2009/5/14 1

European Union CE Mark

Presenter: Cliff Lai

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Agenda:

CE Mark

New Approach / Directive

CE 8 modules

Notify Body

EU Members

CE Directives

Consumer Affairs - RAPEX

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What is CE Marking(CE Mark)

CE Marking (CE Mark) is the symbol. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity".

The product complies with the essential requirements of the relevant European health, safety and environmental protection legislation

CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

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New Approach & Global Approach

Directives based on the principles of the New Approach which provide for CE marking

Directives based on the principles of the New Approach or the Global Approach, but which do not provide for CE marking

conformity assessment, legislation & standardisation

EU Single Market

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New Approach directives (directives providing for CE marking)

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New Approach & Global Approach

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New Approach & Global Approach

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New Approach & Global Approach

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CE 8 modules

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CE 8 modules

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CE 8 modules

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EU Notified Bodies

Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State.

CE 0044http://ec.europa.eu/enterprise/newapproach/legislation/nb/notified_bodies.htm

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EU Notified Bodies

CE 0044

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EU Notified Bodies

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歐洲標準化委員會(European Commission for Standardization, CEN)

歐洲電工標準委員會(European Committee for Electrotechnical Standardization, CENELECE)

歐洲電訊標準協會(European Telecommunication Standards Institute, ETSI)

歐盟標準機構(European Standards Organisations, ESO)

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CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market.

CE marking now provides product access to more then 30 countries with a population of nearly 500 million.

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European Union Member State:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, Netherlands, United Kingdom

Member States as of May 1, 2004: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia

New Member States of 2007: Bulgaris, Romania

(The European Free Trade Association) Iceland, Liechtenstein, Norway and Switzerland

Candidate : Turkey, Croatia, Former Yugoslav Republic of Macedonia

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LVD 2006/95/EC

Low Voltage Equipment

The Directive covers electrical equipment designed for use with a voltage rating of between 50 and 1000 VAC for alternating current and between75 and 1500 VDC for direct current

For most electrical equipment, the health aspects of emissions of Electromagnetic fields (EMF) are also under the domain of the Low Voltage Directive.

SAFETY REQUIREMENTS FOR PLACING ON THE EU MARKET ELECTRICAL EQUIPMENT COVERED BY THE "LOW VOLTAGE" DIRECTIVE

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LVD 2006/95/EC

Low Voltage Equipment

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LVD Directive Flow Chart

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LVD Accident

http://blog.roodo.com/gamy543/archives/4004601.html

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LVD Accident

http://ahmow.blogspot.com/2008/10/blog-post_18.html

Air condition Distributor

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EMC 2004/108/EC

Electromagnetic Compatibility

EMC is the term used to describe how well a device or system is able to function in an electromagnetic environment without introducing electromagnetic disturbances that interfere with the operation of other electrical products in the environment.

EMI: Electromagnetic Interference, a naturally occurring phenomena when the electromagnetic field of one device disrupts, impedes or degrades the electromagnetic field of another device by coming into proximity with it.

EMS: Electromagnetic Susceptibility, a device, piece of equipment, or system to perform without degradation in the presence of an electromagnetic disturbance

EMC = EMI + EMS

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EMC Directive Flow Chart

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R&TTE 1999/5/EC

Radio and telecommunications terminal equipment

‘Apparatus' means any equipment that is either radio equipment or telecommunications terminal equipment or both.

‘Radio Waves' means electromagnetic waves of frequencies from 9 kHz to 3,000 GHz

R&TTE = RF + EMC + LVD

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!

!

Harmonized Un-harmonized

Harmonized

Un-harmonized

Frequency

Standard

XXXXXXXX

R&TTE 1999/5/EC

Radio and telecommunications terminal equipment

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R&TTE Directive Flow Chart

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EUP 2005/32/EC

Energy using Product Directive

Article 8 Conformity assessment

Conformity assessment procedure shall be specify among relevant modules. (93/465/EEC)

Clause 24

CE marking (93/465/EEC)

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On 5 February 2009, the Official Journal published Commission Regulation 107/2009 on ecodesign requirements for simple set-top boxes (SSTBs). The Regulation implements framework Directive 2005/32/EC for the setting of ecodesign requirements for energy-using products (the EuP Directive) with regard to SSTBs.

EUP 2005/32/EC

Energy using Product Directive

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:036:0008:0014:EN:PDF

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EuP DirectiveOther DirectiveCE = EMC + LVD +

WEEE & RoHS & REACH

Many products require conformance to more than one directive

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EUROPEAN DECLARATION OF CONFORMITY

Once the manufacturer has conformed to the requirements to affix the CE marking to its product. The manufacturer must include a "declaration of conformity"

Company name, Address, Phone, FAXName, type or model, lot, batch or serial number, possibly

sources and numbers of items Title and/or number and date of issue of the standard(s) or

other normative document(s) Directive(s). (LVD, EMC, R&TTE.. etc.)

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Technical file

The technical file and report or certification must be made available for inspection by EU surveillance authorities for 10 years after the last product was placed on the market.

The name and the address of the manufacturer and the identification of the product

The list of harmonized standards followed by the manufacturer and/or the solutions adopted to satisfy the essential requirements;

Description of the product;The operating instructions;Test reports, directive.

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CE Mark 93/465/EC

The CE marking must have height of at least 5 mm. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The CE marking must be affixed to the apparatus or it’s data plate. Where this is not possible or not warranted on account of the nature of the apparatus, it must be affixed to the packing, if any, and to the accompanying documents.

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EU Consumer Affairs

RAPEX (Rapid Alert System for non-food consumer products)

RAPEX is the EU rapid alert system for dangerous consumer products – with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. It facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are reported by RAPEX.

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• 1541 notifications under article 12 of GPSD (serious risk)

• 10 notifications under article of GPSD (moderate risk)

• 311 notifications for in formations only

Situations in 2008

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Notifications 2003 - 2008

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Notifications buy EU Country

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Notifications buy EU Country 2004-2008

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Notifications buy product category 2008

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Notifications by country of origin of the notified product

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Notifications by country of origin of the notified product

2004 - 2008

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http://www.newapproach.org

http://vlib.iue.it/images/europe-map.jpg

http://ec.europa.eu/food/food/rapidalert/report2007_en.pdf

http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_home.htm

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Q & A

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TUV Asia Pacific Ltd. Taiwan Branch

漢德技術監督服務亞太有限公司

Cliff Lai / 賴俊仁

Production Certification/ 產品驗證部

Tel: 02-23780578 ext.53

Fax: 02-23780587

Mobile: 0939-980322

E-mail: clai@tuv-nord.com

www.tuvnord.com.tw