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THE
MARK
*********
Where Do I Start?
Revised 17FEB10kd
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
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TESTING
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Radio
Safety
Performance
Energy Star
*Immunity &
Emissions Testing
PRODUCTS TESTED
Medical Devices
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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
The Choices You Make
Now
Can Provide for a
Successful Evaluation
The
Basics
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.
OSHA/NRTL &
ISO 17025 Accredited
Labs
NRTL (Nationally Recognized Test Lab) &
ISO 17025 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
Regulatory Mark
Or The
CE Mark?
Regulatory Mark –
CE Mark –
• Issued by an NRTL
• Controlled by OSHA
• Normally US
• Safety Testing Only
• 15 Different NRTLs
• Issued by The Manufacturer
• Controlled by the
Manufacturer
• Prefer Accredited Labs
• Safety & EMC and much more
• One Mark - CE
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)
The European Union
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
The Road to
Compliance
Keep in mind there are more than just EMC & Safety
Directives & Standards
CE MARK
DECLARATION OF CONFORMITY
TECHNICAL DOCUMENTATION FILE
STANDARDS
STANDARDS
DIRECTIVES
DIRECTIVES
5
m
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.
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
Just a few of The
Directives
http://www.newapproach.org/Directives/Default.asp
• 90/396/EEC
• 2000/9/EC
• 89/106/EEC
• 2004/108/EC
• 94/9/EC
• 93/15/EEC
• 95/16/EC
• 2006/95/EC
• 2006/42/EC
• 2004/22/EEC
Appliances burning gaseous fuels
Cableway installations designed
to carry persons
Construction products
Electromagnetic compatibility
Equipment & protective systems in
potentially explosive atmospheres
Explosives for civil use
Lifts
Low voltage equipment
Machinery safety
Measuring instruments
The Directives
-CONTINUED-
•90/385/EEC
•93/42/EEC
•98/79/EC
•92/42/EEC
•90/384/EEC
•94/62/EC
•89/686/EEC
•97/23/EC
•1999/5/EC
•94/25/EC
•87/404/EEC
•88/378/EEC
Medical devices; active implantable
Medical devices; general
Medical devices; in vitro diagnostic
New hot-water boilers fired with
liquid or gaseous fluids
Non-automatic weighing instruments
Packaging and packaging waste
Personal protective equipment
Pressure equipment
Radio and telecom terminal equipment
Recreational craft
Simple pressure vessels
Toys safety
The Standards
HARMONIZED
&
NON-HARMONIZED
STANDARDS
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
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
Declaration of Conformity
DOC
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
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
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
Typical Information in
a Technical
Documentation File











EMC Test Report
Product Safety Test Report
Operators/Instruction/Installation manual
Electrical Wiring Diagram
Note:
Schematics
These are controlled documents and
Mechanical Drawings
proprietary documents that should
Block diagrams
be part of your document control
Artwork
program
Component Data Sheets
Bill of Materials
Declaration of Conformity Certificate
A little tidbit of
Information
About 7 % of the
manufacturers / importers
place unsafe products
on the single market
(Mc Millan)
PRODUCT
ALERT
PROGRAMS
RAPEX
Rapid Alert System for non-food products
http://ec.europa.eu/consumers/dyna/rapex/rapex_en.cfm
Pilot system in cooperation
with other member states
www.icsms.org
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
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
FIVE
COMMON
LANUAGES
Chinese
Cuidado
Spanish
English
Warnung
警告,告誡;
Caution
German
French
avertir
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
I/O out to Actuator (15m)
48VDC Motor Power (10m)
120psi air input
Device
Or System
For
Evaluation
220VAC/50Hz/5A
I/O in from PC (3m)
 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
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
Typical EMC
Supporting Documentation
Needs
 Operating Manual or instruction
sheet
 Upper Level Schematic(s)
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
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
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
EMC
-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
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
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
BASIC CONCEPT
Electromagnetic Fields Exist
Everywhere
It is NORMAL
There are two paths

Radiated
Airborne
&
Conducted Wires

TYPICAL
Electro-Magnetic
Compatibility Tests
IMMUNITY TESTS
- Radiated Immunity
- Conducted Immunity
- Surge
- ESD
- EFT
- Voltage Dips & Interrupts
EMISSIONS TESTS
- Harmonics
- Flicker
- Radiated Emissions
- Conducted Emissions
Radiated
Immunity
Evaluated by controlling a signal source
and power levels to generate field levels
over a defined set of frequencies
Radiated
Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
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
Conducted
Immunity
Evaluates the product’s ability to resist
electrical signals that may be generated
by the switching of inductive loads or
contactors
Conducted Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Signal injection
Controlled
Signal
Source
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
Surge
Immunity
This tests the equipment’s level of
resistance or immunity to surges
caused by over voltages from
switching and lightning transients
Surge Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Pulse injection
Controlled
Pulse
Source



Surge Immunity
Design Tips
 Use pre-approved power supplies
 Are there surge suppressors installed
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)
ESD Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Electro-static discharge





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
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
EFT Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Signal injection
Controlled
Signal
Source
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
 Use shielded cables
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
Voltage Dips/interrupts
Immunity
Simulation
Consider the acceptable limits
of performance for your device
within the application of use
Voltage injection
Controlled
Voltage
Source
Voltage Dips/interrupts
Immunity
Design Tips
 Use pre-approved power supplies
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.
Harmonic Emissions
Simulation
Signal monitoring
Signal
Monitoring
Device
Coming from the device
Harmonics Emissions
Design Tips
 Use power factor correction circuits
 The current and voltage wave forms
need to be sinusoidal
Flicker
Emissions
The term “flicker” applies to
uncontrolled intermittent
Emissions. It is also known
as surge emission.
ie: light flicker
Flicker Emission
Simulation
Current monitoring
Current
Monitoring
Device
Coming from the device
Flicker Emissions
Design Tips
 Use pre-approved power supplies
RADIATED
EMISSIONS
Intentional Radiators are subject to rules
(FCC, RTTE, etc) for preventing interference
and maximizing the available spectrum
All other electrical products are nonintentional Radiators, such as electrical
circuits, are not designed to generate RF
energy, but do. As a result, they could
interfere with other devices
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
Radiated Emissions
Simulation
Evaluation of
Radiated Emissions at Your
Location –
Clearance Requirements
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
Conducted
Emissions
This is energy that is
transmitted from an
electrical device through
the power cord and back
into the electrical system
Conducted Emissions
Simulation
Signal monitoring
Signal
Monitoring
Device
Coming from the device
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
Have you Noticed
Commonality in
Design Tips?
 Shielded cabling
 Grounding
 Filtering where necessary
 Good workmanship practices
 Using approved power supplies
Electrical Ports
Inputs/Outputs
Testing - Guidance
Port Identity
Input AC Power
Output AC Power
3m and less
Conducted Im.
EFT Im.
Surge Im.
Dips/Interrupts Im.
Conducted Im.
EFT Im.
Surge Im.
Input and Output DC Conducted Im.
Power
Signal I/O
Functional Earth
Conducted Im.
Cable length 1 meter = 3.2808399 feet
>3m (9.8 ft.)
>10m (32.8 ft.)
Conducted Im
EFT Im.
Surge Im. (EN61326)
Conducted Im.
EFT Im.
Conducted Im,
EFT Im.
>30m (98.4 ft.)
Conducted Im.
EFT Im.
Surge Im.
Conducted Im.
EFT Im.
Surge Im.
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
There are
4 Basic Safety
Concerns
Primary Focus Being
HUMAN & PROPERTY SAFETY
• High Energy Levels
• Mechanical Injury
• Fire Hazards
• Electric Shock
Typical Safety Tests
Driven by the Standards












Power Interface
Temperature Monitoring During Tests
Leakage Current
Single Fault Conditions
Leakage Test
Note
For certain Directives there is
Capacitor Discharge
A mandatory requirement
Grounding Impedance
for Risk Assessment to be
performed. Known as
Humidity Conditioning
BS EN 14121-1
Dielectric Withstand test
Mechanical Tests
Durability of Markings
Stability & Abnormal Testing
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
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
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
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
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
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
There are
Other requirements to
Consider Such as
RoHS
WEEE
REACH
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
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
WEEE
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
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
http://ec.europa.eu/enterprise/reach/index_en.htm
Ken DeVore
[email protected]
704-918-4609 or 440-832-0775
Thank You!
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