Since the 1st January 1996, most electrical and electronic products sold in the EU must be constructed so that they do not cause excessive electromagnetic interference and are not duly affected by electromagnetic interference. They must carry the CE mark to show that they comply with these requirements and a manufacturer’s declaration of conformity must be prepared for each product, and be made available to the authorities on request for up to 10 years after the last product of that type has been manufactured. For most equipment, manufacturers must follow one of three routes to demonstrate their products’ compliance:
The Standards Route
Where the declaration of conformity states which harmonised European standards the product meets. These standards must have been referenced in the Official Journal of the European Communities before they can be used for this self-certification route. All applicable electromagnetic phenomena must be covered by the standards chosen.
The Technical Construction File (TCF) Route
Available to manufacturers who are not able, or do not wish to use harmonised standards. Manufacturers assemble a document containing a rationale for their product’s conformity, and technical data to support that claim. The TCF is then assessed by a Competent Body (independent third party organisations appointed by the Governments of the EU countries). Assuming the Competent Body is satisfied (from the data presented) that the product meets the directive, it will issue a certificate which can be referenced on the manufacturer’s declaration.
Radio transmitting equipment
Subject to EC type-examination by a notified body. Failure to comply with these requirements may mean that products are prohibited from the EU and could result in fines or terms of imprisonment which vary throughout the EU.
Phenomena regarded as electromagnetic disturbances
Conducted low-frequency phenomena slow variations of supply voltages, harmonics, interharmonics, signalling voltages, voltage fluctuations, voltage unbalance, power-frequency variations, induced low-frequency voltages, DC in AC networks, DC ground circuits.
Radiated low-frequency phenomena: magnetic fields (continuous or transient), electric fields.
Conducted high-frequency phenomena: induced continuous wave (CW) voltage or currents, uni-directional transients.
Radiated high-frequency phenomena: magnetic fields, electric fields, electromagnetic fields, continuous waves, transients.
Electrostatic discharge (ESD) phenomena.
The following categories of apparatus are exempt from the EMC Directive (But may not require local country regulatory terms): Apparatus for export to a country outside the European Economic Area (EU+Norway+Iceland+ Liechtenstein) Excluded installations comprising two or more items, or a system put together at a given place to fulfil a specific objective, but not designed as a single functional unit, and not intended to be traded across EU internal borders.
Apparatus for export to a country outside the European Economic Area
Excluded installations comprising two or more items, or a system put together at a given place to fulfil a specific objective, but not designed as a single functional unit, and not intended to be traded across EU internal borders.
Apparatus supplied by a manufacturer to his authorised representative who is responsible for complying with the Directive second-hand apparatus, unless it has been modified or it is being sold for the first time in the EEA.
Electromagnetically benign apparatus
Apparatus for use in a sealed electromagnetic environment as long as it is accompanied by instructions stating that the apparatus is suitable for use only in a sealed electromagnetic environment.
Radio amateur apparatus which is not available commercially
In some EU countries, military equipment is exempt, unless it can also be used for non-military purposes.
Active implantable medical devices which are covered by Directive 90/385/EEC
Medical devices which are covered by 93/42/EEC (until 13 June 1998 manufacturers of medical devices may comply with the EMC Directive, comply with the Medical Devices Directive or continue to comply with existing national laws).
Automotive equipment which is covered by Directive 95/54/EEC
Electrical energy meters are exempt from immunity requirements only as these are regulated by Directive 76/89/EEC. Non-automatic weighting instruments are exempt from immunity requirements only as these are regulated by Directive 90/384/EEC.
Three steps to compliance
Choose standards route (self certification), technical construction file route (assessment by third party Competent Body), EC type examination (for radio transmitting equipment only).
Declaration of conformity
EN45014 may help in establishing the format of a Declaration of conformity. For EMC, it should:
- Give the name and address of the responsible person and manufacturer details
- Be signed by a person empowered to bind the manufacturers, and that individual should be identified
- Bear the date of issue
- Give sufficient particulars to allow the apparatus to be identified (part number, etc)
- State the numbers and titles of any applicable EMC standards applied by the manufacturer
- If appropriate, identify the technical construction file relating to the apparatus, give the name and address of the competent body, and details of the report which they issued
- If appropriate, identify the EC type-examination certificate, its date, number, and the name and address of the notified body which issued it
- Certify that the apparatus conforms with the protection requirements
In all cases, the declaration of conformity shall be held by a responsible person at the disposal of the EU national authorities for ten years beginning with the date on which the last item of apparatus is supplied to the end user.
Whichever route a manufacturer has chosen to follow, he is required to complete a declaration of conformity and place the CE marking on the apparatus. The Marking should be affixed to one of the following (in order of preference) the apparatus itself, the packaging for the apparatus, the instructions for use, the guarantee certificate.