1、 American National Standard ANSI/HPS 43.6-2007 Sealed Radioactive Sources Classification Approved August 2007 Reaffirmed September 2013 American National Standards Institute, Inc. Published by Health Physics Society 1313 Dolley Madison Blvd. Suite 402 McLean, VA 22101 Copyright 2007 by the Health Ph
2、ysics 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 ANSI/HPS N43.6-2007 (R2013) ANSI/HPS N43.6-2007 iii The Accredited
3、 Standards Committee N43 subcommittees responsible for generating this standard had the following members: Members of the original subcommittee that produced ANSI N5.10: Barrer, L. Ferraro, E. Milau, J. Beauchamp, E. Gerhart, J. Miller, W. (chairperson) Hendrickson, J. Niemeyer, R. Brown, R. Hetheri
4、ngton, C. ONeill, J. Coleman, E. Horn, L. Santoro, M. Cook, H. L. Howard, N. Selander, C. Dooley, H. Karp, W. Smith, D. Dukes, J. Kreiger, H. Turkanis, M. Edling, D. Lonadier, F. Walz, R. Ewing, R. Malson, H. Members of Subcommittee N43-3.3 who were active during development of revised standard ANSI
5、 N542-1977: Amlauer, K. LaMastra, A. Arndt, R. Landfried, C. Bell, J. Lima, J. Cook, H. L. McLellan, J. (chairperson) Ridout, E. Dooley, H. Seminoff, T. Dukes, J. Sererance, W. Eisenhower, E. Shupe, M. Ferraro, E. Sims, G. Gerhart, J. Smith, D. Hanson, L. Thompson, D. Homa, L. Turkanis, M. Horowitz,
6、 L. Tyree, P. Janzow, E. Walz, R. Kotler, J. Weiler, J. Members of Subcommittee N43-3.3 who were active during review of standard ANSI N43.6-1977(R1989): Amlauer, K. Homa, L. Dukes, J. (chairperson) LaMastra, A. Eisenhower, E. Turkanis, M. Hanson, L. Members of Subcommittee N43-3.3 who were active d
7、uring review and updating of standard ANSI N43.6-1997: Baggett, S. Hoey, J. Brown, W. LaMastra, A. Caines, G. Landfried, C. Dukes, J. (chairperson) Lugtu, C. Ferris, R. Turkanis, M. ANI/HPS N43.6-2007 iv Members of Subcommittee N43.6 who were active during review and updating of standard ANSI/HPS N4
8、3.6-2007: Bayles, C. Krzaniak, M. Buchenberger, J. Lugtu, C. Caines, G. Nimmo, E. Dukes, J. (chairperson) Schrader, J. Evans, H. Selby, J. Fortkamp, J. Turkanis, M. Hoey, J. Von Ahn, K. Jankovich, J. Additional contributing expert: Lee, D. This standard was consensus balloted and approved on 22 Sept
9、ember 2005 by the American National Standards Committee, N43, on Equipment for Non-Medical Radiation Applications. At the time of balloting, the N43 Committee had the following membership: Chairperson Vice Chairperson ABB Industrial Systems, Inc. Alliance of American Insurers American Automobile Man
10、ufacturers Association American Conference of Governmental Industrial Hygienists American Crystallographic Association American Insurance Services Group American Iron and Steel Institute American Public Health Association, Inc. American Society for Nondestructive Testing, Inc. American Society for T
11、esting and Materials Canadian Nuclear Safety Commission Conference of Radiation Control Program Directors Health Physics Society National Council on Radiation Protection leak test; national standard; radiation safety; radiation sources; radioactive sources; radioactivity; sealed sources; standard AN
12、I/HPS N43.6-2007 vi Contents Foreword vii 1.0 Scope 1 2.0 Definitions 1 3.0 Classification Designation .2 4.0 General Considerations .3 5.0 Procedure to Establish Classification and Performance Requirements .5 6.0 Identification 5 7.0 Testing Procedures for Table 16 8.0 Quality Assurance 10 Tables 1
13、. Classification of Sealed Source Performance Tests 11 2. Classification of Radionuclides According to Radiotoxicity 13 3. Activity Levels .14 4. Sealed Source Performance Requirements for Typical Usage 14 Annexes A. Additional Considerations and Test References 15 B. Sample Source Certificate 16 AN
14、SI/HPS N43.6-2007 vii Foreword (This foreword is not part of American National Standard ANSI/HPS N43.6-2007.) Work on this standard was begun in 1962 and culminated in the publication of ANSI N5.10 in 1968. When the original standard was in its final draft form, a copy was sent to the International
15、Standards Organization (ISO). The ISO had been working on standards for sealed sources for several years. When the ANSI version was examined, the ISO decided to adopt the ANSI concept and general format, and ultimately published ISO 2919. Revised Standard ANSI N542-1977 ANSI procedures require that
16、a standard be reviewed every five years. In 1973 when ANSI N5.10 was reviewed, it was decided to, essentially, duplicate the ISO version in its final draft form that was published as ISO/DIS 2919 in November 1972. Although the ANSI version contained sections on Quality Control and Leak Test Methods,
17、 the ISO version deleted these sections and intended to cover these items in separate documents. This revised American National Standard was published as ANSI N542-1977 and was issued in July 1978. It was accompanied by sections in its appendices on Quality Control and Leak Test Methods. The Quality
18、 Control section was expanded to provide a more definitive guide so that production-run sources would have performance characteristics equal to the fully tested sources (prototype, dummy, or other test sources). The Leak Test Methods section was updated to reflect current methods of leak testing. Du
19、ring the period when this standard was being revised, other groups developed standards for brachytherapy sources and self-luminous sources. An attempt was made to merge these two standards, along with the International Atomic Energy Agency (IAEA) tests for special form, into this revised classificat
20、ion standard. This attempt was not successful, but to make this standard more useful, the standards for brachytherapy sources, self-luminous sources, and the special form tests were summarized in appendices. Standard ANSI (N43.6)-1977 (R1989) ANSI Standard N542-1977 was renumbered as ANSI N43.6-1977
21、. Several changes were recommended by the N43 review committee in July 1989. The standard was reissued as ANSI 43.6-1977(R1989) without additional changes. Revised Standard ANSI N43.6-1997 This 5-year review was completed in February 1996. Changes include those recommended for the 1989 version. The
22、most significant change was increasing the temperature requirement in Table 4 from Class 4 to Class 5 for Category IV Gamma Irradiators due to the potential for fires. Numerous references were updated and an immersion test was added to Annex A. The entire document was converted to a new ANSI style.
23、Revised Standard ANSI N43.6-2007 Over the years, standards ANSI N43.6 and ISO 2919 have drifted apart in several areas. Effort was made to bring these two standards back into closer harmony and work toward the possibility of a single joint ISO/ANSI standard by the time of the next review. The ISO be
24、nd test was added to the standard and several details of other tests were modified to achieve better compatibility between the two standards. Table 2 was updated to include many new radionuclides. Those with half-lives less than 30 days and those with impractically low specific activity were deleted
25、. The new radionuclides have been inserted into the appropriate “toxicity” group of the table based on where similar nuclides appeared in the previous table. The annexes in the previous version were deleted and references were added for other standards covering those subjects. Two new annexes are in
26、cluded in this version. The temperature classification ANI/HPS N43.6-2007 viii requirements for gamma irradiator categories II and III were increased from 4 to 5 to be congruent with regulatory concerns and ISO 2919. AMERICAN NATIONAL STANDARD ANSI/HPS N43.6-2007 Sealed Radioactive Sources Classific
27、ation 1.0 Scope This standard establishes a system of classification for sealed radioactive sources based on performance specifications related to radiation safety. It does not consider the radiation output of the sealed source. The standard provides a manufacturer of sealed radioactive sources with
28、 a set of tests to evaluate the safety of its products under specified conditions, and also to assist a user of such sources to select types that suit an application, especially where protection against radioactive contamination is concerned. This standard also provides guidance to regulatory author
29、ities. The tests fall into several groups, including, for example, exposure to abnormally high and low temperature and a variety of mechanical tests. Each test can be applied in several degrees of severity. Although the standard classifies sealed sources by a variety of tests, it does not imply that
30、 a sealed source will maintain its integrity if used continuously at the rated classification. For example, a sealed source tested for one hour at 600C (1112F) may or may not maintain its integrity if used continuously at 600C (1112F). Table 4 of this standard includes a list, which is not intended
31、to be comprehensive, of typical applications of sealed radioactive sources with a suggested performance classification for each application. These classifications are minimum requirements corresponding to the applications in the usual environment. Factors to be considered for applications in especia
32、lly severe environments are listed in Sections 4.2 and 4.3. This standard makes no attempt to classify the design of sources, their method of construction, or their calibration in terms of the radiation emitted. Several subjects relating to sealed sources and their testing are not treated in detail
33、in this standard, including selected brachytherapy sources, self-luminous light sources and IAEA tests for special-form radioactive material. These subjects are covered by separate standards as listed in Section 4.4. 2.0 Definitions The definitions and terms contained in this standard, or in other A
34、merican National Standards referred to in this document, are not intended to embrace all legitimate meanings of the terms. They are applicable only to the subject treated in this standard. capsule: protective envelope used for prevention of leakage of the radioactive material. device: any piece of e
35、quipment designated to utilize a sealed source(s). dummy source: facsimile of a sealed source of exactly the same material and construction as a sealed source but containing, in place of the radioactive material, a substance resembling its physical and chemical properties as closely as is practicabl
36、e. fluence rate: number of particles and/or photons of ionizing radiation emitted per unit time from the sealed source in a defined geometry. leachable: term used to convey that the radioactive material is soluble in water and convertible to dispersible products, specifically, materials that are sol
37、uble in quantities equal to or greater than 0.1 mg of radioactive material per gram of radioactive material present in 100 mL of still H2O at 50C in 4 h (ref. ISO 9978, 5.1.1). leakage: transfer of radioactive material from the sealed source to the environment. model: descriptive term or number to i
38、dentify a specific sealed source design. non-leachable: term used to convey that the radioactive material is virtually insoluble in water and is not convertible into dispersible products, specifically, materials that are soluble in quantities less than 0.1 mg of radioactive material per gram of radi
39、oactive material present in 100 mL of still H2O at 50C in 4 h (ref. ISO 9978, 5.1.1). ANSI/HPS N43.6-2007 2 non-reactive: term used to describe materials that are not reactive in ordinary atmosphere or water (e.g., aluminum, gold, krypton, ceramics, etc.). prototype source: original of a model of a
40、sealed source that serves as a pattern for the manufacture of all sources identified by the same model designation. prototype testing: performance testing of a new sealed source before sources of such design are put into actual use. radiotoxicity: the toxicity attributable to the radiation emitted b
41、y a radioactive substance within the body. reactive: reactive in ordinary atmosphere or water (e.g., sodium, potassium, etc.). sealed source: radioactive source sealed in a capsule or having a bonded cover, the capsule or cover being strong enough to prevent contact with and dispersion of the radioa
42、ctive material under the conditions of use and wear for which it was designed. shall: where “shall” is used for a provision specified herein, that provision is intended to be a requirement if the intent and objectives are to be met. should: “should” is used to indicate provisions that are not requir
43、ed but are recommended as good practices. source assembly: a sealed source contained within or attached to a source holder. source holder: mechanical support for the sealed source. test source: sealed source, used in the performance tests described in this standard, having the same material and cons
44、truction as sealed sources of the model for which classification is being established. A test source may be a dummy, prototype, or production-run source. The following two terms apply to industrial radiography, gamma gauges, and irradiator sources: source in device: sealed source that remains in the
45、 shielding during use. unprotected source: sealed source that, for use, is removed or exposed from the shielding by mechanical or other means. 3.0 Classification Designation The classification of a sealed source shall be designated by the code “ANSI” followed by two digits to indicate the year of ap
46、proval of the American National Standard used to determine the classification, followed by a letter and five digits and, if required, a set of parentheses containing one or more digits. For classifications based on performance tests prescribed in this standard (N43.6-2007), the two digits preceding
47、the letter shall be 07. The letter shall be either a C or an E. “C” designates that the activity level of the sealed source does not exceed the limit established in Table 3. “E” designates that the activity level of the sealed source exceeds the limit listed in Table 3. The five digits following the
48、 letter shall be performance classification results for the temperature, external pressure, impact, vibration, and puncture tests, in that order. If a bending test is required, an additional classification shall be inserted between parentheses following the fifth digit. This describes the type of be
49、nding test the source design has passed. Such bending tests are required for some elongated sources. Detailed specifications are given in Table 1, Section 4.1.4 and Section 7.7. If multiple bending tests are applicable, they shall be performed to satisfy the test criteria. The parentheses may be omitted if no bending test is required. Any classification test identified as a special test shall have the test conditions identified in the source certificate. Any other addition
