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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

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

OBJECTIVES

• Awareness of Standards

• Overview of Product Safety Evaluation

STANDARDS

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

BECAUSE!It’s important for all

the parts to work

together . . .

STANDARDS

BECAUSE!Of Unintentional

Consequences

STANDARDS

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

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

Reliability!

CAN/CSA-Q632-90Reliability and Maintainability

Management Guidelines

STANDARDS

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

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

STANDARDS

ELECTRICAL SAFETY STANDARDS

• Distribution (Transmission)

• Industrial / Commercial

• Consumer electronics / Information

Technology

• Specialty. i.e.: Medical Electrical

Equipment

PRODUCT SAFETY EVALUATION

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”

TYPES OF HAZARD

• fire

• shock

• energy

• physical

• essential performance

• and . . .

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

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

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

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!

CERTIFICATION

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

• CSA mark

• (and a few competitors. . .)

• Some products are exempt, but check

CERTIFICATION

• Evaluation performed by an independent, accredited, body

• Required by local & national regulations

• Liability / Risk mitigation

• Marketing

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

EVALUATION

Evaluate according to applicable standards

Testing• Normal operation

• Fault conditions

Documentation• Descriptive Report for inspections

• Certificate and product listing for client

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

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

CERTIFICATION

Design compliance into your product• Separately approved certified components

• Separately approved external power supplies

• Fault / redundant protection

• Risk Management

• And . . .

CERTIFICATION

(not legal in some jurisdictions)

STANDARDS AND PRODUCT SAFETY

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)

GLOBAL

INTERNATIONAL

IECEE CB Scheme

• International agreement between participating countries

• Common report format

• Access to local certification marks

• Global Market

• Reduced compliance costs

EUROPE

CE Mark

• European Union countries

• Product specific Directives

• Electronic: Low Voltage Directive

• Safety and EMC

• Self-Declaration

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

Examples of standards in the opening video clip

- Compressed gas cylinders

- Roadway construction

- Lighting

- Automotive

- Radio broadcast

- Others???

OBJECTIVES

• Awareness of Standards - Now you know

• Overview of Product Safety Evaluation - Done

• Purpose of Standards

– SAFETY

– COMPATIBILITY

– LIABILITY

– MARKETING

– and . . . .

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.

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/

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

CERTIFICATION

Thank You!47

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