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ELECTROMEDICAL EQUIPMENT
:
Available format(s): Hardcopy, PDF
Withdrawn date: 05-04-2009
Language(s): English
Published date: 31-12-1998
Publisher: Canadian Standards Association
Technical Committee on Environmental ProductsTechnical Committee on Electromedical EquipmentSubcommittee on C22.2 No.125PrefaceIntroductionForeword1 Scope2 Definitions3 General Requirements 3.1 Reference Publications 3.2 Standard Classification of Electromedical Equipment 3.3 Safety Criteria 3.3.1 General 3.3.2 Risk Current 3.3.3 Patient Current Accuracy 3.4 Equipment Sets (or Systems)4 Construction 4.1 General 4.1.1 Electrical Components 4.1.2 Unassembled Equipment 4.1.3 Battery Chargers 4.2 Enclosures 4.2.1 General 4.2.2 Enclosure Strength 4.2.3 Enclosure Durability 4.2.4 Protection from Electric Shock 4.2.5 Resistance to Burning 4.2.6 Confinement of Fire Hazard 4.2.7 Source of Fire Hazard 4.2.8 Reduction of Fire Hazard to a Safe Level 4.3 Mechanical Assembly 4.3.1 General 4.3.2 Parts Subjected to Fluid Pressure 4.3.3 Stability and Transportability 4.4 Means for Limiting Hazards 4.4.1 Interlocks 4.4.2 Capacitor Discharge 4.4.3 Protection Against Ionizing Radiation 4.4.4 Equipment for Use in Oxygen Enriched Environments 4.5 Supply Connections 4.5.1 General 4.5.2 Cord-Connected Equipment 4.5.3 Equipment for Permanent Connection 4.5.4 Terminal Parts and Leads 4.6 Interconnections 4.7 Bushings 4.8 Internal Wirings 4.8.1 General 4.8.2 Protection 4.8.3 Insulation 4.8.4 Printed Wiring Boards 4.9 Motors 4.10 Transformers 4.11 Switches and controls 4.12 Overcurrent, Overload and Overtemperature Protection 4.12.1 General 4.12.2 Interconnecting Cords and Cables Overcurrent Protection 4.12.3 Limitation of Secondary Power Input 4.12.4 Motor Protection 4.13 Spacings 4.14 Separation of Circuits 4.15 Grounding for Protection from Electric Shock5 Marking 5.1 General 5.2 Marking of Therapeutic Equipment 5.3 Operating Manuals 5.4 Receptacles 5.5 Chassis Risk Current 5.6 Equipment for Permanent Connection 5.7 Interconnections 5.8 Double-Insulated Equipment 5.9 High-Voltage Equipment 5.10 Transportable Equipment6 Tests 6.1 General 6.2 Conditions for Test 6.2.1 Test Voltage 6.2.2 Frequency 6.2.3 Ambient Temperatures 6.2.4 Load 6.2.5 Test Location 6.3 Risk Current 6.3.1 General 6.3.2 Test Arrangements 6.3.3 Risk Current Test Procedure 6.4 Patient Current Accuracy Test 6.5 Rating (Input) 6.6 Temperature (Normal Load) 6.7 Dielectric Strength 6.8 Humidity and Ingress of Fluids Test 6.9 Abnormal Test 6.9.1 General 6.9.2 Compliance 6.9.3 Test Procedure 6.10 Deflection Test 6.11 Endurance Test 6.11.1 General 6.11.2 Conditioning Procedure 6.12 Drop Test 6.12.1 General 6.12.2 Procedure 6.12.3 Compliance 6.13 Impact Tests for Enclosures and Equipment 6.13.1 Cathode-Ray Tube Enclosures 6.13.2 Enclosures for Other than Cathode-Ray Tubes 6.13.3 Bench Handling Impact Test 6.14 Extreme Temperature Test 6.15 Starting 6.16 Flaming Oil Test for Other than Cathode-Ray Tubes 6.17 Molten PVC and Copper Test 6.18 Implosion Test for Cathode-Ray Tubes 6.18.1 General 6.18.2 Thermite Test 6.18.3 Liquid Nitrogen 6.19 Pressure Tests 6.20 Bond Strength of Printed Wiring Boards 6.20.1 General 6.20.2 Test Procedure 6.21 Test for Stability and Transportability7 Requirements for Specific Equipment Types 7.1 General 7.2 Defibrillators 7.2.1 Risk Current 7.2.2 Construction of Defibrillators 7.3 High Frequency Electromedical Equipment 7.3.1 General 7.3.2 Electrosurgery Equipment 7.3.3 Diathermy Equipment 7.4 Laser Surgical Equipment8 Double-Insulated Equipment 8.1 General 8.2 Mechanical Assembly 8.3 Supply Connections 8.4 Electrical Insulation 8.5 Transformers 8.6 Spacings9 Battery Powered Equipment 9.1 General 9.2 Risk Current 9.3 Resistance to Burning 9.4 Overcurrent and Overload ProtectionTablesFiguresAppendix A Notes on RequirementsAppendix B Mechanical HazardsAppendix C Flammability of Enclosures
Applicable to electromedical equipment designed for installation and use according to Part 1 of the Canadian Electrical Code, together with battery-powered equipment, not including battery implantable devices, insofar as the requirements apply.
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