the component for which it has been drawn up. A copy of the attestation of conformity
shall accompany every component.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his
behalf and under his responsibility, provided that they are specified in the mandate.
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