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Page 1: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

European Union

Page 2: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

CE标志CE MARKING

• CE Marking is for European Union• EMC Directive• Low Voltage Directive (Safety)• Machinery Directive (Safety)• Radio and Telecommunications Terminal

Equipment Directive (R&TTE)• Self-Declaration allowed for many products

Page 3: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

European Market

• Sector covered by EMC Directive 250 b€• R&TTE equipment: 58 b € /year in the EU in 1998

– Machinery market: >250 b € /year– Telecommunication Services: 200 b € /year in 1999

Page 4: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

DEFINITIONS

• EMC: Electromagnetic Compatibility– Emissions: Unwanted radiated and conducted

electrical energy– Immunity: Undesirable response to external

electrical energy

• Product Safety– Protection from Electrical, Mechanical, Fire and

Chemical Hazards

FOR ELECTRICAL AND ELECTRONICS: EMC and PRODUCT SAFETY

In addition, devices may also have spectrum allocation and control requirements (e.g., FCC Approvals)

Page 5: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

TERMS & DEFINITIONS• European Directive

– Legal Document adopted by EC Council of Ministers

• European Norm (EN)– Common Standard used by all EU countries

• Standards are based on existing standards (CISPR, IEC)

Page 6: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

TERMS & DEFINITIONS• Competent Body

– Appointed by each member state to review Technical Construction Files and generate Certificates of Conformity

– Must demonstrate competence in the area of the Directive– Approved by member state National Authority

• Notified Body– Same credentials as competent body, but can test and issue

EC-Type Examination Certificates– Required for Telecommunications, safety of medical devices– “Notified” means that the organization has been “officially

announced” to the EC and other states by National Authority

Page 7: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

EUROPEAN DIRECTIVESMany Types of Products

DirectiveLow Voltage (73/23/EEC)Simple Pressure Vessels (87/404/EEC)Toy Safety (88/378/EEC)Construction Products (89/106/EEC)EMC (89/336/EEC)Machinery (89/392/EEC)Personal Protective Equipment (89/686/EEC)Gas Appliances (90/396/EEC)Telecommunications Terminal Equipment (91/263/EEC)Hot Water Boilers (92/42/EEC)Medical Devices (93/42/EEC)Satellite Earth Station Equipment (93/97/EEC)Explosive Atmospheres (94/9/EEC)Radio and Telecommunications Terminal Equipment (99/5/EEC)

Date1/1/977/1/921/1/971/1/971/1/961/1/956/30/951/1/951/1/961/1/976/13/98NONE6/30/0304/07/01

Page 8: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

EMC DIRECTIVE: REDUCE ELECTROMAGNETIC

INTERFERENCE

Radiated

Conducted

Page 9: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

EMC DIRECTIVE

• “Electrical Apparatus” Covered• Exceptions: components, large installations and

devices that must comply with other Directives that address EMC (e.g., telecommunications)

• Member states adopt ENs

• Enforcement– Country-by-Country basis.

• Example: UK Requirements:– Fines up to £5000– Up to 3 months imprisonment for misuse of CE mark– Forfeiture of equipment

Page 10: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

EMC DIRECTIVE FOR ELECTRONIC AND ELECTRICAL

PRODUCTS• Examples

Personal Computers Video GamesCD Players Office machinesCopying machines Electronic toysRadio Receivers TVsFax machines Microwave ovensIndustrial Equipment MachineryDishwasher/Refrigerator

• Class A Products: OFFICE/FACTORY• Class B Products: HOME

Declaration of Conformity required for all products

Page 11: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

CLASS A and CLASS B• Class A: Office and Industrial Use

• Class B: Home Use

Page 12: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

COMPLIANCE WITH EUROPEAN DIRECTIVES

• Product-Specific Standards or use

• Generic Standards– Use Generic Requirements if Product-Specific

Standards do not exist

• Method– Declaration of Conformity for all products– Technical File Preparation

Page 13: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Conformity AssessmentTwo methods of Demonstrating Compliance

Self-Certification– Select standard for the product– Test product– Write Report– Make Declaration of Conformity– Put on CE Marking– Can test in-house or at third party laboratory

Simpler, Cheaper, may not be applicable for complex productRetest as standards change

•Self-Declaration•Technical Construction File

Page 14: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Conformity Assessment• Technical Construction File

– Need Competent Body– Create a TCF

• Description of Device(s)• Test plan• Use “Generic Standards” if product-specific standards are not

available

– Test product– Competent Body issues certificate– Make Declaration of Conformity– Affix the CE Marking

More expensive, for complex products

Page 15: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Common EMC Standardshttp://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/emc.html

Equipment Tests Required

Arc Welder EN 50199:1995: Electromagnetic compatibility (EMC) - Product standardfor arc welding equipment

Industrial Equipment EN 55011:1998: Industrial, scientific and medical (ISM) radio-frequencyequipment - Radio disturbance characteristics - Limits and methods ofmeasurement

TVs, Radios EN 55013:1990: Limits and methods of measurement of radio disturbancecharacteristics of broadcast receivers and associated equipment

EN 55020:1994: Electromagnetic immunity of broadcast receivers andassociated equipment

Appliances EN 55014-1:1993: Electromagnetic compatibility - Requirements forhousehold appliances, electric tools and similar apparatus -- Part 1:Emission - Product family standard

EN 55014-2:1997: Electromagnetic compatibility - Requirements forhousehold appliances, electric tools and similar apparatus -- Part 2:Immunity - Product family standard

Lighting EN 55015:1996: Limits and methods of measurement of radio disturbancecharacteristics of electrical lighting and similar equipment

Computers and informationTechnology Equipment

EN 55022:1998: Information technology equipment - Radio disturbancecharacteristics – Limits and methods of measurement

EN 55024:1998: Information technology equipment - Immunitycharacteristics –Limits and methods of measurement

Audio and video for professional use EN 55103-1 and -2:1996: Electromagnetic compatibility – Product familystandard for audio, video, audio-visual and entertainment lighting controlapparatus for professional use

EN 55104:1995: Electromagnetic compatibility – Immunity requirementsfor household appliances, tools and similar apparatus – Product familystandard

Household equipment EN 61000-3-2:1995: Electromagnetic compatibility (EMC) -- Part 3-2:Limits -Limits for harmonic current emissions (equipment input current upto and including 16A per phase)

Household equipment EN 61000-3-3:1995: Electromagnetic compatibility (EMC) -- Part 3: Limits -- Section 3: Limitation of voltage fluctuations and flicker in low-voltagesupply systems for equipment with rated current up to 16 A

Laboratory Equipment EN 61326:1997: Electrical equipment for measurement, control andlaboratory use - EMC requirements

Page 16: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Immunity Testing

• 1000-4 Series– IEC 1000-4-1: Introduction– IEC 1000-4-2: Electrostatic Discharge Requirements– IEC 1000-4-3: Radiated Radio Frequency Immunity– IEC 1000-4-4: Electrical Fast Transient– IEC 1000-4-5: Lightning Surge– IEC 1000-4-6: Conducted Radio Frequency Immunity– IEC 1000-4-8: Magnetic Field Immunity– IEC 1000-4-11: Voltage Interruptions (blackout and

brownouts)

Page 17: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

LOW VOLTAGE DIRECTIVE:for SAFE PRODUCTS

Page 18: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

LVD TEST PROCEDURE

• Self-Declaration

Test ProductReport &

Technical FileManufacturer puts

CE Mark Manufacturer Labels

Products

Sell Product

Page 19: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

• Labeling and marking• Language• User Instructions• Service Information

• Design requirements• Heating• Electrical

characteristics• Abnormal operation• Power connection• Construction

Most Standards address the same issues - Requirements depend on the type of product and where it will be installed

GENERAL REQUIREMENTS

Page 20: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Common Safety StandardsEquipment Tests Required

Arc Welder EN 50199:1995: Electromagnetic compatibility (EMC) - Product standardfor arc welding equipment

Industrial Equipment EN 55011:1998: Industrial, scientific and medical (ISM) radio-frequencyequipment - Radio disturbance characteristics - Limits and methods ofmeasurement

TVs, Radios EN 55013:1990: Limits and methods of measurement of radio disturbancecharacteristics of broadcast receivers and associated equipment

EN 55020:1994: Electromagnetic immunity of broadcast receivers andassociated equipment

Appliances EN 55014-1:1993: Electromagnetic compatibility - Requirements forhousehold appliances, electric tools and similar apparatus -- Part 1:Emission - Product family standard

EN 55014-2:1997: Electromagnetic compatibility - Requirements forhousehold appliances, electric tools and similar apparatus -- Part 2:Immunity - Product family standard

Lighting EN 55015:1996: Limits and methods of measurement of radio disturbancecharacteristics of electrical lighting and similar equipment

Computers and informationTechnology Equipment

EN 55022:1998: Information technology equipment - Radio disturbancecharacteristics – Limits and methods of measurement

EN 55024:1998: Information technology equipment - Immunitycharacteristics –Limits and methods of measurement

Audio and video for professional use EN 55103-1 and -2:1996: Electromagnetic compatibility – Product familystandard for audio, video, audio-visual and entertainment lighting controlapparatus for professional use

EN 55104:1995: Electromagnetic compatibility – Immunity requirementsfor household appliances, tools and similar apparatus – Product familystandard

Household equipment EN 61000-3-2:1995: Electromagnetic compatibility (EMC) -- Part 3-2:Limits -Limits for harmonic current emissions (equipment input current upto and including 16A per phase)

Household equipment EN 61000-3-3:1995: Electromagnetic compatibility (EMC) -- Part 3: Limits -- Section 3: Limitation of voltage fluctuations and flicker in low-voltagesupply systems for equipment with rated current up to 16 A

Laboratory Equipment EN 61326:1997: Electrical equipment for measurement, control andlaboratory use - EMC requirements

Page 21: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

CE Marking• Must be affixed to:

• Product• Packaging• Instructions for use, OR• Guarantee certificate

• Can be used with other marks providing they do not reduce the visibility and legibility of the mark

Page 22: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Labeling and MarkingLabeling and Marking

• Rated voltage or voltage range:115/230V~ or 100-240V~ or 230V~ or 400V 3~

• Rated frequency:50-60Hz or 50/60Hz

• Rated current or power:10/5A or 10-5A; 200W or 200VA

NOTE:

230/ 400V~ are the harmonized voltages for the European Union.

Page 23: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Labeling and MarkingLabeling and Marking• Manufacturer’s name or registered

trademark.

• Model or type number.

• Fuse replacement info (if applicable).

• IEC symbols wherever possible.

• Warnings and Cautions appropriate for the particular equipment.

Page 24: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

LanguageLanguage• ‘Safety-related’ information to be in

appropriate language.

• Service Instructions may be in English.

• Many times, the entire User Manual must be translated (for specific market)

Page 25: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

User InstructionsUser Instructions

• Installation Instructions - information for installation, connection to the AC power, ventilation, etc

• All information regarding use, cleaning, maintenance (if necessary)

• All safety warnings

Page 26: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Service Information Service Information • Fuse and component replacement information.• Special instructions to avoid hazards.• Schematics, wiring diagrams.• Special field installation and/or supply

connection information

Page 27: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Radio Transmittersand Telecommunication

Devices

• R&TTE Directive

PLUS

• License by individual country

Page 28: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

RTTE Main Features

• Scope covers radio and TTE• New Essential Requirements• No Specific Standards• Easier process based on Manufacturer’s

Declaration (increased liability for manufacturer)

Page 29: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

RTTE Requirements• Safety per LVD requirements (but with no lower

voltage limit)• Protection per EMC Directive• Prevention of harm to the network• Radio Equipment shall effectively use spectrum• Apparatus shall:

– work w/other networks

– protect privacy

– support features to prevent fraud

– support access to emergency services

– support access by disabled persons

Page 30: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

RTTE Effects

• Benefits– Reduced Testing Fees– Reduced Time-to-Market– Fewer Test Requirements

• Detriments– Increased Liability– Decreased protection for EU Manufacturers

• Marking– CE Mark (plus NB number for Radio Equipment)

Page 31: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

EU Standards(a partial list)

• ETS 300 339: General EMC Standard for Radio Equipment• ETS 300 342-1: November 1994: EMC Standard for GSM (Part 1:

Mobiles and Portable)• ETS 300 342-2: November 1994: EMC Standard for GSM (Part 2: Base

Stations)• ETS 300 329: November 1994: EMC Standard for DECT• EN60215: Safety Requirements for Radio Transmitting Equipment• EN60950/IEC 950: Safety for Information Technology Equipment

URL: www.etsi.fr

Page 32: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Declaration of ConformityApplication of Council Directive(s):

89/336/EEC, 72/23/EEC

Standard(s) to which Conformity is Declared:

EN55022, EN55024 (1998), EN60950

Manufacturer's Name: COMPANY NAME

Manufacturer's Address: ADDRESS

Importer's Name: (EU Representative's Name)

Importer's Address: (EU Representative's Address)

Type of Equipment: EQUIPMENT DESCRIPTION

Model Number: MODEL NUMBER

Year of Manufacture: (Year of Manufacture)

I, the undersigned, hereby declare that the equipment specifiedabove conforms to the above Directive(s) and Standard(s).

__________________________(Full Name, Title)

__________________________(Signature)

__________________________ (Date)

Page 33: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

WORLD MARKETS• Europe: EU Directive approach to compliance• Non-EU Europe: May accept CE Marking• Australia: C-Tick Mark for EMC (CISPR emissions

now)

• Japan: VCCI- Voluntary Control Council for Interference (CISPR emissions only)

• South Africa: Emissions requirements only• Mexico: NOM Certification

Page 34: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

标签示例EXAMPLE LABEL

V I

S NFI D

NOM

COMPANY NAMEMODEL: XYZ123

LISTEDITEE123456

EN60950

100-240VAC 50/60 Hz130-170VA; 0.8-1.3A

MADE IN CHINA FOR INDOOR USE ONLYFUSE REPLACEMENT: T1.2

LEVEL 3LR12345

COMPANY NAMEOR MODEL NUMBER

US/CANADAUL and/or CSA

SPECIAL INFORMATIONUse, Fuse,Warnings

VOLTAGEFREQUENCY

POWER OR CURRENT

UL & CSA allow manufacturers to use “E” number or “LR” number instead of Manufacturer’s Name

Page 35: Washington Laboratories (301) 417-0220  Lindbergh Dr. Gaithersburg, MD 20879 mikev@wll.com European Union

Washington Laboratories (301) 417-0220 www.wll.com 7560 Lindbergh Dr. Gaithersburg, MD [email protected]

Washington LaboratoriesCapabilities

Testing and Certification Services

– Testing FCC European Norms IEC 801/ 1000

– UL Certificated Agency

– TCB affiliate

• Engineering– Design Engineering for Compliance Requirements

PCB Layout Enclosure and System Design Safety to UL, IEC, VDE, CSA, TUV, NRTL requirements

Training– EMC Design for International Compliance

– Customized, Modular Seminars