UL 416-1993 UL Standard for Safety Refrigerated Medical Equipment (Fourth Edition Reprint with Revisions Through and Including September 27 2013)《制冷医疗设备》.pdf

1、UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL 416 Refrigerated Medical EquipmentUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM ULUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER

2、 REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL Standard for Safety for Refrigerated Medical Equipment, UL 416 Fourth Edition, Dated August 30, 1993 Summary of Topics This revision to UL 416 is being issued to remove the reference to the withdrawal date of UL 873 and to address universal

3、 upkeep of UL Standards for Safety. These revisions are considered to be non-substantive and not subject to ULs STP process. Text that has been changed in any manner or impacted by ULs electronic publishing system is marked with a vertical line in the margin. Changes in requirements are marked with

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10、SEDED REQUIREMENTS notice. SEPTEMBER 27, 2013 UL 416 tr1UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL SEPTEMBER 27, 2013 UL 416 tr2 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT

11、 PERMISSION FROM UL AUGUST 30, 1993 (Title Page Reprinted: September 27, 2013) 1 UL 416 Standard for Refrigerated Medical Equipment The First and Second editions were titled Standard for Oxygen Therapy Equipment, Refrigerated. First Edition August, 1956 Second Edition May, 1973 Third Edition July, 1

12、978 Fourth Edition August 30, 1993 This UL Standard for Safety consists of the Fourth Edition including revisions through September 27, 2013. Comments or proposals for revisions on any part of the Standard may be submitted to UL at any time. Proposals should be submitted via a Proposal Request in UL

13、s On-Line Collaborative Standards Development System (CSDS) at http:/. ULs Standards for Safety are copyrighted by UL. Neither a printed nor electronic copy of a Standard should be altered in any way. All of ULs Standards and all copyrights, ownerships, and rights regarding those Standards shall rem

14、ain the sole and exclusive property of UL. COPYRIGHT 2013 UNDERWRITERS LABORATORIES INC.UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL MARCH 16, 2010 REFRIGERATED MEDICAL EQUIPMENT - UL 416 2 No Text on This PageUL COPYRIGHTED MATERIAL NOT

15、AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL CONTENTS INTRODUCTION 1 Scope .5 2 General 5 2.1 Components .5 2.2 Units of measurement .6 2.3 Terminology .6 2.4 Undated references .6 3 Glossary .6 4 Installation and Operating Instructions .8 CONSTRUCTION 5 General 8 6

16、 Assembly 9 6.1 General .9 6.2 Mechanical protection .9 6.3 Electrical protection 10 7 Accessories .14 8 Enclosures 15 8.1 General 15 8.2 Doors and covers .19 9 Field Supply Connections .20 9.1 General 20 9.2 Permanently connected products 21 9.3 Cord connected products .24 9.4 Grounding .24A 10 Int

17、ernal Wiring and Wiring Methods .25 10.1 General .25 10.2 Permanently connected products .28 10.3 Cord-connected products 28A 11 Separation of Circuits .29 11.1 Patient care equipment .29 11.2 Nonpatient equipment 30 12 Bonding for Grounding 30 ELECTRICAL COMPONENTS 13 Capacitors .33 14 Current-Carr

18、ying Parts 33 15 Electric Heaters 34 15.1 Heater elements .34 15.2 Heater control 35 16 Insulating Material 35 17 Lampholders and Lamps 35 18 Motors and Motor Overload Protection 36 19 Overcurrent Protection 38 20 Printed Wiring 38 21 Receptacles 38 22 Switches and Controllers 39 MARCH 16, 2010 REFR

19、IGERATED MEDICAL EQUIPMENT - UL 416 2AUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL 23 Transformers .40 23.1 Construction .40 23.2 Patient care equipment .41 23.3 Nonpatient equipment 41 24 Valves and Solenoids .41 25 Spacings 42 25.1 High

20、-voltage circuits 42 25.3 Patient-connected circuits .44 25.4 Low-voltage circuits .44 REFRIGERATION SYSTEM 26 Refrigerant .44A 27 Refrigerant Tubing and Fittings 44A 28 Refrigerant-Containing Parts .45 29 Pressure Limiting Device 46 30 Pressure Relief .46 30.1 General .46 30.2 Required discharge ca

21、pacity .47 30.3 Relief valves .47 30.4 Fusible plugs or rupture members 48 PERFORMANCE 31 Instrumentation .48 31.1 Temperature measurements .48 31.2 Pressure measurements 49 32 Test Voltage .49 33 Leakage Current Test .49 33.1 General .49 33.2 Permanently connected equipment .50 33.3 Cord-connected

22、equipment 50 33.4 Patient care equipment .50 33.5 Isolated patient connections .51 33.6 Nonpatient equipment .52A 33.7 Test methods 53 34 Input Test 56 35 Starting Test .56 36 Temperature and Pressure Test 57 37 Heating Test .61 38 Dielectric Voltage Withstand Test .62 39 Condenser Fan Motor Failure

23、 Test 64 40 Condenser Water Failure Test 64 41 Overow Test 65 42 Cleaning and Sterilization Test .65 43 Stability Test .66 44 Mechanical Abuse 67 45 Grounding Impedance Test 67 46 Endurance Test Heater Control .67 47 Burnout Tests 68 47.1 Electric heaters 68 47.2 Other components 68 48 Overvoltage a

24、nd Undervoltage Tests 69 MAY 14, 2004 REFRIGERATED MEDICAL EQUIPMENT - UL 416 2BUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL 49 Current Overload Test Bonding Conductors and Connections 70 50 Insulation Resistance Test .70 50.1 Heaters .70

25、 50.2 Thermal and/or acoustical insulating material 70 51 Limited Short-Circuit Test 71 51.1 General .71 51.2 Motor overload protective devices 72 51.3 Bonding conductors and connections .72 51.4 Motor circuit conductors and connections .72 52 Protective Devices Maximum Continuous Current Test 72 53

26、 Accelerated Aging Test Electric Heaters .74 54 Reliability Test Heater Termination 75 55 Abnormal Operation Test 75 55.1 General .75 55.2 Transformers 77 55.3 Electrolytic capacitor and rectier short-circuit tests .78 56 Printed Wiring Assembly Tests 78A 56.1 Dielectric voltage withstand 78A 56.2 L

27、imited power 79 56.3 Abnormal operation .79 57 Strength Test Pressure Containing Components 80 58 Marking Label Adhesion Tests .81 58.1 General .81 58.2 Oven-aging test 81 58.3 Immersion test .82 58.4 Standard-atmosphere test .82 58.5 Unusual-condition exposure test .82 59 Additional Tests 82 MANUFA

28、CTURING AND PRODUCTION TESTS 60 Pressure Test 82 61 Production Line Dielectric Voltage Withstand Test 83 62 Production Line Grounding Continuity Test .84A MARKING 63 General 84B 64 Permanently Connected Products .86A 65 Cord Connected Products .90 66 Caution and Warning Markings .90 66.1 General .90

29、 66.2 Servicing 91 66.3 Fuse replacement 91 66.4 Flammable anesthetics 91 66.5 Oxygen administering equipment .91 APPENDIX A Standards for ComponentsA1 MARCH 16, 2010 REFRIGERATED MEDICAL EQUIPMENT - UL 416 3UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERM

30、ISSION FROM UL This page intentionally left blank. MAY 14, 2004 REFRIGERATED MEDICAL EQUIPMENT - UL 416 4UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL INTRODUCTION 1 Scope 1.1 These requirements cover refrigerated medical equipment such as

31、 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-compress

32、ors 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 (te

33、nt), 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 ammable anesthetics, as dened in the National Electrical Code, NFPA 70. 1.4 The requirements of this Standard do not con

34、sider the complete spectrum of physiological or therapeutic effects, benecial or otherwise, except where generally accepted limits for potentially hazardous conditions are dened. Devices which necessitate the utilization of conditions exceeding such accepted limits for patient treatment are intended

35、 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 deve

36、loped, and that involves a risk of re, 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 s

37、tandard. 2 General 2.1 Components 2.1.1 Except as indicated in 2.1.2, a component of a product covered by this standard shall comply with the requirements for that component. See Appendix A for a list of standards covering components generally used in the products covered by this standard. 2.1.2 A c

38、omponent need not comply with a specic requirement that: a) Involves a feature or characteristic not needed in the application of the component in the product covered by this standard, or b) Is superseded by a requirement in this standard. 2.1.3 A component shall be used in accordance with its recog

39、nized rating established for the intended conditions of use. 2.1.4 Specic components are recognized as being incomplete in construction features or restricted in performance capabilities. Such components are intended for use only under limited conditions, such as certain temperatures not exceeding s

40、pecied limits, and shall be used only under those specic conditions for which they have been recognized. AUGUST 30, 1993 REFRIGERATED MEDICAL EQUIPMENT - UL 416 5UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL 2.2 Units of measurement 2.2.1

41、If a value for measurement is followed by a value in other units in parentheses, the second value may be only approximate. The rst stated value is the requirement. 2.3 Terminology 2.3.1 The term product refers to any equipment covered by the Scope of this standard. 2.4 Undated references 2.4.1 Any u

42、ndated reference to a code or standard appearing in the requirements of this standard shall be interpreted as referring to the latest edition of that code or standard. 3 Glossary 3.1 For the purpose of this Standard, the following denitions apply. 3.2 ACCESSIBLE PART A part located so that it can be

43、 contacted by a person, either directly or by means of a probe or tool, or that is not recessed the required distance behind an opening. See Assembly. 3.3 ACCESSORY An optional electrical device or other component, intended for installation in or connection to refrigerated medical equipment for the

44、purpose of modifying or supplementing the functions of the equipment. It may be factory installed or intended for installation by the user or service personnel. 3.4 DOUBLE INSULATION An insulation system comprised of both functional insulation and supplementary insulation. See 3.7, 3.19, and 3.22. 3

45、.5 ENCLOSURE An external portion of a product that serves to house and/or support component parts. Enclosures of patient care equipment likely to be contacted by a patient include items such as bedside monitors, bed frames, dental chairs, oxygen therapy equipment, and examination stands. 3.6 FIELD-W

46、IRING TERMINAL Any terminal to which power supply, control, or equipment grounding connections will be made in the eld when the product is installed. 3.7 FUNCTIONAL INSULATION The insulation necessary for the proper functioning of the product and for basic protection against electric shock. 3.8 INTE

47、RLOCK A device used to de-energize electrical components or stop moving parts that may cause injury to persons that become exposed when an enclosure is opened or when a cover is removed. 3.9 ISOLATING TRANSFORMER A transformer of which one or more output windings is electrically separated from the i

48、nput winding and all other output windings by an insulation at least equivalent to double and/or reinforced insulation. 3.10 LEAKAGE CURRENT Leakage current refers to any current, including capacitively-coupled currents, which may be conveyed from accessible parts of a product to ground or other acc

49、essible parts of the product and which is not intended to be applied to a patient. AUGUST 30, 1993 REFRIGERATED MEDICAL EQUIPMENT - UL 416 6UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL 3.11 LIMITED ENERGY CIRCUIT A limited energy circuit is one in which the product and wiring is incapable of releasing sufficient electrical or thermal energy under normal or abnormal conditions to cause ignition of cotton in an oxygen-e