Overcoming Compliance Challenges with the New EMC Directive (2004/108/EC) September 2007 (07B-152)
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The “new” Electromagnetic Compatibility (EMC) Directive 2004/108/EC came into force in July 2007 and will repeal EMC Directive 89/336/EEC in July 2009. Now is the time to understand the main changes and challenges which affect manufacturers and authorized representatives.
Highlights of the changes include:
Focus on manufacturer responsibility for detailed technical documentation and the performance of EMC Assessments for all products within the scope.
Increased market surveillance.
Voluntary use of Notified Bodies. |
The New EMC Directive: An Overview
OBJECTIVES:
Define the scope of regulation and essential requirements
Establish a regulatory mode more adapted for fixed installations
Clarify the role of harmonized standards
Simplify the conformity assessment procedure (unique procedure for equipment)
Improve the market survey by improving the traceability of manufacturers
SCOPE: The Directive 2004/108/EC applies to a vast range of equipment encompassing electrical and electronic appliances, systems, and installations, including electrical and electronic appliances; fixed installations; devices and sub-assemblies intended to be included in an apparatus by the final user and mobile installations.
It excludes:
Equipment covered by the Radio and Telecommunications Terminal Equipment Directive 1999/5/EC
Radio equipment used by radio amateurs
Equipment where EMC is covered by other specific Directives, such as marine equipment if covered by Directive 96/98/EC or active implantable medical devices under 90/385/EEC
Inherently benign equipment
ESSENTIAL REQUIREMENTS: Protection requirements for all equipment: Equipment shall be so designed and manufactured as to ensure that:
The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended
It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use
Specific requirements for fixed installations: Fixed installations shall be installed applying good engineering practices and respecting the information on the intended use of its components.
FINAL PROVISIONS:
20 July 2007: Directive enters into force.
Until 20 July 2009: Transitional period where both EMC Directives 2004/108/EC and 89/336/EEC can be used.
20 July 2009: End of transitional period and only the new Directive 2004/108/EC can be used to place products on the European market.
Complying with the EMC Directive
When complying with this new Directive, your products need to comply with the protection requirements according to Annex I of the EMC Directive. Compliance with these protection requirements is demonstrated by applying the conformity assessment procedure detailed in Annex II (self declaration) or Annex III (use of a Notified Body on a voluntary basis) of the Directive.
Whichever conformity assessment route is chosen, technical documentation must be prepared to demonstrate evidence of compliance with the protection requirements. You must also perform an EMC assessment of your product based on the relevant phenomena in order to demonstrate that it meets the protection requirements.
All measures necessary must be taken to show that your products are manufactured in accordance with the technical documentation. You must also complete an EC Declaration of Conformity and affix the CE Marking. You may opt on a voluntary basis to involve a Notified Body during the conformity assessment procedure to review your Technical Documentation.
Preparing for the New EMC Directive
1. Review the new Directive to assess if you have EMC Assessment expertise within your organization. If not, consider partnering with an organization experienced in EMC and/or use the services of a Notified Body to assess your Technical Documentation and your EMC Assessment.
2. For products in development now, you need to evaluate against the latest product standards and declare against 2004/108/EC using a Notified Body such as Curtis-Straus in USA or LCIE in Europe (Bureau Veritas companies) if you choose.
3. For products in production that have a Declaration of Conformity against 89/336/EEC but will be obsolete by 20 July 2009, there is no need to update these products as the declaration to 89/336/EC is valid until 20 July 2009.
4. For products in production that have been declared compliant to the current 89/336/EEC Directive and are not likely to be obsolete by 20 July 2009, there is a need to re-declare against 2004/108/EC. However, you will need to perform a review of the standards used for your Assessment as they have been revised since your original declaration. This may involve additional testing.
5. If in doubt, contact your local Bureau Veritas Electrical and Electronic Product Services office. We will gladly assist you starting from Step 1! Contact us directly for details.
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KEY CHANGES BETWEEN OLD AND NEW EMC DIRECTIVES
Clear responsibility for manufacturers: Clear focus that responsibility rests squarely on the shoulders of the manufacturer or authorized representative.
You must demonstrate EMC knowledge: An EMC Assessment is required for all products.
Market surveillance will be stepped up under the new Directive: There will be stiffer penalties for those that do not comply.
Notified Bodies involvement in Technical Documentation review is voluntary: The use of a Competent Body under 89/336/EEC was mandatory when there were no or partial harmonized standards
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Bureau Veritas can assist with testing, compliance assistance regarding the EMC Assessment or we can perform the Notified Body review. To request assistance, please contact your local office.
Visit our website for contact details www.electrical.bureauveritas.com or email at electrical@uk.bureauveritas.com
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