Complying with the Directives

Complying with the EMC Directive (89/336/EEC)

Complying with the EMC Directive is straightforward if dealt with in the proper manner. EMC should present no more problems to the designer than the basic design of the product. The problem a lot of manufacturers had, and still seem to have, is not taking EMC into consideration at the correct point in the product development cycle. This is particularly true in the commercial and industrial sectors where product lifetime is relatively short and cost is of considerable importance. In the military sector and sectors where harsh electromagnetic environments are experienced and safety critical systems are required, EMC is generally given the consideration it deserves - though not always.

Compliance with the EMC Directive is by self-certification through the application of Harmonised Product Specific standards or Harmonised Generic standards. In either case, the manufacturer must prepare a technical file which can be vetted all or in part by a Notified Body. Only Harmonised standards, prefixed by EN or BS EN, can be used for self-certification. It is the responsibility of the manufacturer or the Agent importing the product into the EU to ensure that compliance can be demonstrated with ALL relevant Directives, and that the necessary documentation is held on record.

Note that the Technical Construction File route for compliance does not exist under the new EMC Directive.

In the early days, there was a lot of confusion over which products were covered by the Directive and and which were not, what constituted a system and what constituted an installation, and was the product relevant apparatus intended for an end user or was it a component or a sub-assembly that was exempt. Although the new Directive clarifies the situation, particularly with regard to sub-assemblies, there have been instances where manufacturers have been of the opinion that, if a product is manufactured from CE marked components, then the finished product can also be CE marked without further test. This was known as CE=CE+CE and is a route which has lead to several prosecutions for non-compliance. This route is NOT recommended by us at Kernow EMC Limited and is one of the areas of expertise which we offer to avoid problems with assembling finished products purely from bought in sub-assemblies.

Complying with the R&TTE Directive

The introduction of the R&TTE Directive, 1999/5/EC, has considerably simplified the process of certifying radio products, telecommunication terminal products and products containing both radios and telecommunication terminals. Originally, terminal equipment had to undergo national (BABT) approval, radios had to be type approved by the Radiocommunication Agency, and both had to undergo tests for electrical safety and EMC.

Under the R&TTE Directive, 1999/5/EC, test suites covering telecommunications, radio performance and electrical safety still have to be performed. The difference is that the manufacturer or agent can self-certify to harmonised standards with the assistance of a Notified Body if a radio is involved. Notified Bodies are not required if a radio is not part of the product, provided that the standards to be used are harmonised. Where there is a radio and/or the standards are not harmonised, then a Technical Construction File (TCF) must be prepared and vetted by the Notified Body, who should also vet the facility used to perform the testing.

Where the equipment falls within the scope of 'relevant apparatus' as defined in the EMC and Low Voltage Directives, then the procedures specified in these Directives may be followed. In all other cases, the procedures of the R&TTE Directive must be followed.

The R&TTE Directive, 1999/5/EC, has seven Annexes of which only four cover the various options for compliance. The Annex(es) used must be stated on the Declaration of Conformity and a test facility approved for the required Annex(es) must be used.

The Annexes are in summary:

Annex I	Lists equipment not covered by the Directive such as: Non-commercial Amateur Radio Equipment Marine Equipment covered by Directive 96/98/EC Cabling and Wiring Radio and TV broadcast receivers Equipment used in the Civil Aviation industry Equipment used for Air Traffic Management
Annex II	Conformity Assessment Procedure for Telecommunication Terminal Equipment using self-certification against the appropriate Harmonised Standards. A Technical File is required as part of the documentation supporting the Declaration of Conformity.
Annex III	Conformity Assessment Procedure for Telecommunication Terminal Equipment that includes Radio apparatus, using self-certification against Harmonised Standards. A Notified Body is required to assess the radio tests unless they are uniquely defined in the appropriate Harmonised Standard. The procedures of Annex II are also applicable.
Annex IV	Conformity Assessment Procedure for Telecommunication Terminal Equipment that includes Radio apparatus, where Harmonised Standards either do not exist or can only be applied in part. A Technical File is required and the services of a Notified Body to vet the file. More than one Notified Body may be required depending on the range of competencies assigned to each. Annexes II and III are also applicable.
Annex V	Conformity Assessment Procedure for Telecommunications Terminal Equipment that includes Radio apparatus where the manufacturer operates a full ISO9000 type quality control system covering design, manufacture, inspection and test. In this case, the Notified Body is required to vet the quality system implemented by the manufacturer.
Annex VI	Minimum requirements for the appointment of a Notified Body.
Annex VII	Requirements for CE marking.

< Complying with EMC Directive < Top

Complying with the R&TTE Directive - Some observations.

Under Annex II, for Telecommunications Terminal equipment without radios, a Notified Body is not required. Not all the standards available have been harmonised or can be applied in full. It is however acceptable to declare those that have been applied in whole or in part, and how the essential protection requirements have been met, in the technical file. If the product falls within the scope of the EMC and Low Voltage Directives, then they can be invoked directly. If the product does not fall within the scope of these Directives then the protection requirements are invoked via the R&TTE Directive. In the case of the Low Voltage Directive, the low voltage limit would then be removed.
Under Annex III there is a growing list of harmonised ETSI standards covering the radio part of the product. The situation regarding the telecommunications part is still as above. Where the radio tests are uniquely defined in the harmonised standard, a Notified Body is not required. In other cases, a Notified Body will be required.
Under Annex IV, A technical file and the services of a Notified Body are required. The Notified Body must be assessed as competent for all the disciplines (Radio, EMC, Safety and Telecommunications). If not, then several Notified Bodies may be required. Note also that the radio part will include Specific Absorption Rate (SAR) assessment where transmitters are involved.

You should also note that, once certification has been achieved, the Notified Body will have to be advised of changes to the design of the product and re-certification may have to be undertaken depending on his decision.
Under Annex V, the Notified Body assesses the manufacturer for competence to control the certification process himself. A full quality control system must be in place and certification test facilities approved by the Notified Body utilised. The manufacturer then has the power to decide whether modifications require re-test or not. This system puts the onus on the manufacturer, is more flexible regarding minor changes to products, and makes full use of the quality control system operated by the manufacturer. It should also result in cost savings by not requiring so much re-test and use of the services of the Notified Body. The manufacturer can decide whether any modification requires a retest or not.

< Complying with R&TTE < Complying with EMC Directive < Top

Page last updated 19 May 2008