OHIO

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OHIO Global Summit Keys to Global Success
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Real-time diagnostics as you test
Our Goal is to have your product PASS all tests
required!
Testing in Damascus Maryland, Middlefield Ohio,
or at YOUR facility
CERTIFICATIONS CE PED FCC Industry
Canada RTTE Safety Listings C-Tick LVD MACHINERY

PRODUCTS TESTED Medical Devices Laboratory
Equipment Industrial/ Machinery Household
Appliances Audio/Video Transmitters Receivers IT
More . . .
SERVICES Test Assessment Training/Seminars Desig
n Reviews Performance Site Survey Field
Evaluations Energy Star Verifications Free
Listing Transfers
TESTING EMC/EMI Radio Safety Performance Energy
Star Immunity Emissions Testing
YOUR KEY TO WORLD MARKETS! World Class testing
services with a personal touch. Doing things
faster, respond quicker and provide you with
personal attention We get the job done for you
in the time frame that you require
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THE MARK Where Do I Start?
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The Choices You Make Now Can Provide for a
Successful Evaluation Getting the Product To
Market Faster
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The Basics
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CE stands for Conformité Européenne which is
French for "European Conformity."
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The European Union
February 22, 2008

• Member States
• Austria
• Belgium
• Bulgaria
• Cyprus
• Czech Republic
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• Hungary
• Ireland
• Italy
• Latvia
• Lithuania
• Luxembourg
• Malta

• Romania
• Slovakia
• Slovenia
• Spain
• Sweden
• UK

• Candidates
• Croatia
• Former Yugoslav
• Republic of
• Macedonia
• Turkey

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• Who needs a CE mark
• and how do I get one?
• It is EU law that every product that enters the
  European Union meet the CE Directives and
  applicable Standards
• This mark can only be applied to your product
  when you have complied with all of the relevant
  Directives and Standards for the type of system
  you are marketing
• .and a Declaration of Conformity has been
  developed (other types of Declarations exist)

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The Road to Compliance Keeping in mind there are
more than EMC Safety
CE MARK
DECLARATION OF CONFORMITY
TECHNICAL DOCUMENTATION FILE
STANDARD(s)
DIRECTIVE(s)
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Whats a Directive ?

• A Directive is an EU legally binding document
• that is provided to facilitate the free movement
  of goods
• and services Think of it as the Law
• Directives provide for health, safety
  environmental
• requirements for a wide range of products,
  ranging from
• residential to industrial equipment

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Just a few of The Directives

• 90/396/EEC Appliances burning gaseous fuels
• 2000/9/EC Cableway installations designed to
  carry persons
• 89/106/EEC Construction products
• 2004/108/EC Electromagnetic compatibility
• 94/9/EC Equipment protective systems in
  potentially
• explosive
  atmospheres
• 93/15/EEC Explosives for civil use
• 95/16/EC Lifts
• 2006/95/EC Low voltage equipment
• 98/37/EC Machinery safety
• 2004/22/EEC Measuring instruments

http//www.newapproach.org/Directives/Default.asp
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. . . and more Directives

• 90/385/EEC Medical devices active implantable
• 93/42/EEC Medical devices general
• 98/79/EC Medical devices in vitro diagnostic
• 92/42/EEC New hot-water boilers fired with
• liquid or
  gaseous fluids
• 90/384/EEC Non-automatic weighing instruments
• 94/62/EC Packaging and packaging waste
• 89/686/EEC Personal protective equipment
• 97/23/EC Pressure equipment
• 1999/5/EC Radio and telecom terminal equipment
• 94/25/EC Recreational craft
• 87/404/EEC Simple pressure vessels
• 88/378/EEC Toys safety

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Technical Documentation File

• A Technical File (TF) is a document that you must
  produce if you are challenged in the European
  union
• Anyone can challenge you at any time without you
  knowing who it is
• You have 8-10 days to produce this document and
  present it to the European Electrotechnical
  Commission. If it is not produced in this time
  frame then you are considered to not be in
  compliance with any one of the directives used
  and face penalties
• Penalties could lead towards any of the following
• Shipments Stopped at Port
• Fines
• Products Removed From the Markets
• No Further Sales Within the European Union
• Imprisonment

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Typical Information in a Technical Documentation
File

• EMC Test Report
• Product Safety Test Report
• Operational / Instruction / Installation manual
• Electrical Block Diagram
• Schematics
• Mechanical Drawings
• Block diagrams
• Artwork
• Component Data Sheets
• Bill of Materials
• Declaration of Conformity

Note Keep in Mind The TF may be held by the
manufacturer and will need to be made available
to the Authorities of the Member states if
requested for 10 years after date of manufacture
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Declaration of Conformity DOC
A Legally Binding Document gt A sworn statement
of fact lt

• Contains a legal statement that the product
  complies with the requirements of the applicable
  Directives (laws) and Standards (test methods)

• Must be signed by a responsible person
  representing the Manufacturer. Someone who is
  accountable for the design, testing and validity
  of the DOC

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Minimum Information Required in a Declaration
of Conformity

• Description of the system or product
• Model Number/Part Number
• Report number (supplied by the Test Lab)
• Directives Used (supplied by the Test Lab)
• Standards Used (supplied by the Test Lab)
• Signature of the Responsible Person
• On your Letter Head or another Company Document
• Dated and signed

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How are the CE Requirements Enforced?

• NOTIFIED BODY
• A European Government agency
• in the EU responsible for
• conformity assessments
• and port inspections

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What Do You Need to do to Prepare for Testing
Evaluation?

• Provide adequate documentation to
• test the product
• Ensure that the product
• functions as close as possible
• to normal operation for a
• continuous period of time

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The EMC DIRECTIVE

• The Electro-Magnetic Compatibility applies to all
  electronic and electrical products
  manufactured
• Compliance has been mandatory since January 1,
  1996
• Simply stated - in order to comply with this
  Directive the product must have an adequate level
  of immunity shall not interfere with any other
  systems or products

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BASIC Electro-Magnetic Compatibility
EMC is a natural condition that exists when
electrical equipment is performing its designed
functions without
Causing to (Emissions) or suffering from
(Immunity) unacceptable degradation due to
electromagnetic interference to or from other
equipment
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BASIC CONCEPT
Electromagnetic Fields Exist Everywhere It is
NORMAL There are two paths Radiated
Airborne
Conducted Wires
?
?
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TYPICAL Electro-Magnetic Compatibility Tests
IMMUNITY TESTS EMISSIONS TESTS
- Radiated Immunity -
Harmonics - Conducted Immunity -
Flicker - Surge
- Radiated Emissions - ESD
- Conducted
Emissions - EFT - Voltage Dips
Interrupts
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Typical EMC Supporting Documentation Needs

• Operating Manual or instruction
• sheet
• Upper Level Schematic(s)

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Typical Safety Requirements
The product must comply with the design and test
requirements of the proper safety standard
All products placed on the market must be safe
! Even if there is no specific Directive or
Standard that applies
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There are 4 Basic Safety Concerns

• Primary Focus Being
• HUMAN PROPERTY SAFETY
• High Energy Levels
• Mechanical Injury
• Fire Hazards
• Electric Shock

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Typical Safety Tests Driven by the Standards

• Power Interface
• Temperature Monitoring During Tests
• Leakage Current
• Single Fault Conditions
• Leakage Test
• Capacitor Discharge
• Grounding Impedance
• Humidity Conditioning
• Dielectric Withstand test
• Mechanical Tests
• Durability of Markings
• Stability Abnormal Testing

Note For Machinery there is A requirement for a
Risk Assessment to be performed. Known as BS
EN 14121-1
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Typical Safety Supporting Documentation Needs

• Operating Manual or instruction sheet
• Upper Level Schematic(s)
• Outline of Your Mechanical Drawings
• Copies of the Labels Used on the Product
• Bill of Materials
• Artwork of PCB Trace Layout
• Critical Component Data Sheets such as
• Filters, Power Supplies, Transformers, etc
• Lasers CDRH or IEC 60825 report
• Pneumatic Drawings

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THE INSTRUCTION MANUAL

• ??General Content
• Details of manufacturer, name/address
• Description of the product / Marking /
  Declaration of
• Conformity or Incorporation
• Definition of usage (purpose)
• Warning or dangers and miss use
• Also gt Information on - - -
• Transport, installation, assembly, placing into
  operation, training,
• operation, maintaining and repairing,
  dismantling, recycling,
• if needed - disposal

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The only thing certain is change
The NEW Machinery Directive and Your
INSTRUCTIONS
gt2006/42/EClt
Effective December 29th, 2009
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INSTRUCTION LANGUAGE REQUIREMENTS
DIRECTIVE 2006/42/EC Effective December 29th, 2009
The machinery MUST be accompanied by
Instructions in the OFFICIAL COMMUNITY Language
of the member state in which the equipment is to
be installed for use - AND -
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INSTRUCTION LANGUAGE REQUIREMENTS
DIRECTIVE 2006/42/EC Effective December 29th, 2009
Must be marked ORIGINAL INSTRUCTIONS OR TRANSL
ATION OF THE ORIGINAL INSTRUCTIONS - AND -
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INSTRUCTION LANGUAGE REQUIREMENTS
DIRECTIVE 2006/42/EC Effective December 29th, 2009
If the instructions are translated, the
translated instructions shall be accompanied by
the original instructions
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There are Other requirements to Consider Such
as RoHS WEEE REACH
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Product categories within the scope of the RoHS

• Household appliances
• IT and telecom equipment
• Consumer equipment
• Lighting equipment and luminaries
• in households
• Electrical and electronics tools, with the
• exception of large-scale stationary
• industrial tools
• Toys, sports and leisure equipment
• Automatic dispensers

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WEEE

• Directive 2002/96/EC (WEEE) was adopted 27
  January 2003
• ?? Purpose
• Avoiding of Waste from Electrical and Electronic
  Equipment
• Reduction of Waste by Recycling and other Means
• Improvement of the environmental with respect to
  the life cycle of
• materials/products
• Collection, Treatment and Reuse of old
  Electrical- and Electronic
• materials
• Responsibility for Treatment, Reuse and
  environmental correct
  
  
  
  disposal

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REACH Directive EC 1907/2006

• Registration, Evaluation, Authorization
• Restriction of Chemical substances
• The new law entered into force on 1 June 2007
• The new Law aims to improve the protection
• of human health and the environment

http//ec.europa.eu/enterprise/reach/index_en.htm
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Ken DeVore kdevore_at_f2labs.com 440-632-5541 x207
Thank You!
Thank You!
For a Copy of a more detailed Presentation Go
to www.f2labs.com