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atex directive 94/9/EC

What Are the Conformity Assessment Procedures?

The ATEX Directive specifies a number of Conformity Assessment Procedures and the circumstances when they must be used. The procedures are:

EC type examination
Quality assurance
Verification modules
Internal control of production

EC Type Examination

EC Type Examination is a process carried out by a notified body to verify that a product type is in conformity with the relevant essential requirements. The process is specified in Annex III of the directive. The notified body will examine the technical file supplied by the manufacturer and conduct such inspections and tests as may be required to show that the product type complies with the requirements stated by the manufacturer. The notified body may advise on applicable requirements but it is ultimately for the manufacturer to decide the intended use of the product. The EC Type Examination process culminates in a certificate issued by the notified body, attesting that the type as defined in the technical file complies with the directive.

Quality Assurance Modules

There are two Quality Assurance Modules specified in the ATEX directive:

Production Quality Assurance - which applies to Equipment Categories 1 and M1 and to protective systems, and which is specified in Annex IV of the directive.
Product Quality Assurance - which applies to electrical equipment and internal combustion engines only, in Equipment Categories 2 and M2, and which is specified in Annex VII of the directive.

Both of these modules require the manufacturer to have a defined and documented system for controlling the conformity of products to the requirements of the directive as defined in the technical file accompanying the EC type Examination Certificate(s) for the product type(s). The system must be assessed by a notified body and be subject to periodic audit by the body. In addition the body may pay unannounced visits to the manufacturer and may carry out inspection and/or testing of products to check conformity with the certified type.

There are three Verification Modules specified in the ATEX Directive.

Product Verification - specified in Annex V of the directive, which applies to Equipment Categories 1 and M1 and to the protective systems.
Conformity to Type - specified in Annex VI of the directive, which applies to electrical equipment and internal combustion engines in Equipment Categories 2 and M2.
Unit Verification - specified in Annex IX of the directive which may be applied at the option of the manufacturer as an alternative to any other conformity assessment modules.

Although they differ in their specific requirements, the Verification Modules all require each item produced to be inspected and tested for conformity with the requirements of the directive. The Product Verification and Unit Verification processes are carried out by the notified body, while the Conformity to Type is carried out by the manufacturer under the responsibility of a notified body. In all cases the manufacturer is required to draw up a Declaration of Conformity in the format defined in Annex X of the directive.

Iternal Control of Production

Internal Control of Production applies to equipment in Category 2 and M2 which is not electrical equipment nor internal combustion engines and to equipment Category 3. It is specified in Annex VIII of the directive.
Internal Control of Production is a process whereby the manufacturer, on his own responsibility, carries out the necessary work to ascertain that product which he places on the market comply with the requirements of the directive.

Additional CE Marking Directives

There are three other directives that must be looked at during your product evaluation. If your product falls within the scope of these three directives, all directives have to be applied in parallel to fulfil the special requirements of each directive.

Low Voltage Directive 73/23/EEC
Electromagnetic Compatibility Directive 89/336/EEC
Machinery Directive 98/37/EC

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