Washington Laboratories (301) web: Lindbergh Dr. Gaithersburg, MD EMC Directive 2004/108/EC Steve Ferguson

EUROPEAN REQUIREMENTS

EMC EMC – Electromagnetic Compatibility The ability to operate in the intended environment without performance degradation The ability to operate in the intended environment without interfering with operation of other equipment/systems

Terms & Definitions European Directive Legal Document adopted by EC Council of Ministers Must be adopted into National Law by each EC member state Does not call out technical standards; refers to private standards-making bodies to draw up product standards European Norm (EN) Harmonized Standard: Common Standard used for determining conformity Committee process ENs based on existing standards (CISPR, IEC) Must be adopted into National Standards by each EC Member state CENELEC ( Comite Europeen de Normalisation Electrotechnique) European Committee for Electrotechnical Standardization: responsible for generating European Norms CE: Communaute Europeenne

Terms & Definitions Competent Body Review Technical Construction Files and generate Certificates of Conformity Must demonstrate competence in the area of the Directive Approved by member state National Authority Conformity Assessment Bodies (CAB) in US Notified Body “Notified” means that the organization has been “officially announced” to the EC and other states by National Authority

New approach directives Objective: Elimination of Technical Barriers New Approach calls out Essential Requirements Technical Details Left to Committees Harmonization of European Norms (Standards) CENELEC Conformity to European Norms demonstrates compliance Products meeting essential requirements eligible for CE Marking

The EMC Directive 89/336/EEC: The EMC Directive Adopted 1989 by Council of the European Communities Original Implementation 1 January 1992 Amended by 92/31/EEC Affects all products to be placed on the Market Calls out essential “protection requirements” which include emissions as well as susceptibility Does not call out specifications or standards “New Approach Directive” Essential Protection Requirements Allows Self-Certification ”CE” Marking certifying product’s conformance

European directives Directive Low Voltage (73/23/EEC) Amended by 93/68/EEC Simple Pressure Vessels (87/404/EEC) Amended by 90/488/EEC Toy Safety (88/378/EEC) Amended by 93/68/EEC Construction Products (89/106/EEC) Amended by 93/68/EEC EMC (89/336/EEC) Amended by 93/68/EEC Repeal 7/20/2007 EMC (2004/108/EC) Machinery (89/392/EEC) Amended by 93/68/EEC Personal Protective Equipment (89/686/EEC) Non-Automatic Weighing Instruments (90/384/EEC) Amended by 93/68/EEC Gas Appliances (90/396/EEC) Amended by 93/68/EEC Telecommunications Terminal Equipment (91/263/EEC) Amended by 93/68/EEC Hot Water Boilers (92/42/EEC) Amended by 93/68/EEC Medical Devices (93/42/EEC) Satellite Earth Station Equipment (93/97/EEC) Explosive Atmospheres (94/9/EEC) Recreational Craft (94/25/EEC) Radio and Telecommunications Terminal Equipment Directive Mandatory Date: 1/1/97 7/1/92 1/1/97 1/1/96 7/20/09 1/1/95 6/30/95 1/11/02 1/1/95 1/1/96 1/1/97 6/13/98 NONE 6/30/03 6/15/98 4/1/01

2004/108/EC Background Review of 89/336/EEC as part of the SLIM (Simpler Legislation for the Internal Market) established a need to complete, reinforce, and clarify the directive Member states adopt and publish laws to comply with directive by 20 January 2007 Apply laws adopted by 20 July 2007 Repeal 89/336/EEC by 20 July 2007 Not impede market for product complying with 89/336/EEC placed on the market prior to 20 July 2009

2004/108/EC Directive - Changes Clarification of scope and definitions Simplification of compliance methods – DoC Elimination of mandatory NB/CB examinations Modified DoC supporting location of responsible parties by enforcement Requirement for unique product identification Clear treatment of fixed installations and their compliance obligations

Equipment exclusions From draft Guide for the EMC Directive 2004/108/EC dated

Flowchart 1 - notes 1. Equipment without electrical or electronic parts is except 2. Excluded equipment R&TTE (covered by 1999/5/EC) Aeronautical parts, products and appliances Radio equipment used by radio amateurs 3. Equipment covered by other specific community directives Motor vehicles (2004/104/EC) Medical devices (various directives) Marine equipment (6/98/EC) Agricultural and forestry tractors (75/332/EEC) Two or three wheeled motor vehicles (97/24/EC) Measuring instruments (immunity excluded see 2004/22/EC) Non-automatic weighing instruments (immunity excluded see 90/334/EEC) 4. Inherently benign equipment Incapable of generating or contributing to emissions Operate without degradation in the presence of EMI normally present 5. Apparatus or fixed installation classification (to flowchart 4)

Scope for apparatus From draft Guide for the EMC Directive 2004/108/EC dated

Clarification of scope Applicability Equipment (apparatus & fixed installation) Apparatus - Any finished appliance or combination thereof made commercially available as a single functional unit Component or sub-assemblies intended for incorporation into an apparatus by the end user Mobile installation defined by a combination of apparatus intended to be moved and operated in a range of locations Fixed installation - A particular combination of several type of apparatus which are assembled, installed and intended to be used permanently at a predefined location

Applicable provisions From draft Guide for the EMC Directive 2004/108/EC dated

Essential requirements – Article 5 Apparatus Electromagnetic disturbances generated do not exceed level to interfere with operation of radio, telecommunications or other equipment Has a level of immunity to electromagnetic disturbances expected in it’s intended environment Fixed installations Use good engineering practices with a view to meeting apparatus requirements. Document those practices with the documentation on file as long as installation is in operation.

Conformity assessment – article 7 Annex II Perform electromagnetic assessment Evaluate all configurations Prepare technical documentation Hold technical documentation 10-years after last manufacture Attest to compliance by issuing DOC Hold DOC 10-years after last manufacture If manufacturer is not established within the Community, documentation will be held by person placing on the Community market Manufacture according to technical documentation Prepare technical documentation & DOC per Annex IV Annex III (Typically used where harmonized standards are not completely satisfied – e.g., in situ testing) Present technical documentation to Notified Body Notified Body issues compliance statement Include Notified Body statement in the technical documentation

Other markings – article 9 Identify type, batch, serial number or any other information to allow for identification of the apparatus Name and address of manufacturer and authorized representative placing apparatus on market Specific precautions associated with assembly, installation, maintained or used for EMC protection (e.g., installation instructions, shielded cable use, etc.) Restrictions for residential use appearing on the apparatus and packaging Information required to enable the apparatus to be used for intended purpose contained in the accompanying instructions

CE Marking Implementation of the 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 The marking may include: The identification of a notified body involved in assessment

Product Identification Each apparatus to be identified in terms of type, batch, serial number or other information allowing identification Each apparatus shall be accompanied with Community contact information Information must be provided on specific precautions for EMC protection (e.g., installation instructions, shielded cable use, etc.) Use restrictions for items where residential compliance is not ensured Information on use for intended purpose included with the apparatus

Installations From draft Guide for the EMC Directive 2004/108/EC dated

Fixed Installations Special section – Article 13 Applies to a given fixed installation with the apparatus not commercially available CE marking and mandatory pre-testing not required Installation requires application of “good” engineering practices with documentation of EMC precautions incorporated If EMC problems are indicated, authorities may request evidence of compliance If non-compliance is established, appropriate measures to attain compliance may be imposed

Conformity assessment From draft Guide for the EMC Directive 2004/108/EC dated

Conformity Assessment Manufacturer performs an electromagnetic compatibility assessment applying all relevant harmonized standards published in OJ Manufacturer prepares technical documentation providing evidence of compliance – retains at least 10-years after date of last manufacture Manufacturer prepares a Declaration of Conformity (DoC) The “CE” mark may be placed on the equipment

Non-harmonized/Incomplete Application of Standards If harmonized standards are not followed or partially followed: Technical documentation is more complex to justify the DoC describing the steps taken to meet the essential requirements Review by a Notified Body to obtain an opinion on conformity NB opinion adds weight in case of a dispute but does not solely authenticate the DoC

Technical documentation – Annex IV The technical documentation must enable the conformity with the essential requirements to be assessed. It must cover the design and manufacture in particular. Must contain General description of the apparatus Evidence of compliance to the standards In the case where the harmonized standards are not used completely, a description of steps taken to assure compliance with the essential requirements including the EMC assessment, design calculations, examinations accomplished, test reports, etc. Statement from notified body when used

DOC – Annex IV The EC declaration of conformity must contain: A reference to the applicable directive Identification to the apparatus Name and address of manufacturer and authorized Community representative if applicable Dated reference to the specifications to which conformity is declared Date of the declaration Identity and signature of person empowered to bind the company

EMC Test Standards Product specific test standards establish requirements and typically point to test method standards. Normally include: Radiated Emissions – CISPR 11 or CISPR 22 Conducted Emissions – CISPR 11 or CISPR 22 Harmonic Emissions – EN Flicker – EN Electrostatic Discharge – EN Radiated Immunity – EN Electrically Fast Transient Immunity – EN Surge Immunity – EN Conducted Immunity – EN Magnetic Immunity * - EN Voltage dips/interrupts – EN

EMC Design: 10-steps 1. Establish a 0V return 2. Tend to the cables 3. Power distribution 4. Component layout 5. Signal distribution 6. Filtering 7. Filter installation 8. Sealing the enclosure 9. Deal with analog circuits 10. Switch mode power supplies