UL 416
Standard for Refrigerated Medical Equipment

DETAILS
Edition Number:4SCC Approved:--
Edition Date:1993-08-30DOD Approved: --
Price Code:BANSI Approved: --
Type:ulstd

  • SCOPE

    1 Scope

    1.1 These requirements cover refrigerated medical equipment such as thermia and oxygen therapy devices for use in hospitals, nursing homes, medical care centers, medical and dental offices, and similar health care facilities in accordance with the National Electric Code, NFPA 70.

    1.2 Equipment covered by these requirements employ hermetic refrigerant motor-compressors and air- or water-cooled condensers, designed for use on alternating current circuits rated not more than 600 volts. These requirements take into consideration the hazards resulting from the presence of oxygen and the intended use of oxygen administering equipment but do not cover the canopy (tent), or oxygen storage and distribution systems with which the equipment may be used.

    1.3 These requirements do not cover equipment for use in hazardous locations, with respect to flammable anesthetics, as defined in the National Electrical Code, NFPA 70.

    1.4 The requirements of this Standard do not consider the complete spectrum of physiological or therapeutic effects, beneficial or otherwise, except where generally accepted limits for potentially hazardous conditions are defined. Devices which necessitate the utilization of conditions exceeding such accepted limits for patient treatment are intended for use by or under the supervision of licensed medical persons. Such equipment shall be provided with warnings prominently displayed on the device.

    1.5 A product that contains features, characteristics, components, materials, or systems new or different from those in use when the standard was developed, and that involves a risk of fire, electric shock, or injury to persons shall be evaluated using the appropriate additional component and end-product requirements as determined necessary to maintain the level of safety for the user of the product as originally anticipated by the intent of this standard.

  • TABLE OF CONTENTS
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    • Cover
    • Transmittal
    • Table of Contents
    • UL Foreword
      • Body
        • INTRODUCTION
          • 1 Scope
          • 2 General
            • 2.1 Components
            • 2.2 Units of measurement
            • 2.3 Terminology
            • 2.4 Undated references
          • 3 Glossary
          • 4 Installation and Operating Instructions
        • CONSTRUCTION
          • 5 General
          • 6 Assembly
            • 6.1 General
            • 6.2 Mechanical protection
            • 6.3 Electrical protection
          • 7 Accessories
          • 8 Enclosures
            • 8.1 General
            • 8.2 Doors and covers
          • 9 Field Supply Connections
            • 9.1 General
            • 9.2 Permanently connected products
            • 9.3 Cord connected products
            • 9.4 Grounding
          • 10 Internal Wiring and Wiring Methods
            • 10.1 General
            • 10.2 Permanently connected products
            • 10.3 Cord-connected products
          • 11 Separation of Circuits
            • 11.1 Patient care equipment
            • 11.2 Nonpatient equipment
          • 12 Bonding for Grounding
        • ELECTRICAL COMPONENTS
          • 13 Capacitors
          • 14 Current-Carrying Parts
          • 15 Electric Heaters
            • 15.1 Heater elements
            • 15.2 Heater control
          • 16 Insulating Material
          • 17 Lampholders and Lamps
          • 18 Motors and Motor Overload Protection
          • 19 Overcurrent Protection
          • 20 Printed Wiring
          • 21 Receptacles
          • 22 Switches and Controllers
          • 23 Transformers
            • 23.1 Construction
            • 23.2 Patient care equipment
            • 23.3 Nonpatient equipment
          • 24 Valves and Solenoids
          • 25 Spacings
            • 25.1 High-voltage circuits
            • 25.3 Patient-connected circuits
            • 25.4 Low-voltage circuits
        • REFRIGERATION SYSTEM
          • 26 Refrigerant
          • 27 Refrigerant Tubing and Fittings
          • 28 Refrigerant-Containing Parts
          • 29 Pressure Limiting Device
          • 30 Pressure Relief
            • 30.1 General
            • 30.2 Required discharge capacity
            • 30.3 Relief valves
            • 30.4 Fusible plugs or rupture members
        • PERFORMANCE
          • 31 Instrumentation
            • 31.1 Temperature measurements
            • 31.2 Pressure measurements
          • 32 Test Voltage
          • 33 Leakage Current Test
            • 33.1 General
            • 33.2 Permanently connected equipment
            • 33.3 Cord-connected equipment
            • 33.4 Patient care equipment
            • 33.5 Isolated patient connections
            • 33.6 Nonpatient equipment
            • 33.7 Test methods
          • 34 Input Test
          • 35 Starting Test
          • 36 Temperature and Pressure Test
          • 37 Heating Test
          • 38 Dielectric Voltage Withstand Test
          • 39 Condenser Fan Motor Failure Test
          • 40 Condenser Water Failure Test
          • 41 Overflow Test
          • 42 Cleaning and Sterilization Test
          • 43 Stability Test
          • 44 Mechanical Abuse
          • 45 Grounding Impedance Test
          • 46 Endurance Test – Heater Control
          • 47 Burnout Tests
            • 47.1 Electric heaters
            • 47.2 Other components
          • 48 Overvoltage and Undervoltage Tests
          • 49 Current Overload Test – Bonding Conductors and Connections
          • 50 Insulation Resistance Test
            • 50.1 Heaters
            • 50.2 Thermal and/or acoustical insulating material
          • 51 Limited Short-Circuit Test
            • 51.1 General
            • 51.2 Motor overload protective devices
            • 51.3 Bonding conductors and connections
            • 51.4 Motor circuit conductors and connections
          • 52 Protective Devices – Maximum Continuous Current Test
          • 53 Accelerated Aging Test – Electric Heaters
          • 54 Reliability Test – Heater Termination
          • 55 Abnormal Operation Test
            • 55.1 General
            • 55.2 Transformers
            • 55.3 Electrolytic capacitor and rectifier short-circuit tests
          • 56 Printed Wiring Assembly Tests
            • 56.1 Dielectric voltage withstand
            • 56.2 Limited power
            • 56.3 Abnormal operation
          • 57 Strength Test – Pressure Containing Components
          • 58 Marking Label Adhesion Tests
            • 58.1 General
            • 58.2 Oven-aging test
            • 58.3 Immersion test
            • 58.4 Standard-atmosphere test
            • 58.5 Unusual-condition exposure test
          • 59 Additional Tests
        • MANUFACTURING AND PRODUCTION TESTS
          • 60 Pressure Test
          • 61 Production Line Dielectric Voltage Withstand Test
          • 62 Production Line Grounding Continuity Test
        • MARKING
          • 63 General
          • 64 Permanently Connected Products
          • 65 Cord Connected Products
          • 66 Caution and Warning Markings
            • 66.1 General
            • 66.2 Servicing
            • 66.3 Fuse replacement
            • 66.4 Flammable anesthetics
            • 66.5 Oxygen administering equipment
    • APPENDIX A