standards & product safetywhitmore/courses/ensc305/pdf... · global international iecee cb...

STANDARDS & PRODUCT SAFETY

Simon Fraser UniversitySchool of Engineering Science

Ken Rutledge

CSA Group - Richmond

Standards & Product Safety

FIRST -

An attention-grabbing

introduction . . .

. . . there will be a quiz later

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truck_full_of_gas_cylinders_crashes_and_explodes_in_russia.mp4


Ken Rutledge

Assistant Operations Manager – CSA Group Vancouver Laboratories; Occupational Health & Safety; Environmental Management; Facility; Administration.

Joined CSA 1994

Co-Op Student → Lab Tech → Certifier → Manager

Audio/Video; Electro-medical; Laboratory; Test & Measurement Equipment

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OBJECTIVES

• Awareness of Standards

• Overview of Product Safety Evaluation

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STANDARDS

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WHY?

STANDARDS

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BECAUSE!

• Compatibility – device / national / global

• Product safety – fire / shock / physical

• Compliance – Local / National / International

• Liability – mfr / retail / user / etc

• Marketing – quality / assurance / added value

• and . . . .

STANDARDS

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BECAUSE!It’s important for all

the parts to work

together . . .

STANDARDS

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BECAUSE!Of Unintentional

Consequences

STANDARDS

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Definitions

• Something considered by an authority, or bygeneral consent, as a basis of comparison

• An approved model

• A basis of weight, measure, value, comparison, orjudgment

• A document that defines common characteristics of devices, functions and practices

STANDARDS

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Practical Examples

Electromagnetic Compatibility (EMC);

Communications & Information Systems;

Electrical Codes (CEC, NEC);

Product Safety; Building Codes; Fire; Food; Biocompatibility; Management Systems; Usability; Transportation, Gas, OH&S; Environment, Energy; Ethics; Organics; Aging; Blood handling, etc, etc, etc. . .

And of course. . .

STANDARDS

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Reliability!

CAN/CSA-Q632-90Reliability and Maintainability

Management Guidelines

STANDARDS

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STANDARDS DEVELOPMENT

• Written by consensus

• Representation from:o industryo standards publishers (i.e.: CSA)o Academics o Subject Matter Experts (SMEs)o special interest groups

STANDARDS

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STANDARDS DEVELOPMENT

• NOT Written by:

STANDARDS

HARMONIZED STANDARDS

• International Electrotechnical Commission – IEC

• Adopted by individual Countries

• National Standards with differences

• Global Market

• Reduced compliance costs

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STANDARDS

ELECTRICAL SAFETY STANDARDS

• Distribution (Transmission)

• Industrial / Commercial

• Consumer electronics / Information

Technology

• Specialty. i.e.: Medical Electrical

Equipment

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PRODUCT SAFETY EVALUATION

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Charles DarwinEvolution / On the Origin of Species

“It is not the strongest of the species that survive, nor the most

intelligent, but the one most responsive to change”


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TYPES OF HAZARD

• fire

• shock

• energy

• physical

• essential performance

• and . . .

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Unintended Use . . . 22


EXAMPLE

Available current & Power in a household mains branch supply:

– 120V, 15A nominal

– 30A for up to 2m before breaker trips

– Up to 20kA momentary fault

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EXAMPLE

Typical limits for shock hazards @ 60Hz

– Current ~0.5mA = reaction

– Current >10mA = can’t let go

– Physiology controlled by electrical impulses

– Conflicting impulses can cause fibrillation or arrest

– MED Standards patient contact limit <10µA

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OTHER HAZARDS

– Fire: • Power > 15W = potential fire hazard

– Electric Burn: • 0.5µC @ > 60V = hazardous charge

• 3μF @ 170Vpk (120Vac)

– Physical Burn: • Metal: 75C

• Polymer: 95C

– Mechanical / Physical

– Essential Performance

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ESSENTIAL PERFORMANCE

Non-critical function:

- Home Electronics display 60db but actual o/p is 58db – No Big Deal . . .

Critical Function:

- Ventilator delivery

- Defibrillator impulse

- ECG display . . . BIG DEAL!

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27

???


CERTIFICATION

• Most electrical / electronic devices sold in Canada require product safety certification

• CSA mark

• (and a few competitors. . .)

• Some products are exempt, but check

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CERTIFICATION

• Evaluation performed by an independent, accredited, body

• Required by local & national regulations

• Liability / Risk mitigation

• Marketing

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EVALUATION

Document review. Manuals, drawings, technical specifications, Risk Management files, etc

Physical examination

Applicable Requirements. Determine applicable requirements. Interpret requirements as they apply to a specific product

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EVALUATION

Evaluate according to applicable standards

Testing• Normal operation

• Fault conditions

Documentation• Descriptive Report for inspections

• Certificate and product listing for client

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CERTIFICATION

FOLLOW-UP

Ongoing conformity assessment ensures products continue to meet requirements

• Manufacturing Inspections– Unannounced

– Frequency of inspection varies with product

– Average 4-8 inspections per year

• Re-Examination– May be required in special cases.

– i.e.: uncertified critical components

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COMPLIANCE

STRATEGIES FOR COMPLIANCE

Be Informed. Knowledge of the standards and

other requirements that apply to your product

Prepare. Evaluate your product before applying

for Product Safety Evaluation

– Internal Compliance team

– External consultants. i.e.: CSA Technical Information Service

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CERTIFICATION


Design compliance into your product• Separately approved certified components

• Separately approved external power supplies

• Fault / redundant protection

• Risk Management

• And . . .

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CERTIFICATION


(not legal in some jurisdictions)

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STANDARDS AND PRODUCT SAFETY

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OTHER MANDATORY REGULATIONS

Electromagnetic Compatibility

• Industry Canada

• US FCC

• Others – see notes

Medical Device Registration

• Health Canada

• US Food & Drug Administration (FDA)

• EU Medical Device Directive (MDD)

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GLOBAL

INTERNATIONAL

IECEE CB Scheme

• International agreement between participating countries

• Common report format

• Access to local certification marks

• Global Market

• Reduced compliance costs

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EUROPE

CE Mark

• European Union countries

• Product specific Directives

• Electronic: Low Voltage Directive

• Safety and EMC

• Self-Declaration

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EUROPE

WEEE Directive

• Waste Electrical and Electronic Equipment

• EU Member countries

• Coming soon to North America

• Landfill content

• Producer responsible for recycling costs

• Manufacture with ‘friendly’ materials

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QUIZ

Examples of standards in the opening video clip

- Compressed gas cylinders

- Roadway construction

- Lighting

- Automotive

- EMC

- Radio broadcast

- Others???

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OBJECTIVES

• Awareness of Standards - Now you know

• Overview of Product Safety Evaluation - Done

• Purpose of Standards

– SAFETY

– COMPATIBILITY

– LIABILITY

– MARKETING

– and . . . .

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You know they’re out there . . . 43

CSA GROUP

CSA Group is a not-for-profit membership association

serving consumers, business and government. Our

purpose is to make standards work for people and

business.

Codes & Standards Standards development, information

products, sale of publications, training & education, and

membership services

Testing & Certification Product safety evaluation and

certification

Consumer product evaluation Pre-production evaluation;

Pre-purchase testing; shipment inspections; etc.

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RESOURCES

CSA Group: http://www.csagroup.org/

CSA Standards:http://www.csagroup.org/us/en/services/codes-and-standards

Great resource: http://www.safetylink.com/

EMC: http://www.nwemc.com/links/

Health Canada: http://www.hc-sc.gc.ca/

US FDA: http://www.fda.gov/

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http://www.csagroup.org/

http://www.csagroup.org/us/en/services/codes-and-standards

http://www.safetylink.com/

http://www.nwemc.com/links/

http://www.hc-sc.gc.ca/

http://www.fda.gov/

CERTIFICATION

RESOURCES

IECEE CB Scheme: http://iecee.org/

European Union EE Legislation:http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/

European Union Guide:http://ec.europa.eu/DocsRoom/documents/11502/attachments/1/translations/en/renditions/native

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http://iecee.org/

http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/

http://ec.europa.eu/DocsRoom/documents/11502/attachments/1/translations/en/renditions/native

CERTIFICATION

Thank You!47

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