ELECTRICAL PRODUCT SAFETY

Simon Fraser UniversitySimon Fraser UniversitySchool of Engineering ScienceSchool of Engineering Science

Ken RutledgeCSA International

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ELECTRICAL PRODUCT SAFETY

WHY?WHY?

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PURPOSEPURPOSE

• public safetypublic safety

• government requirementgovernment requirement

• liability – liability – mfr / retail / user / etcmfr / retail / user / etc

• marketingmarketing

• and . . . .and . . . .

ELECTRICAL PRODUCT SAFETY

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BECAUSE!BECAUSE!Someone will find a way to Someone will find a way to use your product in a way use your product in a way that you didn’t intend it to that you didn’t intend it to be usedbe used

ELECTRICAL PRODUCT SAFETY

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STANDARDS

WHY? WHY?

• Public / Consumer Safety Public / Consumer Safety

• Consistency – Consistency – competitors / countriescompetitors / countries

• Compatibility – Compatibility – communication / inter-communication / inter-connectionconnection

• Global MarketsGlobal Markets

• Risk mitigation Risk mitigation

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STANDARDS

•Standards used to evaluate products for Standards used to evaluate products for hazards hazards

•Hazards may be unique to class of Hazards may be unique to class of product. ie: electro-medical products 2-product. ie: electro-medical products 2-part seriespart series

part-1 general requirementspart-1 general requirements 50+ ‘part 2’ product-specific requirements50+ ‘part 2’ product-specific requirements

•CSA 2500 published standardsCSA 2500 published standards

•350+ electrical / electronic350+ electrical / electronic

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STANDARDS

STANDARDS DEVELOPMENTSTANDARDS DEVELOPMENT

•Written by consensusWritten by consensus

•Representation from:Representation from: industryindustry standards committeesstandards committees academicsacademics special interest groupsspecial interest groups

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STANDARDS

ELECTRICAL / ELECTRONICELECTRICAL / ELECTRONIC

industrial / commercialindustrial / commercial consumerconsumer information technologyinformation technology distributiondistribution electro-medicalelectro-medical

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STANDARDS

HARMONIZED STANDARDSHARMONIZED STANDARDS

•International Electrotechnical International Electrotechnical Commission - IECCommission - IEC

•International AdoptionInternational Adoption

•National Standards with differencesNational Standards with differences

•Global MarketGlobal Market

•Reduced compliance costsReduced compliance costs

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HAZARDS

TYPES OF HAZARDTYPES OF HAZARD

• firefire

• electric shockelectric shock

• energyenergy

• physical physical

• essential performanceessential performance

• or . . . or . . .

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HAZARDS

. . . a complete lack of common sense

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HAZARDS

AVAILABLE CURRENT / POWERAVAILABLE CURRENT / POWER

household mains branch supply:household mains branch supply:

120V, 15A nominal120V, 15A nominal can deliver 30A / 2m before breaker tripcan deliver 30A / 2m before breaker trip up to 20kA momentary faultup to 20kA momentary fault T-slot receptacles – 40A / 2mT-slot receptacles – 40A / 2m

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HAZARDS

TYPICAL LIMITS FOR HAZARDSTYPICAL LIMITS FOR HAZARDS

Fire: Power > 15W = potential fire hazardFire: Power > 15W = potential fire hazard

Electric Burn: 0.45Electric Burn: 0.45µµC @ > 60V = hazardous C @ > 60V = hazardous chargecharge

Physical Burn: Physical Burn: Metalic: 75CMetalic: 75C Polymeric: 95CPolymeric: 95C Secondary hazardSecondary hazard

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HAZARDS

TYPICAL LIMITS FOR HAZARDSTYPICAL LIMITS FOR HAZARDS

SHOCK SHOCK - Current > 0.5mA = reaction - Current > 0.5mA = reaction

SHOCK SHOCK - Current > 10mA = can’t let go- Current > 10mA = can’t let go

SHOCKSHOCK – Current > 0.01mA patient contact – Current > 0.01mA patient contact

Physiology controlled by electrical impulsesPhysiology controlled by electrical impulses

Conflicting impulses can cause fibrillation or arrestConflicting impulses can cause fibrillation or arrest

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HAZARDS

ESSENTIAL PERFORMANCE (medical)ESSENTIAL PERFORMANCE (medical)

• Non-critical function: Non-critical function:

- Stereo display 60db but actual 54db - Stereo display 60db but actual 54db

• Critical Function:Critical Function:

- Ventilator delivery- Ventilator delivery

- Defibrillator impulse - Defibrillator impulse

- ECG display- ECG display

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COMPLIANCE

STRATEGIES FOR COMPLIANCESTRATEGIES FOR COMPLIANCE

• Design compliance into productDesign compliance into product

• Test before applying for evaluationTest before applying for evaluation

• Preliminary consultation Preliminary consultation

• Risk ManagementRisk Management

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COMPLIANCE

STRATEGIES FOR COMPLIANCESTRATEGIES FOR COMPLIANCE

• Separately approved componentsSeparately approved components

• External approved power supplyExternal approved power supply

• Fault protectionFault protection

• Redundant protectionRedundant protection

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CERTIFICATION

PURPOSEPURPOSE

• Independent compliance evaluation Independent compliance evaluation by an accredited 3by an accredited 3rdrd party party

• Required by local regulators Required by local regulators

• Access to international marketsAccess to international markets

• On-going conformity assessmentOn-going conformity assessment

• MarketingMarketing

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CERTIFICATION

PRODUCT EVALUATIONPRODUCT EVALUATION

• Physical examinationPhysical examination

• TestingTesting• Normal operation Normal operation • Fault conditionsFault conditions

• DocumentationDocumentation• Descriptive Report for inspectionsDescriptive Report for inspections• Certificate and product listing for clientCertificate and product listing for client

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CERTIFICATION

FOLLOW-UPFOLLOW-UP

• Manufacturing InspectionsManufacturing Inspections

• Re-ExaminationRe-Examination

• Annual feesAnnual fees

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CERTIFICATION

ELECTROMAGNETIC COMPATIBILITYELECTROMAGNETIC COMPATIBILITY

• MandatoryMandatory

• Industry CanadaIndustry Canada

• US FCC US FCC

• InternationalInternational

• HarmonizedHarmonized

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INTERNATIONAL

CB SCHEMECB SCHEME

• International agreementInternational agreement

• Harmonized standardsHarmonized standards

• Common report formatCommon report format

• Issue local certification markIssue local certification mark

• Global MarketGlobal Market

• Reduced compliance costsReduced compliance costs

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INTERNATIONAL

CE MARKCE MARK

•European Union countriesEuropean Union countries

•Product specific DirectivesProduct specific Directives

•Electronic: Low Voltage DirectiveElectronic: Low Voltage Directive

•Safety and EMC Safety and EMC

•Self-Declaration Self-Declaration

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INTERNATIONAL

WEEE DIRECTIVEWEEE DIRECTIVE

• Waste Electrical and Electronic Waste Electrical and Electronic EquipmentEquipment

• EU Member countriesEU Member countries

• Landfill contentLandfill content

• Producer responsible for recycling costsProducer responsible for recycling costs

• Manufacture with ‘friendly’ materialsManufacture with ‘friendly’ materials

• Will become CE Mark requirementWill become CE Mark requirement

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ELECTRICAL SAFETY COMPLIANCE

PURPOSEPURPOSE

• public safetypublic safety

• government requirementgovernment requirement

• liabilityliability

• marketingmarketing

• and . . .and . . .

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ELECTRICAL SAFETY COMPLIANCE

You know they’re You know they’re out there . . . out there . . .

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Questions?

Ken RutledgeCSA International

ELECTRICAL SAFETY COMPLIANCE