Manufacturers will not need EMC or conformity assessments but will need to illustrate the

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1 EMC Directive 2004/108/EC: Implications for Manufacturers Kenneth L. Boston, PE, NCE January 2011 As of July 2007, 2004/108/EEC replaced the previous standard, which required manufacturers to create a Technical Construction File (TCF) for a large system, and to enlist the involvement of a competent body. Although assessment by a competent body is no longer required, manufacturers must still take steps to ensure that the system and environment are protected. Manufacturers will not need EMC or conformity assessments but will need to illustrate the application of Good Manufacturing Practices (GMP) or Good Engineering Practices (GEP). This would appear to reduce potential onsite testing, but lack of EMC expertise as well as unfamiliarity with the standards has most industrial concerns looking outside for expertise. Essential Requirements The new directive offers better definitions of essential requirements. These include protection requirements and specific requirements for apparatus and fixed installations. The directive also provides clarification of information and documentation requirements. Definitions: Apparatus and Installations An apparatus is defined as: an electrical and electronic appliance a component which is intended for incorporation by the end user: e.g., a CD ROM drive a mobile installation Fixed installation covers many apparatus or components assembled and installed at a predefined location. This includes large machines and networks such as electrical or telecom networks. Apparatus Assessment Path Under the new directive, most apparatus can be evaluated via an assessment to the appropriate harmonized standards, or by an assessment performed by a Notified Body, which results in the manufacturer creating a declaration of conformity, or DoC. (This is a selfdeclaration by the manufacturer.) Note that these installations are not required to have: an electromagnetic compatibility assessment Page 1 of 7

2 a conformity assessment an EC declaration of conformity the CE marking affixed Fixed Installation Requirements However, 2004/108/EC does set forth compliance requirements for fixed installations: Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that: (a) The electromagnetic disturbance generated does not exceed the level above which radio and telecommunication equipment or other equipment cannot operate as intended (b) the installation 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. Other requirements for fixed installations: A fixed installation shall be installed applying good engineering practices and considering the intended use of its components, with a view to meeting the protection requirements of both emissions and immunity. Practices shall be documented and held by the person(s) responsible at the installation. These documents will be held at the disposal of national authorities, for as long as the fixed installation is in operation. The Role of the Responsible Person The directive also outlines the role of the responsible person, who ensures that the fixed installation complies with protection requirements and also keeps compliance documentation available for national authorities. It is up to each member state to set rules identifying the responsible person. Application of Good Engineering Practices The directive specifies that the good engineering practices employed shall be documented and that the responsible person holds these documents ready for inspection by national authorities for as long as the fixed installation is in operation. However, documentation required for a fixed installation is not the same as is required for an apparatus. The evaluation of an apparatus for EMC compliance will always require a more comprehensive view of EMC requirements. Should we assume that the use of good modern EMC engineering practices is required? After all, using non EMC good engineering practices (e.g., complying with the IEEE s wiring regulations) will not help ensure that the fixed installation complies with the EMC protection requirements. Page 2 of 7

3 The answer lies in using harmonized standards for qualifying items and apparatus. Using Harmonized Standards Harmonized standard means a technical specification adopted by a recognized standardization body under a mandate from the European Union. Compliance with a harmonized standard is not required, but it is recommended, and it provides a level playing field. If challenged, market surveillance authorities must prove that the apparatus does not meet the essential requirements. If complaints of interference are received, national EMC authorities within any EU member state may request evidence of compliance or initiate an investigation. Where noncompliance is established, authorities may impose measures to bring the apparatus into compliance with protection requirements. New Elements of EMC Assessment Several new elements were introduced in 2004/108/EC: No mandatory third party (CAB/NB) involvement is required even when harmonized standards are not used. This was not the case with 89/336/EEC. Performing an EMC assessment requires someone who is an expert in EMC. The manufacturer is allowed to make decisions but must rely on having EMC expertise available to make those decisions correctly. Correct application of all relevant harmonized standards is equivalent to making an EMC assessment. The manufacturer must ensure compliance with all applicable requirements in the standard and follow prescribed test procedures in the standard (or test standards). Ensuring compliance does not always require testing, particularly when only a small revision has been made of the apparatus. Other methods of applying relevant harmonized standards include partial tests, simulations, and calculations. Items Intended for Incorporation into the Marketplace Items intended for incorporation could be systems (of any size) or any other apparatus, subsystems, or devices. If items are products placed on the market for distribution or final use such as PCs, ethernet devices, power supplies, motor drives, instrumentation and control modules, or generators they must comply with all of 2004/108/EC s provisions and also have an EU declaration of conformity and the CE mark. Page 3 of 7

4 If an item is intended solely for a specific installation, 2004/108/EC still applies but does not require it to comply with protection requirements, undergo a conformity assessment procedure, or carry the CE marking. Basic Standards, Immunity Several basic EMC standards fall under the umbrella of 2004/108/EC: ESD Enclosure, all environments Radiated E. Field Enclosure, all environments EFT Mains, cables, all environments SURGE Mains, some cables, all envrnmts Conducted E. Field Mains, cables, all environments Power Harmonics (Guidance document only) Mag Field; 50/60hz Enclosure, all environments Pulse Mag Field Enclosure, special environments Oscillatory Mag Field Enclosure, special environments Dips Interrupts Mains, all environments Oscillatory Waves Mains, cables, special environments Mains Harmonics Mains, some environments Creating Documents To create the appropriate documents, suppliers of items need to know the fixed installation s EM environment but does 2004/108/EC require a full assessment of the EM environment to be conducted, as would be needed for proper EMC engineering? Or is it enough to classify a fixed installation as domestic, commercial, light industrial or heavy industrial? The generic standards (EN series) indicate precautions to be taken during incorporation to avoid compromising the compliance of the fixed installation. Is it enough simply to list EM mitigation measures (such as shielding, filtering, power conditioning) and let someone else worry about what to do in practice? Role of a Conformity Assessment Body/Notified Body It seems reasonable to assume that 2004/108 requires a fixed installation to employ someone who has (or has access to) state of the art knowledge of EMC standards and guides, skill in assessing EM environments, and understanding of EM good practices for assembly, installation, and remedial measures (EM fixes). Page 4 of 7

5 It also seems reasonable to assume that this person has access to EM measuring equipment, has necessary authority over suppliers, and compiles documentation on good engineering practices. A Conformity Assessment Body/Notified Body (CAB/NB) can carry out tasks pertaining to the conformity assessment procedures referred to in the directive. What a CAB/NB Can Do for the Manufacturer A manufacturer may wish to use a CAB/NB because: There is no in house EMC expert. There is an in house EMC expert, but a third party opinion is desired. There are no clearly relevant harmonized standards. The manufacturer chooses to apply the standard in part or not at all. The manufacturer chooses to use a non harmonized standard. General Practice Many currently use the CE + CE = CE approach, which requires no EMC skills or testing, and thus is low cost. This approach relies entirely upon assembling an installation using items, subassemblies and components which are individually CE compliant and are so identified. But this approach has no technical or legal basis and was never sufficient for 89/336/EEC, and clearly won t meet 2004/108/EC s requirements for fixed installations and their incorporated items: Must comply with protection requirements regarding the state of the art. Do not have to undergo conformity assessment, have a declaration of conformity, or have CE marking, but must use good engineering practices and respect the information on the intended use of the items incorporated into it, and document the good engineering practices. For each fixed installation, someone will be identified as being responsible for the above. The Role of a CAB as a Notified Body or EMC Consultant 2004/108/EC does not require the use of a CAB/NB for the assessment of apparatus or even for fixed installations. However, there may be EMC problems for which the manufacturer will require technical expertise. Although the directive does not prohibit the use of a CAB/NB in these situations, the CAB/NB will not be acting as a CAB/NB but rather as an EMC expert. Page 5 of 7

6 It is up to the manufacturer to specify to the CAB/NB what parts of the essential requirements it wants assessed. The CAB/NB then must take into consideration whether it is technically feasible to make an assessment based on the limited information provided. If a CAB/NB is used to provide a statement to only a portion of the essential requirements, consideration must be given of how CAB/NB involvement should be reflected in the DoC and the Technical File. Information and Marking Requirements Marking requirements: each apparatus shall be identified in terms of type, batch and serial number. Traceability requirements: the apparatus must include the name and address of the manufacturer, authorized representative, and person responsible for placing the item on the market. Precautions: information must include specific precautions when assembling, installing, and maintaining the apparatus. Residential/industrial instructions must be provided to enable use of the installation for the intended purpose. Declaration of Conformity The Declaration of Conformity must include: reference to the applicable directive(s) identification of the apparatus, such as model and serial number name and address of the manufacturer reference to specifications and system parameters date of declaration responsible person identification and signature Conclusions The new directive does not remove the assessment requirements. It still requires an assessment of the apparatus and/or the installation. The revised EMC directive specifically places the EMC assessment in the hands of the manufacturer. The use of harmonized standards simplifies this assessment. Page 6 of 7

7 Author Contact Information If you would like more information, feel free to contact me: Kenneth Boston, PE, NCE (262) Page 7 of 7