THE MARK

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THE MARK Where Do I Start?
Revised 17FEB10kd
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Real-time diagnostics as you test
Our Goal is to have your product PASS all tests
required!
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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 Choices You Make Now Can Provide for a
Successful Evaluation
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The Basics
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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.
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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

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Regulatory Mark Or The CE Mark?

• Regulatory 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

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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 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)

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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

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

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

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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
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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.

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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 and
  environmental
• requirements for a wide range of products,
  ranging from
• residential to industrial equipment

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Just a few of The Directives http//www.newapproac
h.org/Directives/Default.asp

• 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

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The Directives -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

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The Standards
HARMONIZED NON-HARMONIZED STANDARDS
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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

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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

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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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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

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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
• 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
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A little tidbit of Information
About 7 of the manufacturers / importers place
unsafe products on the single market (Mc Millan)
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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
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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 gt Information on - - -
• Transport, installation, assembly, putting into
  operation, training,
• operation, maintaining and repairing,
  dismantling, recycling,
• if need be disposal

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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
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FIVE COMMON LANUAGES
Chinese Spanish English German French
??,??
Cuidado
Caution 
Warnung
avertir
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What are the Basics For an RFQ?

• Identify the countries you wish to place the
  product
• Draw a simple block diagram

120psi air input
Courtesy Power Outlet 220VAC
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

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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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Typical EMC Supporting Documentation Needs

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

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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 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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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
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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
gtgtgtgtFor Exampleltltltlt 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
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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
gtgt For Example ltlt 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
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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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Radiated Immunity
Evaluated by controlling a signal source and
power levels to generate field levels over a
defined set of frequencies
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Radiated Immunity Simulation
Consider the acceptable limits of performance
for your device within the application of use
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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

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Conducted Immunity
Evaluates the products ability to resist
electrical signals that may be generated by the
switching of inductive loads or contactors
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Conducted Immunity Simulation
Consider the acceptable limits of performance
for your device within the application of use
Signal injection
Controlled Signal Source
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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

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Surge Immunity
This tests the equipments level of resistance
or immunity to surges caused by over voltages
from switching and lightning transients
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Surge Immunity Simulation
Consider the acceptable limits of performance
for your device within the application of use
Pulse injection
?
?
Controlled Pulse Source
?
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Surge Immunity Design Tips

• Use pre-approved power supplies
• Are there surge suppressors installed

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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)
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ESD Immunity Simulation
Consider the acceptable limits of performance
for your device within the application of use
?
Electro-static discharge
?
?
?
?
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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

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EFT (Electrical Fast Transients) Immunity
EFT is a test process to demonstrate the
equipments resistance to line transients
through the connecting leads simulating relay
and contact bounce
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EFT Immunity Simulation
Consider the acceptable limits of performance
for your device within the application of use
Signal injection
Controlled Signal Source
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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

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

• Use pre-approved power supplies

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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.
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Harmonic Emissions Simulation
Signal monitoring
Signal Monitoring Device
Coming from the device
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Harmonics Emissions Design Tips

• Use power factor correction circuits
• The current and voltage wave forms
• need to be sinusoidal

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Flicker Emissions
The term flicker applies touncontrolled
intermittent Emissions. It is also known as
surge emission. ie light flicker
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Flicker Emission Simulation
Current monitoring
Current Monitoring Device
Coming from the device
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Flicker Emissions Design Tips

• Use pre-approved power supplies

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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
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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
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Radiated Emissions Simulation
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Evaluation of Radiated Emissions at
Your Location Clearance Requirements
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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
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Conducted Emissions Simulation
Signal monitoring
Signal Monitoring Device
Coming from the device
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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

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Electrical Ports Inputs/Outputs Testing -
Guidance
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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
General Product Safety Directive 2001/95/EC
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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 certain Directives there is A mandatory
requirement for Risk Assessment to be performed.
Known as BS EN 14121-1
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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

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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

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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

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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

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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

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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

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There are Other requirements to Consider Such
as RoHS WEEE REACH
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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
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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

• 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

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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
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Ken DeVore kdevore_at_f2labs.com 704-918-4609 or
440-832-0775
Thank You!
For a Copy of Todays Presentation Go
to www.f2labs.com