Upload
oswald-wilkerson
View
219
Download
0
Tags:
Embed Size (px)
Citation preview
ELECTRICAL PRODUCT SAFETY
Simon Fraser UniversitySimon Fraser UniversitySchool of Engineering ScienceSchool of Engineering Science
Ken RutledgeCSA International
2
ELECTRICAL PRODUCT SAFETY
WHY?WHY?
3
PURPOSEPURPOSE
• public safetypublic safety
• government requirementgovernment requirement
• liability – liability – mfr / retail / user / etcmfr / retail / user / etc
• marketingmarketing
• and . . . .and . . . .
ELECTRICAL PRODUCT SAFETY
4
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
5
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
6
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
7
STANDARDS
STANDARDS DEVELOPMENTSTANDARDS DEVELOPMENT
•Written by consensusWritten by consensus
•Representation from:Representation from: industryindustry standards committeesstandards committees academicsacademics special interest groupsspecial interest groups
8
STANDARDS
ELECTRICAL / ELECTRONICELECTRICAL / ELECTRONIC
industrial / commercialindustrial / commercial consumerconsumer information technologyinformation technology distributiondistribution electro-medicalelectro-medical
9
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
10
HAZARDS
TYPES OF HAZARDTYPES OF HAZARD
• firefire
• electric shockelectric shock
• energyenergy
• physical physical
• essential performanceessential performance
• or . . . or . . .
11
HAZARDS
. . . a complete lack of common sense
12
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
13
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
14
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
15
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
16
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
17
COMPLIANCE
STRATEGIES FOR COMPLIANCESTRATEGIES FOR COMPLIANCE
• Separately approved componentsSeparately approved components
• External approved power supplyExternal approved power supply
• Fault protectionFault protection
• Redundant protectionRedundant protection
18
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
19
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
20
CERTIFICATION
FOLLOW-UPFOLLOW-UP
• Manufacturing InspectionsManufacturing Inspections
• Re-ExaminationRe-Examination
• Annual feesAnnual fees
21
CERTIFICATION
ELECTROMAGNETIC COMPATIBILITYELECTROMAGNETIC COMPATIBILITY
• MandatoryMandatory
• Industry CanadaIndustry Canada
• US FCC US FCC
• InternationalInternational
• HarmonizedHarmonized
22
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
23
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
24
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
25
ELECTRICAL SAFETY COMPLIANCE
PURPOSEPURPOSE
• public safetypublic safety
• government requirementgovernment requirement
• liabilityliability
• marketingmarketing
• and . . .and . . .
26
ELECTRICAL SAFETY COMPLIANCE
You know they’re You know they’re out there . . . out there . . .
27
Questions?
Ken RutledgeCSA International
ELECTRICAL SAFETY COMPLIANCE