Washington Laboratories, Ltd. www.wll.com 301 417-0220

1. Washington Laboratories, Ltd.www.wll.com301 417-0220 Regulations for Product Compliance Triway Jiangsu Delegation June 2009

2. 欢迎光临! Washington Laboratories is a full-service testing and Certification lab. Offices in China: 北京 台北市 深圳市 上海 Working in and with China since 1999

3. WL Product Testing Specialties • Radio Frequency Testing • Electromagnetic • Product Safety • Machinery • Environmental

4. Overview • Legal Compliance Overview • Regulations & Requirements • Electronics • Machinery

5. “Compliance” is a Multi-Disciplinarian World • Protection of People and Services • Health and Safety • Electrical and Mechanical • Spectrum & Communications • Environmental Protection • Air & Water

6. Simplified Regulatory Structure in US Federal Government States Communications Health, Safety & Environment National Defense International Agreements Building & Construction City/Local Authorities Manufacturers Inspectors Public

7. North American Safety Requirements Product Liability/Lawsuits Customer / Contractual Requirements OSHA (CFR 1910.399) requires electrical equipment used in the workplace to be NRTL Listed National Electric Code requires NRTL listing of telecom products

8. U.S. REGULATORY AUTHORITIES for Safety • Workplace Safety • Local Inspection Authorities • State • County • Local Municipality

9. Maryland Local Authority • Maryland Department of Labor, Licensing and Regulation, Division of Labor and Industry • Safety Inspection includes elevator/escalator • Inspection by Licensed Professionals • Enforcement by local inspectors

10. Authority for Inspection and Maintenance • Elevator Safety Review Board • Elevator Mechanic • 3 Years of Documented Experience • Pass the Mechanic Exam from the National Elevator Industry Educational Program • Completed Apprenticeship Program • Approved and Accredited Training Program(s)

11. U.S. REGULATORY AUTHORITIES for Radio Communications • Federal Communications Commission (FCC) • Control use and protection of Radio Frequency Services for Public • National Telecommunications and Information Administration

12. Electromagnetic Compatibility • Radiated and conducted interference • Conducted Interference Enters and Exits Equipment through Wiring and Cabling • Radiated Interference Enters and Exits Equipment through Wiring and Enclosure Penetration Radiated Emissions Noise Your Equipment Conducted Susceptibility Conducted Emissions

13. Environmental Americans discard over 100 million computers, cell phones, and other electronic devices each year An estimated 60 million PCs have already been buried in US landfills Between 2004 and 2009, 250 million computers will become obsolete or 136,000 computers a day Electronic waste is accumulating almost 3 times faster than ordinary household trash

14. USA 31 states already have some regulations for restricting substances or for electronics recycling requirements California: Electronic Waste Recycling Act of 2003 which provides for collecting and recycling of computers and TVs. Proposition 65. New energy efficiency standards for certain electronic products. Materials ban SB20 takes effect 1/2007. State by state list of RoHS\WEEE type requirements at http://www.newark.com/services/rohs/index.html.

15. European Union

16. CECE MARKING • CE Marking is for European Union • EMC Directive • Low Voltage Directive (Safety) • Machinery Directive (Safety) • Radio and Telecommunications Terminal Equipment Directive (R&TTE) • Medical Device Directive • Self-Declaration allowed for many products • Emissions, Immunity, Product Safety (and Spectrum Compliance) for CE Marking

17. New Approach Directives • Low voltage equipment (73/23/EEC, amendment 93/68/EEC) • Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC) • Toys (88/378/EEC, amendment 93/68/EEC) • Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC) • Machinery (98/37/EC, amendment 98/79/EC) • Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC) • Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC) • Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/EEC) • Gas appliances (90/396/EEC, amendment 93/68/EEC) • Hot water boilers (92/42/EEC, amendment 93/68/EEC) • Civil explosives (93/15/EEC) • Medical devices (93/42/EEC, amendment 98/79/EC) • Potentially explosive atmospheres (94/9/EC) • Recreational craft (94/25/EC) • Lifts (95/16/EC) • Refrigeration appliances (96/57/EC) • Pressure equipment (97/23/EC) • In vitro diagnostic medical devices (98/79/EC) • Radio and telecommunications terminal equipment (99/5/EC)

18. EU Policy for Products • Principles: • limited to harmonisation of safety, health and environmental essential requirements • requirements are legal, not technical • technical solutions to meet these requirements laid down in harmonised standards developed by European Standardisation Organisations • Harmonised standards remain voluntary and manufacturers can use other methods • When complying with harmonised standards presumed to comply with the Directive and hence free circulation within the EU

19. Outline • Product Safety Compliance Requirements • Product Safety Hazards • Product Safety Design Guidelines • CE Mark

20. European Safety Requirements • CE Mark • New Approach Directives • Self-Certification • Technical Construction File • Evidence of conformity to all essential requirements • typically EMC and Safety • Manufacturer Affixes CE Mark • Notified Body Required for some products

21. What is a TF ? • A TF brings together all required elements to show compliance with applied standards and incorporates the items outlined in the directive. • The TF is a neat, organized, professionally prepared report which will be accepted by any authority in Europe • The TF should make the product as understandable as possible to a third-party not familiar with the product

22. Anatomy of a Technical File Cover Page EMC Report Safety Report Test Equip. List Parts List Photos EMC Report Safety Report Photos Schem- atics Ratings Label User’s Manual Theory Of Operat’n Specs Certs User’s Manual Specs Certs Test Plan EMC Design Quality System Risk Assess. OPTIONAL

23. Labeling and marking Language User Instructions Service Information Design requirements Heating Electrical characteristics Abnormal operation Power connection Construction GENERAL REQUIREMENTS Most Standards address the same issues - Requirements depend on the type of product and where it will be installed

24. Labeling 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.

25. Labeling 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.

26. Washington Laboratories Capabilities • FCC Testing • CE Marking • Radiation Hazard Measurements ANSI C95.1 • Domestic and International Safety Testing: • UL, CSA, CB, CE • Low Voltage & Machinery Directives • Seminars and Workshops • Large Item Test Capability • On-site testing • Design Support • Subsidiary in Taiwan (ATCB) • Representative in Beijing • http://www.wll.com

27. 谢谢!