Need to store a technical file?

Happy new year everyone! Today we would like to present one of our services – storage of technical file. This is relevant for all manufacturers of non-electrical ATEX equipment and interesting read for all end-users of ATEX equipment.

Following completion of the equipment design phase and completion of the ignition hazard assessment, together with application of any required preventive measures and protection concepts, the manufacturer should select the appropriate conformity assessment route.

Under ATEX Directive 2014/34/EU non-electrical equipment Category 2 and 3 are covered by self-declaration of conformity by the equipment manufacturer. Here there is no involvement of a notified body in the conformity assessment activities. The required tests may be done by manufacturer itself or in any independent laboratory the manufacturer considers adequate.

Retention by a notified body

In case of equipment-group I and II, category M2 and 2, technical documentation for the equipment shall be issued to a notified body, which retains it in its facilities (e.g. Gexcon Certification). The notified body does not examine the conformity of the received documentation. In some cases, it can be requested that the documentation file is sealed. The documentation file is stored in notified body’s archives upon the request of manufacturer (or its authorized representative).

For received and stored documentation, the notified body issues an identifiable “Acknowledgement of Receipt”.
The ATEX Directive 2014/34/EU uses two terms for the documentation, both “The Dossier” and “The Technical Documentation”. But normally the general term “The Technical File” is used.

The Technical File shall be stored with a Notified Body. According to the directive the Technical File is not to be returned to the manufacturer on request (but may be added to), and in general it is retained for a period of ten years following the last placing of the product onto the market. The intention is that market surveillance authorities in the different Member States should be given access to this dossier, in cases where there is a need to investigate the design or manufacturing details of a particular product.

There are some slight differences in responsibilities in between EU-Type Examination in accordance with Annex III, Internal Control of Production in accordance with Annex VIII, or Unit Verification in accordance with Annex IX, but for these information purposes you should know the technical requirements are the same.

Content of the technical file

So, what should be included in a technical file?

The technical 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) involved with the equipment. This means the documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacturing, and operation of the product.

The technical documentation shall contain at least the following elements:

1. A general description – type identification and performance information.
2. Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. – to contain everything that is relevant to demonstrate compliance with the directive or the harmonised standards.
3. Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product – to explain any special conditions.
4. 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 the ATEX 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 – references to standards and documentation together with an ignition hazard assessment (The ISO/EN 80079-36 standard contains a recommended format for the ignition hazard assessment which should be used by the manufacturer).
5. Results of design calculations made, examinations carried out, etc. – to demonstrate and record how the equipment fulfil the requirements.
6. Test reports – if required above calculations and examinations to demonstrate suitability.
7. A copy of the EU declaration of conformity.

Gexcon Certification may provide assistance if you have a requirement for this service or need more information. Please contact us or send an email to certification@gexcon.com.