ATEX DIRECTIVE - EC TYPE EXAMINATION

Info Sheet PO14 - Issue 1 : March 1996

Note: This Info Sheet is one of a series covering the ATEX Directive. For an introduction see
Info Sheet P010.

What is EC Type Examination?

EC Type Examination is a process carried out by a Notified Body Info Sheet P010 [Introduction] to
verify that a product type is in conformity with the relevant essential requirements Info Sheet PO11.
The process is specified in Annex III of the Directive. The Notified Body will examine the dossier of
technical information (known as the technical file Info Sheet PO14 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 the 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.

What is a product type?

A product type is a unique design that is sufficiently well defined that items manufactured to that
definition will be in compliance with the requirements applicable to the product type. The concept of
product type is of particular importance where products are to be manufactured in volume and where
the cost of a notified body verifying the conformity of each item produced would be prohibitive.

What features must be defined?

In compiling the technical file, the manufacturer must prepare a set of documents, normally in the form
of drawings, that specify every feature of the product that could affect conformity with the essential
requirements. Different features will be addressed by different requirements. For example the
materials of which the product is made must have adequate strength and stability and be resistant to
the operating conditions - including corrosion, heat and ultraviolet light for example - defined by the
manufacturer. The dimensions of component parts must be suitably toleranced that the required
degree of fit will be achieved.
The sample(s) presented for inspection and testing must be in conformity with the specified design
features. Where a particular test, for example mechanical impact, is to be applied, the sample(s) must
represent the worst-case condition such as the minimum wall thickness of an enclosure. The
sample(s) must also be sufficiently representative of the production methods to be used not to
adversely affect the outcome of the tests. If a plastic case has been fabricated from sheet materials for
testing purposes and the final product is to be moulded, it may be necessary to repeat some tests on
the moulded article if there is a possibility that the moulding process may give rise to weaknesses such
as flow lines.

How do I obtain an EC Type Examination certificate?

The manufacturer or his legally appointed representative in the EU must lodge an application for an
EC Type Examination Certificate with a Notified Body of his choice.
The application must include:

the name and address of the manufacturer and, if the application is lodged by an authorised
representative, his name and address as well
a written declaration that the same application has not been lodged with any other notified body
the technical file defining the product

A sample of the product, representative of the production envisaged, must be placed at the disposal of
the Notified Body. The Notified Body may request further samples if needed for carrying out the test
programme.

What about work already carried out prior to application?

The manufacturer may include in the technical file the results of examinations and tests that they have
carried out or that have been carried out on their behalf by another body. The Notified Body may
decide to accept such information as demonstrating conformity with one or more essential
requirements. The Notified Body will need to justify the acceptance of the results on the basis of the
assessed competence of the body conducting the work. Assessed competence could be
demonstrated, for example, by accreditation by a national body or by the Notified Body's own

assessment.

What about product variants?

It is possible to include product variants within an EC Type Examination Certificate to the extent that
the differences from the original product type do not affect the results of the examination and testing
already carried out. It may be possible to repeat some parts of the examination or testing to cover the
differences in the variant but there will be a stage at which the extent of the differences make it more
economical to have a separate EC Type Examination Certificate. In any event the documentation
control can become an increasing problem for the manufacturer if the variations become too extensive.

What about changes to certified products?

Any change to a product covered by an EC Type Examination Certificate that affects any feature
defined in the technical file must be submitted to the Notified Body. The Notified Body will assess the
change and decide whether it can be approved on the basis of the work carried out under the original
EC Type Examination or whether further examination and testing is required. It must be made clear by
the manufacturer whether the change is being introduced in order to add a variant to the product type
or whether it applies to the original type and some or all of the variants. These details must be clearly
specified in the amendment to the technical file and reflected in the supplementary EC Type
Examination Certificate that the Notified Body will issue.

Retention of records
The manufacturer or his legally appointed representative in the EU must keep the technical file,
together with copies of the EC Type Examination certificates and their supplements for a period of at
least 10 years after the last product was manufactured.

For more information and details of EECS services contact:

Electrical Equipment Certification Service
Health and Safety Executive
Harpur Hill
Buxton SK17 9JN
United Kingdom
[44] (0) 1298 28000 Fax: [44] (0) 1298 28244