cemark by F4wkcr

VIEWS: 11 PAGES: 86

									THE        MARK
  *********
Where Do I Start?

    Revised 17FEB10kd
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CERTIFICATIONS             SERVICES             TESTING            PRODUCTS TESTED
        CE            Test & Assessment        *EMC/EMI              Medical Devices
       PED              Training/Seminars         Radio            Laboratory Equipment
       FCC               Design Reviews           Safety            Industrial/ Machinery
 Industry Canada           Performance         Performance         Household Appliances
     R&TTE                  Site Survey        Energy Star              Audio/Video
  Safety Listings       Field Evaluations                               Transmitters
      C-Tick                Energy Star          *Immunity &             Receivers
                                               Emissions Testing
       LVD                 Verifications                                      IT
   MACHINERY          Free Listing Transfers                               & 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     • Issued by The Manufacturer
• Controlled by OSHA    • Controlled by the
• Normally US             Manufacturer
• Safety Testing Only   • Prefer Accredited Labs
• 15 Different NRTLs    • 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          • Romania
                     • Belgium          • Slovakia
                     • Bulgaria         • Slovenia
                     • Cyprus           • Spain
                     • Czech Republic   • Sweden
                     • Denmark          • UK
                     • Estonia
                     • Finland
                     • France             Candidates
                     • Germany
                                          • Croatia
                     • Greece
                                          • Former Yugoslav
                     • Hungary
                                            Republic of
                     • Ireland
                                            Macedonia
                     • Italy
                                          •Turkey
                     • Latvia
                     • Lithuania
                     • Luxembourg
                     • Malta
                     • Netherlands
                     • Poland
                     • Portugal
           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          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
         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
 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
   Mechanical Drawings             These are controlled documents and
                                     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     警告,告誡;

 Cuidado   Spanish
           English   Caution

Warnung    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              120psi air input

         I/O out to Actuator (15m)     Device
                                                         220VAC/50Hz/5A
                                      Or System
                                         For             I/O in from PC (3m)
                                      Evaluation
       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
      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               EMISSIONS TESTS

- Radiated Immunity           - Harmonics
- Conducted Immunity          - Flicker
- Surge                       - Radiated Emissions
- ESD                         - Conducted Emissions
- EFT
- Voltage Dips & Interrupts
        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 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
       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                                 Cable length 1 meter = 3.2808399 feet
                        3m and less            >3m (9.8 ft.)           >10m (32.8 ft.)     >30m (98.4 ft.)
Input AC Power      Conducted Im.
                    EFT Im.
                    Surge Im.
                    Dips/Interrupts Im.
Output AC Power     Conducted Im.
                    EFT Im.
                    Surge Im.
Input and Output DC Conducted Im.         Conducted Im              Conducted Im.
Power                                     EFT Im.                   EFT Im.
                                          Surge Im. (EN61326)       Surge Im.
Signal I/O                                Conducted Im.                                  Conducted Im.
                                          EFT Im.                                        EFT Im.
                                                                                         Surge Im.
Functional Earth    Conducted Im.         Conducted Im,
                                          EFT 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
   Capacitor Discharge          For certain Directives there is
                                   A mandatory requirement
   Grounding Impedance           for Risk Assessment to be
   Humidity Conditioning            performed. Known as
                                         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
      kdevore@f2labs.com

704-918-4609 or 440-832-0775
           Thank You!

For a Copy of Today’s Presentation
              Go to
         www.f2labs.com

								
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