Testing Disciplines
European EMC Directive FAQ's
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The EMC Directive is a policy statement published by The Council of the European Communities. It declares two essential requirements: I. "Apparatus" sold within the European Union (EU) will be constructed such that " the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunications equipment and other apparatus to operate as intended." II. "Apparatus" sold within the European Union (EU) will have "an adequate level of intrinsic immunity of electromagnetic disturbance to enable it to operate as intended". Each member state has three (3) months to create a national law to comply with the provisions of the directive and six (6) months to apply the provisions of the directive. Apparatus is defined in the EMC directive as "all electrical and electronic appliances together with equipment and installations containing electrical and/or electronic components." Note: The word "Installations" has been removed from the requirements because installations are stationary and are not part of free trade. 3. How can I determine if my product is a component or an apparatus? For a product to be classified as an apparatus it must meet four (4) criteria: I. It must be a
finished product. Additional clarification may be found in the following document, "Guideline on the application of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the member states relating to Electromagnetic Compatibility amended by Directives 92/31/EEC and 93/68/EEC." 4. Who are the members of the European Union? Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, and Sweden. Additional countries that have expressed interest in joining the EU include: Czech Republic, Hungry, Norway, Poland, Slovakia and Turkey. 5. Are the national laws consistent? Yes, consistency is mandated. 6. Do I have to test my apparatus to sell it within the European Union? Probably. The EMC Directive states that any apparatus sold within the European Union must bear the mark to indicate compliance with the Directive. There are essentially three methods to demonstrate compliance with the EMC Directive. 7. What are the three methods used to demonstrate compliance with the EMC Directive? 1. Self Declaration- Subject your apparatus to the tests specified by European Normalized Standards. Compile a technical file to contain the apparatus' technical information and test results. Issue a Declaration of Conformance (DoC), affix the mark and hold a copy of the Declaration of Conformance "at the disposal of the Competent Authority". 2. Technical Construction File - for equipment not covered by standards or that is impractical to test. The manufacturer compiles a Technical Construction File containing information required to assess the EMC characteristics of the apparatus. The completed file is submitted to a Notified Body to determine if the file demonstrates that the apparatus will comply with the intent of the requirements. The Notified Body issues a report either indicating the apparatus is in compliance or detailing deficiencies. If deficiencies are noted, corrective action is taken by the manufacturer and the apparatus resubmitted for evaluation. If the Notified Body indicates that the apparatus is in compliance, the manufacturer can issue a Declaration of Conformance, affix the mark and hold a copy of the Declaration of Conformance "at the disposal of the Competent Authority". 3. Notified Body- for apparatus for which Normalized Standards do not exist a Notified Body may recommend appropriate testing. This testing would be conducted by a Competent Body and reviewed by a Notified Body. When the Notified Body is satisfied that the apparatus is in compliance, the manufacturer compiles a technical file to contain the apparatus' technical information and test results. The manufacturer issues a Declaration of Conformance, affixes the mark and holds a copy of the Declaration of Conformance "at the disposal of the Competent Authority". 8. What are Normalized Standards? For a standard to be normalized it must meet three criteria: I. It must be identified by an "EN" designation. II. It must be published in the "Official Journal of the European Communities" (OJ). III. It must be adopted by at least one of the member states. The mark is a symbol, specified by law, which identifies an apparatus as complying with all applicable directives. All apparatus offered for sale within the EU must have the mark or they cannot be sold. Failure to have the mark can result in legal penalties. 10. Who can affix the mark to my apparatus? The mark is affixed by the manufacturer after demonstrating compliance with all applicable Directives. 11. Am I required to provide any documentation to support the marking? Yes. The mark on the product is required to be substantiated with a Declaration of Conformity (DoC). The Declaration of Conformity (DoC) needs to be supported with documentation kept on file by the manufacturer. The DoC must be " held at the disposal of the Competent Authority for ten years following the placing of the apparatus on the market." 12. What is a Declaration of Conformity (DoC)? A Declaration of Conformity (DoC) is a standardized document used to summarize the details of the apparatus' compliance. 13. How do I hold my DoC "at the disposal of the Competent Authority"? One approach is to provide the DoC as part of the owner's manual. 14. How long must I hold my DoC "at the disposal of the Competent Authority"? You must hold your DoC "at the disposal of the Competent Authority" for ten (10) years after the product enters the market. 15. Does this mean that ten years after I start selling a product I no longer need the DoC? No. Ten years after the last date of sale you are no longer required to have the DoC available for the Competent Authorities. 16. Can a third party issue a Declaration of Conformity (DoC)? No. The manufacturer is required to issue the Declaration of Conformity (DoC) and is responsible for it's content. All other third party references and signatures have no legal standing. 17. What is a Competent Authority? A Competent Authority (a.k.a. National Authority) is generally the member state's government agency responsible for control of the RF spectrum. A Notified Body is an organization, appointed by the EU member's National Authority (a.k.a. Competent Authority) , which has the technical competence to evaluate compliance to a directive. They do not necessarily have test capabilities. 19. Who are the Notified Bodies? In many cases the Notified Bodies are those organizations that were formally the national experts, such as VDE in Germany. A complete list of Notified Bodies is published in the "Official Journal of the European Communities." 20. Where can I get the "Official Journal of the European Communities"? You can get a subscription to the "Official Journal of the European Communities" by calling 800 274-4888 or contact the US Department Of Commerce, EC Affairs Office to purchase select reprints. 21. If a Notified Body does not have test facilities, can they designate their authority? No. A Notified Body may only direct testing to designated laboratories on apparatus for which no Normalized Standards exist. The Notified Body then notifies the European Commission of the designated laboratory. These laboratories are designated as Competent Bodies. A Competent Body cannot certify your apparatus, the authority remains with the Notified Body. 22. Do I have to use a Competent Body to test my product to the Normalized Standards? No. When there are Normalized Standards, which are applicable to your apparatus, you do not need to utilize a Competent Body. 23. Who are the Competent Bodies? A Competent Body is an organization, located within the same member state as the Notified Body, that is authorized to conduct specific testing. A list of Competent Bodies is published in the "Official Journal of the European Communities." 24. Can a company or organization not located in a EU member country become a Competent or Notified Body? No. Competent Bodies and Notified Bodies, by definition, must be organizations located within the geographical boundaries of the EU. Competent Body or Notified Body status does not extend to subsidiaries or related enterprises located in a third country. 25. What approvals are required to test in accordance with the European Normalized Standards? None. Contrary to the abundant marketing hype, no certification, accreditation, approval, European ownership or myriad of other supposed prerequisites exist. 26. Who can conduct testing in accordance with European Normalized Standards? Anybody! Once a standard is adopted anybody, including the manufacturer themselves, may conduct testing in accordance with the Normalized Standards. 27. Can I have testing performed by a US laboratory, self certify, and affix the mark? Yes, but is important to remember that the liability for the accuracy and completeness of the testing always remains with you as the manufacturer or your importer. 28. Who should conduct my testing? Most manufacturers will benefit from utilizing the services of an independent third party test laboratory. American Environments Company, Inc. (AECO) core competency is testing with demonstrated expertise in the application of European test methods. 29. How can I tell if a laboratory is qualified to conduct testing in accordance with the Normalized Standards? Good engineering judgment is required to selected a laboratory. Questionable accreditation (See Questions 30 & 32), meaningless approvals and participation on international committees, while they may be presented impressively, are not criteria for selecting a laboratory. Some of the objective, technical evidence of a EU test capability is as follows: I. Facilities- In order to conduct testing in accordance with the EU Normalized Standards specific test facilities are required.
II. Calibration Data - To develop a test capability, specific calibrations must be performed.
III. Specialized Test Set Ups- Some standards specify unique equipment requirements. For example, the Electrical Fast Transient testing requires a capacitive coupling clamp. AMERICAN ENVIRONMENTS' EQUIPMENT IS AVAILABLE FOR YOUR INSPECTION. IV. Experience - AMERICAN ENVIRONMENTS' HAS BEEN PROVIDING TESTING SERVICES SINCE 1974. Finally, you should find a laboratory who's personnel spend the time helping you understand the Directives as opposed to dazzling you with technical terminology. 30. Are there US laboratories which are accredited for European testing? No. Laboratories can be accredited only within the EU. The EU system does not allow for third party certifications, accreditation or approval unless the organization is operating under a mutual recognition agreement negotiated between the EU and government authorities of the third country. The US cannot become a member of the EU, there is a Mutual Recognition Agreements that has been initialed but not executed. The US Department of Commerce is engaged in ongoing negotiations. 31. Once an agreement is signed, how will laboratories be accredited? The framework for the accreditation process is now being constructed. One of the key stipulations is that US laboratories will be accredited by a US Competent Authority. American Environments Company, Inc. is participating in the process and is on the list of organizations interested in pursuing accreditation. 32. How can a laboratory claim to be accredited and produce documentation to support the claim? Several European Competent Bodies, for a fee, have entered into an accreditation scheme with some US laboratories. However, Competent Bodies do not have the authority to grant accreditation, therefore, the accreditation has no legal merit. Laboratories with integrity will not claim to be accredited. 33. Can I have my apparatus certified by a third party that is not a Notified Body? No. Only a Notified Body has the authority to certify an apparatus. The EU system does not allow for third party certifications, accreditation or approval unless the organization is operating under a mutual recognition agreement negotiated between the EU and government authorities of the third country. 34. Why shouldn't I utilize the services of a Competent or Notified Body anyway? I. Convenience - Competent and Notified Bodies are located in Europe. II. Cost - The added cost of sending your equipment and personnel to Europe is unnecessary when facilities such as American Environments exist domestically. III. Communication - There are no cultural or language barriers present when dealing with American Environments. 35. Do I need any other EMC certifications beyond the mark to market apparatus within the EU? Except for some telecommunication equipment, no. The purpose of the mark is to provide free movement of goods within the European market. It alone indicates compliance with all applicable requirements. All other marks are superfluous. 36. Do I need additional testing besides EMI performed before I can sell my apparatus? Maybe. There are other New Approach Directives which require testing, affixing the mark to your apparatus indicates that the apparatus complies with all applicable directives. 37. What other new approach directives are there that require testing? At the time of this information sheet, the key New Approach Directives which required testing were, as follows: 89/392/EEC Machinery
Directive Additional Directives are in process. 38. Where can I get Directives? Directives are published in "Official Journal of the European Communities" or contact the US Department Of Commerce, EC Affairs Office to purchase reprints. 39. When is my apparatus considered to have entered the market? An apparatus is considered to have entered the market when it is received by the consumer. A marked apparatus can be warehoused in the EU. If additional requirements are adopted prior to delivery to the end user, it cannot be legally sold. If an apparatus is on order, and other requirements are adopted before the apparatus is delivered, the apparatus must meet the new requirements before delivery. Call American Environments at 516 736-5883. Find out how we can assist you in self certification and the application of the mark to your product. |
