EMC Directive

1
EMC Directive
2
Contents

• 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

3
The EMC Directive

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

4
History

• 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

5
History

• 1997SLIM 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.

6
Objectives

• 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

7
Scope of the EMCD (I)

• 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)

8
Scope - examples

• 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 RTTE Directive
• Covered by specific directives

X
9
Essential requirements
Protection requirements

• 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

Specific requirements for apparatus
Specific requirements for installations
10
Essential requirements (II)

• 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).

11
Application Guide

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

12
Introduction

• 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

13
Scope evaluation
14
Classification as apparatus
15
Provisions assignment
16
Instalations
17
Decision flow chart (I)

• 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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Decision flow chart (II)

• 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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Decision flow chart (III)

• 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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Decision flow chart (IV)

• 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

21
Decision flow chart (V)

• 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

22
Decision flow chart (VI)

• 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

23
Decision flow chart (VII)

• 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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Decision flow chart (VIII)

• 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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Competent body (I)

• 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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Competent body (II)

• 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

27
Technical Construction File

• 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

• 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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Application of EMCD to machines

• 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

30
Standardisation

• 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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Standardisation
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.
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Harmonised standards

• 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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Conformity Assessment Procedure
34
Conformity assessment procedures (I)

• 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

35
Conformity assessment procedures (II)

• 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

36
Conformity assessment procedures (III)

• 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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Summary EMCD New Approach Directive

• 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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Role of Member States

• 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

39
International activities

• International activities
• PECA
• MRA

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International activities (I)

• 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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International activities (II)

• 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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Further reading

• 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