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ELECTRICAL PRODUCT SAFETY Simon Fraser University School of Engineering Science. Ken Rutledge CSA International. ELECTRICAL PRODUCT SAFETY. WHY?. ELECTRICAL PRODUCT SAFETY. PURPOSE public safety government requirement liability – mfr / retail / user / etc marketing and . . . .
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ELECTRICAL PRODUCT SAFETY Simon Fraser UniversitySchool of Engineering Science Ken RutledgeCSA International
ELECTRICAL PRODUCT SAFETY PURPOSE • public safety • government requirement • liability – mfr / retail / user / etc • marketing • and . . . .
ELECTRICAL PRODUCT SAFETY BECAUSE! Someone will find a way to use your product in a way that you didn’t intend it to be used
STANDARDS WHY? • Public / Consumer Safety • Consistency – competitors / countries • Compatibility – communication / inter- connection • Global Markets • Risk mitigation
STANDARDS • Standards used to evaluate products for hazards • Hazards may be unique to class of product. ie: electro-medical products 2-part series • part-1 general requirements • 50+ ‘part 2’ product-specific requirements • CSA 2500 published standards • 350+ electrical / electronic
STANDARDS STANDARDS DEVELOPMENT • Written by consensus • Representation from: • industry • standards committees • academics • special interest groups
STANDARDS ELECTRICAL / ELECTRONIC • industrial / commercial • consumer • information technology • distribution • electro-medical
STANDARDS HARMONIZED STANDARDS • International Electrotechnical Commission - IEC • International Adoption • National Standards with differences • Global Market • Reduced compliance costs
HAZARDS TYPES OF HAZARD • fire • electric shock • energy • physical • essential performance • or . . .
HAZARDS . . . a complete lack of common sense
HAZARDS AVAILABLE CURRENT / POWER household mains branch supply: • 120V, 15A nominal • can deliver 30A / 2m before breaker trip • up to 20kA momentary fault • T-slot receptacles – 40A / 2m
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
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
HAZARDS ESSENTIAL PERFORMANCE (medical) • Non-critical function: - Stereo display 60db but actual 54db • Critical Function: - Ventilator delivery - Defibrillator impulse - ECG display
COMPLIANCE STRATEGIES FOR COMPLIANCE • Design compliance into product • Test before applying for evaluation • Preliminary consultation • Risk Management
COMPLIANCE STRATEGIES FOR COMPLIANCE • Separately approved components • External approved power supply • Fault protection • Redundant protection
CERTIFICATION PURPOSE • Independent compliance evaluation by an accredited 3rd party • Required by local regulators • Access to international markets • On-going conformity assessment • Marketing
CERTIFICATION PRODUCT EVALUATION • Physical examination • Testing • Normal operation • Fault conditions • Documentation • Descriptive Report for inspections • Certificate and product listing for client
CERTIFICATION FOLLOW-UP • Manufacturing Inspections • Re-Examination • Annual fees
CERTIFICATION ELECTROMAGNETIC COMPATIBILITY • Mandatory • Industry Canada • US FCC • International • Harmonized
INTERNATIONAL CB SCHEME • International agreement • Harmonized standards • Common report format • Issue local certification mark • Global Market • Reduced compliance costs
INTERNATIONAL CE MARK • European Union countries • Product specific Directives • Electronic: Low Voltage Directive • Safety and EMC • Self-Declaration
INTERNATIONAL WEEE DIRECTIVE • Waste Electrical and Electronic Equipment • EU Member countries • Landfill content • Producer responsible for recycling costs • Manufacture with ‘friendly’ materials • Will become CE Mark requirement
ELECTRICAL SAFETY COMPLIANCE PURPOSE • public safety • government requirement • liability • marketing • and . . .
ELECTRICAL SAFETY COMPLIANCE You know they’re out there . . .
ELECTRICAL SAFETY COMPLIANCE Questions? Ken Rutledge CSA International