Transcript Safety_Requirements

318-595 Safety
Product Safety
• What consumer product was recently 100%
recalled for a safety defect (voluntarily)?
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NEWS from CPSC
http://www.cpsc.gov/
U.S. Consumer Product Safety Commission
Office of Information and Public Affairs
FOR IMMEDIATE RELEASE
September 14, 2006
Release #06-258
Washington, DC 20207
Segway’s Recall Hotline: (800) 750-6557
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
Segway Media Contact: Carla Vallone
(866) 473-4929
Segway Inc. Announces Recall to Repair Segway® Personal Transporters
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the
following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Segway Personal Transporter (PT) [also known as the Segway Human Transporter (HT)]
Units: About 23,500
Manufacturer: Segway Inc., of Bedford, N.H.
Hazard: The personal transporter can unexpectedly apply reverse torque to the wheels, which can cause a rider
to fall. This can occur when the device is tilted back by the Speed Limiter and the rider comes off and then back
onto the device within a short period of time. - (May cause head and wrist injuries to the user)
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Types of Safety Protections and Mitigations
• Protection Against Known Hazards
-Common Knowledge Gained from Experience
• Protection Against Unsafe Failure Modes
-Single Occurrence Failures With No Safety Risk
-Double Occurrence Failures With Minimal or No Safety Risk
• Protection Against Unwanted or Unsafe Usage
-Misuse of Products is Commonly the Root Cause in Safety Issues
• Design and Testing to Certify Product to Industry or Government Stds
• Failure Modes & Effects Analysis
• What If Testing (aka: monkey testing)
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Product Safety
• Protection Against Known Hazards
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Electric Shock
High or Low Temperatures
EMI/EMC
Sharp Edges, Pinch Points, Rotating, Shearing, other
Explosion, Shattering and other failure modes
Chemicals and Substances such as Lead, Mercury, Cadmium, etc
Radiation Energy
Acoustical Energy
Optical Energy
Child Safety, Swallowing, Cords, etc
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Product Safety
• Protection Against Unsafe Failure Modes, Operations
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Current Limiting and Fast Switching
Voltage Limiting and Clamping
Reverse Voltage Clamping
Grounding or Low Potential of all touchable conducting surfaces
Ground Fault Current Detection
Watchdog Timing and Reset
Input Power Filtration and dI/dT limiting
Insulation of High Voltages
Unique external Connectors
Max Power Limiting
Fault Indications and Operator Warnings
Thermal Sensing
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Product Safety
• Mitigation of Unwanted Usage
– Improper Power Input
– Applications Outside of Product Labeling
– Specific Conditions and Environments that could result in
product failure or Hazards and Unsafe events
– User Limitations such as Age and other Demographics
– Improper Disposal
Products Must Be Accompanied By Sufficient Clear Instructions, Warnings and Labels to
mitigate the possibility to a reasonable level for unsafe occurances
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Test Labs
• Test Products to key Safety Standards and authorize a product
to be marked with test lab label as well as key standard label
• Labs may need to be certified as part of standards process
• Some Test Labs also propose and harmonize Safety
Standards (UL, CSA, etc)
• Labs Often have their own label or marking that a product
shall bear to indicate passing this test labs regime
• Examples:
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UL: Underwriters Labs www.ul.com
CSA: Canadian Standards Association www.csa.ca
NRTLs: Nationally Recognized Testing Labs (OSHA)
Intertek (ETL) http://www.intertek-etlsemko.com/
TUV http://www.tuv.com/en/index.php
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Standards Bodies & Government
Agencies
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Create, Harmonize and Adopt Safety Standards – Do NOT Test
Some are sanctioned by Governments
May be Industry or Product Segment Specific
Standards may govern constructions, materials, testing and
applications of components and products
• Examples of Stds Bodies:
– ANSI: American National Standards Institute http://www.ansi.org/
– CENELEC: European Committee for Electrotechnical Standardization
http://www.cenelec.org/Cenelec/Homepage.htm
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IEC: International Electrotechnical Commission http://www.iec.ch/
EIA: Electronic Industries Alliance http://www.eia.org/
NEMA: National Electric Manufacturers Association http://www.nema.org/
ETSI: European Telecommunications Standards Institute http://www.etsi.org/
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Government Agencies
• Create and Adopt Safety Standards – Most Do NOT Test
• US Government Agencies Fall Under Specific Departments
• Standards may govern constructions, materials, testing and
applications of components and products
• USA Examples: http://www.firstgov.gov/Agencies/Federal/All_Agencies/index.shtml
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FDA: USA-Food and Drug Administration (DO-HHS) http://www.fda.gov/
FAA: USA-Federal Aviation Adminstration (DO-Transportation) http://www.faa.gov/
OSHA: USA-Occupational & Health Administration (DO-Labor) http://www.osha.gov/
NIST: USA-National Inst of Standards & Tech (DO-Commerce) http://www.nist.gov/
NEST: USA-Nuclear Energy Science & Technology (DO-Energy)
http://www.doe.gov/engine/content.do?BT_CODE=OF_PONEST
 FCC: USA-Federal Communications Comm – Congressional http://www.fcc.gov/
 CSPC: USA-Fed Consumer Product Safety Comm – Congressional http://www.cpsc.gov/
• EU Example:
 Directive 2001/95/EC: General Product Safety
(see file: 2006 General Product Safety Stds.pdf)
US Gov Safety & Compliance Controls
Management
Design Controls
Production &
Process Controls
Corrective &
Preventive
Actions
Material
Controls
Records,
Documents, &
Change Controls
Equipment &
Facility Controls
Responsibilities
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Design Control Terms
• Design Inputs
• Requirements, Constraints and other information which is needed to
formulate a set of design outputs for a given product.
• Design Inputs must include customer (user) level requirements as well
as product level and flow down to block level requirements
• Design Outputs
• All drawings, documents, procedures, instructions and other
information necessary to describe the constituent parts, assembly,
manufacturing process, service and disposal processes for a product.
• Design outputs from one team may sometimes become the design
inputs to another team.
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Design Control Terms
• Verification
• Design analysis, simulation or prototype testing which provides
objective evidence that a design meets all of its block or product level
requirements
• Is performed at sub-block, block and system levels and usually requires
lab testing
• Validation
• Product field, clinical or customer trial which provides objective
evidence that a product meets its customer (user) requirements.
• Intended use is an important part of the product labeling.
• Must be performed on units which have been constructed using fully
verified, released engineering and manufacturing drawings and processes
• Is only performed at the system level on completed products
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Design Control Terms
• Design Reviews
• Peer review of design inputs and design outputs are a mandatory part
of many industry product development processes.
• Reviews must include objective evidence of attendees, documented
issue list with dispensation actions, signatures and dates.
• Reviews must include appropriate stake holders (management,
customers, other design teams)
• Reviews must include at least 1 unbiased, knowledgeable external
reviewer
Many Companies in Regulated Industries Must Show
Objective Evidence of Proper Design Inputs, Outputs,
For Example: 21CFR820
Reviews, Verification and Validation to Government
Agencies
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CPSC Overview:
Sanctioned by the US Congress (No direct cabinet level tie)
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable
risks of serious injury or death from more than 15,000 types of consumer products under the agency's
jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than
$700 billion annually. The CPSC is committed to protecting consumers and families from products that pose
a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety
of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer
products over the past 30 years.
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Government Agencies may also act as Standards
Bodies
• Global Examples:
 SCC: Standards Council of Canada
http://www.scc.ca/
 CEN: Comm on European (EU) Normalization
http://www.cenorm.be/cenorm/index.htm
 SAC: Standard Administration of China
http://www.sac.gov.cn/english/home.asp
 JSA: Japanese Standards Association http://www.jsa.or.jp/default_english.asp
 BIS: Bureau of Indian Standards http://www.bis.org.in/index_home.htm
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A brief Tutorial on the
Organization of the US
Government Departments
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US Executive Branch Cabinet
Cabinet Level Departments
Headed by Secretary’s
Of Special Interest
• Vice President
• Agriculture
• Commerce
• Defense
• Education
• Energy
• Health and Human Services
• Homeland Security
• Housing and Urban Development
• Interior
• Labor
• State
• Transportation
• Treasury
• Veterans Affairs
• Justice, Attorney General
• Administrator, Environmental Protection Agency
• Director, Office of Management and Budget
• Director, National Drug Control Policy
• U.S. Trade Representative.
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Dept of Commerce
US Department of Commerce Organization
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US Department of Homeland Security Organization
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US Dept of HHS
US Department of Health & Human Services Organization
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US Department of Energy Organization
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How the US DoD is organized
National
• President
Command
• Secretary of Defense
Authority
Office of the Secretary of Defense
Military Departments
Chairman of the JCS
• Plan &
• Train & equip
coordinate
Unified Commands
• Conduct operations
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Comparison of DOD to Large
Corp
*2002 Figures
Company
Budget/
Revenue*
Employees*
US DoD
$371 billion
2,036,000
Wal-Mart
227 billion
1,383,000
ExxonMobil
>200 billion
GE
150 billion
97,900
320,000
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Office of the Secretary of Defense
Military Departments
Chairman of the JCS
Unified Commands
Secretary of Defense
Deputy Secretary of Defense
Chairman, JCS
Vice Chairman, JCS
Chief of Staff, Army
Commandant, Marine Corps
Chief of Naval Operations
Chief of Staff, Air Force
Director,
Joint Staff
J-1
Manpower and
Personnel
J-2
Intelligence
(DIA)
J-3
Operations
J-4
Logistics
J-5
Strategic
Plans & Policy
J-6
Command,Control
Communications
Computers
J-7
Operational Plans
& Interoperability
J-8
Force Structure,
Resources &
Assessment
Office of the Chairman, JCS
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Office of the Secretary of Defense
Military Departments
Unified Commands
Chairman of the JCS
Secretary of Defense
Deputy Secretary of Defense
Northern
Command
European
Command
Transportation
Command
Central
Command
Special
Operations
Command
Southern
Command
Strategic
Command
Pacific
Command
Joint Forces
Command
• Direct link to President & Secretary of Defense
• 5 Commanders have geographic responsibility
• 4 Operations Commanders have worldwide responsibility
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Office of the Secretary of Defense
Unified Commands
Chairman of the JCS
Military Departments
Department of Defense
Military Departments
U.S. Army
U.S. Air Force
U.S. Navy
U.S. Marine
Corps
Department of
Transportation
U.S. Coast
Guard
Main Branches Formulate MIL-STDs
Office of the Secretary of Defense
Military Departments
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Chairman of the JCS
Unified Commands
Department of Defense
Military Departments
U.S. Army
U.S. Air Force
U.S. Navy
Department of
Transportation
U.S. Marine
Corps
A Few Key MIL-STDs
• MIL-STD-883 Test Method for Microcircuits
• MIL-STD-750 Test Method for Semiconductor Devices
• MIL-PRF-38534 Perf Spec for Hybrid Microelectronic Devices
• MIL-PRF-38535 Perf Spec for Integrated Circuit Mfg
• MIL-HDBK-344 Environmental Stress Screening of Elec Equipment
• MIL-HDBK-1547 Elec Parts, Materials & Processes for Space Launch Vehicles
• MIL-HDBK-2036 Preparation of Electronic Equipment Specifications
• MIL-PRF-31032 Perf Spec for Printed Wiring Boards
• MIL-STD-202 Test Method Standard for Elec & Electronic Components
U.S. Coast
Guard
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Standards, Test Labs &
Standards Bodies
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Standards, Test Labs and Agencies
• National Electrical Code - Standard
– Originally developed in 1897 by the NFPA
– Revised every 3 years, Currently 9 chapters, >700 pages
– Controls methods, systems and materials used in electrical
wiring, and building power distributions
– USA Specific but referenced outside US
– Also See www.mikeholt.com
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Standards, Test Labs and Agencies
• Underwriters Labs – Test Lab
(www.ul.com)
– Originally developed in 1894
– Mission is to certify the safety of industrial, commercial and
consumer products.
– Government Independent, Non-for-profit organization
– 5 Locations including, Northbrook IL (HQ), Research Triangle NC,
Melville NY, Santa Clara CA, Camas WA
– Certifications of products, Certifications of Companies
– Cross agreement with CSA
– Product Certifications
C
• Listed: Ready to use complete products
• Recognized: Certified as a component for use in other products
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Example:
UL60950
Safety of Information Technology Equipment
This standard is applicable to mains-powered or battery-powered information technology
equipment, including electrical business equipment and associated equipment, with a
RATED VOLTAGE not exceeding 600 V and designed to be installed in accordance with
the
Canadian Electrical Code, Part I, CSA C22.1; CSA C22.2 No. 0
National Electrical Code, NFPA 70
The standard is also applicable to equipment, unless otherwise identified by a marking or
instructions, designed to be installed in accordance with
Article 645 of the National Electrical Code, NFPA 70
Standard for the Protection of Electronic Computer Data-Processing
Equipment, NFPA 75
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Standards, Test Labs and Agencies
UL60950
Safety of Information
Technology Equipment
Covers this type of
equipment and more
accounting machines
motor operated files
bookkeeping machines
PABX's
calculators
paper jogging machines
cash registers
paper trimmers (punchers
cutting
machines,separators)
copying machines
data circuit
terminatingequipment
personal computers
data processing equipment
plotters
data terminal equipment
point of sale terminals
includingassociated
electronic scales
dictation equipment
postage machines
document shredding machines
public information terminals
duplicators
staplers
electrically operated
drawingmachines
telephone answering
machines
erasers
telephone sets
facsimile equipment
text processing equipment
key telephone systems
typewriters
magnetic tape handlers
visual display units
mail processing machines
micrographic office equipment
modems
monetary processing machines
including automated teller (cash
dispensing) machines
photoprinting equipment
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Example:
UL6500
Audio/Video and Musical Instrument Apparatus for
Household, Commercial, and Similar General Use
1.1 Scope
1.1.1 This International Standard applies to electronic apparatus designed to be fed from the MAINS or from a SUPPLY APPARATUS and intended for reception,
generation, recording or reproduction respectively of audio, video and associated signals. It also applies to apparatus designed to be used exclusively in combination with
the above mentioned apparatus. This standard concerns only safety aspects of the above apparatus; it does not concern other matters, such as style or performance.
- receiving apparatus and amplifiers for sound and/or vision;
- independent LOAD TRANSDUCERS and SOURCE TRANSDUCERS;
- SUPPLY APPARATUS intended to supply other apparatus covered by the scope of this standard;
- ELECTRONIC MUSICAL INSTRUMENTS, and electronic accessories such as rhythm generators, tone generators, music tuners and the like for use with electronic or non-electronic musical instruments;
- audio and/or video educational apparatus;
- video projectors;
- video cameras and video monitors;
- household video games and flipper games;
NOTE 2 - Video and flipper games for commercial use are covered by IEC 60335-2-82 [7] UL 22Figures in square brackets refer to the bibliography given in annex p.
- juke boxes;
- household electronic gaming and scoring machines;
NOTE 3 - Electronic gaming and scoring machines for commercial use are covered by IEC 60335-2-82 [7] UL 22
- teletext equipment;
- record and optical disc players;
- tape and optical disc recorders;
- antenna signal converters and amplifiers;
- satellite receiver antenna positioners;
- Citizen's Band apparatus;
- apparatus for IMAGERY;
- light effect apparatus;
- intercommunication apparatus, using low voltage MAINS as the transmission medium.
- video apparatus intended for entertainment purposes in health-care facilities;
- cellular phones, wireless modems, and similar transceiving devices;
- audio or video apparatus that are used with a battery supply.
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A few UL Standards
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UL 60745-1
UL 60730-1A
UL 60601-1
UL 60335-1
UL 60065
UL 2388
UL 2251
UL 2231-1
UL 2202
UL 2111
UL 2054
UL 1998
UL 1989
UL 1981
UL 1977
UL 1876
UL 1778
UL 1741
UL 1740
UL 1703
UL 1664
UL 1642
UL 1641
UL 1637
UL 1577
UL 1559
UL 1492
UL 1459
UL 1449
UL 1433
Hand-Held Motor-Operated Electric Tools - Safety - Part 1: General Requirements
Automatic Electrical Controls for Household and Similar Use, Part 1: General Requirements
Medical Electrical Equipment, Part 1: General Requirements for Safety
Safety of Household and Similar Electrical Appliances, Part 1: General Requirements
Audio, Video and Similar Electronic Apparatus - Safety Requirements
Flexible Lighting Products
Plugs, Receptacles and Couplers for Electric Vehicles
Personnel Protection Systems for Electric Vehicle (EV) Supply Circuits: General Reqs
Electric Vehicle (EV) Charging System Equipment
Overheating Protection for Motors
Household and Commercial Batteries
Software in Programmable Components
Safety Standard for Standby Batteries
Central-Station Automation Systems
Component Connectors for Use in Data, Signal, Control and Power Applications
Isolating Signal and Feedback Transformers for Use in Electronic Equipment
Uninterruptible Power Systems
Inverters, Converters, and Controllers for Use in Independent Power Systems
Safety Standard for Robots and Robotic Equipment
Flat-Plate Photovoltaic Modules and Panels
Safety Standard for Immersion Detection Circuit Interrupters
Lithium Batteries
Installation and Classification of Residential Burglar Alarm Systems
Safety Standard for Home Health Care Signaling Equipment
Standard for Safety of Optical Isolators
Insect-Control Equipment - Electrocution Type
Audio-Video Products and Accessories
Safety Standard for Telephone Equipment
Transient Voltage Surge Suppressors
Control Centers for Changing Message Type Electric Signs
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A few more UL Standards
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UL 1434
UL 1419
UL 1416
UL 1412
UL 1411
UL 1283
UL 1244
UL 1236
UL 1196
UL 1082
UL 1077
UL 1066
UL 1053
UL 1047
UL 1034
UL 1023
UL 1020
UL 1018
UL 1010
Thermistor-Type Devices
Professional Video and Audio Equipment
Overcurrent and Overtemperature Protectors for Radio- and Television- Type Appliances
Fusing Resistors and Temperature-Limited Resistors for Radio- and TV- Type Appliances
Transformers and Motor Transformers for Use in Audio-, Radio-, and TV-Type Appliances
Electromagnetic Interference Filters
Electrical and Electronic Measuring and Testing Equipment
Battery Chargers for Charging Engine-Starter Batteries
Standard for Safety for Floating Waterlights
Household Electric Coffee Makers and Brewing-Type Appliances
Supplementary Protectors for Use in Electrical Equipment
Safety Standard for Low Voltage AC and DC Power Circuit Breakers used in Enclosures
Standard for Safety for Ground-Fault Sensing and Relaying Equipment
Isolated Power Systems Equipment
Burglary-Resistant Electric Locking Mechanisms
Household Burglar-Alarm System Units
Thermal Cutoffs for Use in Electrical Appliances and Components
Electric Aquarium Equipment
Receptacle-Plug Combinations for Use in Hazardous (Classified) Locations
www.ul.com
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Standards, Labs and Agencies
• CSA International - Test Lab
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See www.csa.ca
Established in 1919 in Toronto, Canada
Similar to UL, Independent, but growing Internationally
Controls materials, processes, products, companies
Cross certification agreements with UL
Does NOT differentiate between products & components
Local offices in Canada, US and Asia
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IEC – International Electrotechnical Commission
www.iec.ch
IEC Mission
• The International Electrotechnical Commission (IEC) is the leading global organization that prepares and
publishes international standards for all electrical, electronic and related technologies. These serve as a basis
for national (government) standardization and as references when drafting international tenders and contracts.
• Through its members, the IEC promotes international cooperation on all questions of electrotechnical
standardization and related matters, such as the assessment of conformity to standards, in the fields of
electricity, electronics and related technologies.
• The IEC charter embraces all electrotechnologies including electronics, magnetics and electromagnetics,
electroacoustics, multimedia, telecommunication, and energy production and distribution, as well as associated
general disciplines such as terminology and symbols, electromagnetic compatibility, measurement and
performance, dependability, design and development, safety and the environment.
The Commission's objectives are to:
• Meet the requirements of the global market efficiently
• Ensure primacy and maximum world-wide use of its standards and conformity assessment
schemes
• Assess and improve the quality of products and services covered by its standards
• Establish the conditions for the interoperability of complex systems
• Increase the efficiency of industrial processes
• Contribute to the improvement of human health and safety
• Contribute to the protection of the environment.
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IEC – International Electrotechnical Commission
Standards Areas
•GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION.
•SOCIOLOGY. SERVICES. COMPANY ORGANIZATION AND MANAGEMENT. ADMINISTRATION. TRANSPORT
•MATHEMATICS. NATURAL SCIENCES
•HEALTH CARE TECHNOLOGY
•ENVIRONMENT. HEALTH PROTECTION. SAFETY
•METROLOGY AND MEASUREMENT. PHYSICAL PHENOMENA
•TESTING
•MECHANICAL SYSTEMS AND COMPONENTS FOR GENERAL USE
•FLUID SYSTEMS AND COMPONENTS FOR GENERAL USE
•MANUFACTURING ENGINEERING
•ENERGY AND HEAT TRANSFER ENGINEERING
•ELECTRICAL ENGINEERING
•ELECTRONICS
•TELECOMMUNICATIONS. AUDIO AND VIDEO ENGINEERING
•INFORMATION TECHNOLOGY. OFFICE MACHINES
•IMAGE TECHNOLOGY
•PRECISION MECHANICS. JEWELLERY
•ROAD VEHICLE ENGINEERING
•RAILWAY ENGINEERING
•SHIPBUILDING AND MARINE STRUCTURES
•AIRCRAFT AND SPACE VEHICLE ENGINEERING
•MATERIALS HANDLING EQUIPMENT
•PACKAGING AND DISTRIBUTION OF GOODS
•TEXTILE AND LEATHER TECHNOLOGY
•CLOTHING INDUSTRY
•AGRICULTURE
•FOOD TECHNOLOGY
•CHEMICAL TECHNOLOGY
•MINING AND MINERALS
•PETROLEUM AND RELATED TECHNOLOGIES
•METALLURGY
•WOOD TECHNOLOGY
•GLASS AND CERAMICS INDUSTRIES
•RUBBER AND PLASTICS INDUSTRIES
•PAPER TECHNOLOGY
•PAINT AND COLOUR INDUSTRIES
•CONSTRUCTION MATERIALS AND BUILDING
•CIVIL ENGINEERING
•MILITARY ENGINEERING
•DOMESTIC AND COMMERCIAL EQUIPMENT. ENTERTAINMENT. SPORTS.
•(No title)
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IEC – International Electrotechnical Commission
Example of Standards Area
3316010 Amplifiers (part of Telecom, Audio & Video area)
33.160.10
IEC 60268-3 (2000-08)
Sound system equipment - Part 3: Amplifiers
33.160.10
IEC 60268-3 (2000-08)
Versión Oficial en Español - Equipos para sistemas electroacústicos. Parte 3: Amplificadores.
33.160.10
IEC 60268-8 (1973-01)
Sound system equipment. Part 8: Automatic gain control devices
33.160.10
IEC/TR 61292-1 (1998-01)
Fibre optics - Parameters of amplifier components
33.160.10
IEC/TR 61292-2 (2003-01)
Optical amplifier technical reports - Part 2: Theoretical background for noise figure evaluation using the electrical spectrum analyzer
33.160.10
IEC/TR 61292-3 (2003-06)
Optical amplifiers - Part 3: Classification, characteristics and applications
33.160.10
IEC/TR 61292-4 (2004-08)
Optical amplifiers - Part 4: Maximum permissible optical power for the damage-free and safe use of optical amplifiers, including Raman amplifiers
33.160.10
IEC/TR 61292-5 (2004-07)
Optical amplifiers - Part 5: Polarization mode dispersion parameter - General information
33.160.10
IEC 61305-3 (1995-05)
Household high-fidelity audio equipment and systems - Methods of measuring and specifying the performance - Part 3: Amplifiers
33.160.10
IEC 61305-3 (1995-05)
VERSION OFICIAL EN ESPANOL - Sistemas y equipos domésticos de sonido de alta fidelidad. Métodos de medir y especificar las características de
funcionamiento. Parte 3: Amplificadores.
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What is the “CE” Mark?
CE Marking is the symbol “CE” as shown on the top of this page. The letters "CE" are the abbreviation of French
phrase "Conformité Européene" which means "European Conformity". The term initially used was "EC Mark" and
it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU
official documents.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential
requirements of the relevant European health, safety and environmental protection legislations, in practice by
many of the so-called Product Directives
• “Essential Requirements" are the performance levels contained in harmonized standards
to which the products must conform.
• “Product Directives” are the legal directives and laws which specify the harmonized
standards for certain types and classes of products to conform. Ex; 95/94/EEC: Automotive
Products
• “Harmonized Standards” are the technical specifications (European Standards or
Harmonization Documents) which are established by several European standards agencies
(CEN, CENELEC, etc).
• CEN is the European Committee for Standardization.
• CENELEC is the European Committee for Electrotechnical Standardization.
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Purpose of the CE Mark
• The CE Mark is a Manufacturer’s Declaration that the product placed onto the
EU market conforms with all the applicable essential requirements in the
harmonized standards. ie; The Product is Safe and Complies with all
Standards
• CE Marking on a product indicates to governmental officials that the product
may be legally placed on the market in their country.
• CE Marking on a product ensures the free movement of the product within
the EFTA & European Union (EU) single market (total 37 countries).
• CE Marking on a product permits the withdrawal of any non-conforming
products by customs and other enforcement authorities.
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• CE Mark History
CE Mark
– 15 countries in original EU (European Union) established
harmonized standards
– EC/EEC (European Committee/European Economic
Community) is the body driving establishment of standards for
any product sold in or entering into the EU.
– Members may add additional more stringent standards but may
not contradict existing EC approved standards
– Some of the EC Product Directives:
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88/106/EEC: Safety of Toys
89/106/EEC: Construction of Products
89/336/EEC, 92/31/EC: EMC
89/392/EEC, 91/368/EC, 3/44/EEC: Machinery
89/686/EEC, 93/95/EEC: Personal Protective Equipment
91/263/EEC, 93/97/EEC, 98/13/EEC: Telecommunications
93/42/EEC: Medical Devices
72/23/EEC: Low Voltage Products
95/94/EEC: Automotive Products
96/57/EC: Energy Efficiency for consumer refrigeration systems
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ISO – International Organization for
Standardization
Standards Body
www.iso.org
• ISO is a network of the national standards institutes of
148 countries, on the basis of one member per country.
• Central Secretariat in Geneva, Switzerland, coordinates
the system
• ISO is a non-governmental organization
• ISO occupies a special position between the public and
private sectors
• Many of its member institutes are part of the
governmental structure of their countries, or are mandated
by their government.
• Other members have their roots uniquely in the private
sector, having been set up by national partnerships of
industry associations.
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ISO – International Organization for
Standardization
ISO 9000 Quality
The ISO 9000 Family of Standards via ISO web site
:
http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/iso9000family.html
ISO: 9000:2000, Quality management systems - Fundamentals and vocabulary
9001:2000, Quality management systems - Requirements (replaces 1994 versions of
9001, 9002 & 9003)
9004:2000, Quality management systems - Guidelines for performance improvements
10005:1995, Quality management - Guidelines for quality plans
10006:1997, Quality management - Guidelines to quality in project management
10007:1995, Quality management - Guidelines for configuration management
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ISO 9000 and ISO 14000 Standards
• The ISO 9000 and ISO 14000 families are among ISO's most widely
known standards ever.
• ISO 9000 and ISO 14000 standards are implemented by some
610,000 organizations (companies & corporations) in 160 countries.
• The ISO 9000 family is primarily concerned with "quality
management“
• This means what the organization does to fulfill:
- the customer's quality requirements, and
- applicable regulatory requirements, while aiming to
- enhance customer satisfaction, and
- achieve continual improvement of its performance in pursuit of these
objectives.
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ISO 9000 and ISO 14000 Standards
• Similar to the US EPS, the ISO 14000 family of standards is primarily
concerned with “Environmental Management"
• Specifies what an organization must do to:
- minimize harmful effects on the environment caused by its activities
- achieve continual improvement of its environmental performance
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Other Safety Standards Organizations
• AAMI - American Association of Medical Instrumentation
• ANSI - American National Standards Institute
• ASTM - American Society for Testing and Materials
• NFPA - National Fire Protection Association
• SCC - Standards Council of Canada
See: http://ulstandardsinfonet.ul.com/catalog/stdscatframe.html
For an exhaustive list of potentially applicable safety standards (> 200 stds)
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UL Std Example: UL1236
Battery Chargers for Charging Engine-Starter Batteries
UL 1236
Scope
1.1 These requirements cover battery chargers rated 600 volts or less and intended for household
or commercial use to charge engine-starter batteries, in accordance with the National Electrical
Code, ANSI/NFPA 70.
1.2 A battery charger for use with an internal combustion engine is to be investigated under the
requirements of this standard and the applicable requirements for the end product.
1.3 These requirements do not cover a battery charger for use in a marina or boatyard, or other
marine application excepting a battery charger intended to be permanently installed on a boat; for
fire protection signaling service; or an appliance or system in which a battery charger is used.
UL StandardsInfoNet | Underwriters Laboratories Inc.
Copyright © 2003 Underwriters Laboratories Inc.
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Project Safety Std Examples
Lasers and Products Containing Lasers
US/FDA:
IEC:
21 CFR 1040.10- Laser Products
60820 - Electrical Safety of Laser Equipment and Installations
60825 - Radiation Safety of Laser Products, Equipment Classification, Requirements
and User's Guide
60601-2-22 Diagnostic and Therapeutic Laser Equipment
Other:
ANSI Z136.3 - Safe use of lasers in health care facilities
Imaging and Display Including CRT Type Video Monitors
US/FDA:
Other:
21 CFR 1020.10- Television Receivers (x-ray emissions)
SMPTE Standards and Publications (test paterns)
Broadcast TV Standards by Country (NTSC, PAL, SECAM etc.)
Video Recording Formats & Standards (VHS, Beta, Hi 8 etc.)
Imaging Systems: Range of Factors Affecting Image Quality
Telephone Terminal and Communications Equipment
US/FCC:
47 CFR 68 Connection of terminal equipment to the telephone network
IEC:
60617-9 Graphical symbols for diagrams part 9: telecommunications: switching and
peripheral equipment
EC:
1999/5/EC R&TTE - Radio & Telecommunications Terminal Equipment Directive
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Project Health and Safety Aspects
• Key Safety Requirements Checklist - Electrical
 Over current or short circuit protection on power inputs
 Over current or short circuit protection on power outputs and higher
energy signal outputs
 Internal over current protection on all power supplies
 XFMR Isolation from AC power line to electronic circuits
 Low leakage (<1mA) to earth ground return
 Proper wire gauges and trace widths vs. max application current
 Insulation and creepage distance versus voltage between
conductors
 Min 50% derating of wattage components
 Worst case ambient thermal rise internal to product accounted for
 Diagnostic Tests or Failure Mode Indicators for Operator/Service
 Failure Modes & Effects Analysis (what happens if any one
component fails, ie; shorts inputs to outputs or opens?)
 Electromagnetic Compliance
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Project Health and Safety Aspects
• Key Safety Requirements Checklist - Mechanical
 Product is free from pinch points and sharp or rough edges
 Electronics/mechanics susceptible to dirt, fluids, are reasonably
sealed from environment? (thru packaging or potting)
 Consideration for handles, carrying, ergonomics, etc
 If the product is > 40 lbs, must provide considered handles,
fixtures, etc for the user including OSHA mfg issues?
 Maximum surface temperature of product must not exceed
40oC on any surface that can be touched by a user
 Does the product emit other energy output such light, sound,
heat, etc and is there a safe level which can be related to a
Safety Standard?
 Does the product have sufficient stand-up stability with no
reasonable tip hazard or sliding hazards
 Has the product been designed and assembled to withstand
designated lifetime of mechanical stresses including shipping
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Project Health and Safety Aspects
• Key Safety Requirements Checklist – Materials and
Usage
 Does the Operator Manual include specific labeling of usage
 Does the Operator/Service Manuals include proper warnings
for typical hazardous misuses
 Has the product been labeled adequately for misuse by
children or other demographic groups
 Are there any hazardous materials including Pb, Cd, Cr+6, Hg,
Polybrominated Biphenals (PBB) and Diphenal Ethers (PBDE)
used in the product. If so, where are they and in what
concentrations.
 What chemicals and raw materials are used in the product and
have the Material Safety Data Sheets (MSDS) been reviewed
for these materials?