Technical Committee on Environmental Products
Technical Committee on Electromedical Equipment
Subcommittee on C22.2 No.125
Preface
Introduction
Foreword
1 Scope
2 Definitions
3 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 Shock
5 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 Equipment
6 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 Transportability
7 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 Equipment
8 Double-Insulated Equipment
    8.1 General
    8.2 Mechanical Assembly
    8.3 Supply Connections
    8.4 Electrical Insulation
    8.5 Transformers
    8.6 Spacings
9 Battery Powered Equipment
    9.1 General
    9.2 Risk Current
    9.3 Resistance to Burning
    9.4 Overcurrent and Overload Protection
Tables
Figures
Appendix A Notes on Requirements
Appendix B Mechanical Hazards
Appendix C Flammability of Enclosures