1. Simon Fraser University School of Engineering Science ELECTRICAL PRODUCT SAFETY Simon Fraser University School of Engineering Science Ken Rutledge CSA International

2. 2 ELECTRICAL PRODUCT SAFETY WHY?

3. 3 PURPOSE public safety public safety government requirement government requirement liability – mfr / retail / user / etc liability – mfr / retail / user / etc marketing marketing and.... and.... ELECTRICAL PRODUCT SAFETY

4. 4 BECAUSE! Someone will find a way to use your product in a way that you didn’t intend it to be used ELECTRICAL PRODUCT SAFETY

5. 5 STANDARDS WHY? Public / Consumer Safety Public / Consumer Safety Consistency – competitors / countries Consistency – competitors / countries Compatibility – communication / inter- connection Compatibility – communication / inter- connection Global Markets Global Markets Risk mitigation Risk mitigation

6. 6 STANDARDS Standards used to evaluate products for hazards Standards used to evaluate products for hazards Hazards may be unique to class of product. ie: electro-medical products 2-part series 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 CSA 2500 published standards 350+ electrical / electronic 350+ electrical / electronic

7. 7 STANDARDS STANDARDS DEVELOPMENT Written by consensus Written by consensus Representation from: Representation from:  industry  standards committees  academics  special interest groups

8. 8 STANDARDS ELECTRICAL / ELECTRONIC  industrial / commercial  consumer  information technology  distribution  electro-medical

9. 9 STANDARDS HARMONIZED STANDARDS International Electrotechnical Commission - IEC International Electrotechnical Commission - IEC International Adoption International Adoption National Standards with differences National Standards with differences Global Market Global Market Reduced compliance costs Reduced compliance costs

10. 10 HAZARDS TYPES OF HAZARD fire fire electric shock electric shock energy energy physical physical essential performance essential performance or... or...

11. 11 HAZARDS... a complete lack of common sense

12. 12 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

13. 13 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

14. 14 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

15. 15 HAZARDS ESSENTIAL PERFORMANCE (medical) Non-critical function: Non-critical function: - Stereo display 60db but actual 54db Critical Function: Critical Function: - Ventilator delivery - Defibrillator impulse - ECG display

16. 16 COMPLIANCE STRATEGIES FOR COMPLIANCE Design compliance into product Design compliance into product Test before applying for evaluation Test before applying for evaluation Preliminary consultation Preliminary consultation Risk Management Risk Management

17. 17 COMPLIANCE STRATEGIES FOR COMPLIANCE Separately approved components Separately approved components External approved power supply External approved power supply Fault protection Fault protection Redundant protection Redundant protection

18. 18 CERTIFICATION PURPOSE Independent compliance evaluation by an accredited 3 rd party Independent compliance evaluation by an accredited 3 rd party Required by local regulators Required by local regulators Access to international markets Access to international markets On-going conformity assessment On-going conformity assessment Marketing Marketing

19. 19 CERTIFICATION PRODUCT EVALUATION Physical examination Physical examination Testing Testing Normal operationNormal operation Fault conditionsFault conditions Documentation Documentation Descriptive Report for inspectionsDescriptive Report for inspections Certificate and product listing for clientCertificate and product listing for client

20. 20 CERTIFICATION FOLLOW-UP Manufacturing Inspections Manufacturing Inspections Re-Examination Re-Examination Annual fees Annual fees

21. 21 CERTIFICATION ELECTROMAGNETIC COMPATIBILITY Mandatory Mandatory Industry Canada Industry Canada US FCC US FCC International International Harmonized Harmonized

22. 22 INTERNATIONAL CB SCHEME International agreement International agreement Harmonized standards Harmonized standards Common report format Common report format Issue local certification mark Issue local certification mark Global Market Global Market Reduced compliance costs Reduced compliance costs

23. 23 INTERNATIONAL CE MARK European Union countries European Union countries Product specific Directives Product specific Directives Electronic: Low Voltage Directive Electronic: Low Voltage Directive Safety and EMC Safety and EMC Self-Declaration Self-Declaration

24. 24 INTERNATIONAL WEEE DIRECTIVE Waste Electrical and Electronic Equipment Waste Electrical and Electronic Equipment EU Member countries EU Member countries Landfill content Landfill content Producer responsible for recycling costs Producer responsible for recycling costs Manufacture with ‘friendly’ materials Manufacture with ‘friendly’ materials Will become CE Mark requirement Will become CE Mark requirement

25. 25 ELECTRICAL SAFETY COMPLIANCEPURPOSE public safety public safety government requirement government requirement liability liability marketing marketing and... and...

26. 26 ELECTRICAL SAFETY COMPLIANCE You know they’re out there...

27. 27 Questions? Ken Rutledge CSA International ELECTRICAL SAFETY COMPLIANCE