1、 iANSI/HPS N43.5-2005 American National Standard Radiological Safety Standard for the Design of Radiographic and Radioscopic Non-Medical X-Ray Equipment Below 1 MeV Approved: 2005 American National Standards Institute, Inc. ii Published by Health Physics Society 1313 Dolley Madison Blvd. Suite 402 M
2、cLean, VA 22101 Copyright 2005 by the Health Physics Society All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the United States of America iiiMembers of Subcom
3、mittee N43-7 that had responsibility for the development of ANSI N 537 - 1976 are listed below. John K. Aman, Chairman K. Dieter Markert, Secretary Bernard W. Boisvert James E. Borucki Carl B. Braestrup Edward Criscuolo Otis C. Gamble David Haas Melvin L. Jackson Marcel U. Marechal Glenn O. McClurg
4、Edwin A. Miller Herbert C. Sharpe Peter J. Valaer Warren J. Weldon Members of Subcommittee N43.5 that had responsibility for the development of ANSI N43.5 - 2005 are listed below. K. Dieter Markert, Chairman John C. Taschner, Vice Chairman Gordon M. Lodde Anthony LaMastra Gregory R. Komp William Mor
5、ris Kenneth Gornto Frank Cerra iv This standard was consensus balloted and approved by the ANSI-Accredited HPS N43 Committee on July 23, 2004. At the time of balloting, the HPS N43 Committee had the following membership: Chair Gordon M. Lodde Vice Chair William Morris ABB Industrial Systems Inc. Joh
6、n R. Dukes Alliance of American Insurers Thomas F. Bresnahan American Automobile Manufacturers Association Donald A. Greschaw William Watt (alt.) David A. Felinski (alt.) American Conference of Governmental Industrial Hygienists Gordon M. Lodde American Crystallographic Association Camden Hubbard Am
7、erican Insurance Services Group Stewart M. Fastman American Iron and Steel Institute Anthony LaMastra Peter A. Hernandez (alt.) American Public Health Assoc., Inc. Jesse Lieberman American Society for Nondestructive Testing, Inc. K. Dieter Markert American Society for Testing and Materials Marvin M.
8、 Turkanis American Welding Society Edward L. Criscuolo Atomic Energy Control Board R. E. Irwin Conference of Radiation Control Program Directors Mike Henry Bart Lago (alt.) Health Physics Society Sandy Perle William Harris (alt.) National Council on Radiation Protection and Measurements Susan M. Lan
9、ghorst National Institute of Standards and Technology Douglas M. Eagleson James W. Tracy (alt.) Nuclear Regulatory Commission John P. Jankovich Underwriters Laboratories, Inc. Peter Boden David Dini (alt.) Univ. of California (Los Alamos Natl Lab) VACANT U.S. Dept of the Air Force, Office of the Sur
10、geon General Ramachandra K. Bhat U.S. Dept of the Army, Office of the Surgeon General Frances Szrom U.S. Dept of the Army, Army Material Command Gregory R. Komp U.S. Dept of Energy Peter OConnell Joel Rabovsky (alt.) U.S. Dept of the Navy David E. Farrand William Morris (alt.) Steven Doremus (alt.)
11、U.S. Dept of Health and Human Services - Public Health H. Thompson Heaton Frank Cerra (alt.) Individual Members John C. Taschner David Lee vTable of Contents Preface .1 1. Scope 1 2. Definitions and acronyms 1 3. Instructions 2 3.1 Installation instructions 2 3.2 Operation Instructions .3 3.3 Instru
12、ction manual .3 4. Controls .3 4.1 Line power control .3 4.2 Key switch .4 4.3 “X-ray on” control.4 4.4 “X-ray” off control.4 4.5 “X-ray production limiting device .4 5. Control panel display4 5.1 Visual indicators 4 5.2 Line power indicator 5 5.3 High voltage indicator5 5.4 Selection indicator (s)
13、for x-ray tube assembly (s) and focal spot .5 5.5 “X-ray on” indicators 5 6. Radiation warning indicators .5 6.1 Warning displays on equipment 5 6.2 Warning devices for the x-ray tube assembly .6 6.3 External warning system .6 6.4 Shutter status indicators6 7. Safety interlocks.6 8. X-ray tube assem
14、bly 6 8.1 Classification .6 8.2 Incorporated items.6 8.3 Measurement of x-ray tube assembly leakage radiation 6 8.4 X-ray tube assembly classification label .7 9. Beam limitation .7 10. Radioscopic and radiographic x-ray equipment shielding7 10.1 General7 10.2 Design considerations for viewing radio
15、scopic output 7 11. Other considerations 7 11.1 Ground fault.7 11.2 Automatically discharging capacitors 8 12. Revision of American National Standards referred to in this document 8 vi Annex: Radiation measurements .9 A1 Preface .9 A2 Instrumentation .9 A3 Special instructions requirements.9 A4 Meas
16、urement of the useful beam .10 A5 Radiation protection surveys.10 A6 References11 1AMERICAN NATIONAL STANDARD Preface This standard provides guidelines specific to the radiation safety aspects of the design of non-medical x-ray equipment operating at energies below 1 MeV for radiographic and radiosc
17、opic applications, wherein the x-rays are generated by electronic means. It does not apply to x-ray equipment used for industrial gauging applications. The objective is to achieve safe design of non-medical x-ray equipment by establishing requirements for some components that are critical for radiat
18、ion safety. These include controls, panel displays, warning indicators, tube assembly, and shielding. Other considerations, which are generally the responsibility of the manufacturer, are also included. These include instructions, provisions for means of connecting interlocks, and labeling. 1. Scope
19、 This standard provides guidelines specific to the radiation safety aspects of the design of non-medical x-ray equipment operating at energies below 1 MeV for radiographic and radioscopic applications, wherein the x-rays are generated by electronic means. It does not apply to x-ray equipment used fo
20、r industrial gauging applications. It does not include safety guidelines or considerations outside the realm of radiation safety. 2. Definitions and Acronyms The definitions and terms contained in this standard, or in other American National Standards referred to in this document, are not intended t
21、o embrace all legitimate meanings of the terms. They are applicable only to the subject treated in this standard. Accessory: An optional component part intended for attachment to or use with x-ray equipment that, when attached or used, affects quantity, quality, or direction of x-rays. C/kg: Coulomb
22、s/kilogram. ANSI/HPS N43.5-2005 Control Panel: A device containing means for regulation and activation of x-ray equipment or for the preselection and indications of operating factors. Deadman switch: A device so designed that a closed circuit can be maintained only by continuous operator pressure. G
23、round fault: An accidental electrical grounding of an electrical conductor. Key switch: A device that requires a key for making and breaking electrical connections. Leakage radiation: Radiation, other than the useful (or primary) beam, emitted from the x-ray tube assembly. Line Power Switch: A devic
24、e for making and breaking the connections to the electrical supply. Manufacturer: Any person engaged in the business of manufacturing, assembling, or importing x-ray equipment. Non-shielded x-ray tube assembly: An x-ray tube assembly that does not meet the requirements of paragraph 8.1.2 of this sta
25、ndard. Radiation safety interlock: A device for precluding access to an area of radiation hazard by automatically removing the hazard. Radiograph: An image of an object produced on a sensitive medium (such as a radiographic film) by photons (or x-rays). Radiographic: Relates to the process that depe
26、nds on the differential absorption of photons (or x-rays) transmitted through an object to produce a radiograph. Radioscopic: The electronic production of a radiologically generated image that follows very closely the changes with time of the object being imaged. 1Real-time radioscopy: Radioscopy th
27、at is capable of following the motion of the object without limitation of time. Scatter radiation: Radiation that has been deviated in direction as a result of the interaction of the photons with matter and has usually been reduced in energy. Shall: Where “shall” is used for a provision in this stan
28、dard, that provision is intended to be a requirement if the purpose and intent of this standard are to be achieved. Shielded x-ray tube assembly: An x-ray tube assembly designed to meet the requirements of paragraph 8.1.1 of this standard. Should: Where “should” is used for a provision in this stand
29、ard, that provision is not required but is recommended as good practice. Shutter: A movable device used to block the useful (or primary) beam emitted from an x-ray tube assembly. Stray radiation: Radiation other than the useful (or primary) beam. It includes leakage and scatter radiation. Supplier:
30、The person or organization from which the user buys or takes delivery of a product. Timer: A time-measuring device designed to automatically make or break electrical connections at the end of a preset time interval. User: That person or organization that will have administrative control over the equ
31、ipment. Useful beam: All the primary radiation from a x-ray tube assembly that emerges through open shutter(s), collimator, diaphragm, or cone. X-ray tube assembly: A tube housing with the tube installed. It may include high voltage and filament transformers and other appropriate elements when they
32、are contained within the tube housing. 3. Instructions Written instructions for the installation, assembly, interconnection, adjustment, and test of each x-ray unit or accessory shall be supplied by the manufacturer or supplier of such equipment at the time of sale or transfer to the first user if t
33、he manufacturer or supplier is not providing the services for the user. 3.1 Installation instructions 3.1.1 Installation instructions shall describe radiation safety considerations pertaining to positioning and fastening each unit or accessory in place. 3.1.2 Assembly instructions shall include inst
34、ructions for assembly operations not performed by the manufacturer. 3.1.3 Interconnection instructions shall include at least the descriptions of cable and wire connections not performed by the manufacturer. Examples include interconnection of radiation safety interlock systems, warning light system
35、s, and audible alarm systems not supplied by the manufacturer. 2 3.1.4 Test instructions shall include a description of the steps necessary for the user to determine that the x-ray system and accessory components are operating properly. Test instructions shall also include descriptions of the steps
36、necessary for the user to evaluate the interlock systems, warning lights, and other radiation safety devices. Prior to routine operation, a qualified expert shall perform a radiological survey of the installation. (See Annex.) 3.1.5 Instructions shall state that when any component affecting the radi
37、ation safety of the x-ray system is serviced or replaced a qualified expert shall perform a radiological survey of the installation to ensure continuity of adequate personnel radiation safety. 3.1.6 Instructions shall include a warning of radiation hazards caused by the improper installation and use
38、 of the x-ray equipment. 3.1.7 Instructions shall state the classification of the x-ray tube assembly. (See paragraph 8.1.) 3.1.8 Written instructions shall state that both the supplier and the user should acknowledge in writing the final acceptance. 3.1.9 The person who installs the x-ray equipment
39、 should acknowledge in writing to the supplier/manufacturer that the installation has been performed according to the manufacturers instructions. 3.1.10 The user should acknowledge in writing to the supplier/manufacturer that the interlock system, warning lights, and other radiation safety devices w
40、ere all operating properly after installation. 3.2 Operation instructions The manufacturer or supplier of the equipment at the time of sale and/or transfer to the first user shall supply written instructions for the operation of the x-ray unit or accessory equipment. These instructions shall: 3.2.1
41、Direct the user to consult governmental regulations and industry standards governing the operation of x-ray equipment. 3.2.2 Inform the user of the need for proper operational and radiation safety training and supervision in the use of x-ray equipment. 3.2.3 Describe personnel dosimetry and survey d
42、evices suitable for measurements associated with the use of the equipment and accessories. Such instructions shall include the characteristics of the radiation to be measured and may include reference to specific commercially available instruments. 3.2.4 Include a warning of radiation hazards caused
43、 by the improper use of x-ray equipment. The warning shall include the classification of the x-ray tube assembly. 3.2.5 Include concise descriptions of shutdown procedures to be followed by the operator in case of emergency. 3.2.6 Include periodic equipment safety check and maintenance procedures, w
44、ith the suggested frequency with which such procedures shall be performed. 3.3 Instruction manual 3An instruction manual should be obtainable from the manufacturer for at least 7 years from the date of initial purchase of the equipment. The cost of the instruction manual should not exceed the overhe
45、ad cost of printing and distribution. The instruction manual should direct the user to report accidental radiation occurrences (AROs) to the manufacturer so that they may be reported to the Food and Drug Administration as required in 21 CFR 1002.20. 4. Controls 4.1 Line power control 4.1.1 The contr
46、ol panel shall be equipped with a device that shall disconnect the line power to all components involved in the production of x-rays. This function can be accomplished by a device such as, but not limited to, a “power switch” or a “circuit breaker.” It is not necessary to be able to disconnect the l
47、ine power to components independent from the production of x-rays such as, but not limited to, cooling pumps. 4.1.2 The function and the “on-off” positions of the component disconnecting the line power shall be clearly marked. 4.1.3 When toggle- or lever-type switches are used, the “on” position sha
48、ll be the uppermost, or the most forward, or the most right. 4.1.4 When rotary-type switches are used, the “on” position shall be clockwise. 4.2 Key switch 4.2.1 The control panel shall be equipped with a positive control that shall prevent the production of x-rays when in the “off” position. Exampl
49、es of positive controls include key switches and password-protected computer controls. 4.2.2 If a key is used it shall be removable only when the switch is in the “off” position. 4.2.3 The function and the “on” and “off ” position of the key switch shall be clearly marked. 4.2.4 When toggle- or lever-type key switches are used, the “on” position shall be the uppermost, or the most forward, or the most right. 4.2.5 When rotary-type key switches are used, the “on” position shall be clockwise. 4.3 “X-ray on” contr
