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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 Directive 2
The EMC Directive◦ History◦ Objectives◦ Scope◦ Essential requirements◦ Harmonised standards◦ Conformity assessment procedures◦ Role of Member States
EMC Directive 3
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 Directive 4
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 Directive 5
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 Directive 6
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 Directive 7
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 Directive 8
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
EMC Directive 9
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).
EMC Directive 10
Application Guide
◦ Introduction◦ Decision flow chart◦ Competent body◦ Technical Construction File◦ Instructions for use◦ Application of EMCD to machines◦ Standardisation
EMC Directive 11
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 Directive 12
EMC Directive 13
EMC Directive 14
EMC Directive 15
EMC Directive 16
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 Directive 17
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 Directive 18
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 Directive 19
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 Directive 20
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 Directive 21
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 Directive 22
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 Directive 23
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 Directive 24
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 Directive 25
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 Directive 26
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 Directive 27
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 Directive 28
◦ 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 Directive 29
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 Directive 30
EMC Directive 31
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
EMC Directive 32
EMC Directive 33
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
EMC Directive 34
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 Directive 35
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 Directive 36
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
EMC Directive 37
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 Directive 38
International activities
◦ PECA◦ MRA
EMC Directive 39
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 Directive 40
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 Directive 41
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 Directive 42