Transcript Slide 1

STANDARDS & PRODUCT SAFETY
Simon Fraser University
School of Engineering Science
Ken Rutledge
CSA International
STANDARDS
WHY?
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STANDARDS
PURPOSE
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Product safety
Compatibility
Liability
– fire / shock / physical
– device / national / global
– mfr / retail / user / etc
Marketing
and . . . .
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STANDARDS
BECAUSE!
Someone will find a way to
use your product in a way
that you didn’t intend it to
be used
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STANDARDS
BECAUSE!
Unintended consequences
when standards not used
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STANDARDS
Examples
Electromagnetic Compatibility (EMC);
Communications & Information Systems;
Canadian Electrical Code (CEC);
Building Codes & Construction
Fire; Food; Business & Management Systems;
Usability; Transportation, Gas, Environment,
Energy; Ethics; Organics; Aging; etc, etc,
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STANDARDS
STANDARDS DEVELOPMENT
• Written by consensus
• Representation from:
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industry
standards committees
academics
special interest groups
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ELECTRICAL SAFETY
STANDARDS
• Individual standards address hazards
for specific products
• Complex products may also have
multiple sub-standards with specific
requirements unique to a product. ie:
Electromedical products ‘part-2 series
 part-1 general requirements
 50+ ‘part 2’ product-specific requirements
• CSA 2500 published standards
• 350+ electrical / electronic
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ELECTRICAL SAFETY
STANDARDS
ELECTRICAL / ELECTRONIC
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industrial / commercial
consumer
information technology
distribution
electro-medical
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ELECTRICAL SAFETY
STANDARDS
HARMONIZED STANDARDS
• International Electrotechnical
Commission - IEC
• International Adoption
• National Standards with differences
• Global Market
• Reduced compliance costs
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ELECTRICAL SAFETY
STANDARDS
TYPES OF HAZARD
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fire
electric shock
energy
physical
essential performance
but . . .
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HAZARDS
Standards only work when they are followed. . .
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HAZARDS
AVAILABLE CURRENT / POWER
household mains branch supply:
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120V, 15A nominal
can deliver 30A / 2m before breaker trip
up to 20kA momentary fault
T-slot receptacles – 40A / 2m
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HAZARDS
TYPICAL LIMITS FOR HAZARDS
 Fire: Power > 15W = potential fire hazard
 Electric Burn: 0.45µC @ > 60V = hazardous
charge
 Physical Burn:
 Metalic: 75C
 Polymeric: 95C
 Secondary hazard
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HAZARDS
TYPICAL LIMITS FOR HAZARDS
 SHOCK - Current > 0.5mA = reaction
 SHOCK - Current > 10mA = can’t let go
 SHOCK – Current > 0.01mA patient contact
 Physiology controlled by electrical impulses
 Conflicting impulses can cause fibrillation or arrest
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HAZARDS
ESSENTIAL PERFORMANCE (medical)
• Non-critical function:
- Stereo display 60db but actual o/p is 54db
• Critical Function:
- Ventilator delivery
- Defibrillator impulse
- ECG display
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HAZARDS
Lightning Strike to Outdoor Wiring
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COMPLIANCE
STRATEGIES FOR COMPLIANCE
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Design compliance in to your
product
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Test before applying for evaluation
Preliminary consultation
Risk Management
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COMPLIANCE
STRATEGIES FOR COMPLIANCE
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Separately approved components
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External approved power supply
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Fault protection
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Redundant protection
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CERTIFICATION
PURPOSE
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Independent compliance evaluation
by an accredited 3rd party
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Required by local regulators
Access to international markets
On-going conformity assessment
Marketing
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CERTIFICATION
PRODUCT EVALUATION
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Physical examination
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Testing
• Normal operation
• Fault conditions
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Documentation
• Descriptive Report for inspections
• Certificate and product listing for client
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CERTIFICATION
FOLLOW-UP
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Manufacturing Inspections
Re-Examination
Annual fees
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CERTIFICATION
ELECTROMAGNETIC COMPATIBILITY
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Mandatory
Industry Canada
US FCC
International
Harmonized
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INTERNATIONAL
CB SCHEME
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International agreement
Harmonized standards
Common report format
Issue local certification mark
Global Market
Reduced compliance costs
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INTERNATIONAL
CE MARK
• European Union countries
• Product specific Directives
• Electronic: Low Voltage Directive
• Safety and EMC
• Self-Declaration
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INTERNATIONAL
WEEE DIRECTIVE
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Waste Electrical and Electronic
Equipment
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EU Member countries
Landfill content
Producer responsible for recycling costs
Manufacture with ‘friendly’ materials
Will become CE Mark requirement
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STANDARDS
PURPOSE
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SAFETY
COMPATIBILITY
LIABILITY
MARKETING
and . . . .
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ELECTRICAL SAFETY COMPLIANCE
You know they’re
out there . . .
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STANDARDS AND
PRODUCT SAFETY
Thank You
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