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Guidelines 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 (Directive 89/336/EEC amended by Directives 91/263/EEC, 92/31/EEC, 93/68/EEC, 93/97/EEC) ‘A great deal of additional information on the European Union is available on the Internet. It can be accessed =| through the Europea server (http://europa.eu. int) Cataloguing data can be found at the end of the publication Luxembourg: Office for Official Publications of the European Communities, 1997 © European Communities, 1997 Reproduction is authorized provided the source is acknoxledged Printend in Luxembourg Preface by Stefano Micossi Director-General for Industry of the European Commission tioning of Harmonisation of technical rules on protection against electromagnetic inertere free movement of electric and electronic products and for the proper f telecommunication networks and apparatus in the European internal market ‘The importance of these aims for the developing information society, increasingly based on clectronics and data communication networks, is self-evident Since 1989, the European Union has established a regulatory framework for such harmonisation: the ‘Electromagnetic Compatibility Directive’ (Courcil Diective 89/336/EEC}, based on the ‘new approach’ to technical harmonisation, The Directive became mandatory on 1 January 1996 and therefore ‘total’ hatmonisation is now achieved. However, electromagnetic compatibility is intrinsically a matter of considerable complexity. Moreover the scope ofthe Directive is extremely wide, including all kinds of electrical and electronic appliances, systems and even installations containing electrical or electronic components. Finally, many products covered by this Directive are also subject tothe requirements ‘ofother Directives: the ‘Low Voltage Directive’, he Machinery’ Directive ete. Therefore, an urgent need arose for detailed guidance on substantive aspects of the practical application of the Electromagnetic Compatibility Disective, ‘This Guide seeks to establish an agreed, consensus based reference to facilitate effective and consistent application of the Directive by all those concerned, It has been prepated by the Commission Services, with the vital contribution and agreement of experts of the competent Administrations of the Member States, Industry, Conformity Assessment and European Standardisation Bodies. I wish to take this opportunity to thank them all hope that this document will substantially facilitate the application of the Directive, thereby enhancing the competitiveness ofthe industry sectors concerned and leading to eater satisfaction for users and consumers. It will also facilitate the pre-accession negotiations of Eastern European Countries by improving their understanding on our EMC approach. The Commission will continue to closely monitor developments and progress inthis area Helene Wier Notes |. These wuidelines are intended co be a manual for all partes ditectly or indirectly ae are also intended to ensure the free movement of products in the EU internal market by agri to this guide). ‘To determine whether the equipment may be considered exempt from the EMC Directive with regard to the criteria described in Section 5.4 which are commonly accepted by all parties involved in writing these guidelines, $1010! The manufacturer has to determine the classifi cation of his electrical apparatus as component, finished product, system or installation. This technical-commercial slassificarion is based on the definitions given in this guide together with the detailed clarifications and different eases given in the relevant sectors for components, finished prod lets, systems and installations, Components with a direct function must always be accom: panied by the instructions for use as requited by the EMC Directive in its Annex fll, Only when they have a direct function and they are placed on the market as single commer cial units for distribution and/or a final user are they subject to the other provisions of the Directive. A definition, criteria and illstrative examples are given in chapter 6.2 Finished products must always be accompanied by instruc: tions for use as required by the EMC Directive in Annex Il Only when they are placed on the market as single commer: cial units for distribution andlor a final user are they subject 10 the other provisions of the Directive. A definition, criteria and illstrative examples are given in Section 6.3 Systems and installations are covered by the EMC Directive, but the specific provisions are detailed respectively in Sec tion 6.4 for systems and 6.5 for installations. Note 1: If the manufacturer uses the flow chart described above and if he concludes that his equipment is excluded from the EMC Dicective, then he is not obliged to provide an EC declaration of conformity ‘not to CE mark the equipment. However, the man facturer (or his authorized representative, the im: Porter or any person who places the equipment on ‘the market) is strongly advised co keep documenta tion available at the disposal of the competent authority for inspection purposes under the same conditions as the EC declaration of conformity, in which the reasons for his decision are clearly stated, This is particularly important in the case of the seventh step if he concludes that his equipment meets the criteria of Section 5.4, Note 2: For the purpose of simplification the flow chart is limited to new equipment. Used, second-hand and repaired apparatus together with spare parts are covered by Chapter 7 3 Decision flow chart Equipment — eee no Contains electrical! ] is electronic components? L 7 | Totally excluded from the > EMC Directive? 2] (Section 5.5.1) L3 for he eleva ae Partially included inthe oe EMC Direcrve? 3 (Section 5.5.2) Tor ahealcvantincaded requirements Passive EM equipment? ‘Section 53) 4 2 a = Ss 2 Explicity listed in the as z EMC Directive? 5 a (Section 5.2) 2 m7 3 “dt z Covered by harmonized — fe standards published inthe OJ : iB tinder the EMC Dicecive?> g hess & no 3 = |3 ‘2 Mets he eri of Seton 2 is 3 (ey a [ a 1 8 ‘Component | Finished product system | Installation (ection 62) = Direc funciond> | 9 | | (Sexton 63) oY, Placed on the market 3 10 wean SCU" for inal se? A section 65) oe (secions6232 BFE Wi ceions 623.1 and 63.1 Y The only mandatory : The only mandatory provision: All provi ions of o EMC provision: Article 4 instructions for use ehhh aimee of the EMC Directive [NB: Specific provisions are detailed and have ro be carefully considered inthe sections indicated inthe decision flow chart. * CU: single commercial uns 4 5. Scope of the Directive Sa. General Within the limits explained in Chapter 4 above, the Directive applies roa vast range of apparatusencompassing as hredls 3s possible all eleteical applances, systems and installations ‘whether or not they are connected to the mains, Moreover, recitals 3,4 and 12 of the Directive clearly indicate that £0 protect electricity distribution networks" and publictelecom. ‘munication networks, equipment capable of being con: ected to them must comply with the Directive 50 as not 10 affect the electromagnetic characteristics or cause elect magnetic interference to these networks when connected 10 ‘them, or to any other equipment operating in the environ: ‘ment where they will be functioning. ‘The Directive does not impose any lower or upper limits on the apparatus as regards power output or selection of trans mission frequencies. ‘The Directive, therefore, directly covers several sectors of electrical and electronic engineering, in particular household appliances, consumer electronics, industrial manufacturing, information technology, radio communication and telecom. ‘munications apparatus, 5.2. 5.2.5 5.26. 5.27. 5.2.8. Apparatus explicitly listed within the scope of the EMC Directive (emission and immunity); non-restrictive list Flecrial household appliances, portable cools and similar equipment (last recital of the EMC Directive and Annex Ig) Fluorescent lighting luminaires firted with starters (last rectal of the EMC Directive Fluorescent lamps (partially Annex HK). Industrial manufacturing equipment (Annex III(b) 0 the EMC Directive, Information technology equipment (Annex TI) Domestic radio and television receivers Radio and television broadcast transmitters (An: rex IN}. ‘Aeronautical and marine radio apparatus” (An- ‘nex I(h) (see Sections 15.4, and 15.8.) Educational electronic equipment (Annex II Apparatus in training, research and educational ‘establishments intended for studying electromagnetic phenomena may exceed the limits of emieted distur- bance contained in the relevant standards published in accordance with Article 7(1) of the EMC Directive. "See definition given by the International Electrotechnical Vocab- lary inthe TEV 50-601, " See definition given by che International Electrotechnical Vocabu- lary inthe IEV 50-701, * Marine equipment is covered by Directive 96/98/EC (OJ L 46, 20.12.1996), which constitutes a specif Directive within the ‘meaning of Article 22) of the EMC Directive for equipment Included in its scope. Equipment intended for use in alrcraf in flights covered by Couneil Regulation (EEC) No 3922/91, which 'salso considered a specific Regulation 5.21 However, the EC declaration of conformity must in such a case indicate which EM phenomena the ap- paratus is used to study, and must also indicate that the instructions for the apparatus specify that such apparatus may only be operated under the supers sion of qualiied personnel, and that where elect magnetic disturbances cause a problem, the person n sueh institutions mint take the newest measures to eliminate such disturbances. The trait. ‘ng, Fesearch or educational establishment shall take all necessary measures to ensure that apparatus in stalled outside the electromagnetic environment can function properly. Radio equipment intended for use in amateur radio bands if commercially available (Article 2(3)). This 's subject to the conformity assessment procedures laid down in Article 10(2) and of the EMC Directive {see also 5.2.12), ‘Telecommunications apparatus: (see also Section 13.1) ‘elecommunication terminal equipment covered by Directive 91/263/EEC") and earth stations for com ‘munications by satellite equipment (covered by Di fective 93/97/EEC*): For apparatus covered by these Directives, the provisions related eo electromagnetic ‘ompatibility phenomena laid down by the three Directives 89/336/EEC, 91/263/EEC, 93/97/EEC have to be observed on 3 complementary basis, The electromagnetic compatibility essential require ments to be observed for apparatus covered by Directive 91/263/EEC or 93/97/EEC, in so lar as they are not specific" to such apparatus, are those laid down in the Directive 89/3 36/EEC. Radiocommunication transmitters nor covered by Directive 91/263/EEC nor by Directive 93/97/EEC are subject to the conformity assessment procedure laid down in Article 10(5) of Directive 89/336/EEC. ‘This apparatus includes transmitters such as Citi= zens’ Band (CB), walkie-alkies, etc. The Directive does not apply to the normal operating frequency band, as already mentioned in Chapter 4 of this 4uide. This band is outside the scope ofthe Directive. Frequencies outside the required bandwidth, called Spurious emissions, are, of course, subject to the Directive, Radiocommunication receivers ate subject to the conformity assessment procedures laid down in Article 10(2) and of Directive 89/336/EEC. 5.3. Passive-EM equipment ‘The Directive applies to apparatus liable to cause electro- ‘magnetic disturbances or whose normal operation may be affected by such disturbances (see Chapter 3). In this context, electromagnetically passive (passive EM) equipment, defined below, i excluded from the scope of the EMC Directive, since itis considered not liable to cause or be susceptible to disturbances, * OF 128, 23.5.1991, amended by Directive 968/EEC (0 L 220, 30.8.1993), ® OJ 290, 24.11.1993, » GenelecETSI, Annex Il to their coport ROBT-OOVETR 238 of October 1995 disevses the ‘specific and non-specitc EMC phenomena Is To facilitate the practical interpretation of this clause, the general definition of passive EM equipment s given hereafter, Together with practical criteria and illustrative examples. 5.3.1. Definition and examples Equipments considered passive EM equipment if when used as intended (without internal protection measures such as tiktering or shielding) and withour any user intervention, it does not create or produce any switching or oscillation of current or voltage and is not affected by electromagnetic disturbances. ‘The immediate application of the definition enables the ex: clusion, for example, of the following equipment from the application of the EMC Diective, on the lear understanding, that it includes no active electronic part (a) cables and cabling systems, cables accessories; (b) equipment containing only resistive loads without any automatic switching device, for example simple domes: tic heaters with no controls, thermostat, or fans (e)_ batteries and accumulators. 3.4, Additional practical criteria (accepted by consensus) to exclude equipment from the scope of the EMC Directive 1. Practical criteria and illustrative examples Alehough it should in principle be considered as within the scope of the Directive, the following apparatus can be con sidered as exempted,’ based upon both of the following criteria, which have ‘also been taken into account in the development of EMC standards: 1 The emission level is by the inherent nature ofthe physical characteristics and mode of operation (without internal protection measures such as filtering, or shielding) fae below the most stringent limits of the relevant EMC standards, 2. With regard co immunity, experience shows that such apparatus does function satisfactorily by the inherent nature of its physical characteristies without additional measures when used as instructed by the manufacturer in the intended electromagnetic environment. + Prorection equipment which only produces transitory dis- turbances of very short duration (e.g. << 1 s) during the clearing of a short-circuit faule or an abnormal situation ina circuit and which does not include electronic compo- nents which are EM active. Ulusteative examples: (a) Fuses. (b) Circuit breakers without electronic parts or compo- nents which are EM active. + Manual switches: appliances’ switches, home and building, switches, etc., which do not contain any components which are EM active. “Manufacturers should be aware thatthe characteristics and in- stallaion of such equipment can_have a very significant impact upon the EMC performance of the systems into which they are installed 16 + High-voleage equipment in which possible sources of dis rurhances ate due only to localized insulation defects Which may be the result of the ageing process and are anyway under the control of othee technical measures included in non-EMC product standards (e-. partial dis: charge tests), and which do not include electronic compo- nents which are EM active Uluseative examples |} High voltage inductors, (b) High voleage transformers Note 3: Some of the equipment mentioned above may also be exempred from some provisions of the EMC Directive, as components not intended for final use and without 2 direce function (see 6.2.3.2), Other equipment fulfilling the criteria above Illusteative examples: (a) Capacitors (e.g. power factor correction capacitors) (b)_ Induction mocors Note 4: High evels of harmonics in the applied voltage may have a significant effect in causing overheating and therefore a reduction in life duration of capacitors and motors which directly interface withthe applied voleage (a) Quarte wrist watches without additional functions (e.g. radio receivers). {b)_ Filament lamps (bulbs). 5.4.2. Technical justification Only three types of emitted disturbances have to be consid ered at present: (a) conducted (continuous and intermirtent) radio-fe- guency disturbance; (b) radiated radio frequency disturbances (o} harmonics, licker and voltage fluctuations on the mains power supply. Regarding immunity, the list of phenomena to be considered is given in the relevant standards, A careful examination of the circuit, mode of operation and. physical characteristics of an apparatus which does not con- ‘ain electronic components which are EM active may indicate whether itis liable to cause electromagnetic disturbances of cone of the three types identified above. If this isnot the case, such non-electronic equipment should be considered ex cempred from the EMC Directive. “This analysis should be performed with great cate as sources cof important disturbances may not always be obvious. Asa guideline, sources of disturbance inthe abovementioned apparatus are, for example: (a) for radio-frequency disturbance, all operations inside apparatus which lead to any form of switching of oscil- lation of current, or voltage, or arcing (b) for voltage fluctuations on the mains power supply, the presence of high in-rush or starting currents. od side i the 5.5. Apparatus partially or totally excluded from the EMC Directive ‘These exclusions are based on either Article 2(2), specific «exclusions laid down in the EMC Directive, or in accordance with common interpretation reached by’ Member States overnment experts during various EMC Dicective applica tion meetings Article 2.2 of the EMC Directive states that: “Insofaras prorection requirements specified in this Directive are harmonized, inthe case of certain apparatus, by specific Directives, this Directive shall not apply or shall cease to. apply with regard to such apparatus or protection require ‘ments upon the entry into force of those specific Directives.” However, ifthe EMC requirements for a given apparatus or category of apparatus are dealt with in a specific directive, the later should clearly and in a more complete way specify the EMC requirements with which to comply. 5.5.1. Apparatus totally excluded (emission and immunity) from the EMC Directive (non-restrictive list) 5.5.1.1. Radio equipment used by radio amateurs unless the apparatus is available commercially (Article 2(3) of the EMC Directive) This exclusion has been stipu- lated because of the specific nature of the activities ofradio amateurs, which do not constitute any kind cof commercial transaction. Radio amateurs are per- Sons carrying out experimental activities within the field of radiocommunications, according to defini tion No $3 ofthe ITU (Ineernational Telecommuni- cation Union) radiocommunications Regulation. Amateur radio equipment which is commercially available comes within the scope of the Directive (see 5.2.10). 5.5.1.2. Motor vehicles: covered by specific Directive 72RASIEEC® (see Section 15.3). 5.5.1.3, Active implantable medical devices: covered by spe- ‘ific Directive 90/38S/EEC* (see Section 15.6). S514. Medical devices: covered by specific Directive 93/42/EEC?, after the end of the transitional period. scheduled for 14 June 1998; during the transitional Period the manufacturer can choose whether. to apply the EMC Directive or the medical devices Directive (see Section 15.3) 5.5.1.5. In vitro diagnostic medical devices: to be covered by the proposal for a Directive (COM(95) 130 nal), as soon as this proposal is adopted and imple- ‘mented in full (see Section 15.7). © O}L 152, 67.1972, amended by Directives 89/491/EEC (OJ L 238, 15.8.1989) and 9S/58/EC (OJ L 266, 8.11.1995), See sepa rate section on this, °* OJ L 189, 20.7.1990 amended by Ditectives 93/42/EEC (0) L 169, 12.7.1993) and 98/68/EEC [OJ L 220, 30.08.1993). See Separate section on ths © O} L 169, 12.7.1993, amended by Directive 93/68/FEC (O] L 220, 30.81993) Se separate section on this. 5.5.1.6, Equipment intended for use in aircraft in flight covered by Council Regulation (EEC) No 3922/91 ‘of 16 December 1991," Marine equipment: if covered by the specific Direc tive 96/98/EC.* after the end of the transitional Period scheduled for 31 December 1998. Purine: ‘ansitional period the manutacturer van chunse whether 10 apply the EMC Directive or the marine equipment Directive (see Section 15.8), 5.5.2. Apparatus partially excluded (a). Emission requirements covered only by the EMC Direc Non-automatic weighing instruments: the EMC Direc: tive covers the emission requirements, The immunity fequirements are laid down in Annex I-8(2) to Directive S0/384/EEC.” (b) Immunity requirements covered only by the EMC Di rective: Agricultural and forestry tractors: the EMC Directive covers the immunity requirements. The emission re bined into a system (intended to be placed on the market in view of its free movement as a single functional unit) by a professional person, As a professional person, he is supposed to understand the FMC-related cechnical implicationy uf the parts when com bined into a system and make the right judgments 50 a8 (0 fulfil the objectives of she Directive. He becomes manufc- turer in the full sense, The system is therefore an apparatus in the sense of the EMC Directive and must comply with all its provisions. The EC declaration of conformity as well as the instructions for use, must refer to che system as a whole, Ie must be clear by enclosing a lise of all pars) which islare the combi rnation(s) that form(s) the system placed on the market for distribution and/or use, The system manufacturer assumes esponsibility for compliance with the Directive, in particular with the protection requirements in all expected electromag. netic envionments, and must therefore, in accordance with Chapter 10, provide clear instructions for assemblyfinstalla- ‘on/operation/maintenance in the instructions for use. One ‘CE marking is sufficient, affixed just once on the main part of the system, if all parts are supplied as one unit. Those parts of the system which are themselves compliant apparatus may, ot course, be distributed andior used outside the system. If the electromagnetic environment in which the system is used is diferent from that intended by the system manufac- turer, the system may be subject to EMC problems. The user, the assembler or the installer must theretore overcome these specific unforeseen EMC problems (e.g. by following the procedure within Section 6.4.3), or else purchase another system suitable for thar environment, 6.4.3. System or apparatus with various configurations Often systems or apparatus are offered in different configu rations, to perform different tasks. These configurations are variants of a complete or complex configuration, The system manufacturer (assembler or integeator) can follow the ap- roach below, which is suggested as a way to simplify his tasks while fully complying with the EMC Directive, ‘The responsible person should attempt to define, from an EMC perspective, the configuration most likely to cause the maximum disturbance, of to be the most susceptible t0 possible disturbances. This configuration, often called the worst case" should be defined, so that the other possible configurations are included in it in EMC terms.” Such a configuration is then brought into full compliance with the Directive, in accordance with Article 10. The manufacturer then declares conformity and affixes the CE marking, Once the worst case configuration defined above is in con- formity, the manufacturer (assembler or integrator) can place fom the market any of the possible variants or configurations without further verification, since they ate included init in EMC terms. They have better electromagnetic performance, ice. they do not introduce new electromagnetic disturbances not covered in the worst case configuration(s) or do not deteriorate the immunity compared with the (fully EMC compliant) worst case configuration(s). He then draws up This worst case’ may be identified by a simple consideration of the various combinations, limited testing, o both, The worst ease may often be the most complex variant. ° He can use the services and advice of an EMC expert if he sin doubt. 2 and signs the EC declaration of conformity and affixes the CE marking to each variant ‘The responsible person might wane to add some new compo- nents that were not included in the original (fully EMC ‘ompliant) worst case configuration(s), from the EMC per: spective, that were fully EMC verified. He may use either clectromagnetically ‘relevant’ or electromagnetically‘ircele vant’ components, la che context of various configurations the following defini ‘ions apply An electromagnetically relevant component is defined as one that, due to its electromagnetic characteristics, is liable to ‘cause, of have its performance degraded by, electromagnetic disturbances such that it influences the EMC characteristics or the intended operation of typical assemblies into which it ‘may be incorporated." An electromagnetically irrelevant component is then defined as one that, due to its electromagnetic characteristics, is neither liable to cause, nor have its performance degraded by, electromagnetic disturbances such that it will not influence ‘the EMC characteristics or the intended operation of typical assemblies into which it may be incorporated, Ir must be noted that some passive EM equipment may not be electromagnetically irrelevant in particular applications. ‘Therefore, the classification of components as electtomag- neticaly relevant or irelevant is strictly related to the appli- tation and may change from application to application. {Some examples include induerors, motors and cables.) The effece of this phenomenon must be taken into account by the assembler of the system or apparatus. If the manufactucer (assembler or integrator) later wants to add some new electromagnetically irrelevant components :0 his configuration(s), that were not included in the original EMC worst case that was fully EMC compliant, he i not requested to carry out further verifications from the EMC point of view. He then signs the EC declaration of conformity and affixes the CE marking to the configuration(s). However, ifthe manufacturer (assembler or integeator) later wants to add some new electromagnetically relevant compo- nents co his configuration(s), chat were not included in the ‘worst cases) that washwere fully EMC-compliant, he must then ensure that the new EMC worst case configuration(s) 'slare in full compliance with the Directive. 6.5. Application of the Directive to installations 6.5.1. A common understanding of ‘installations’ In normal usage the word ‘installation’ is sometimes used to refer to an optional combination of several types of appara ‘us, to perform a specific task where the end-user isthe person who decides which apparatus is to be used ro construct this so-called ‘installation’ and where the apparatus is not in- tended to be placed on che market asa single functional unit. Such installations must be considered like those combinations described in Section 6.4.1 which are commonly referred to as This can be considered as widely understood within the industry and, in partculag by the professional manufacturer [assembler ot integrator). Experience, good engineering practices and the state ‘ofthe art, in addition tothe intnnsic EM characters of the ‘component, help the manufacturer to make such a judgment. 2 ‘systems’ and treated as such. They are not treated further in this chapter, A good example of such an installation is a hil installation ‘composed of an amplifier cuner, CD player and cassette deck, each of them separately CE marked and separately placed on the market 6.5.2. Fixed ‘installation’ within the EMC Directive 65.2.1. General Under Articles 1(1) and 2(1) the Dieective applies ro installa- sons containing electrical andior electronic components. ‘The application of the EMC Directive to installations is, from the experience obtained over the last four years, a very controversial issue. Iris therefore important to present in this chapter an analysis on the applicability of the Directive, based fon its spirit: "Fixed Installation’, in the broadest sense, is defined as ‘a combination of several types of equipment, systems, finished products and/or components (hereinafter called "parts”) as- semble and/or erected by an assemblerfinstaller at a given place to operate together in an expected environment t0 perform a specific task, but not intended to be placed on the ‘marker as a single functional or commercial unit’ The Directive does not distinguish between different kinds of installations, bue in order to avoid unnecessary burdens for ‘manufacturers of partsand assemblersiinstallers, itis conven- ‘ent to investigate which provisions of the Directive can be declared non-applicable without compromising the objec tives of the Directive 6.2.2. Application of the EMC Directive to fixed installations In the installations defined in Section 6.5.2.1, parts not intended ro be placed on the market as a single Commercial 6 functional unit may well be used, and it makes no differ- ence whether they were placed on the market by the same or different manufacturers because none of these manufacturers ‘will know the final electromagnetic effect the combination of parts in the installation will have; they can only assume responsibility for each individual part when placing it on the market. EMC problems in apparatus when used in installations are solved on a case by case basis, by cooperation berween manufacturers of parts incorporated into the installation, the uuser and, on some occasions, an instalation contracting, company. The combined expertise of these parties results in the correct operation of the coal instalation, and also enables its integration into a network. ‘The installation must comply with the essential requirements of the Directive as defined in Article 4. The person(s) responsible forthe design, engineering, and constriction (assembly and erection) becomes the maniac turer inthe sense of the Directive, and asumes responsiblity for the insallaion’s compliance with all applicable provi sions of the Directive, when taken ino service. The EMC assembly instructions given by the mansfactorerts) of parts, fand the whole method of installation, have tobe in accord Since with good engineering practice within the context of installations, as well as installation rules (national, regional or local) that will ensure the compliance of the whole instal- Tation withthe essential requirements ofthe EMC Direc. Such rales mast, ofcourse, be fully compatible with the EC ‘Treaty and, in particulas, cannot influence the design and ‘manufacture of apparatus thac ate already in conformity with the EMC Directive. Such an installation cannot enjoy free (physical } movement within the EEA marker, and in respect of the EMC Directive there is no need for CE marking or an FC declaration of conformity or 10 involve a competent body. The manutae turer of the installation must provide clear instructions for operation and maintenance in the instructions for use in accordance with Chapter 10. 6.5.3. Application of the Directive to movable installations Installations which are intended to he moved to and operated sn.a range of locations (e.g. the outside broadcast vehicle of a TV or radio station} may experience or cause changes in the electromagnetic environment. Such a movable installa ‘ion has free (physical) movement within the EEA market, or within the EEA territory. Therefore, such movable installa tions have to comply with the Directive like a system as described in Section 6.4 If such installations are, however, intended to substitute for, or toextend,a fixed installation (eg. for electricity generation or transmission inthe high-voltage network), they have ro be {reated in the same way as fixed installation in Section 6.5.2, ‘The temporary connections to the networks of such installa tions must be carefully planned, and installed by experts. 7. Application of the Directive to used, second-hand, and repaired apparatus, and to spare parts ‘Within chis context, ewo points should be made (a) In all that follows, we will refer only co apparatus for which the EMC Directive is potentially applicable under the criteria developed in Chapters 4, 5 and 6 of this guide. Apparatus not subject to the EMC Dicective is, therefore, excluded from these discussions. {b) The application of the EMC Directive to an ‘as-new apparatus’ is without any prejudice to intellectual prop- erty legislation.” 7.1. Definitions *+ Used apparatus: an apparatus which has previously been placed on the EEA market and put into service on the EEA territory. This apparatus was in compliance with the then applicable legislation: national or EU, depending on the date." Ie must have complied with the provisions of the EMC Directive, f applicable to it at that date Used apparatus that was on the market and used in the FEA before the date of entry into force of the EMC Directive is not covered by it. had been marketed and used in accord- ance with the then existing regulations; it was ‘legal’ then and it continues to be so today, unless such apparatus is modified See Directive 89/104/EEC ceasing tothe marks and the decision ofthe European Court of Jusoce of 11 July 1996 in Joined Cases €-427/93, €429193 and C-43693 Bristol Meyer Squibb, See Chapter I ofthis guide fo transitional periods. such that it becomes “as-new apparatus’ It circulates in the EEA based on Arricles 30/36 of the EC Treaty Used apparacus imported from a third country made avail able for the first time in the EEA for the purpose ul distribu tion and/oruse inthe EEA is not considered as used apparatus 8s regards the application of the EMC Directive. but 9 net apparatus, + Second-hand apparatus: this is used apparatus, which is supplied to a user and which may or may not have been ‘modified by refurbishment, reconditioning or reconfigu- ration, Reconditioned (or refurbished") apparatus: this is a used apparatus whose performance has changed over time (due to ageing, obsolescence, etc. and which has been modified so a8 to be restored. The case of an apparatus whose external appearance has been modified and improved by a cosmetic (oF aesthetic operation after it has been placed on the market and put into service is a particular form of refurbishment aimed at restoring the external appearance of the apparatus.” Reconfigured apparatus: a reconfigured apparatus is a used apparatus whose configuration has been modified, by the addition (upgrading) or the removal (downgrading) of one ‘oF more parts (components, subassemblies such as plug-in cards or modules, ete" ‘As-new apparatus’: this is an apparatus already taken into Service which is subject co an industrial operation thac implies 4 substantial modification in order to obtain identical (or similar) performance as, and adapted to the technical pro: gress to, the new apparatus placed on the market atthe sare 7.2. Application of the EMC Directive The general principle is thar the EMC Directive reapplies only if the modifier claims that the modified apparatus is to be considered ‘as-new apparatus’ in accordance with the defi tion given in Section 7.1, and if i is intended co be placed again on the EEA marker for distribution and/or use as a single commercial unit, Nevertheless, the following criteria can be applied, in addi- tion ro those covered in Chapters 4, § and 6 ofthis guide: 7.2.1, The ‘original’ appararus was not CE marked, not in compliance with the EMC Directive (because it did noc then apply}. 7.2.1.1. If, after the modifications, of the apparatus it does not become an as-new apparatus, the EMC Direc: tive is not mandatory. The ‘original’ one had been acceptable and it would not be logical to force compliance inthis case", Ie will cizculate inthe BEA Both terms, reconltioned/efurbished, aswell as ceconditioning/ refurbishment are used interchangeably inthis chapter Thiscan involve modification af electromagnetic characteristics. ‘The use of different material of different enteral dimensions of the apparatus might change EMC performance. For example, metalic enclosure may provide much berter clectromagnetic Shielding than a plastic enclosure ‘An example of reconfiguration commonly encountered in the ITE Sector isthe ease ofa PC_ with diferent options, whose mernory ‘capacity (Bro 16 Mbytes) and the number of ports (om to eight. for instance) may be changed from one option to ancthce. ‘The responsible parry can, ofcourse, choose to bring the appara ‘usin fll compliance with the Directive, with al ts applicable provisions, asses conformity, certify it, declare wand afixthe CE marking 2B based on Articles 30/36 of the EC Treaty. The person responsible for placingiiton the EEA market should be able, however, ro justify his decision in case of challenge by the competent authorities. He should also ensure that the name of any ‘new" ‘manufacturer (modifier is included inthe operating instructions supplied with the apparatus 7.2.1.2. If however, the modified apparatus results in an as-new apparatus, it makes sense to request compli- ‘ance with the EMC Directive, co insist on the necessary protective actions and protect other {equipment in its environment. The party responsi ble for the as-new apparatus is here considered as the manufacturer and all the applicable criteria (and simplifications) given in this guide should be ad 7.2.2. The ‘original’ apparatus was CE marked, it com: plied with the EMC Directive 7.2.2.1. If the modified apparatus does not result in an asmnew apparatus, the reapplication of the EMC Directive is not mandatory. The modifier must, in any case, document what he has done, his EMC analysis, tests carried out, if any, and his final conclusions. Such documentation will be requiced in case of challenge. The resulting apparatus should bear sufficient information that permits en- forcement authorities and the end-user to know that this is a modified apparatus and to permit the ‘identification of the modifier; the “original” manu: facturer could otherwise be considered responsible for things that he has not done. 7.2.2.2. If, however, the modified apparatus results in an as-new apparatus, it makes sense to reapply the EMC Directive, to insist on the necessary protect actions and protect other equipment in its environ- ‘ment, The party responsible for the modification is here considered as the manufacturet and all appli- cable criteria (and simplifications) given in this juide should be addressed, Inall cases ifthe modified configuration had been envisaged and documented by the ‘original’ manufacturer and made part of his assessment of conformity, as EMC conformant variants or configurations of his apparatus before it was placed on the marker (as in Section 6.3 of this guide) and if the modifier follows strictly the ‘original’ manufacturer's instructions and limitations, the Directive does not need to ‘be reapplied. In these conditions, the modifier has not altered the manufacturer's conformity assessment; he has not done anything not intended by the ‘original’ manufacturer He ‘does not need to carty out additional tests etc. The ‘original’ ‘manufacturer remains responsible for the EMC conformity and the ‘origina’ assessment is valid. ‘Whoever produces an ‘as-new' apparatus from an original apparatus through an industrial operation that implies a substantial modification in order to obtain identical (or similar) performance as the new apparatus placed on the market at the same time must, therefore, be able to certify its «conformity before placing it on the market again. He can do so by assuming, in full, the responsibility of manufacturer and completing the full EMC analysis, conformity assess- ‘ment, EC declaration of conformity and CE marking. 7 Tn the instructions for use or in any other documentation issued by the original” manufacturer under his responsibil. Pry 7.3. Modifications carried out by the end-user (under his responsibility) Such modifications should be considered excluded from the application of the EMC Directive. They are made under the sole responsibility ofthe end user, subject to product liability and other pertinent legislation, but-not under the EMC Directive. This apparatus is not being traded. The ‘client receiving the modified apparatus is here the end-user (and modifier) himself; he cannot claim that anybody else is re sponsible for what he has done. Action to correct possible EMC problems generated by the modification affecting other apparatus in its environment will have co be taken by the end-user if challenged. In any case, he should not trade such ‘modified apparatus unless itis brought into conformity with the applicable provisions of the Directive, In any case, he ought to document what he has done, EMC analyses, tests carried Out if any, and his final conclsions Such documentation will be required incase of challenge by the competent authorities. The resulting apparatus musthave fn itor nits documentation the name of the modifier and dltiils of the modifications, insomuch as they affect EMC performance, which aust be made available to the competent Euthorites incase of challenge; the ‘original manufacturer gould other be considered response or things that he 7.4, Repaired apparatus and spare parts Repaired apparatus: this is an apparatus whose functionality has been restored following a defect without adding new features or any other modification. This operation does nor affect che EMC characteristics of the ‘original apparatus. From the EMC point of view, the repaired apparatus is not different from the original product. The EMC Directive does not apply. [A spare part: this is any item intended ro replace a defective for worn out item of apparatus, equipment or system pre- viously placed and pur into service on the EEA market. A typical repair operation would be replacement by a spare pare If the manufacturer of the original spare part offers a ne, different one in its place (due to technical progress, discon- tinued production of the old part, etc.), and itis used for the repaig, the repaired apparatus does not need to be brought into conformity again with the EMC Directive, if such parts ) European. Telecommunications Standards Institute (ETSI) , 650 route des Lucioles, F-06921 Sophia Antipo- lis Cedex; and (c) Fucopean Committee for Standardsization (CEN), rue de Stassart 36, 1050 Brussels National transpositions of harmonized standards are avail- able from the national standardization bodies (see Annex 9). ‘The list of harmonized standards published in the Official Journal is also available atthe following Internet address: hetpswww2.echo.lu/nasd/ 14.2. Standardisation programme By way of information, Annex 8 provides the two stand: ardization programmes addressed to che European stand: ardization bodies. Each one isthe subject of a standardization mandate drawn up by the Commission. ‘The first mandate was addressed to Cenelec (BCICLC-02/92) and was adopted by the committee established under Direc tive 83/189/EEC on 7 October 1992. ‘The second was addressed to CEN, Cenelec and ETSI (M/237) and was adopted by the committee established under 30 Directive 83/189/EEC on 13 December 1995. Within these mandates, the standardization bodies concerned have to prepare standards covering the electromagnetic emissions find immunity. These standards will define the limits and the test methods that are necessary and sufficient to provide a presumption of conformity with the Directive for the appa: Fatus chat is builtin conformicy with relevant harmonized standards, 15. Application of the Directive to some specific cases 15.1. Application of the EMC Directive to telecommunication and radiocommunication equipment 15.1.1. Telecommunication terminal equipment ‘Telecommunication terminal equipment is covered by Direc tive 91/263/EEC and satelice earth station equipment is covered by Directive 93/97/EEC. For apparatus covered by these Directives, the provisions related to electromagnetic compatibility phenomena laid down by the three Dicectives 89/336/EEC, 91/263/EEC and SISTIEEC have to be observed on a complementary basis, Electromagnetic compatibility protection requirements to be observed for apparatus covered by Ditectives 91/263/EEC or 93/97/EEC, in so far as they are not specific” to such equip- ‘ment, are those laid down by Directive 89/336/EEC. ‘This implies that forall non-specific electromagnetic pheno ‘mena the conformity assessment procedures of Article 10(1) or of Directive 89/336/EEC apply to equipment covered by Dieetives 91/263EEC and 93/97IEEC; this includes radio telecommunication terminal equipment. Mobile telecommunication apparatus which, even ifcapable of being used in a vehicle, is by definition not intended for fitment (installation) therein, must comply with Directive '89/336/EEC and the TTE Directive, and they are not covered by the motor vehicle Directive, 95/S4/EC. 15.1.2. Radiocommunication equipment + Radiocommunication transmitters not covered by Direc: tive 91/263/BEC nor by Directive 93/97/EEC are subject to the conformity assessment procedure laid down by Article 10(5) of Directive 89/336/EEC. + Radiocommunication receivers ate subject to the con: formity assessment procedures laid down in Article 10(1) and of Directive 89/336/EEC. For the two types of equipment mentioned above, the Direc tive does not apply to the normal operating frequency bands, as already mentioned in Chapter 4 of this guide. They are outside the scope of the Directive. % CenelesETSI, Annex Il to thet veport ROBTOOVETR 238 of ‘October 1995 describes the specific and non-specific EMC phenomena. The ITU has defined ourof-band emissions a5 un ‘wanted emissions (basic definitions of RRI-17). 15.1.2.1. Emissions outside the required bandwidth In every type of radio transmission (emission) there isa band of frequencies occupied chat constitutes the fundamental ‘transmission (emission) and which is due to the modulation process used. The content of the emission and the bandwidth ‘recupied are dependent on the technique and form of me lation process used, which may be analogue or digital ‘This occupied band of frequencies is basically made up of wo parts, which form what is known as che transmitter mask ‘The two parts which make up ¢his mask are defined by the ITU as follows: [Necessary bandwidth: ‘for a given class ofemission, the width of the frequency band which is just sufficient to ensure the ‘transmission of information at the rate and with the quality ‘required under specified conditions’ (Article 1, No 146 of the radio Regulations); Ourof-band emissions: ‘Emissions on a frequency or fre quencies immediately outside the necessary bandwith which result from the modulation process, but excluding spurious ‘emissions’ (Article 1, No 138 of the radio Regulations). ‘The transmitter mask defined above isan element used in the planning and allocation of frequency bands for all radio Services. [tis important to note that although out of band ‘missions contain the unwanted emissions due to the modu lation process they are part of the transmitter mask and are ‘taken into account in the planning of the frequency band Inconsequence, out of band emissions, ifused when planning. and allocating the frequency band for radio services and needed in the management of the radio spectrum, are not subjec co the Directive, = ‘| 0 So In every modulation process additional undesired signals exist. They are summarised under the expression ‘spurious emissions’, as defined in Article 1, No 139 of the radio Regulations, Spurious emission: ‘Emission on a frequency or frequencies which ae oid the necessary bandwidth and te level of which may be reduced without affecting the corresponding ‘tansmission of information. Spurious emissions nce har tonic emissions, parsse emisions, intermodulation prod: Us and feguency conversion products, but exclude outofband emissions Spurious emissions are subject ro the Directive. 15.2. Application of the EMC Directive to machines 15.2.1. Parallel application of the EMC and machinery Directives tn order ty avoid coutasion i the interpretation of the texts of the EMC and the machinery Directives." its important ‘0 point out that the essential requirements stipulated by these ‘wo Directives are of very different nature. + The EMC requitements laid down by the machinery Di rective (see 89/S92/EEC, Annex I, parageaphs 1.5.10 and 1.5.11) concern only the emission of radiation," airned at the user's protection, safety and immunity to external radiation, aimed at ensuring its proper functioning. + On the other hand, the EMC requirements stipulated by the electromagnetic compatibility Directive (Article (a) and are aimed at functional protection of the apparatus itself and other apparatus in its environment, for emis. sions and immunity. It is definitely not user-oriented a5 such, and not limited to radiation, which isonly one EMC aspect to be considered, Their requirements and objectives being clearly different, neither of these «wo Directives can be regarded as being specific one to the other. Both Directives have to be applied in a parallel and complementary way by following the approach described as follows 15 2. Criteria of applicability of the EMC Directive The machinery sector is characterized by a very vast range of products of different types, sizes and nature, from small ‘machines produced in series to large and even very I ‘machines sometimes manufactured as ‘one-off’ according to the technical requirements and needs laid down by the eus- tomer. Some are apparatus, others have to be considered a5 systems, others as installations ‘The sector is also characterized by a majority of SMEs, which are experienced professionals in mechanical engineering, but often with limited knowledge of EMC and other related matters, and ltee or no EMC test equipment. As explained in Chapters 4, 5 and 6, the manufacturer of the {equipment (in this case machinery) should perform an EMC analysis to define what essential safety and/or protection ‘equitements apply to his apparatus, rom which applicable directive and how co conform to them, using the choices of procedures given in each directive that applies, which, in turn, may also depend on the extent of use of voluntary harmo” nized standaeds. Inall cases, where the machine's manufacturer uses only CE- ‘marked apparatus (complying with the EMC Directive) and follows scrictly the instructions and limitations of use of the ‘manufacturer ofthese products who intended them to be used in machinery, the finished machine could be considered in ‘compliance with the EMC Directive and no further verifica- tion would then be needed. The EC declaration of conformity Directives 89/392/EEC, 91/368/EEC, 93/44/EEC and 93/68/EEC Annex paragraph 1.5.10 reads:’Machinery must be 20 designed and constructed that any emission of radiation i limited tothe extent necessary fr is operation and thatthe efects om exposed Persons are non-existent of reduced to non-dangesous propor Annex" paragraph 15.11 reads: "Machinery must beso designed and constructed that external radiation does not incefere with its operation.” 3M as well as the instructions for use must refer tothe finished machine asa whole, The manufacturer assumes responsibilty for compliance with che Directive in all expected electromag netic environments and must therefore, in accordance with Chapter 10, provide clear instructions for assembly/installa tion/operation/maintenance in the instructions for use. The finished machine as a whole does not need to bear the CF marking. (All chs applies even if i is offered on the market sa single functional unit, as long as each part beats the CE marking) This is consistent with the riteria and procedures developed in Sections 6.4.2.1 and 6.5. The addition of elec- ‘romagneticaly irrelevant components (see definition in Sec ‘ion 6.4.3) should also have the same effect, since the EMC characteristics are mainly due to the electrical and electronic devices incorporated in the machine, and not to the mechani- cal components, chat ate ‘electromagnetically irzelevant’ in this context. ‘This simplification does not ater the fll responsibility ofthe machine's manufacturer. Ifthe resulting machine needs addi- tional EMC protective measures to fulfil the EMC protection fequirements, they must be undertaken by him, bur nor subject to the procedures of the EMC Directive. Inall other cases where the machine's manufacturer does not restrict himself to using only CE-marked apparatus, the criteria and procedures of Sections 6.4.2.2 and 6.5 can be applied accordingly. Within this context, the EMC analysis and the nature of the machine will enabie the manufacturer to know if his machine is an apparatus (finished product, system or installation) and apply the respective criteria of this guide (and, of cours, its simplifications) eo comply with the EMC Directive. 15.2.3. Harmonized standards that may be used for machines ‘The so-called harmonized generic standards for the residen- tial, commercial, and light industrial envigonment and indus- trial environment can be used by machine manufacturers to bring machines into compliance with the EMC Directive until specific product family standards (already under preparation) are available as harmonized standards, 15.3. Application of the EMC Directive to motor vehicles (Directive 95/54/EC) ‘The EMC protection and safety requirements applicable to ‘motor vehicles are laid down in Directive 95/54/EC, which amends Directive 72/245/EEC concerning electromagnetic interference produced by spark ignition engines intended to In recognition of the need for more stringent safety standards for the electromagnetic compatibility of vehicles and related ‘components, the Member States and industry agreed on the establishment of specific EMC provisions, under the terms of Article 2(2) ofthe EMC Directive. Directive 95/54/EC, the so- called “Auomotive EMC Directive’ was therefore adopted, entering into force on 1 January 1996, as specific Directive with respect to Directive 89/336/EEC. Scope and application of the automotive EMC Directive (Directive 95/54/EC) + For new types of vehicles placed on the EEA market after 1 January 1996, new types of components and new types of separate technical units intended tobe fired into motor ‘ehiles and placed on the EEA market after 1 January 1996, the specific Directive 95/S4/EC is mandatory. These 32 products must bear the ‘e’ marking that confers free movement throughout the EEA area, + For new components and mew separate technical units ypeapproved before | Jansary 1996 within Dicecve TEIRASIEEC, which continue to be placed on the EEA rocket andlor por into serice afer 1 January. 1996 Compliance with Directive 95/S4FEC is optional una October 2002. For those products, Directive 95/54/EC will become man- datory only on 1 October 2002. In other words, Directive 9STS47EC has a certain degree of optionality for such items until 1 October 2002. The ciccumstances under which the EMC Directive may continue to apply co products in the vehicle sector, for which Directive 9S/S4/EC is optional, are described in more derail later in the guide. Specific case of in-car entertainment products Entertainment products (e.g. radios, cassette and compact disc players), intended for fitment in vehicles, fll within the scope of Directive 95/54/EC and are governed by the substan- tive provisions therein. With the aim of clarifying the applicability of both EMC Directive 89/336/FEC and Automotive EMC Directive (9SISS/EC amending 72/24S/EEC) to in-car entertainment products intended to be incorporated into a motor vehicle, such as ear radios, CD players, etc, ducing the period from 1 January 1996 t0 1 October 3002, the Commission issued 4 communication setting out its interpretation of the appl cation of Directive 95/54/EC. This incerpretation is explained as follows; 1. Directive 95/54/EC establishes more stringent and appro- priate safety requirements for the electromagnetic com- patibility for vehicles and theie components than are found in the general Directive 89/336/EEC. Therefore Directive 95/54/EC, which entered into force on 1 January 1996, constitutes a specific Directive for the purposes of Articie 2(2) of Directive 89/336/EEC. 2. Entertainment products (e.g. radios, cassere and com- pact-dise players), intended for fitment in vehicles, fal within the scope of Directive 95/54/EC and are governed by the substantive provisions therein. For such products, for the purposes of European type-approval, these provi- sions apply on an optional basis until 1 October 2002, as stated in Article 2(5) of the Directive. From that date the provisions of Directive 95/54/EC become mandatory. 3. During this optional phase of the Directive, Member States may deny free circulation to such products, in- tended for fitment in vehicles and which comply with Directive 89/336/EEC, on duly motivated satety grounds, shaving respect to Articles 30 and 36 of the EC Treaty. 4. Therefore, due to its more stringent provisions, only compliance with Directive 95/54/EC provides a guarantee of free cicculation within the EEA with respect to the electromagnetic compatibility of products intended for fitment in vehicles. 5. Products which are intended for fitment in both vehicles and other applications (such as boats or caravans) may >be CE marked in respect ofthat other application bur such marking does not confer free circulation for products intended for fitment in vehicles. 15.4. Application of the EMC Directive to equipment to be fitted into aircraft ‘This chapter cannot yer be completed: discussions continue The general approach is chat apparatus covered by Council Regulation (EEC) No 3922/91 is excluded from the applica fiom of the EMC Directive thi. Regulation beingspecihe th respect to the EMC Directive (S9/336/EEC|, in accordance with Article 22), As soon as it can be completed, this chapter will be added to the document. 15.5. Application of the EMC Directive to medical devices 1. The requirements of the medical devices Directive (93/42/EEC) are fully applicable from 1 January 1995 (Article 22(1) of this Directive), 2. Member States will accepr, until 14 June 1998, the placing fon the EEA market andor the putting into service of medical devices complying with legislation in force in theie territory at 31 January 1994 (Article 22(4) of this Direc tive) Asa consequence, the manufacturer has the following choices to comply with the EMC requirements: la} From I January 1995 to 14 June1998, + cither the requirements of Directive 93/42/EEC, or + those of the EMC Directive (89/536/EEC), using the criteria developed in this guide [bl From 15 June 1998, the end of the transitional period, the requirements of Directive 93/42/EEC are mandatory ‘The EMC Directive (89/3 36/EEC) will no longer apply. Harmonised standards: the ceference of standard EN 60601 1-2 has been published in the Official Journal of the Euro. bean Communities, any national transposition of this European standard can be used to provide a presumption of conformity with the EMC requirements, 15.6. Application of the EMC Directive to Active implantable medical devices ‘The requirements of the ‘active implantable medical devices’ Directive (90/38S/EEC) are fully applicable from 1 Januacy 1993, Member States accepted, until 31 December 1994, the placing on the EEA market and/or the putting nto service, of active implantable medical devices complying with egislation in force in their territory at 31 December 1992 (Article 16(1) of this Direcrive), As a consequence, the EMC Directive (89/336/EEC) has not applied since 31 ‘December 1994, the ‘active implantable medical devices‘ Directive (90/385/EEC),heing a fully specific Directive. 15.7. Application of the EMC Directive to in vitro diagnostic medical devices reannat yet we general approach 's that apparatus covered by the proposal for a Directive (COM(95) 130° final) will be excluded from the application of the EMC Directive, this Directive being. specific with respect to the EMC Directive (89/336/EEC}, in accordance with Article 2(21, upon the date of entry into force of this specific Dieective umpleted. 15.8. Application of the EMC Directive to marine equipment 1, The requirements of the matine equipment Directive (96/98/EC)* will be fully applicable trom 30 June 1998 (Article 20 of this Directive) 2. Member States will accept, until 31 December 1998, the placing on the BEA marker and/or the putting into service of marine equipment cavered by chs Directive complying with legislation in force in their terricory at 29 June 1998 (Article 20 of this Directive), Asaconsequence, the manufacturer has the fallowing choices to.comply with the EMC requirements: (a), from 30 June 1998 t0 31 December 1998: + cither the requirements of Directive 96/98/EC, or + those of the EMC Directive 189/336/EEC), using the criteria developed in this guide, (b) from 1 January 1999, the end of the transitional period, the requirements of Directive 96/98/EC are mandatory, ‘The EMC Directive (89/336/EEC) will no longer apply For all marine equipment no: covered by the ‘marine equip ment’ Directive (96/98/EC), the EMC Directive has been ‘mandatory from 1 Janary 1996. 15.9, Additional information A\ proposal for a Directive covering certain measurement instruments subject to legal control is under preparation. The immunity requirements for those measurement instruments will only be covered by this proposal for a Diecave: the emission requirements are still under discussion between jRovernment experts and the Commission, ‘These guidelines are free of charge and can be obtained from the following: (a) Competent authorities (see Annex 4); (b) Cenelec (see Annex 9); () Orgalime (see Annex 9), © C172, 77.1995, OPE 46, 20:12.1996, 33 ANNEX 1 ‘Text of Directives 89/336/EEC and 92/31/EEC, and extracts from Directives 91/263/EEC, 93/68/EEC and 93/97/EEC 35 235.89 Official Journal of the European Communities No L 139/13 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE of 3 May 1989 fon the approximation of the laws of the Member States relating to electromagnetic compatibility (89/336/EEQ) ‘THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Eco: nomic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (), In cooperation with the Furopean Parliantent (*), Having regard to the Opinion of the Economic and Social Commitee (), Whereas it is necessary to adopt measures with the aim of progressively establishing the inteznal market over a period ‘expiring on 31 December 1992; whereas the internal market ‘comprises an area without internal fontiers in which the free movement of goods, persons, services and capital is ensured Whereas Member States are responsible for providing ade- ‘quate protection for radiocommunications and the devices, apparatus or systems whose performance may be degraded by electromagnetic disturbance produced by electrical and electronic apparatus against the degradation caused by such disturbances; ‘Whereas Member States are also responsible for ensuring that electric energy distriburion networks are protected from elec- tromagnetic disturbance which can affect them and, conse- quently, equipment fed by them; Whereas Council Directive 86/361/EEC of 24 July 1986 on the initial stage of the recognition of type approval for telecommunications terminal equipment ('} covers in particu 4 32 and ©} NoC 69 20.3.1989, p.72 () Of No C322, 212.1987, ) OJ No C26, 10.10 1988, (2) O} No C 134, 245.1988, p. (*) OJ NoL 217, 5.8.1986, p21. lar che signals emitted by such equipment when iis operating normally and the protection of public telecommunications networks from harm; whereas its therefore still necessary to provide adequate protection for these networks, including the {equipment connected to them, against temporary distur: bances caused by signals of an accidental nature that may be emitted by this equipment; Whereas, in some Member States, mandatory provisions define in particular the permissible electromagnetic distur- bance levels that this equipment is liable to cause and its degree of immunity to such signals; whereas these mandatory provisions do not necessarily lead to different protection levels from one Member State to another but do, by theit disparity, hinder trade within the Community; ‘Whereas the national provisions ensuring such protection 'must be harmonized in order to guarantee the free movernent of electrical and electronic apparatus without lowering exist- ing and justified levels of protection in the Member States; Whereas Community legislation as it stands at present pro- vides that, notwithstanding one of the fundamental rules of the Community, namely the free movement of goods, barriers to intra-Community trade resulting from disparities in na- tional laws on che marketing of products have to be accepted insofar as those provisions may be recognized as necessary to satisfy essential requirements; whereas the harmonization of laws in the case in point must cherefore be confined to those provisions needed to comply with the protection require- ‘ments relating to electromagnetic compatibility; whereas these requirements must replace the corresponding national provisions; Whereas this Directive therefore defines only protection re- quirements relating to electromagnetic compatibility; whereas, to facilitate proof of conformity with these require ‘ments, it is important to have harmonized standards at European level concerning electromagnetic compatibility, 50 37 No 1.13920 that products complying with chem may be assumed 10 comply with the protection requirements; whereas these standards harmonized at European level ate drawn up bY private bodies and must remain non-binding texts; whereas for that purpose the European Commute for Electrorechnt cal Standardization (CENELEC) is recognized as the compe- tent body in the field of this Directive for the adoption of harmonized standards in accordance with the general guide lines for co-operation between the Commission and the Euro~ pean Commitee for Standardization (CEN) and CENELEC signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard isa technical spec tion (European standard or harmonization document) adopted by CENELEC upon a remit from the Commission in accordance with the provisions of Council Ditective 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical stand- ards and regulations ('), as last amended by Direc- tive 88/182/EEC (9), and pursuant to the abovementioned general guidelines; ‘Whereas, pending the adoption of harmonized standards for the purposes of this Directive, the free movement of goods should be facilitated by accepting, asa transitional measure, fon a Community level, apparatus complying with the na: tional standards adopred, in accordance with the Communiry inspection procedure ensuring that such national standards meet the protection objectives of this Directives ‘Whereas the EC declaration of conformity concerning the apparatus constitutes a presumption of its conformity with this Directive; whereas this declaration must cake che simplest possible form; ‘Whereas, for apparatus covered by Directive 86/36 1/EEC, in order to obtain efficient protection as regards electromag netic compatibility, compliance with the provisions of this Directive should nevertheless be certified by marks or certifi- cates of conformity issued by bodies notified by the Member States, whereas, to facilitate the mutual recognition of marks and certificates issued by these bodies, the criteria to be taken into consideration for appointing them should be haemo- nized; ‘Whereas it is nevertheless possible that equipment might disturb radiocommunications and telecommunications net- ‘works, whereas provision should therefore be made for a procedure to reduce this hazard; Whereas this Dicective applies tothe appliances and ‘equipment covered by Directives 76/889/EEC (°) and ‘76/890/EEC (*) which relate tothe approximation ofthe laws ‘of the Member States relating to radio interference caused by ‘electrical household appliances, portable tools and similar ‘equipment and to the suppression of radio interference with regard to fluorescent lighting luminaires fitted with starters; whereas those Directives should therefore be repealed, ( O[NoL 108, 26.4.1983, 8 ©) OF NoL 81, 26.3.1988, .75. (0) OF NoL 336, 4.12.1976, p. 1 (4) Of NoL 336, 412.1976, p. 22. 38 Official Journal of the European Communities 23.5.89 HAS ADOPTED THIs DIRECTIVE: Article 1 For the purposes of this Directive 1. "Apparatus" means all electrical and electronic appli- ances together with equipment and installations contain- ing eleerical andlor electronic components. Electromagnetic disturbance" means any electromag: netic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromag- netic disturbance may be electromagnetic noise, an un- wanted signal or a change in the propagation medium itself 3. "Immunity" means the ability of a device, unit of equip- ment or system to perform without degradation of qual ity in the presence of an electromagnetic disturbance. 4. “Electromagnetic compatibility” means the ability of a device, unit of equipment or system to function satisfac rorily in its electromagnetic environment without intro- ducing intolerable electromagnetic disturbances 0 anything in that environment. 5. “Competent body” means any body which meets thecrit- cia listed in Annex II and is recognized as such, (6. "EC rype-examination certificate” isa document in which 4 notified body referred to in Article 10 (6) certifies that the type of equipment examined complies with the provi- sions of this Directive which concem it. Article 2 1, This Directive applies to apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance. Ir defines the protection requirements and inspection proce dures relating thereto. 2, Insofar as protection requirements specified in this Directive are harmonized, in the case of certain apparatus, by specific Directives, this Directive shall not apply or shall cease +o apply with regard to such apparatus or protection require- ments upon the entry into force of those specific Directives. 3. Radio equipment used by radio amateurs within the meaning of Article 1, definition 53, of the radio regulations in the International Telecommunications Convention, shall be excluded from the scope of this Directive, unless the apparatus is available commercially, 235.89 Article 3 Member States shall take all appropriate measures to ensure ‘hat apparatus as refered ro in Article 2 may be placed an the market or taken into service anly if ie complies with the requirements laid down by this Directive when iti properly installed and maintained and when itis used for the purpose for which iis intended, Article 4 ‘The apparatus referred to in Article 2 shall be so constructed that la) the electromagnetic disturbance it generates does not exceed @ level allowing radio and telecommunications ‘equipment and other apparatus to operate as intended; (b) the apparatushas an adequate level ofintrinsicimmunity to electromagnetic disturbance to enable it ro operate as intended ‘The principal protection requirements are set out in An nex Il Article S Member States shall not impede for reasons relating to clectromagnetic compaibilty the placing on the market and the taking into service on their territory of apparatus covered by this Directive which satisfies the requirements thereof Article 6 1, ‘The requirements of this Directive shall not prevent the application in any Member State of the following special (a) measures with cegard to the taking into service and use of the apparatus taken for a specific site in order to ‘overcome an existing or predicted electromagnetic com- paubilty problem; (b) measures with regard to the installation of the apparatus taken in order to protect the public telecommunications networks or receiving of transmitting stations used for salety purposes. 2. Without prejudice to Directive 83/189/EEC, Member States shall inform the Commission and the other Member States ofthe special measures taken pursuant to paragraph L 3. Special measures that have been recognized as justified shall be contained in an appropriate notice made by the Commission in the Official Journal of the European Com- ursies. Official Journal of the European Communities No L 139721 Article 7 1. Member States shall presume compliance with the pro: fection requirements referred to in Article 4 in the case of apparatus which is in contormitys {a) with the relevant national standards transposing the harmonized standards, the reference numbers of which have been published in the Official Journal of the Exro- ean Communities. Member States shall publish the feference numbers of such national standards; ry ‘or with the relevant national standards referred to in Paragraph 2 insofar as, in the areas covered by such standards, no harmonized standards exist. 2. Member States shall communicate to the Commission the texts of their national standards, as referred to in para graph 1 (b), which they regard as complying withthe prorec- tion requirements referred co in Article 4. The Commission shall forward such texts forthwith to the other Member States. In accordance with the procedure provided for in Article 8 (2), it shall notify the Member States of those national standards in respect of which there is a presumption of conformity withthe protection requirements relerred to in Article 4 Member States shall publish the reference numbers of those standards, The Commission shall also publish ehem in the Official Journal of the European Communities 3. Member States shall accepe that where the manufac: turer has not applied, or has applied only in part, the stand- ards referred to in paragraph 1, or where no such standards exist, apparatus shall be regarded as satisfying the protection requirements referred t0 in Article 4 where their conformity with those requirements has been certified by the means of attestation provided for in Article 10 (2). Article 8 1, Where a Member State or the Commission considers that the harmonized standards referred to in Article 7 (1) (a) do ‘not entirely satisfy the requirements referred to in Article 4, the Member State concerned or the Commission shall bring the matter before the Sanding Committe set up by Dire {ive 83/189/EEC, hereinafter referred to a8 "the Commirtee”, ‘giving the reasons therefor. The Committee shall deliver an opinion without delay. Upon receipt of the Committee's opinion, the Commission shall inform the Member States as soon as possible whether fof nor it is necessary to withdraw in whole of in part ‘hose standards from the publications referred to in Arti- cle 7(1) (a). 2. __After receipt of the communication referred to in Arti- cle 7 (2), the Commission shall consult the Committee. Upon receipt ofthe latter's opinion, the Commission shall inform the Member States as soon as possible whether or not the ‘national standard in question shall enjoy the presumption of 39 No L139/22, conformity and, if so, that the ceferences thereof shall be published nationally the Commis n or a Member Stare considers that J no longer satisfies the necessary conditions ‘or presumption of compliance with the protection requite- ments referred co in Article 4, the Commission shall consult the Committee, which shall give its opinion without delay Upon reccipr of the latter's opinion, the Commission shal inform the Member States as soon as possible whether or not national stan the standard in question shall continue to enjoy a presump sion of conformity and, if nor, thar it must be withdrawn in whole or in pact from the publications referred to in Arti- cle 7 (21 Article 9 1. Where a Member State ascertains that apparatus ac companied by one of the means of attestation provided for in Article 10 does not comply with the protection require ments relerred to in Article 4, it shal take all appropriate measures co withdraw the apparatus from the market, pro- hibits placing on the market or restrict is free movement. The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particulas, whether non-compliance is due (a) failure co satisfy the protection requirements referred to in Article 4, where che apparatus does not meet the standards referred to in Article 7 (1); (b) incorrect application of the standards referred to in Article 7 ( ic}. shortcomings in the standards referred to in Article 7 (1) themselves, The Commission shall consuls the parties concerned as soon as possible. Ifthe Commission finds, after such consult ations, thatthe action is justified, i shall forthwith so inform the Member State that took the action and the other Member States. Where the decision eferred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after con- sulting the parties, shall bring the matter before the Commit tee within ewo months if the Member State which has taken the measures intends to uphold them, and shal initiate the procedures referred to in Article 8 3. Where apparatus which does not comply is accompa- nied by one of the means of attestation referred to in Article 10, the competent Member State shall take appropriate ac tion against the author ofthe artestation and shall inform the ‘Commission and the other Member States thereof. 4. ‘The Commission shall ensuce that the Member States are kept informed of the progress and outcome of this proce- dure 40 Official Journal of the European Communities 235.89 Article 10 1. Inthe case of apparatus for which the manufacturer has apie the standards referred tin Article 711. the eonfonr 1. ot apparatus with this Directive shall be certiied by an EC declaration of conformity issued by the manufacturer of his authorized representative established withia the Corarmu- nity. The declaration shall be held at the disposal of the competent authority for ren years following the placing of the apparatus on the market. The manufacturer or his authorized representative estab- lished within the Community shall also affix the EC conform: ity mark to the apparatus or else to the packaging, instructions for use oF guarantee certificate Where neither the manufacturer nor his authorized repre- sentative is established within che Community, the above obligation to keep the EC declaration of conformity available shall be the responsibility of che person who places the apparatus on the Community market The provisions governing the EC declaration and the EC mack are set out in Annex 1 2. Inthecaseof apparatus for which the manufacturer has ‘not applied, or has applied only in part, the standards relerred toin Article 7 (1) o failing such standards, the manufacturer or his authorized representative established within the Com ‘munity shall hold at the disposal of the relevant competent authorities, as soon as the apparatus is placed on the market, a technical construction file. This file shall describe the appa- tus, set out the procedures used ro ensure conformity of the apparatus with the protection requirements referred t0 in Article 4 and include a cechnical report or certificate, one or other obtained from a competent bod. The file shall be held atthe disposal of the competent authori ‘ies for ten years following the placing of the apparatus on the marker. ‘Where neither the manufacturer nor his authorized repre sentative is established within the Community, this obligation to keep a technical file available shall be the responsiilicy of the person who places the apparatus on the Community marker ‘The conformity of apparatus with that described in che technical file shall be certified in accordance with the proce- dure laid down in paragraph 1 Member States shall presume, subject to the provisions ofthis paragraph, that such apparatus meets the protection requite- ments referred to in Arvicle 4 3. Where the standards referred coin Article 7 (1) are not yet in existence, and without prejudice to the provisions of paragraph 2 ofthis Article, the apparatus concerned may, on 4 transitional basis until 31 December 1992 ar the latest, ‘continue to be governed by thenational arrangementsin force ‘on the date of adoption of this Directive, subject to the compatibility of such arrangements with the provisions of the “Treaty at ithe 235.89 4. Conformity of apparatus covered by Article 2 (2) of Directive 86/36 1/EEC with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph 1 once the manufacturer or his authorized foptescitative established within the Community has oby tained an EC type-examination certificate concerning this, apparatus issued by one of the notified bodies referred to in paragraph 6 of this Article, 5. The conformity of apparatus designed for the transmis- sion of radiocommunications, as defined in the International Telecommunication Union Convention, with the provisions of this Directive shall be certified in accordance with the procedure laid down in paragraph I once the manufacturer or his authorized representative established within the Com- ‘munity has obtained an EC type-examination certificate con- cerning this apparatus issued by one of the notified bodies referred to in paragraph 6 below. This provision shall not apply to the above apparatus where it is designed and intended exclusively for radio amateurs ‘within the meaning of Article 2 (3) 6. Each Member State shall notify the Commission and the other Member States of the competent authorities referred to in this Article and of the bodies responsible for issuing the EC rype-examination certfcaves refered to in paragraphs 4 and 3. The Commission shall publisha list of those authorities, and bodies, for informacion purposes, in the Official Journal of the European Communities and shall ensure that the list is updated. Such notification shall tate whether those bodies are compe- tent for all apparatus covered by this Directive or whether their responsibilty is limited to certain specific areas. Member States shall apply the criteria listed in Annex Il for the assessment of the bodies to be notified. Bodies which comply withthe assessment criteria fixed by the relevant harmonized standards shall be presumed to comply with the aforementioned criteria Official Journal of the European Communities No 1.13923 'A Member State which has norified a body must withdraw approval if i Finds that the bad no longer meets the criteria listed in Annes Tl. Itshall forthwith inform the Commission and the usher Member States thereot Article 11 Directive 76/889/EEC and Dicective 76/890/FEC shall be repealed as from 1 January 1992, Article 12 1, By 1 July 1991, Member Srates shall adopt and publish the laws, regulations and administeative provisions necessary 0 comply with this Directive. They shall inform the Comin sion thereof, ‘They shall apply these provisions as from 1 Januaev 1992 2. Member Srates shall communicate to the Commission ‘he texts of the provisions of national law which they adopt inthe field covered by this Disective Article 13 This Directive is addressed to che Member States. Done at Brussels, 3 May 1989, For the Council The President P.-SOLBES a NoL 139/24 2 Official Journal of the European Communities 235.89 ANNEX I EC declaration of conformity The EC declaration of conformity must contain the following — description of the apparatus to which ie refers; — reference to the specifications under which conformity is declared, and, where appropriate, to the national measures implemented to ensure the conformity of the apparatus with the provisions of the Dicective; — identification of the signatory empowered to bind the manufacturer or his authorized representatives — where appropriate, reference ro the EC type-examination certificate issued by a notified body. EC conformity mack = The EC conformity mark shall consist of the letters CE as set out below and the figures of the year in which the mack was affixed. — This mark should, where appropriate, be accompanied by the distinctive leters used by the notified body issuing the EC type-examination certificate — Where apparatus is the subject of other Directives providing for the EC conformity mark, the affixing of the EC mark shal also indicate conformity with the relevant requirements of those other Directives. 4 235.89 Official Journal of the European Communities No L 139/25 ANNEX IT Criteria for the assessment of the bodies to be notified The bodies designated by the Member States mus fulfil the following minimurn conditions: 1 availability of personnel and of the necessary means and equipment; 2. technical competence and professional integrity of personnel; 3. independence, in carrying out the tests, preparing the reports, issuing the certificates and performing the verification function provided for in this Directive, of staff and technical Personnel in relation to all circles, groups or persons directly or indirectly concerned with the product in question; 4. maintenance of professional secrecy by personnel; 5. possession of civil liability insurance unless such liability is covered by the State under national law. Fulfilment of the conditions under points 1 and 2 shall be verifed at intervals by the competent tuthoriies of che Member States. 8 Nol 139726 44 Official Journal of the European Communities 23.5.89 ANNEX Ill Intutrative list of the principal protection requirements, “The maximum electromagnetic disturbance generated by the apparatus shall be such as not to hinder the use of in particular the following apparatus (a) domestic radio and TV receivers bo) industrial manufacturing equipment (6) mobile radio equipment (a) mobile radio and commercial radiotelephone equipment (e) medical and sienifc apparats (8) information technology equipment ) domestic appliances and household electronic equipment th) aeronautical and marine radio apparatus (i) educational electronic equipment (i) telecommunications nerworks and apparatus (k) radio and television broadcast eeansmitters (i) lights and Fluorescent lamps Apparatus, and especially the apparatus referred ro in) t0(), should be constructed in sucha way that ithas an adequate level of electromagnetic immunity in the usual electromagnetic compatiblity tnvitonment where the apparatus intended to work 30330 allow ts unhindered operation raking into account the levels of disturbance generated by apparatus complving with the standards laid down in Arcicle 7. ‘The information required to enable use in accordance with the intended purpose of the apparatus ‘must be contained in the instructions accompanying the apparatus 23.591 Official Jourtial of the European Communities NoL 128/1 (Acts whose publication is not obligatory) COUNCIL EXTRACT OF THE COUNCIL DIRECTIVE of 29 April 1991 ‘on the approximation of the laws of the Member States concerning telecommunications terminal equipment, including the mutual recognition of their conformity (91/263/EEC) ‘THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Eco- nomic Community, and in particular Article 1004 thereof, Having regard to the proposal from the Commission ("), In cooperation with the European Parliament), Having regard to the opinion of the Economic and Social Comittee (), ‘Whereas Directive 86/361/EEC (*) introduced the initial stage of the mutual recognition of type approval for telecommuni- cations terminal equipment and in particular in is Article 9 envisaged a further stage for full mutual recognition of type approval for terminal equipment; ‘Whereas the terminal equipment sector is a vital part of the telecommunications industry, which is one of the industrial mainstays of the economy in the Community; ‘Whereas harmonizing conditions forthe placing on the mar- ket of telecommunications terminal equipment will create the conditions for an open and unified market; ‘Whereas Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of Member States relating to () OFNoC211, 17.8. 1989, p12, (2) O} NoC 113, 7. 5, 1990; and Oj No C .9, 28. 1.1991, p88 (2) ©] No.C 329, 30.12. 1989, p. 1 1") OJ NoL 217, 5.8. 1986, pi. clectromagnetic compatibility() is applicable, inter alia, to the fields of telecommunications and information technol- ‘ogys whereas itis, however, appropriate to delete the provi- sions of Directive 89/336/EEC in so far as they refer to the definition of celecommunications terminal equipment and to the conformity assessment procedures to be applied for such ‘equipment; HAS ADOPTED THIS DIRECTIVE: CHAPTER 1 Scope, placing on the market and free cieculation Article 1 1, This Directive shall apply co terminal equipment, 2. For the purpose of this Directive: — “public elecommunications network” means the public telecommunications infrastructure which permits the conveyance of signals berween defined network termina- tion points by wire, by microwave, by optical means or by other electromagnetic means, — “terminal equipment” means equipment intended to be connected 0 the public telecommunications network, OF Nok 139, 23. 5.1989, p. 19. 45 (a) to be connected directly tothe termination of a public telecommunications network; Ib) to interwork with a public telecormmunications ner work being connected directly or indirectly to the termination of a public telecommunications nerwork in order to send, process of receive information. The system of connection may be wite, radio, optical or other electromagnetic system, — "technical specification” means a specification contained in a document which lays down the characteristics re- quired ofa product such as levels of quality, performance, safety or dimensions, including the requirements applica- ble to the product as regards terminology, symbols, test. ing and est methods, packaging, marking and labelling, — “standard” means a technical specification adopted by a recognized standards body for repeated or continuous application, compliance with which is not compulsory. 3. The intended purpose of the equipment, shall be de- clared by the manufacturer or supplier of the equipment. However, terminal equipment within the meaning of para- graph 2 which makes use of a system of communication employing the radio frequency spectrum is presumed to be intended for connection to the public telecommunications network (CHAPTER It Conformity assessment Article 9 1. According to the choice of the manufacturer or his authorized representative established within the Community, ‘eeminal equipment shall be subject to either the EC type-ex- amination, as described in Annex I, oF to the EC delearation of conformity, as described in Annex IV. 2. An EC type-examination as described in Annex I shall be accompanied by a declaration issued according to the EC 46 declaration of conformity to type procedure as described in ‘Annex Ilo Annex IIL 3. The records and correspondence relating to the proce: dure reterred to in this Article shall be in an official language of the Member State where the said procedure will be carried out, or ina language acceptable to the notified body involved 4. Article 10 (4) of Directive 89/336/EEC is h leved, by de- Article 17, 1. Member States shall take the measure necessary t0 comply with this Directive not later than 6 November 1992, ‘They shall forewith inform the Commission thereof. ‘When Member States adopr these measure, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States. 2. Member States shall inform che Commission of the ‘main provisions of domestic law which they adopt in the field governed by this Directive. Article 18 ‘This Directive is addressed to the Member States. Done at Luxembourg, 29 April 1991 For the Council The President R. GOEBBELS ANNEX IO VIII (not reproduced) 12.592 Official Journal of the European Communities NoL 126/11 (Acts whose publication is not obligatory) COUNCIL COUNCIL DIRECTIVE 92/31/EEC of 28 April 1992 amending Directive 89/336/EEC on the approximation of the laws of the Member States relating to electromagnetic compatibility ‘THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Eco- omic Community, and in particular Article 100a thereof, Having regard co the proposal from the Commission (, In cooperation with the European Parliament (*), Having regard to the Opinion of the Economic and Social Committee (, Whereas Directive 89/336/EEC (') provides for complete har ‘monization relating to electromagnetic compatibility; ‘Whereas a uniform application of that Directive requires the availability of harmonized standards; whereas these stand- ards will not be available by the date of application of that Directives, Whereas that Directive has not provided for an adequate transitional period during which it would be permitted to place on the market apparatus manufactured in accordance with national regulations applicable before the date of appli cation of the said Directive; ‘Whereas manufacturers must have the time needed to allow apparatus in stock to be marketed; Whereas Directive 89/336/EEC should accordingly be amended, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 89/336/EEC is hereby amended as follows: 1, Article 10 (3) shal be deleted, (0) OJ No C126,21.6.1991, p.7. (2) OJ No C 13,20.1.1992, p $06 and OJ No C 94, 13.4.1992, (2) Of No C339, 31.12.1994, pl, (*) 0} No L139, 23.5.1989, 6.19, Directive amended by Directive SURESMEEC (OJ No L 138.235.1991, pI. 2. Amticle 12 (1) shall be supplemented by the following paragraph: "However, Member States shall, for the period up to 31 December 1995, authorize the placing on the mar. ket and/or the putting into service of apparatus re- ferred to in this Directive conforming to the national regulations in force in theit territory on 30 June 1992," Article 2 1. Member States shall adopt and publish the laws, regu: lations and administrative provisions necessary to comply with this Directive not later than three months after its adoption. They shall forthwith inform the Commission thereof, When Member States adopr these measures, they shall con: tain a reference to this Directive or shall be accompanied by such reference on the occasion of theie official publication, ‘The methods of making such a reference shal be laid down by the Member States. Membr States shall apply these provisions not later than six months after the adoption of this Directive. 2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 28 April 1992 For the Council The President Arlindo MARQUES: 308.93 Official Journal ofthe European Communities 1 No L220 (Acts whose publication is not obligatory) COUNCIL EXTRACT OF THE COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/BEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility),89/392/EEC (machinery), 89/686/EEC{personal protective equipment), 90/384/EEC. (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fucls), 91/263/EEC|telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits) ‘THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Eco- nomic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (", In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (), ‘Whereas the Council has already adopted a series of Ditec- tives designed to remove technical barriers to trade in accord- ance with the principles established in its Resolution of 7 May 1985 on a new approach to technical harmonization and standards (); whereas each of these Directives provides for the affixing of the ‘CE’ marking; whereas, therefore, in the interests of simplifying Community legislation and making it ‘more consistent, these various provisions need to be replaced by uniform’ prescriptions; whereas itis therefore necessary to harmonize these provisions, particularly with regard to products which may fall within the scope of several of these Directives: 0) OF No € 160, 20.6.1991, p. 14; and OJ No C28, 2 Pt. (°) 0 No € 125, 185.1992, p. 178; OJ No C115, 26.4.1993, p. 117; and Decision of 14 July 1993 (not yet published in the 2.1993, Official Journal. (P} Of No C14, 20.1.1992, p. 15; and OJ No C 128, 10.5.1993, p : (t) Of No C136, 4.6.1985, p. 1 48 ‘Whereas, in its communication of 15 June 1989 on a global approach to certification and testing (°), the Commission ‘proposed that common rules be drawn up concerning a'CE" conformity marking with a single design; whereas, in is Resolution of 21 December 1989 on a global approach to ‘conformity assessment (*, the Council approved as a guiding principle the adoption of a consistent approach such as this ‘with regard to the use of the ‘CE’ markings ‘Whereas the ewo basic elements of the new approach which must be applied are cherefore the essential requirements and the conformity assessment procedures; ‘Whereas this harmonization of the provisions concerning the affixing and use of the 'CE’ marking cequires that existing Directives undergo detailed amendment to bring them into line with the new arrangements, HAS ADOPTED THIS DIRECTIVE: Article 1 The following Directives are hereby amended: 1. Council Directive 87/404/BEC of 25 June 1987 on the harmonization of the laws ofthe Member States relating to simple pressure vessels’); FY OJ No C 231, 8.9.198, p. 3; and OJ No C 267, 19.10.1989, 3 p. (4) 0 No C 10, 16.1.1990, p. 1 (°) OJ No L 220, 8.81987, p. 48; Directive amended by Diectve 90ISBB/EEC (OJ No L 270, 2.10.1990, p. 25), Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States con cerning the safety of toys 5. Council Directive 99/106/KEC of 21 Lecember 1988 on the approximation of the laws, regulations and admin: iscrative provisions of the Member States celating to cconstruetion products ("} 4. Councti Directive 89/336/EEC of 3 May 1989 on the approximatio ofthe laws of the Member States relating, to electromagnetic compatibility ("); 5. Council Directive 89/392/BEC of 14 June 1989 on the approximation of the laws of che Member States relating, 0 machinery ("}s 6. Council Directive 89/686/EEC of 21 December 1989 0n ‘he approximation of the laws of the Member States, relating to personal protective equipment ("); 7. Council Directive 90/384/EEC of 20 June 1990 on the harmonization of the laws of the Member States relating 0 non-automati weighing instruments () 8. Council Directive 90/38S/EEC of 20 June 1990 on the approximation of the laws ofthe Member States relating tw active implantable medical devices ('*s 9. Council Directive 90/396/EEC of 29 June 1990 on the approximation ofthe laws of the Member States relat ing to appliances burning gaseous fuels), 10. Council Directive 91/263/EEC of 29 April 1991 on the approximation of the laws of the Member States con- cerning telecommunications terminal equipment, cluding the mutual recognition of their conformity ( 11, Council Directive 92/42/EEC of 21 May 1992 on eff

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