Procedure for Assessment of Conformity of Products Intended to be Placed on the Market




The EMC Directive specifies three types of procedures for the evaluation of the conformity of an apparatus :

  • art 10.1 describes the procedures in the case of apparatus for which the manufacturer has applied harmonised standards
  • art 10.2 describes the procedures where the manufacturer has not applied the standards, or has applied them only in part, or in the absence of relevant standards (Technical Construction File route).
  • art 10.5 describes the specific procedure for apparatus designed for the transmission of radio communications (EC type examination route).

Example of Content list for Technical Construction File (TCF)

Part I : Description of the Apparatus :

  • Identification of Apparatus;
  • A technical description;

Part II : Procedures used to ensure conformity of the apparatus to the protection requirements :

  • A technical rationale;
  • Details of significant design elements;
  • Test evidence where appropriate.

Part III : A report or certificate from a 'Competent Body'.

The report from the Competent body might mirror the contents of parts one and two of the TCF assembled by the manufacturer. Hence, it could :

  • Refer to the exact build state of the apparatus assessed, cross referencing with part (1).
  • Comment on the technical rationale.
  • State what work was done to verify the contents and authenticity of the design information in the TCF, cross referencing with Part II (2).
  • Comment where appropriate on the procedures used to control variants and on environmental, installation and maintenance factors which may be relevant.
  • Contain an analysis of the tests performed either by the manufacturer, a third party laboratory, or the competent body itself and the results obtained, so as to assess whether those tests indicate that the apparatus should comply with the essential requirements of the EMC Directive, cross referencing with Part II (3).

In which circumstances should the TCF be used ?

There are at least five scenarios where use of the TCF might be appropriate.

  • For apparatus where there is no applicable harmonised EMC standard. Although the availablilty of generic standards theoretically means that a standard exists for every product, it is recognised that in practice their use may not be practicable for some products.
  • For apparatus where harmonised standards exist but the manufacturer applied that standard in part only, eg where a manufacturer can justify that a particular type of apparatus complies with the protection requirements of the EMC Directive without performing tests to any or all of the phenomena described in the relevant harmonised specifications
  • For installations where testing to harmonised standards is not practicable due to the physical properties. (eg size, location) of the installations.
  • For products where the testing of each individual product to harmonised standards is not practicable due to the large number of similar product variants.
  • For products having existing certification to EMC standards not recognised by the European Union, but which are nevertheless regarded as indicating compliance with the protection requirements of the EMC Directive.