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

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

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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

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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.

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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

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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)

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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

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X

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

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Protection requirementsProtection requirements

Specific requirements for installations

Specific requirements for apparatusSpecific requirements for apparatus

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).

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Application Guide

◦ Introduction◦ Decision flow chart◦ Competent body◦ Technical Construction File◦ Instructions for use◦ Application of EMCD to machines◦ Standardisation

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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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

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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

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◦ 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

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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

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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.

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

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EMC Assessment or

Application of HS

EMC Assessment or

Application of HS

D.o.CD.o.C

Technical Documentation

Technical Documentation

Optional report fromnotified body

Product typeProduct type

Application of protection

requirements

Application of protection

requirements

ApparatusApparatus

Installation

Installation

Name of :manufacturer

importer

Name of :manufacturer

importer

Type : xxx-yyyS/N : 123456

Type : xxx-yyyS/N : 123456

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

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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

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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)

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New Approach pillar essential requirements

of EC directives (EMCD : emission +

immunity) reference to technical

specifications defined in harmonized standards

compliance of products with essentialrequirements

market surveillance (tool for New Approach Directive's enforcement)

Stakeholders EU Member States

authorities = legislators

European standardization bodies

Manufacturers + "third" parties

National Authorities

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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

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International activities

◦ PECA◦ MRA

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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

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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

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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

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