Washington Laboratories, Ltd' www'wll'com 301 4170220

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Washington Laboratories,
Ltd.www.wll.com301 417-0220
Regulations for Product Compliance Triway
Jiangsu Delegation June 2009
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• Washington Laboratories is a full-service testing
  and Certification lab.
• Offices in China
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• Working in and with China since 1999

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WL Product Testing Specialties

• Radio Frequency Testing
• Electromagnetic
• Product Safety
• Machinery
• Environmental

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Overview

• Legal Compliance Overview
• Regulations Requirements
• Electronics
• Machinery

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Compliance is a Multi-Disciplinarian World

• Protection of People and Services
• Health and Safety
• Electrical and Mechanical
• Spectrum Communications
• Environmental Protection
• Air Water

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

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U.S. REGULATORY AUTHORITIES for Safety

• Workplace Safety
• Local Inspection Authorities
• State
• County
• Local Municipality

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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

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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)

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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

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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
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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

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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/roh
  s/index.html.

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European Union
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CECE MARKING

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

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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)

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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

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Outline

• Product Safety Compliance Requirements
• Product Safety Hazards
• Product Safety Design Guidelines
• CE Mark

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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

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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

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Anatomy of a Technical File
Cover Page
EMC Report
Photos
Safety Report
Test Equip. List
Parts List
Photos
Safety Report
EMC Report
Ratings Label
Certs
Users Manual
Schem- atics
Theory Of Operatn
Specs
Certs
Users Manual
Specs
Test Plan
EMC Design
Quality System
Risk Assess.
OPTIONAL
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GENERAL REQUIREMENTS
Most Standards address the same issues -
Requirements depend on the type of product and
where it will be installed

• Design requirements
• Heating
• Electrical characteristics
• Abnormal operation
• Power connection
• Construction

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

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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.

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Labeling and Marking

• Manufacturers 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.

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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

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