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CE Marking EMC Regulatory Overview KYAW SOE HEIN [email protected]

CE Marking- EMC- Products Regulatory

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Page 1: CE Marking- EMC- Products Regulatory

CE MarkingEMC Regulatory Overview

KYAW SOE [email protected]

Page 2: CE Marking- EMC- Products Regulatory

CE Marking

The CE Conformity Marking DirectiveThe overall aim of the CE Directive is to:Symbolize that a product complies with the level of protection stated in the harmonization Directive(s)Indicate that the manufacturer has undergone all the evaluation procedures laid down by EU law in respect of the products.

Page 3: CE Marking- EMC- Products Regulatory

EU Context

EU Member States have responsibility for “Protection Radio communications, electrical supply networks and telecommunications networks, as well as related equipment, from electromagnetic disturbance.

•DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC

Page 4: CE Marking- EMC- Products Regulatory

Directive on Electromagnetic Compatibility

Directive 2004/108/E•Harmonize the rules governing the sale within the EU of equipment liable to generate electromagnetic disturbance or to be affected by it.

This directive doesn’t cover “Radio Equipment and Telecommunications Terminal Equipment”.

Essential requirements regarding EMC for equipment covered are set out in Annex 1 of the directive.

Page 5: CE Marking- EMC- Products Regulatory

Conformity Assessment

“Internal Production Control carried out by manufacturer.”However, the manufacturer can also choose to follow a supplementary procedure to be sure that the equipment is compliant with Directive.

Asking the relevant Notified Body to access the technical documentation.To find the Notified Bodies appointed by the Member States for conformity assessment of equipment covered by this Directive, manufacturers can use NANDO.

•Notified Bodies can be located by Directive or by country via the NANDO homepage.

Page 6: CE Marking- EMC- Products Regulatory

NANDOBody Type Name Country

TAB UL International (UK) United Kingdom

NB 0539 UL International Demko A/S Denmark

NB 0843 UL International (UK) LTD United Kingdom

NB 0984 UL Verification Services Inc United States(MRA)

NB 1731 UL Japan, Inc Japan (MRA)

NB 2334 UL VS United Kingdom Limited Trading

United Kingdom

NB 0889 UL VS Ltd United Kingdom

Page 7: CE Marking- EMC- Products Regulatory

Road To CE MarkingFollow six steps to affix a CE Marking to product:

•Identify the applicable directive(s) and harmonised standards;•Verify product specific requirements;•Identify whether an independent conformity assessment (by a notified body) is necessary;•Test the product and check its conformity;•Draw up and keep available the required technical documentation;•Affix the CE marking and draw up the EU Declaration of Conformity 

Page 8: CE Marking- EMC- Products Regulatory

1.Choosing Directives• Choose your product groupHere, I will choose “Electromagnetic Compatibility”.

The EMC Directive 2004/108/EC applies to a vast range of equipment encompassing electrical and electronic appliances, systems and

installations

Harmonized Standards- for EMC can be found here.http://ec.europa.eu/growth/single-market/european-standards/

harmonised-standards/electromagnetic-compatibility/index_en.htm

Page 9: CE Marking- EMC- Products Regulatory

2.Verifying Requirements• Choose appropriate standards and requirements for your

product typeSay “ITE- Information Technology Device”

EN 55022:2010 Information technology equipment — Radio disturbance characteristics — Limits and methods of measurement CISPR 22:2008 (Modified)

EN 55024:2010 Information technology equipment — Immunity characteristics — Limits and methods of measurement CIS CISPR 24:2010

Page 10: CE Marking- EMC- Products Regulatory

3.Need for Notified Body?• Under EMC conformity assessment, the manufacturer is obliged to

perform an EMC.EMC directive does not require the intervention of a Notified Body. But Notified Body can help manufacturers can review and assess the technical

requirement and testing also. If they meet the requirement of Directives, NB will issue a statement confirming

it. This shall be part of technical documentation.

Refer to NANDO Slide 4-5 in the presentation.

Then the manufacturer draws up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the

DoC is a legal obligation.

Page 11: CE Marking- EMC- Products Regulatory

4.Check Conformity Internal Production Control procedure carried out by the manufacturer.

Meets the EMC requirement set out in Annex 1 or relevant EU harmonized Standards.

Details can be referred in Annexes 2 and 3 of the directive.

The Manufacturer draws up and signs the EC Declaration of Conformity.

Once Conformity Assessment process is complete, the manufacturer can fix the CE marking to the equipment. Refer Annex V of the directive.

Page 12: CE Marking- EMC- Products Regulatory

5.Technical Documentation

Annex II to the EMC Directive requires the manufacturer to establish the technical documentation.•A general description of the apparatus;•Evidence of compliance with the harmonized standards, if any, applied in full or in part;•When it has not applied harmonized standards, explanation of the steps taken to meet the essential requirements of the Directive. Annex II, point 1 , results of design, examinations carried out, test reports, etc.•A statement from the notified body, when the procedure referred to in Annex III has been followed.“Keep copies of technical documentation for a period of 10 years after

the last product was placed in market.”

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6.Affix CE MarkingAfter necessary steps completed, the logo must be affixed to the product.

If the product is subject to other Directives covering other aspects, have to comply with all.

Page 14: CE Marking- EMC- Products Regulatory

CENELEC European Committee for Electro-technical StandardizationCENELEC Guide 24This guide advise on 1)the application of the generic and basic EMC standards,2)Preparation of product - product-family or dedicated product EMC standards

Characteristic of EMC Standardsa.Basic Standardsb.Generic Standardsc.Product Standards (product family standards and dedicated product standards)

Page 15: CE Marking- EMC- Products Regulatory

Basic StandardsBasic EMC StandardsTwo Types of basic EMC standards-those for tests and measurements-those related to other aspects

Basic standards are important for conformity assessment purposes.a)Basic standards for emission and immunity tests and measurementsThese standards give a definition and description of the phenomena, detailed test and measurement methods, test instrumentation and basic set up. Ranges of test levels (immunity) – characteristic of measuring equipment or measuring methods.These standards shall not include prescribed limits and detailed performance criteria.

b) Other types of basic standards and documentsThey describe the fundamental elements of EMC-Guidelines on migration measures, eg. IEC 61000-5-1-Description & Classification of Environment, ranges of environmental and or compatibility levels.

Page 16: CE Marking- EMC- Products Regulatory

Generic StandardsGeneric EMC StandardsThese standards for emission & immunity define EMC requirements (including limits) and which standardized tests are applicable.

They do not include detailed test and measurement methods or test instrumentation but refer for that purpose to basic standards.

Generic immunity standards specify a limited number of essential tests.

Generic immunity standards also include those performance criteria of general application which are associated with specific test levels.

They should be used when no corresponding product standards exist or are deemed necessary.

Page 17: CE Marking- EMC- Products Regulatory

Product StandardsProduct EMC Standards

1)Product Family StandardsThey define specific EMC requirements (immunity & emission) and precise tests for the products within their scopes.-normally NOT include detailed measurement methods or instrumentation.-Reference to basic standards-All necessary information for reproducible testing of those products.-Tests & limits in product-family standards should be coordinated with those in the generic standards.-They include more specific and detailed performance criteria than generic standards.

For assessment of compliance with EMC Directive, product-family standards take precedence over generic standards.

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Product StandardsProduct EMC Standards

2) Dedicated Product StandardsThey define specific EMC requirements within the general-purpose (performance characteristic) standards dedicated to those specific (dedicated) products.-EMC clauses within these general-purpose standards shall be separated.-Regarding emission requirements: when a particular product is covered by a product-family standard, dedicated product standard is seldom justified.-Product specific functional characteristics have to be taken into consideration when determining the product’s immunity requirements. -Dedicated product EMC standards or clauses shall give precise performance criteria.

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Structure of Standards

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CE Marking For CE Marking, three key pieces of legislation

EMC directive as well as Radio & Telecommunication Terminal Equipment (R&TTE) Directive (1995/5/EC) is necessary to considered. Low Voltage Directive (LVD); 2006/95/EC , it covers electrical equipment operating with a voltage between 50 and 1000V for AC and between 75 and 1500V for DC. (input / output, not voltages may appear inside the equipment).

The R&TTE and LVD will be covered in another piece.