1. THE MARK
*********
Where Do I Start?
Revised 17FEB10kd

2. 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
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LVD
MACHINERY
SERVICES
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Training/Seminars
Design Reviews
Performance
Site Survey
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Energy Star Verifications
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TESTING
*EMC/EMI
Radio
Safety
Performance
Energy Star
*Immunity & Emissions Testing
PRODUCTS TESTED
Medical Devices
Laboratory Equipment
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Household Appliances
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Transmitters
Receivers IT
& More . . .
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

3. Can Provide for a Successful Evaluation
The Choices You Make
Now
Can Provide for a Successful Evaluation

4. The
Basics

5. CE stands for Conformité Européenne, which is French for "European Conformity." A product in one of the controlled product categories cannot legally be sold in the EU unless it has passed the tests to receive the CE marking.

6. OSHA/NRTL & ISO 17025 Accredited Labs
NRTL (Nationally Recognized Test Lab) & ISO Laboratories are organizations that have demonstrated as meeting certain Business and Technical Disciplines
Capability, Technically & Administratively
Control Programs
Complete Independence
Reporting & Complaint Handling
Procedures to Test and Certify

7. Regulatory Mark Or The CE Mark?
Issued by an NRTL
Controlled by OSHA
Normally US
Safety Testing Only
15 Different NRTLs
CE Mark –
Issued by The Manufacturer
Controlled by the
Manufacturer
Prefer Accredited Labs
Safety & EMC and much more
One Mark - CE

8. 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 fully complied with all 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)

9. The European Union Member States Candidates Austria Belgium Romania
December 2009
Member States
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden UK
Candidates
Croatia
Former Yugoslav
Republic of
Macedonia
Turkey

10. The Road to Compliance CE MARK DECLARATION OF CONFORMITY
Keep in mind there are more than just EMC & Safety Directives & Standards
CE MARK
DECLARATION OF CONFORMITY
TECHNICAL DOCUMENTATION FILE
STANDARDS
STANDARDS
DIRECTIVES
DIRECTIVES

11. 5 m
The CE symbol must be affixed on the equipment itself in such a manner that it cannot be easily removed. The minimum size is 5 mm. (0.2").
Only if your equipment is too small, or the usage of a sign is incompatible with the function of your equipment, may it be used on any accompanying documentation for identification.

12. What’s 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 and environmental
requirements for a wide range of products, ranging from
residential to industrial equipment

13. 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
2006/42/EC Machinery safety
2004/22/EEC Measuring instruments

14. The Directives 90/385/EEC Medical devices; active implantable
-CONTINUED-
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

15. HARMONIZED & NON-HARMONIZED STANDARDS
The Standards
HARMONIZED
&
NON-HARMONIZED
STANDARDS

16. Harmonized Standards Also known as ‘mandated standards’
Fulfills the requirements of the European Directives
The standards are published in the Official European Journal
Adopted by the European Committee for Standardization & the European Committee for Electrotechnical Standardization
Widely accepted throughout the world today

17. Non-Harmonized Standards
An example – American Standards (UL, CSA, ANSI, Mil)
Those standards are NOT published in the official European Journal
Have NOT been Adopted by the European Committee for Standardization or the European Committee for Electrotechnical Standardization
May Require the use of a 3rd party (Known as Notified Body) and possibly some additional documentation between testing and placing the CE mark on your product. Normally there are additional costs involved

18. DOC Declaration of Conformity A Legally Binding Document
> A sworn statement of fact <
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

19. Declaration of Conformity
Information Required
on 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

20. Penalties could lead towards any of the following
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

21. Typical Information in a Technical Documentation File
EMC Test Report
Product Safety Test Report
Operators/Instruction/Installation manual
Electrical Wiring Diagram
Schematics
Mechanical Drawings
Block diagrams
Artwork
Component Data Sheets
Bill of Materials
Declaration of Conformity Certificate
Note:
These are controlled documents and proprietary documents that should be part of your document control program

22. About 7 % of the manufacturers / importers place unsafe products
A little tidbit of
Information
About 7 % of the manufacturers / importers place unsafe products
on the single market (Mc Millan)

23. PRODUCT ALERT PROGRAMS
RAPEX
Rapid Alert System for non-food products
Pilot system in cooperation
with other member states

24. THE INSTRUCTION MANUAL
􀂄General Content
Details of manufacturer, name/address
Description of the product / Marking / EC declaration of
conformity
Determination of the use (purpose)
Warning on remaining dangers and miss use
Also > Information on - - -
Transport, installation, assembly, putting into operation, training,
operation, maintaining and repairing, dismantling, recycling,
& if need be disposal

25. MANUAL LANGUAGE REQUIREMENTS
The Language shall be acceptable
by the Country in which the equipment
is to be installed for use
The Documentation intended for use by
Service personnel should be in English

26. FIVE COMMON LANUAGES Chinese Spanish English German French
警告,告誡;
Cuidado
Caution 
Warnung
avertir

27. What are the Basics For an RFQ?
Identify the countries you wish to place the product
Draw a simple block diagram
Courtesy Power Outlet 220VAC
120psi air input
220VAC/50Hz/5A
I/O out to Actuator (15m)
Device
Or System
For
Evaluation
I/O in from PC (3m)
48VDC Motor Power (10m)
List all electrical inputs & outputs and identify if they are
power or I/O
Provide the maximum lengths for each input & output cable
Identify any fluid, gas or air requirements and pressures

28. for Testing & Evaluation?
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

29. Supporting Documentation
Typical EMC
Supporting Documentation
Needs
Operating Manual or instruction
sheet
Upper Level Schematic(s)

30. Supporting Documentation
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 report
Pneumatic Drawings

31. 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

32. “Causing to” (Emissions) or “suffering from” (Immunity)
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

33. EMC EMC (Electro-Magnetic Compatibility)
-CONTINUED-
EMC (Electro-Magnetic Compatibility)
2 conditions must be satisfied: The device does not generate electromagnetic noise and does not malfunction due to extraneous noise
EMI (Electro-Magnetic Interference) The device does not generate electromagnetic noise beyond established levels
EMS (Electro-Magnetic Susceptibility) The device does not abnormally malfunction due to extraneous noise within the environment the
device will be used

34. Immunity AKA Susceptibility
…a condition that exists when equipment continues to operate within acceptable limits of performance when exposed to interference in which the environment where it is used
>>>>For Example<<<<
Equipment may work fine in the home but may fail if it is placed inside a machine shop. Why? Equipment is immune to the low level residential disturbances but not immune to high level industrial-strength disturbances

35. Noise / Leaking Radio Frequency
Emissions
AKA
Noise / Leaking Radio Frequency
A condition that exists when your equipment suffers from unacceptable degradation of performance as a result of electromagnetic interference
>> For Example <<
Hospitals equipment have failed to operate or had false alarms due to electronic devices emitting EMI.
An example you all can relate to - Cell Phones are now prohibited from use many hospitals locations

36. Electromagnetic Fields Exist Everywhere
BASIC CONCEPT
Electromagnetic Fields Exist Everywhere
It is NORMAL
There are two paths
Radiated
Airborne
&
Conducted Wires  

37. 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

38. Radiated Immunity Evaluated by controlling a signal source
and power levels to generate field levels
over a defined set of frequencies

39. Radiated Immunity Simulation
Consider the acceptable limits
of performance for your device
within the application of use

40. Radiated Immunity Design Tips
Are you using shielded cabling
Is your enclosure shielded
Limit your “vent” openings in the enclosure
Use ferrites on cabling if needed
Make sure the connectors are grounded
properly
Make sure the enclosure has a continuous
ground
Use multi-layer PCBs where possible

41. Conducted Immunity Evaluates the product’s ability to resist
electrical signals that may be generated
by the switching of inductive loads or
contactors

42. Conducted Immunity Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Signal injection
Controlled
Signal
Source

43. Conducted Immunity Design Tips
Are you using shielded cabling
Is your enclosure shielded
Are there I/O line filters
Use ferrites on cabling if needed
Use multi-layer PCBs where possible
Are you using a power line filter

44. Surge Immunity This tests the equipment’s level of
resistance or immunity to surges
caused by over voltages from
switching and lightning transients

45.    Surge Immunity Simulation Pulse injection
Consider the acceptable limits
of performance for your device
within the application of use
Pulse injection  
Controlled
Pulse
Source 

46. Surge Immunity Design Tips
Use pre-approved power supplies
Are there surge suppressors installed

47.  ESD Immunity Electrostatic Discharges are
applied to all relevant points
while the apparatus is in
operation. These are applied
either by air or by touch (contact)

48.      ESD Immunity Simulation Electro-static discharge
Consider the acceptable limits
of performance for your device
within the application of use
                                     
Electro-static discharge    

49. ESD Immunity Design Tips
Make sure the enclosure has a common
ground plane
Make sure the AC mains has the 3rd wire
Ground and is used
If a plastic enclosure, consider conductive
coatings
With keyboards consider using a
“back-plane” ground sheet

50. (Electrical Fast Transients)
EFT
(Electrical Fast Transients)
Immunity
EFT is a test process to demonstrate
the equipment’s resistance to line
transients through the connecting
leads simulating relay and
contact bounce

51. EFT Immunity Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Signal injection
Controlled
Signal
Source

52. EFT Immunity Design Tips
Make sure the enclosure has a
common ground plane
Does your unit have a power
line filter
Are there transient suppression
components employed on the PCBA
Use shielded cables
Employ multi-layer PCBs

53. Voltage Dips & Interrupts Immunity
Simulates voltage variations,
and interruptions caused by
short circuits or rapid changes
in power. This may cause a sudden
and extreme increase in current and a
reduction in voltage

54. Voltage Dips/interrupts Immunity Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Voltage injection
Controlled
Voltage
Source

55. Voltage Dips/interrupts Immunity
Design Tips
Use pre-approved power supplies

56. Harmonic Emissions Harmonics is a distortion
of a normal sine wave. When a
product produces distortion it
does this at multiples of the power
line frequency are generated.

57. Harmonic Emissions Simulation
Signal monitoring
Signal
Monitoring
Device
Coming from the device

58. Harmonics Emissions Design Tips
Use power factor correction circuits
The current and voltage wave forms
need to be sinusoidal

59. Flicker
Emissions
The term “flicker” applies to uncontrolled intermittent
Emissions. It is also known
as surge emission.
ie: light flicker

60. Flicker Emission Simulation
Current monitoring
Current
Monitoring
Device
Coming from the device

61. Flicker Emissions Design Tips
Use pre-approved power supplies

62. RADIATED
EMISSIONS
Intentional Radiators are subject to rules (FCC, RTTE, etc) for preventing interference and maximizing the available spectrum
All other electrical products are non-intentional Radiators, such as electrical circuits, are not designed to generate RF energy, but do. As a result, they could interfere with other devices

63. Radiated Emissions Verifies that the product's RF emissions do not
exceed a level that will
interfere with the
operation of other
electrical devices in the
operating environment

64. Radiated Emissions
Simulation

65. Radiated Emissions at Your Clearance Requirements
Evaluation of
Radiated Emissions at Your
Location –
Clearance Requirements

66. Radiated Emissions Design Tips
Are you using shielded cabling
Is your enclosure shielded
Limit your “vent” openings in the enclosure
Use ferrites on cabling if needed
Make sure the connectors are grounded
the port properly
Make sure the enclosure has a continuous
ground
Use multi-layer PCBs where possible

67. Conducted
Emissions
This is energy that is transmitted from an electrical device through the power cord and back into the electrical system

68. Conducted Emissions Simulation
Signal monitoring
Signal
Monitoring
Device
Coming from the device

69. Conducted Emissions Design Tips
Are you using shielded cabling
Is your enclosure shielded
Limit your “vent” openings in the enclosure
Use ferrites on cabling if needed
Make sure the connectors are grounded
the port properly
Make sure the enclosure has a continuous
ground
Use multi-layer PCBs where possible

70. Have you Noticed Commonality in Design Tips?
Shielded cabling
Grounding
Filtering where necessary
Good workmanship practices
Using approved power supplies

71. Electrical Ports
Inputs/Outputs
Testing - Guidance

72. 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
General Product Safety Directive 2001/95/EC

73. HUMAN & PROPERTY SAFETY
There are
4 Basic Safety
Concerns
Primary Focus Being
HUMAN & PROPERTY SAFETY
High Energy Levels
Mechanical Injury
Fire Hazards
Electric Shock

74. 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 certain Directives there is
A mandatory requirement
for Risk Assessment to be
performed. Known as
BS EN

75. Safety Design Tips For Product Enclosures
Top openings 4mm dia × 100mm long
Bottom openings 2mm dia max × 3mm spacing or wire mesh or baffle
Fasteners for covers/filters over hazardous live parts
and mechanical hazards shall require a tool to remove
Stability: 10° tilt
Handles capable of withstanding force of four times the weight of the equipment

76. Safety Design Tips For Grounding, Wiring
User-accessible conductive parts shall be bonded to the Protective Earth (PE) ground
The integrity of the PE bonding shall be assured
Circuit/wiring connections shall not cause accessible parts to become live in normal or single fault condition

77. Safety Design Tips For Grounding, Wiring
-CONTINUED-
PE soldered connection/s require mechanical securing in addition to solder
PE shall not be used for other purposes such as fixing constructional parts
Hinges and slides shall not be used for PE path
Exterior metal braids/foils of cables shall not be considered as PE bonding
PE conductors may be bare or insulated; clear or green/yellow for PE insulation color

78. Safety Design Tips - General
Circuit breakers for AC supply are not polarized in Europe
Accidental loosen of wiring and screws shall not cause accessible part to become live
Self-tapping screws and screws of insulating material should not be used for electrical connections
Edges, corners accessible to users shall be rounded or smoothed

79. Minimum Safety Design Tips Labels & Markings
Products shall bear voltage, current, power, and frequency ratings, model number and company identification markings
Input & Output ratings
Convenience outlets marked with voltage and current ratings
On/off symbols should be used for disconnect switches
Internal markings – AC terminals identified, PE symbol adjacent to ground, earth symbol

80. Safety Design Tips Flammability
Plastics for fire enclosures rated V-1
PCB rated V-1
V-2 for plastics enclosures that have other means to prevent the spread of fire; for example, a metal sub-enclosure
Plastics in I/O connectors with non-hazardous voltages, rated V-2
Connectors and plastic on which components are mounted, rated V-2
Plastic air filters, rated V-2 or HF-2
Plastic enclosures and decorative parts outside fire enclosures, rated HB
Plastic wire insulation, rated FV-1

81. There are
Other requirements to
Consider Such as
RoHS
WEEE
REACH

82. Purpose of the Directive
RoHS
Purpose of the Directive
As from 1 July 2006, Directive 2002/95/EC
on the Restriction of Hazardous Substances
(RoHS) restricts the use of lead, cadmium,
hexavalent chromium, mercury &
polybrominated biphenyls (PBB) &
polybrominated diphenylethers (PBDE)
for NEW electrical & electronic products

83. Product categories within the scope of the RoHS
Small household appliances
Large household appliances
IT and telecommunications equipment
Consumer equipment
Lighting equipment (electric light bulbs and luminaries in households
Electrical and electronics tools, with the exception of large-scale stationary industrial tools
Toys, sports and leisure equipment
Automatic dispensers

84. WEEE Reduction of Waste by Recycling and other Means
The European Directive 2002/96/EC (WEEE) was adopted on 27 January 2003
􀂄 Target
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

85. REACH REACH is a new European Community
Regulation on chemicals and their safe use.
EU Directive EC 1907/2006 & deals with the
Registration, Evaluation, Authorization and
Restriction of Chemical substances. The new law
entered into force on 1 June 2007.
The new Regulation aims to improve the
protection of human health and the environment

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