2.  The EMC Directive ◦ History ◦ Objectives ◦ Scope ◦ Essential requirements ◦ Harmonised standards ◦ Conformity assessment procedures ◦ Role of Member States  Application Guide ◦ Introduction ◦ Decision flow chart ◦ Competent body ◦ Technical Construction File ◦ Instructions for use ◦ Application of EMCD to machines ◦ Standardisation  International activities ◦ PECA ◦ MRA EMC Directive2

3.  The EMC Directive ◦ History ◦ Objectives ◦ Scope ◦ Essential requirements ◦ Harmonised standards ◦ Conformity assessment procedures ◦ Role of Member States EMC Directive3

4.  The Electromagnetic Compatibility (EMC) Directive 2004/108/EC repeals the previous EMC Directive 89/336/EEC (as amended by Directives 91/263/EEC,92/31/EEC, 93/68/EEC and 93/97/EEC7) and maintains the same  Directive published in 1989 ◦ Transposition into national law by 1 July 1991 ◦ Provisions apply since 1 January 1992 ◦ However a longer transition period was necessary  Directive 92/31/EEC to allow a transitional period until end 1995 ◦ As of 1 January 1996, Member States have abolished national regulations concerning EMC  EMC Directive is a total harmonisation Directive EMC Directive4

5.  1997:SLIM process: Simpler Legislation for the Internal Market  EMC Directive identified as a candidate  Conclusions of debates: ◦ Clarify the scope; ◦ Include ready-made connecting devices; ◦ Clarify treatment of fixed installations ◦ Enhanced clarity through more detailed essential requirements; ◦ Clarification the role of harmonised standards; ◦ Simplify the conformity assessment procedure ◦ Cut “red tape” by abolishing compulsory third-party intervention ◦ Improve market surveillance through better traceability of the manufacturer. EMC Directive5

6.  Objectives : functioning of the internal market ◦ functioning of the internal market ◦ free movement of apparatus ◦ acceptable Electromagnetic Environment  adequate protection of radio communications  adequate protection of telecommunications networks  Means : ◦ Definition of essential requirements ◦ Definition of Conformity assessment procedures ◦ Compliant products bear the CE Mark.  Enforcement by Member States EMC Directive6

7.  Scope (Article 1.1) : ◦ Apparatus (all definitions are in Article 2)  all electrical and electronic appliances, equipment and installations containing electrical and/ or electronic components ◦ liable to cause electromagnetic disturbance  or ◦ the performance of which is liable to be affected by such disturbance  Excluded equipment is explicitly listed (Article 1.2) ◦ Covered by the RTTE Directive ◦ Other covered by specific directives ◦ Aeronautical products, parts ect. ◦ Radio amateurs equipment ◦ Incapable to generate EM radiation and not sensitive to it when used as intendent  Precedence is given to specific Directives, if existing (Article 1.2) EMC Directive7

8.  Clarification of the scope - Equipment : ◦ Apparatus  Electrical and electronic appliance  Component  Ready made connecting device ◦ Fixed installation  Machines  Networks  Exclusion of certain equipment ◦ Covered by R&TTE Directive ◦ Covered by specific directives EMC Directive8 X

9.  Protection requirements unchanged  Verification apparatus meets the protection requirements in all configurations without external devices  Unique identification of apparatus identification of manufacturer precaution and restriction of use  No a priori EMC assessment  MS to request compliance EMC Directive9 Protection requirements Protection requirements Specific requirements for installations Specific requirements for apparatus

10.  Apparatus, and especially apparatus referred to in Annex III of the EMCD, should be constructed in such a way that it has an adequate level of electromagnetic immunity in the usual electromagnetic compatibility environment where the apparatus is intended to work, so as to allow its unhindered operation taking into account the levels of disturbance generated by apparatus complying with the harmonised standards.  The information required to enable use in accordance with the intended purpose of the apparatus must be contained in the instructions accompanying the apparatus (Article 9.5). EMC Directive10

11.  Application Guide ◦ Introduction ◦ Decision flow chart ◦ Competent body ◦ Technical Construction File ◦ Instructions for use ◦ Application of EMCD to machines ◦ Standardisation EMC Directive11

12.  Guide to the application of EMC Directive ◦ Addressed to all parties affected by the Directive ◦ Aid for the interpretation of the Directive ◦ Does not substitute the Directive which is the only legally binding text ◦ Agreed by consensus among Member States' government experts and other parties concerned  Topics ◦ Scope of the Directive ◦ Application to components, finished products, systems and installations ◦ Application to used, second-hand, repaired products and spare parts ◦ Conformity assessment procedures ◦ Competent authorities, competent bodies, notified bodies ◦ Application of the Directive to some specific cases EMC Directive12

13. EMC Directive13

14. EMC Directive14

15. EMC Directive15

16. EMC Directive16

17.  Definitions ◦ Finished product  Any device or unit of equipment that has a direct function, its own enclosure and – if applicable – ports and connections intended for end users ◦ Direct function  Any function of a component or a finished product which fulfils the intended use specified by the manufacturer in the instructions for use for an end user. This function can be available without further adjustments or connections other than simple ones which can be performed by any person not fully aware of the EMC implications. EMC Directive17

18.  Components ◦ with direct function  the direct function is available without further adjustment, It may be placed on the market as an SCU  if further adjustment is necessary the component must not be placed on the market for end user  examples  plug in cards for computers  programmable logic controllers  lift controls  electric motors  computer disc drives  power supply units  fully subject to all provisions of the EMC Directive EMC Directive18

19.  Components ◦ with direct function  If there is no intention to put the components on the market for final use or distribution  the manufacturer has only to deliver the relevant instruction to enable the operation within the apparatus in which they will be incorporated  no other element of the EMC Directive is mandatory EMC Directive19

20.  Components ◦ without direct function  examples  resistors, capacitors, coils  diodes, transistors, thyristors, triacs etc.  integrated circuits  cables and cable accessories  all or nothing relays  plugs, sockets, terminal blocks etc.  light emitting diodes, liquid crystals etc.  simple electromechanical thermostats ◦ the EMC Directive does not apply at all EMC Directive20

21.  Finished Products ◦ When intended to be put on the market for final use and distribution  fully subject to all provisions of the EMC Directive ◦ When not intended to be put on the market for final use and distribution  only the relevant instructions have to be delivered to enable the operation within the apparatus in which they will be incorporated  none of the other provisions are mandatory EMC Directive21

22.  Systems  for the purpose of the EMC Directive system is defined as a combination of several types of equipment, finished products and/or components combined, designed and put together by the same person (system manufacturer) intended to be placed on the market for distribution as a single functional unit for an end user and intended to be installed and operated to perform a specific task EMC Directive22

23.  System assembled only of CE marked apparatus  Declaration of conformity for the whole system  instruction for the whole system  no CE Marking for the whole system  System assembled also from apparatus without CE marking  Declaration of conformity for the whole system  instructions as well  one additional CE Marking on the main part is sufficient EMC Directive23

24.  Fixed Installations  combination of types of equipment, systems... assembled and/or erected by an assembler/installer at a given place to operate together in an expected environment but not to be placed as a SCU on the market  Examples : telecommunication networks, high voltage substations  the installation must comply with the Essential Requirements as defined in Article 4  such installation cannot enjoy free physical movement and in respect to the EMC Directive there is no need for CE Marking, Declaration of conformity or the intervention of a competent body  the manufacturer must provide clear instructions EMC Directive24

25.  Body responsible for issuing technical reports or certificates according to article 10.2 of the EMC directive  He verifies that the procedures used by the manufacturer to state direct compliance to the directive are correctly applied.  His EMC competence is essential to avoid non- compliant products to be put on the market.  The competent body does not : ◦ certify conformity of a product ◦ draw DoC  This remains the role of the manufacturer  A competent body is not necessary a test laboratory, but there is no obligation of separation.(Note : Manufacturer's laboratory can be recognized as competent body) EMC Directive25

26.  A body can be recognised as competent by a competent authority of a Member State: ◦ Either by an accreditation body recognised as such by the competent authority, or ◦ By a body representing the supervisory authority of a Member State ◦ Use of accreditation systems and of European Standards like EN 45001, 45004 and EN 45011 in establishing compliance with EMCD: member state prerogative - Directive is not prescriptive  Designation criteria : Annex II EMCD ◦ availability of necessary staff and equipment ◦ technical competence ◦ independence ◦ respect of professional secrecy  List of competent bodies are transmitted to the Commission by the competent authority and published on its Web site EMC Directive26

27.  EMC Directive : "This file shall describe the apparatus, set out the procedures used to ensure conformity of the apparatus with the protection requirements and include a technical report or certificate, one or other obtained from a competent body"  Contents ◦ A general description of the product ◦ Design and manufacturing drawings (lay-out diagrams covering components, subassemblies,..) ◦ Descriptions and explanations needed for understanding the drawings and diagrams as well as the operational aspects of the product ◦ List of standards applied in whole or in part. Description of solutions to comply with the requirements in cases where standards have not been applied ◦ Design calculations araising from EMC tests ◦ Technical report or certificate issued by competent body ◦ Copy of the declaration of conformity ◦ Copy of the instructions for use EMC Directive27

28.  Instructions for use must accompany the apparatus  Must give the following information ◦ Intended conditions for use ◦ Instructions on  Installation  Assembly  Adjustment  Taking into service  Use  Maintenance ◦ Where necessary, warnings about limitations of use EMC Directive28

29. ◦ the EMC Directive is to be applied in parallel with the Directive on machinery  If manufacturer uses only CE marked electrotechnical products and strictly follows instructions, the finished machine may be considered in compliance with the EMC Directive and no further verifications will be needed  Declaration of conformity and instructions for the whole machine must be provided.  no extra CE Marking is mandatory  if the manufacturer of the machine uses non-CE- marked products he has to follow the procedures for systems or installations EMC Directive29

30.  Types of EMC standards ◦ Basic standards ◦ Generic standards ◦ Product-family and dedicated product standards  Harmonised standards ◦ Elaborated by CEN/CENELEC/ETSI under mandate of Commission ◦ Published in OJEU and give presumption of conformity ◦ Example : Harmonised standards ITE  Emission – harmonics : EN 61000-3-2 (only for eqpt for connection to LV supply, up to 16A)  Emission – voltage fluctuations : EN 61000-3-3 (only for eqpt for connection to LV supply, up to 16A)  RF emission : EN 55022  Immunity : EN 55024 EMC Directive30

31. EMC Directive31 When a new edition (or amendment) is published in the OJEU the list indicates the date of cessation of presumption of conformity of the superseded standard.

32.  Presumption of conformity with the protection requirements of the Directive in case of compliance with the relevant harmonised standards (Article 6.2) ◦ Harmonised standards reflect the state of the art for the addressed aspect ◦ List(s) of harmonised standards published in the Official Journal  Official Journal of the European Union C172 (22 July 2003)  Application of harmonised standards is voluntary (Article 6.1) ◦ Conformity to be demonstrated according Art 10.2 EMC Directive32

33. EMC Directive33 EMC Assessment or Application of HS EMC Assessment or Application of HS D.o.C Technical Documentation Technical Documentation Optional report from notified body Product type Application of protection requirements Application of protection requirements Apparatus Installation Name of : manufacturer importer Name of : manufacturer importer Type : xxx-yyy S/N : 123456 Type : xxx-yyy S/N : 123456

34.  All apparatus except radiocommunication transmitters (Article 7, Annex II and III)  The manufacturer applies harmonised standards ◦ The manufacturer ensures and declares that the apparatus concerned conforms to the applicable harmonised standards ◦ The manufacturer draws up the EC declaration of conformity and affixes the CE marking  Procedure used in approximately 95 % of the cases  Correct selection and application of standards is responsibility of manufacturer EMC Directive34

35.  All apparatus except radiocommunication transmitters (Article 7, Annex II and III)  The manufacturer does not apply harmonised standards, or applies them only in part. ◦ The manufacturer ensures and declares that the apparatus satisfies the protection requirements of the EMC Directive. ◦ The manufacturer prepares a Technical Construction File including a technical report or certificate obtained from a Competent Body. ◦ The manufacturer draws up the EC declaration of conformity and affixes the CE marking.  Procedure used in approximately 5 % of the cases  Responsibility for DoC lies with the manufacturer EMC Directive35

36.  EC Declaration of conformity (Annex I) ◦ Description of the apparatus to which it refers ◦ Reference to the specifications under which conformity is declared ◦ Identification of the signatory empowered to bind the manufacturer or his authorised representative ◦ Where appropriate, reference to the EC type-examination certificate issued by a notified body  CE marking ◦ Initials 'CE' in the form (i.e. without the grid) : ◦ Reduction or enlargement have to respect proportions ◦ Indicates compliance with all Directives – providing for CE conformity marking - applicable to the product ◦ Not less than 5 mm (vertical dimension) EMC Directive36

37.  New Approach pillar  essential requirements of EC directives  (EMCD : emission + immunity)  reference to technical specifications defined in harmonized standards  compliance of products with essential requirements  market surveillance (tool for New Approach Directive's enforcement)  Stakeholders  EU Member States authorities = legislators  European standardization bodies  Manufacturers + "third" parties  National Authorities EMC Directive37

38.  Member States ensure that only compliant product are put on  the EU market (Article 3) : market surveillance.  Any non-compliant product to be prohibited, withdrawn from the market or restricted in its free movement ◦ Measure to be notified to the Commission (safeguard clause)  Member States designate Competent / Notified Bodies and need to apply continual surveillance of these bodies to ensure compliance with the Criteria  Assessment criteria notified bodies ◦ Availability of personnel and equipment. ◦ Technical competence and professional integrity of personnel ◦ Independence vs those concerned with the product in question ◦ Maintenance of professional secrecy ◦ Civil liability insurance EMC Directive38

39.  International activities ◦ PECA ◦ MRA EMC Directive39

40.  PECA (Protocol to the Europe Agreement on Conformity Assessment) ◦ Trade agreement ◦ Pre-accession tool  Agreements with candidate countries by which mutual recognition operates on the basis of the acquis communautaire  Extends the benefits of the internal market and ensures effective operation before accession  Recognises advances that candidate countries have made in aligning their legislation and practices ◦ EMC  PECA concluded : Czech Republic, Estonia, Hungary, Latvia, Lithuania, Slovakia, Slovenia  PECA initialled : Malta  PECA under negotiation : Bulgaria, Poland, Romania EMC Directive40

41.  MRA (Mutual Recognition Agreements) ◦ Trade agreement  Between Community an a third country which is on a comparable level of thechnical development and have a compatible approach concerning conformity assessment  Based on mutual acceptance of demonstrations of conformity issued by the conformity assessment bodies of one of the Parties of the Agreement in conformity with the legislation of the other Party ◦ EMC  Australia/New Zealand, Canada, Japan, Switzerland, USA EMC Directive41

42.  European Commission DG Enterprise website on the EMC Directive ◦ Directive ◦ Guidelines on the application of the Directive ◦ Conformity assessment bodies ◦ Standardisation ◦ Working structure within EU ◦ The review of the EMC Directive ◦ Frequently asked questions EMC Directive42