| Radiocommunications Agency
Compliance of equipment for EMC
The regulatory regime for electrical and electronic products in Europe is now dominated by a number of EC Directives, of which the most important and general are the Low Voltage Directive (LVD, for electrical safety), the EMC Directive and the R&TTE Directive. Each of these Directives is an instruction by the European Council to each member state to embody the requirements of the Directive into its own laws. The principal purpose of each Directive is to try to ensure that technical requirements (for safety, EMC and telecom/radio issues) imposed by individual countries do not result in barriers to trade within the EC. The Directives are also recognised by countries outside the European Union but within the European Economic Area (EEA).
The New Approach
In the mid-1980s the European Commission mandated the task of setting detailed technical requirements to the European standards bodies, specifically CEN, CENELEC and ETSI. This was known as the “New Approach”. The published Directives give only general essential requirements, and state that conformity to these requirements can be demonstrated by compliance with “harmonised” standards. The process of harmonising a standard means that the Commission is advised by the standards body that the standard is suitable for embodying the essential requirements of a Directive, and the Commission then publish the reference of the standard in a list in the Official Journal of the EC.
The CE Mark
Compliance with all applicable New Approach Directives for a given product is signified by the manufacturer affixing the CE Mark to the product, or its packaging or instructions. The CE Mark is not in any sense a guarantee or a mark of quality: it is more akin to a passport. It states that the manufacturer (or importer) believes that his product complies with the Directives. Manufacturers may well apply different levels of diligence to their CE Marking.
The Declaration of Conformity
The EC declaration of conformity is required in all cases and must include the following components:
a description of the apparatus to which it refers;
a reference to the specifications under which conformity is declared;
an identification of the signatory empowered to bind the manufacturer or his authorized representative;
a declaration that the apparatus conforms to the essential protection requirements.
The compliance via standards route only gives a presumption of conformity with the essential requirements. The declaration is a statement that the product is believed to meet the essential requirements, using the harmonised standard as an indication of this.
The EMC Directive
This Directive (89/336/EC) applies to all equipment placed on the market or taken into service, so that it includes systems as well as individual products. Its scope is all apparatus “liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance”, although it does not apply to all products, e.g. medical, automotive, which are covered by other Directives. It operates as follows: it sets out the essential requirements (quoted below); it requires a statement to the effect that the equipment complies with these requirements; and it provides alternative means of determining whether the essential requirements have been satisfied.
The essential requirements are:
"The apparatus shall be so constructed that
equipment shall not generate electromagnetic disturbances exceeding a level allowing radio and telecommunications equipment and other apparatus to operate as intended;
The Directive has been fully operational since the beginning of 1996 and as experience has been gained with it, so the official guidance on how to apply it has been extended. The most recent guidance document was published in mid-97. There is now a second version of the EMC Directive being drafted.
The R & TTE Directive
The Radio & Telecommunications Terminal Equipment Directive went into effect on April 8th 2000, with a transition period to April 7th 2001; after this date all equipment within the scope must comply with its provisions. The scope is telecommunications terminal equipment, radio equipment, and such apparatus even if it incorporates medical devices or vehicle components. Exceptions to the scope are:
apparatus exclusively used for public security, defence, state security, and state activities in the area of criminal law;
marine equipment, civil aviation equipment and air traffic management equipment (all covered by their own regulations);
amateur radio equipment, broadcast radio receivers, and cabling and wiring.
It represents a fairly fundamental shift in the way that radio and telecom equipment, previously subject to national and pan-European type approval regimes, have been regulated.
The R & TTE requirements incorporate the requirements of the LVD and EMCD and allow a continuation of the conformity assessment regime already in place for those Directives. An important extension is the removal of the lower voltage limit (50V AC or 75V DC) for application of the LVD. This means that safety requirements apply even to handheld, battery powered apparatus, meaning, for example, mandatory application of limits on electromagnetic fields for human health.
The type approval regime for radio transmitters has been abolished, by adding an additional requirement for effective use of the spectrum so as to avoid harmful interference. This does not prevent national authorities from applying restrictions on the grounds of local spectrum management through the licensing process, but they must not attempt to enforce a type-approval regime in this context. There is a requirement to inform the relevant national authorities whenever it is intended to place on the market equipment that uses non-harmonized spectrum allocations.
The conformity assessment procedures allowed under the R&TTE Directive are outlined in a series of annexes to the Directive. Their applicability varies depending on whether the equipment is telecoms terminal, or radio equipment; the receiving part of radio equipment is treated as telecoms equipment. In either of the cases of annexes ii or iii, there is no absolute requirement for the involvement of a notified body. The specific tests in annex iii must be identified by a notified body unless they are already defined in the harmonized standard(s). Otherwise, these annexes represent pure self-certification on the part of the manufacturer.