Directives

If your product(s) fall(s) within the sector 'Equipment and protective systems for potentially explosive atmospheres (ATEX)' the following directive applies:

• Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)
• For further information on the ATEX Directive 2014/34/EU on Equipment and protective systems please see the webpage on equipment for potentially explosive atmospheres
• See more on harmonised standards for ATEX

Verify requirements

The New Approach Directives for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The ATEX Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres specifies in detail the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.

In addition to equipment and protective systems intended for use in potentially explosive atmospheres, the directive also applies to safety devices, controlling devices and regulating devices for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of ATEX equipment and protective systems with respect to the risks of explosion. The directive does not apply to medical devices, means of transport, seagoing vessels, or personal protective equipment covered by Directive 89/686/EEC. It also does not apply to equipment and protective systems where the hazard only results from the presence of explosive substances or unstable chemical substances, or from accidental leakage of fuel gas.

For further details on the products covered please consult Chapter 1, Article 1 of the ATEX Directive 2014/34/EU.

The essential health and safety requirements – as set out in Annex II of the directive – foresee among others that products must be designed with a view to integrated explosion safety. They can only be manufactured after due analysis of possible operating faults in order to preclude dangerous situations as far as possible. In this sense, the products must be accompanied by instructions and must be marked legibly and indelibly with a list of minimum particulars such as the name and address of the manufacturer, designation of series or type, the specific marking of explosion protection followed by the symbol of the equipment group and category and others.

Furthermore, where necessary, they must also be marked with all information essential to their safe use.

In terms of selection of materials, the directive requires a special selection of risk-reducing materials as laid down in Annex II, 1.1. Annex II covers further requirements regarding design and construction, potential ignition source, hazards arising from external effects, requirements in respect of safety-related devices and integration of safety requirements relating to the system. Please closely consult Annex II for a complete overview.

Also, please carefully consult 2014/34/EU to ensure that your product complies with all the essential health and safety requirements.

Need for notified body?

Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a notified body.

In the case of equipment and protective systems for potentially explosive atmospheres, it depends on the specific product whether the conformity assessment by a notified body is obligatory or not. For further details please consult 2014/34/EU.

A notified body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the notified body is involved in the production control phase, its identification number will follow the CE marking.

When the notified body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up an EU declaration of conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant directive. The establishment of the DoC is a legal obligation.

The EU declaration of conformity must include the manufacturer’s details such as his name and address, essential characteristics and requirements the product complies with, any European harmonised standards and performance data and the identification number of the notified body as well as a legally binding signature on behalf of the organisation. For further details please consult the directive, in particular Annex II.

To find the notified bodies appointed by the Member States to carry out conformity assessment, look no further than NANDO – the New Approach Notified and Designated Organisations database. You can search for notified bodies by directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures to be followed by manufacturers prior to affixing the CE marking on their products are set out in Chapter 3, Article 13 of the ATEX Directive 2014/34/EU. There are different procedures to be followed, depending on the type of equipment or protective system in question. The equipment groups and categories are explained in Annex I to the directive and the details of the various conformity assessment procedures are set out in Annexes III to IX.
For example, with differences depending on the specific product group as set out in Annex I, for equipment where a very high level of protection is needed, the directive requests an EU-type examination procedure in conjunction with production process quality assurance or product verification: the single steps are defined in Annexes III to V. In the case of internal combustion engines or electrical equipment, the manufacturer or his authorised representative, in addition to the EU-type examination, should also assess conformity to type or the product quality assurance, as described in Annexes VI to VII.

Whether a notified body has been involved or not, the manufacturer must draw up and sign the EU declaration of conformity.

Technical documentation

After completion of the conformity assessment, the procedure has to be documented as set out in ATEX Directive 2014/34/EU, Annexes III to IX, Nr. 3, for the EU-type examination. The technical documents must enable the assessment of the appliance’s conformity with the requirements of the directive. The technical file should comprise at least the following

• a general type-description
• conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.
• descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product
• 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
• results of design calculations made, examinations carried out, etc.
• test reports

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed to the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

The various components of the CE marking must have substantially the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other directives.

If a notified body is involved in the production control phase, its identification number must be also displayed.

△ The above picture and text are from the Internet. If there is any infringement, please contact us in time and we will delete it immediately.

As the first global market access digital platform, BWTCmall.com offers a new and unprecedented online service experience for its many users.

As a technology-driven company, BWTCmall.com is committed to developing a powerful and scalable platform that not only enables global manufacturers to quickly and accurately find the best way to reach the global market, but also to experience cost-effective cutting-edge technology and services. Let the global market access market truly enter a virtuous circle of fairness, objectivity, harmony and win-win.

Please visit the solution for get your best way of testing and certification / approvals to the target market.