Regulatory Guide 6.2
| ML13064A083 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1974 |
| From: | US Atomic Energy Commission (AEC) |
| To: | |
| References | |
| RG-6.002 | |
| Download: ML13064A083 (2) | |
July 1974 U.S. ATOMIC ENERGY COMMISSION
REGULATORY
DIRECTORATE OF REGULATORY STANDARDS
GUIDE
REGULATORY GUIDE 6.2 INTEGRITY AND TEST SPECIFICATIONS FOR SELECTED BRACHYTHERAPY SOURCES
A. INTRODUCTION
sealed medical sources used in interstitial, intracavitary, and topical therapy. This standard was approved by the Manufacture of brachytherapy sources containing American National Standards Institute (ANSI) on byproduct material is an activity requiring a license August 16, 1973, and designated ANSI N44.1-1973. 1 pursuant to section 30.3, "Activities Requiring License," The standard is limited to the traditional type sources of 10 CFR Part 30, "Rules of General Applicability to with well-established medical uses and does not provide Licensing of Byproduct Material;" Brachytherapy standards for sources used in afterloaded devices. The sources manufactured under such license must meet three source type categories covered by the standard are certain integrity requirements and pass certain tests. tubes or capsules and needles containing Ra-266, Co-60,
Paragraph 32.74(a)(2)(iii) of 10 CFR Part 32, "Specific or Cs-137, and beta applicators containing either Sr-90
Licenses to Manufacture, Distribute, or Import Certain or Ra-226. The standard establishes performance test Items Containing Byproduct Material," requires that an specifications for temperature, impact, percussion, bend- application for a specific license to manufacture and ing, tensile stress, and puncture. The temperature, distribute brachytherapy sources and devices containing impact, and percussion tests, which are the same tests byproduct material to persons licensed under Section for classification of a source as "special form" under the
35.14, "Special Licenses for Certain Groups of Medical transportation regulations of the Department of Trans- Uses," of 10 CFR Part 35, "Human Uses of Byproduct portation and the International Atomic Energy Agency Material," include a description of procedures for, and are applicable to all source types. In addition, the the results of, the prototype tests performed to demon- bending test is applicable to interstitial needles, and the strate that the source or device will maintain its integrity tensile stress and puncture tests are applicable to the under stresses likely to be encountered in normal use beta applicators. According to ANSI N44.1-1973, a and accidents. Paragraph 32.74(aX2Xiv) of 10 CFR Part source is deemed to pass these tests if it is "free of visual
32 requires that the application also include details of defects" and "demonstrates leakage of less than 50
the quality control procedures which assure that pro- nanocuries (nCi) (10 nanocuries of radon in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in duction sources and devices meet the standards of the the case of Ra-226 sources)."
design and prototype tests. This guide describes integrity requirements and test specifications acceptable to the Regulatory staff for selected brachytherapy sources. The standard also includes a quality control program
"to insure that the production units will have the same integrity and meet the same requirements as the proto-
B. DISCUSSION
type units tested pursuant to this standard." The quality control program further requires that, before transfer, Subcommittee N44-2, Therapeutic Radiology, of the each source be tested and demonstrate leakage of less American National Standards Institute Committee on than 5 nanocuries (1 nanocurie of radon in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in Equipment and Materials for Medical Radiation Appli- the case of Ra-226 sources).
cation, N44, has developed a standard presenting integ- rity requirements and test specifications for selected
]Copies may be obtained from the American" National Standards
- Line indicates substantive changes from previous issue. Institute, Inc., 1430 Broadway, New York, New York 10018.
USAEC REGULATORY GUIDES Copies of published guides mey be obtained by request indicating the divisions desired to the US. Atomic Energy Commission, Washington, D.C. 20545, Regulatory Guides are issued to describe and make available to the public Attention: Director of Regulatory Standards. Comments and suggestions for methods acceptable to the AEC Regulatory staff of implementing specific parts of inmprovements in these guides are encouraged and should be sent to the Secretary the Commission's regulations, to delineate techniques used by the staff in o1f the Commission, U.S. Atomic Energy Commission, Washington, D.C. 20545.
evaluating specific problems or postulated accidents, or to provide guidance to Attention: Chief, Public Proceedings Staff.
applicants. Regulatory Guides are not substitutes for regulations and compliance with them is not required. Methods and solutions different from those set out in The guides are issued in the following ten broad divisions:
the guides will be acceptable if they provide a basis for the findings requisite to the issuance or continuance of a permit or license by the Commission. 1. Power Reactors
6. Products
2. Research and Test Reactors
7. Transportation
3, Fuels and Materials Facilities 8. Occupational Health Published guides will be revised periodically, as appropriate, to accommodate 4. Environmental arid Siring 9. Antitrust Review comments and to reflect new information or experience. . 5. Materials and Plant Protection 1
0. General
C. REGULATORY POSITION
materials with exactly the same characteristics as the iaterials used in the qualified prototype units.
,the' requirements and recommended practices con- tained in ANSI N44.1-1973, "Integrity and Test Specifi- 5. Section 5.4 of ANSI N44.1-1973, "Acceptance
1 cations for Selected Brachytherapy Sources," con- Testing," states .that the acceptability of the source shall stitute a generally acceptable procedure for be indicated by removal of less than 5 nanocuries of the demonstrating the integrity of those medical brachy- radioisotope in one of the tests designed to demonstrate therapy sources identified in the standard, subject to the contamination of the outer capsule, and it recommends following: that a value not greater than 1/10 of the radioactivity limit above be chosen as a-production control point and
1. Section 4.1 of ANSI N44.1-1973 states that non- that no source which exceeds this value be transferred radioactive prototypes may be substituted for radio- by a manfacturer to a user for use as a brachytherapy active units in cases where evidence of integrity can be source.
established by leakage test methods appropriate to nonradioactive sources. The integrity of the source will The acceptability of a source for transfer by a be established if the source is tested by a method manufacturer to a user for use as a brachytherapy source capable of accuratelT' and reliably measuring leakage should be indicated by removal of less than 0.5 rates of 107 7 atm cm /sec or less for dry air at 25 0 C and nanocurie of the radioisotope in one of the tests for a pressure differential of one atmospheric against a designed to demonstrate contamination of the outer vacuum of 1/100 atmosphere or less, with negative capsule and by presence of a hermetic seal according to a results. leakage test designed to demonstrate, this situation. The vacuum leach tests, helium mass spectrometer tests, and Kr-85 leak tests 2 are acceptable for the purpose of
2. Item 2 in Section 4.1 states that leakage of less than demonstrating a hermetic seal.
SO nanocuries from sources subjected to tests described in Section 4.2 demonstrates retention of integrity after 6. Manufacturers of brachytherapy sources should main- the test. Prototype sources subjected to tests described tain results of prototype and acceptance tests. The test in Section 4.2 should retain their integrity and leak results should be expressed in terms of activity measured esentially no radioactive materiaL This will be demon- and include identification of the test method, instrumen- strated for the purpose of these prototype tests, if leak tatim, and calibration procedures used.
tests performed both. prior to and after each test described in Section 4.2 indicate removal of less than 5 7. The Atomic Energy Commission does not license nanocuries in each case. sources and devices containing Ra-226 and its daughters.
Persons licensed by the AEC for byproduct, source, or
3. To the comiderations described in Section 5.2, special nuclear material who also possess sources con-
"Design Requirements," should be added the possible taining radium and its daughters must limit the radiation deleterious effects on source materials (both radioactive exposu-e from both licensed material and other sources and nonradioactive) due to the inherent nature of the of radiation such as radium so that the limits in Part 20
source and resulting from radiation damage, chemical are not exceeded (§20.101). Also, many of the States and physical changes (e.g., those resulting in the evolu- and all of the Agreement States do regulate the use of tion of gases or changes in density and volume of sources of radium and its daughters. For that reason, the contained radioactive materials), and chemical reactions parts of ANSI N44.1-1973 dealing specifically with between source materials. testing of sealed radium brachytherapy sources are included in this guide, although the AEC has made no determination as to their adequacy.
4. Section 5.3, "Materials Specification. and Control,"
states that the quality control program shall assure that 2 R.G. Neimeyer, "Leak Testing. Encapsulated Radioactive
"substantially the same .... materials .... are incorpo- Sources" ORNL-4529, July 1972, available from National rated in all production units." (Emphasis supplied.) All Technical Information Service, U.S. Department of Commerce, production units should be produced with and contain 5285 Port Royal Road, Springfield, Va. 22151.
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