By: Eur Ing Panagiotis Chr. Stefanides* Head of Standards and Certification EMC Hellas SA,

1. MedPower08Compliance of Equipment in Accordance with an Adequate Level of ElectromagneticCompatibility By: Eur Ing Panagiotis Chr. Stefanides* Head of Standards and Certification EMC Hellas SA, Affiliate of Hellenic Aerospace Industry SA [HAI] 2-4, Messogion Ave [Athens Tower], 11527 Athens, Greece Tel: +302262046414, Fax:+302262052592, E-mail:pstefanides@haicorp.com

2. CONTENTS page I. PROLOGUE 3 II. EMC LEGISLATION 5 III. DEFINITION OF EQUIPMENT10 IV. ESSENTIAL REQUIREMENTS12 V. CONFORMITY ASSESSMENT PROCEDURE14 VI. CEMARKING AND OTHER MARKS AND INFORMATION19 VII. NOTIFIED BODIES AND CRITERIA FOR THEIR 21 ASSESSMENT FOR NOTIFICATION VIII. FIXED INSTALLATION24 IX. MARKET SURVEILLANCE AND COMPETENT CONTROL26 SERVICES X. EPILOGUE 29 XI. REFERENCES 30 XII. BIOGRAPHY 31 ABSTRACT 36 Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

3. I (a). PROLOGUE This paper concerns the electromagnetic compatibility [EMC] of equipmentregulated by the new Directive2004/108/EC, whose provisions aim to ensure that the internal market will function by requiring equipment to comply with an adequate level of electromagnetic compatibility. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

4. I (b). PROLOGUE • Equipment, complying with this Directive, will function satisfactorily in its electromagnetic environment, withoutintroducing intolerable electromagnetic disturbances to other equipment, and it will have a level of immunity to operate in the presence of electromagnetic disturbance, without degradation. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

5. II (a). EMC LEGISLATION • The new Directive 2004/108/EC [1],referred to here as the Directive, is the EMC Directive of the European Parliament, which has repealed EMC Directive 89/336/EEC [2]. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

6. II (b). EMC LEGISLATION TheDirective requires that, for the • transitional periodMember Stateswill not impede the placing on the market or the putting into service of equipment which is in compliancewith the provisions of Directive 89/336/EEC, and placed on the market before20 July 2009, and for the • transposition, the Member States will adopt and publish the laws, regulations and administrative provisions, necessary to comply with it by 20 January 2007, will inform the Commission, and will apply its provisions as from20 July 2007. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

7. II (c). EMC LEGISLATION • The Greek adaptationto this Directive [Common Ministerial Resolution] ΚΥΑ50268/5137/07, referred to here as KYA, is published in [ Government’s Gazette] ΦΕΚ 1853Β/13-09-2007[3]. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

8. II (d). EMC LEGISLATION The design and manufacture of equipment is subject to • essential requirements in relation to the electromagnetic compatibility, and the • compliance of equipment with the relevant harmonised standards [whose references are published in the Official Journal of the European Union], will raise a presumption, on the part of the Member States of • conformity with the essential requirements, which are • protection requirements for equipment and • specific requirements for fixed installations. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

9. II (e). EMC LEGISLATION For the free movement of equipment, the requirements of the Directive will not prevent the application, in any Member State, of the following special measures concerning the putting into service or use of equipment: • measures to overcome an existing or predicted electromagnetic compatibilityproblem at a specific site, • measures taken for safety reasonsto protect public telecommunications networks or receiving or transmitting stations when usedfor safety purposes [safeguarding human life or property], in well-defined spectrum situations. Member States will notify those special measures to the Commission and to other Member States, and when they are accepted they will be published, by the Commission, in the Official Journal of the European Union. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

10. III (a).DEFINITION OF EQUIPMENT According to the Directive, • equipment means any apparatus or fixed installation, and • apparatus means any finished appliance or combination thereof made commercially available as a single functional unit, intended for the end user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance, and for the purpose of the Directive, • components sub-assemblies and mobile installations are deemed to be apparatus, • fixed installation means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

11. III (b). DEFINITION OF EQUIPMENT The Directive willnot apply to: radio equipment and telecommunications terminal equipment, since they are covered by Directive 1999/5/EC, aeronautical products, parts and appliances, as referred to in Regulation (EC) No 1592/2002 of the European Parliament, radio amateur apparatus, which is not commercially available, equipment which is inherently benign in terms of electromagnetic compatibility, equipment for which the essential requirementsare more specifically laid down by other Community Directives. The Directive does not deal with the safety of equipment, since that is dealt with by separate Community or national legislation. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

12. IV (a).ESSENTIAL REQUIREMENTS For the protection requirements, equipment is so designed and manufactured, having regard to the state of the art, as to ensure that: • thegenerated electromagnetic disturbancedoes not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended, where disturbance isdefined by the Directive, asany electromagnetic phenomenon which may degrade the performance of equipment, and which may beelectromagnetic noise, an unwanted signal or a change in the propagation medium itself, and, Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

13. IV (b). ESSENTIAL REQUIREMENTS • equipment has a level of immunityto the electromagnetic disturbanceto be expected in its intended use, which allows it to operate without unacceptable degradation of its intended use, and according to the Directive, • immunity is the ability of equipment to perform as intended without degradation in the presence of electromagnetic disturbance, which may be electromagnetic noise, or an unwanted signal. • The specific requirements for a fixed installation is that, it will be installed applying good engineering practices, which will be documented, and the documentation will be held by the person responsibleat the disposalof the relevant national authorities for inspection purposes. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

14. V(a).CONFORMITY ASSESSMENT PROCEDURE The manufacturer, for the compliance of apparatus with the essential requirements, will perform an EMC assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the protection requirements. The correct application of all the relevant harmonised standards will be equivalent to carrying out of the EMC assessment. • A technical documentation [for KYA a technical file], is drawn up by the manufacturer, or his authorized representative in the Community, whichprovides evidence of the conformity of the apparatus with the essential requirements, and whosecompliance is attestedby the issue of anEC declaration of conformity. Further, at the discretion of the manufacturer, compliance of apparatus may be completed, by presenting the technical documentation to a notified body with the request for an assessment, of specified aspects of the essential requirements. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

15. V(b). CONFORMITY ASSESSMENT PROCEDURE • The notified body will review the technical documentation, will assess if these requirements have been met, andif compliance is confirmed, will issue a statement, which will be limited to those aspects of the essential requirements assessed, confirming compliance. Following themanufacturer will add the statement of the notified body to the technical documentation Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

16. V(c). CONFORMITY ASSESSMENT PROCEDURE • Themanufacturer established within the Community, holds the technical documentation and the EC declaration of conformity at the disposal of the Competent Authorities, for at least ten (10) years and • in the case that neither the manufacturernor his authorised representativeis establishedwithin the Community, this obligation lies with the person who places the apparatus on the Community market. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

17. V(d). CONFORMITY ASSESSMENT PROCEDURE Thetechnical documentation enables the design, manufacture, and assessment of the apparatus, andit covers: • a general descriptionof the apparatus, • a statement from the notified body, when used, according to the requirements of the Directive, • evidence of compliance with the harmonised standards, if any applied in full or in part, and, • where the manufacturer has not applied harmonisedstandards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements, including a description of the electromagnetic compatibility assessment set out in it, results of design calculations made, examinations carried out, test reports, etc. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

18. V(e). CONFORMITY ASSESSMENT PROCEDURE The EC declaration of conformity contains: • a reference to the Directive, • an identification of the apparatus to which it refers, as set out in the Directive, • the name and address of the manufacturer and, where applicable, the name and address of his authorised representative in the Community, • dated reference to the specifications under which conformity is declared to ensure the conformity of the apparatus with the provisions of the Directive, • the date of that declaration, • the identity and signature of the person empowered to bind the manufacturer or his authorised representative. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

19. VI (a).CE MARKING AND OTHER MARKS AND INFORMATION Apparatus whose compliance has been established, bears the CE marking, whose characteristics are specified by the Directive, affixed to it or to its data plate, and where this is not possible, to its packaging and its accompanying documents. • Where the apparatus is subject to other Directives, covering other aspects, and which also provide for the CE marking, this indicates that the apparatus also conforms to those other Directives. • Themanufacturer, or his representative in the Community, isresponsible for the affixing of the marking. • It is prohibited to affix marks which mislead third parties in relation to the meaning of the CE marking. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

20. VI (b).CE MARKING AND OTHER MARKS AND INFORMATION • Eachapparatus is identified in terms of type, batch, serial number and the name and address of the manufacturer, who should provide information on any specific precautionsfor the assembly, installation, maintenance or use of the equipment, assuring that apparatus forwhich compliance with the protection requirements is not ensured in residential areas, is accompanied bya clear indication of this restriction of use. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

21. VII(a).NOTIFIED BODIES AND CRITERIA FOR THEIR ASSESSMENT FOR NOTIFICATION Bodiescomplying withthe assessment criteriaestablished bythe relevantharmonised standards, arenotified to the Commission by Member States,forcarrying out tasks which are referred to in the Directive. The Commission publishes a list of notified bodies in the Official Journal of the European Union. The bodies notifiedwill fulfill the following minimum conditions: • availability of personneland of the necessary meansandequipment, • technical competence and professional integrityofpersonnel, Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

22. VII (b).NOTIFIED BODIES AND CRITERIA FOR THEIR ASSESSMENT FOR NOTIFICATION • independence in preparing the reports and performing the verification function provided by the Directive, • independence of staff and technical personnel in relation to all interested parties, groups or persons directly or indirectly concerned with the equipment in question, • maintenance of professional secrecyby personnel, • possession of civil liability insurance unless such liability is covered by the Member State under national law. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

23. VII (c).NOTIFIED BODIES AND CRITERIA FOR THEIR ASSESSMENT FOR NOTIFICATION TheGreek notified bodiesaredesignated by Resolutions of theMinister of Transport and Communications, and for these bodies it is required thattheyareaccredited by either ESYD [Hellenic Accreditation System]orbya body member ofthe Mutual Accreditation Recognition Agreement [MLA]. • EMC Hellas SA, was notified body for the EMC Directive 89/336/EEC, and currently, by the Ministerial Resolution YA 43252/1054/08 [ΦEK 600B/08-04-2008], is designated notified body, for technical file assessment, according to KYA 50268/5137/07 [adaptation to the new Directive 2004/108/EC]. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

24. VIII(a).FIXED INSTALLATION Afixed installationis a particular combinationof several types of apparatus, which are assembled, installed and intendedto be used permanentlyat a predefined location. • Apparatus which has been placed onthemarket and which may beincorporated into a fixed installationis subjectto allrelevant provisions for apparatusof the Directive. • As the provisions of certain articles of the Directive are not compulsory, for not commercially available apparatus, the accompanying documentation will identify the fixed installation and its electromagnetic compatibility characteristics, and • precautions should be taken for the incorporated apparatus, in order not to compromise the conformity of the installation. • The competent authorities, require evidence of compliance of the fixed installation, and set out provisions for identifying the person responsible for the establishment of compliance. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

25. VIII(b). FIXED INSTALLATION Thecompetent authorities of the Member State concerned, request evidence of compliance of the fixed installation, where there are complaints about disturbances being generated by the installation, and set out provisions for identifying the person responsible for the establishmentof compliance of a fixed installation withthe relevant essential requirements. • For Greece, in the case that the legislation requires a license for the fixed installation, the owner appoints a duly qualified person who will be responsiblefor its compliance. He willdraw up the technical file of the installation and will keep it together with all documentation, by which the compliance ofthe incorporated equipment iscertified. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

26. IX(a).MARKET SURVEILLANCE AND COMPETENT CONTROL SERVICES For KYA, the purpose of market surveillance is to control: • the CE marking, • the technical file [the completeness of the technical documentation and its compliance with legislation], • the details of the notified body [where used], • the application of the requirements of the technical file, • the performance of macroscopic controls of equipment, • equipment at its place of operation, • samples, taken for testingby appropriately accredited laboratories [defined by the Minister of Transport and Communications] at their establishments or by their mobile units, with the following provisions: Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

27. IX(b). MARKET SURVEILLANCE AND COMPETENT CONTROL SERVICES • TheDirectorates of Transport and Communicationsof the Prefectures’ Local Governments arethecompetentcontrollingauthoritiesfor the verificationthat the regulations of EMC are observed. • Teamswhich haveaccesstomanufacturing areas, are abletoinspect, order the operationof equipment at the inspected area, and take samples, toan appropriate tests and measurements laboratory for control, arethecontrolling bodiescalled Mixed Control Teams, which are formed by Governor’s ruling, and lists oftheir available representativesarenotifiedto the Prefectures’ Local GovernmentsbytheMinister of Transport and Communications and bythe EETT [Hellenic Telecommunications & Posts Commission]. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

28. IX (c). MARKET SURVEILLANCE AND COMPETENT CONTROL SERVICES • During the surveillance of the market, if problems are encountered, the authorities may request from the Minister of Transport and Communications, the participation, among others, of an EMC consultant. • By Ministerial ruling, procedures and details are specifiedforthe commissioning of notified bodies and approved laboratories, to control equipment, examine technical files, and perform tests and measurements. • As from20 July 2009, a person holding a“Market Supervisor’s Certificate for the electromagnetic compatibility” will beincluded in the Mixed Control Teams and in thePrefectures’ Hearing Committees, which are established by Governor’s ruling and who is Competent for imposing ratifications. The task of the Prefectures’ Hearing Committees is to examine the written or oral views of those audited by the Mixed Control Teams and found to violate the Directive. • By ruling of the Minister of Transport and Communications, a permanent committee, of eleven members, supplying consultation service on matters concerning electromagnetic compatibility, is constituted. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

29. X.EPILOGUE As the electromagnetic compatibility is a complex engineering subject, design engineers and manufactures should take any possible care, consulting in detail the requirements of the Directive, together with those of KYA for Greece, before designing, manufacturing, or placing on the market of equipment. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

30. XI. REFERENCES [1] Directive 2004/108/EC of the European Parliament and of the council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC, Official Journal of the European Union L390/24 , of 31.12.2004, pp 24-37. [2] Council Directive of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility [ 89/336/EEC], Official Journal of the European Community, No L 139/19, of 23.5.89, pp 19-26. [3] Adaptation of the Greek legislation to the electromagnetic compatibility Directive 2004/108/EC, by KYA 50268/5137/07, repealing KYA 94649/8682/93, ΦΕΚ 1853Β/13-09-2007, pp 26615 - 26626 Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

31. XII(a).BIOGRAPHY Eur Ing Panagiotis Chr. Stefanides BSc(Eng)Lon(Hons) MSc(Eng)Ath TEE CEng MIET, Head of Standards and Certification EMC Hellas SA, Affiliate of HAI. • (C.V.)http://www.stefanides.gr • Born: 05.01.1945 , Athens, • Professional and Academic Qualifications: • Chartered Electrical Engineer of the Engineering Council (UK), • Member of the Institution of Engineering and Technology [IET], • Certified Lead Auditor [Cranfield University], • Member of the Technical Chamber of Greece TEE, • Electrical and Mechanical Engineer of the National Technical University ofAthens, • Electrical Engineer of the University of London. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

32. XII(b). BIOGRAPHY Professional Experience: 2008-1978 [HAI] • Electromagnetic Compatibility Control and Certification EMC Hellas SA, Affiliate of HAI, • Research and Development of Electronic Systems’ Tests and Certification, • Engineering Quality and Reliability Section Engineer, and HAI’s Quality System Lead Auditor, • Engines’ Directorate Engineering methods of the M53P2 Engine Nozzle Manufacturing [SNECMA- HAI Co-production Programme]. • Engines’ Tests and Electrical Accessories. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

33. XII (c). BIOGRAPHY 1978-1974 • G.E., Athens, • Continental Electronics Dallas Texas and EDOK-ETER Consortium, of 2MW Superpower Transmitter installations in Saudi Arabia, • Chandris Shipyards Engineer and Vessels Superintendent, Salamis Island. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

34. XII (d). BIOGRAPHY Training: • Public Power Corporation [GR], Sizewell Nuclear Power Station [UK], Ocean-going Steamship [S/S Chelatros ] and, • Motor Vessels’ Navigation[Celestial , Radio, Coastal] and Engines’, of “Kassos” Shipping Co. Ltd. [R&K London]. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

35. XII (e). BIOGRAPHY Presentations, Publications, Conferences, Awards: • http://www.stefanides.gr/Pdf/CV_STEFANIDES.pdf Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

36. ABSTRACT The objective of the new electromagnetic compatibility[EMC] Directive 2004/108/EC of the European Parliament, and that of the Greek [Common Ministerial Resolution] KYA 50268/5137/07 published in the Government’s Gazette ΦΕΚ 1853Β/13-09-2007, is toensure that the internal market will function, by requiring equipment to comply with an adequate level of electromagnetic compatibility. During the design and manufacture of equipment, both documents, for Greece, should be taken into account, and during the stage of manufacturing or after, the required tests and measurements should be performed according to the relevant harmonised standards, which are technical specifications adopted by a recognized European standardization body under a mandate from the Commission. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

37. ABSTRACT (Cont.) Thus, complying equipment placed on the market will have the ability to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment, and it, also, will have a level of immunity. • Keywords: electromagnetic compatibility, disturbance, immunity, equipment, essential requirements, conformity assessment, EC declaration of conformity, CE marking, notified bodies, market surveillance. Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility

38. MedPower08 Compliance of Equipment in Accordancewith an Adequate Level of Electromagnetic Compatibility by: Eur Ing Panagiotis Chr. Stefanides Compliance of Equipment in Accordance with an Adequate Level of Electromagnetic Compatibility