ML20207H763
| ML20207H763 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1974 |
| From: | NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| References | |
| REGGD-06.002, REGGD-6.002, NUDOCS 8808300026 | |
| Download: ML20207H763 (2) | |
Text
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Revision 1 e^'C f os, July 1974 0 {k ai HEF6i.IV6 RY gg/ DIRECTORATE OF REGULATORY STANDARDS GUIDE REGULATORY GUIDE 6 2 INTEGRITY AND TEST SPECIFICATIONS FOR SF.LECTED BRACHYTHERAPY SOURCES A. INTRODUCTION sealed medical sources used in interstitial, intracavitary, and topical therapy. This standard was approved by the Manufacture of brachytherapy sources contaming American National Standards Institute (ANSI) on hy product material is an activity requinng a license August 16, 1973, and designated ANSI N44.1 1973.1 purmant to section 30.3. "Activities Requinng 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 Licenstng of Byproduct Material." B.achytherapy standards for sources used in afterloaded devices. The sources manufactured under such license must meet three source type categories covered by tl.e standard are certain mtegrity 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 oi Cs 137, and beta applicators contaming either St 90 Licenses to Manufacture, Distribute, or import Certain or Ra 226. The standard establishes perform'nnce test items Containing Byproduct Material," requires that an specifications for temperature, impact.percu,sion, bend-appheation for a specific license to manufacture and ing, tensile stress, and puncture. The temperature, distnbute brachytherapy ~ sources and devices containing impact, and percussion tests, which are the same tests 1 byproduct material to persons licensed under Section for classification of a source as"special form" under the l 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 desenption of procedures for, and are appheable to all source types. In addition, the (V / be results of, the prototype tests performed to demon-str e that the source or device will maintam its integrity bendmg test is apphcable to interstitial needles, and tne tensile stress and puncture tests are appbcable to the l unde . tresses hkely to be encountered in normal use beta appheators.. According to ANSI N t4.1 1973, a I and acu *nts. Paragraph 32.74(aX2Xiv) of 10 CFR Part source is deemed to pass these tests ifit is "free of usual 32 require that the application also include details of defects" and "demonstrates leakage of less than 50 the quahty 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 duct 2on sousces and devices meet the standards of the design and prototype tests. This guide describes integrity 4 the case of Ra 226 sources)." ,
requirements and test specifications' acceptable to the l Regulatory staff for selected brachytherapy sources. The standard also includes a quality control program '
"to insure that the production units will have the same l B. DISCUSSION integrity and meet the same requirements as the proto- j type units tested pursuant to this standard. The quality Subcommittee N44-2, Therapeutic Radiology, of the c ntr I program further requires that, before transfer, Amencan National Standards Institute Committee on each source be tested and demonstrate leakage of less Equipment and Matenals for Medical Radiation Appli- than 5 nanocuries (I nanocurie of radon m 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in cation, N44. has developed a standard presenting integ- the case of Ra 23 sources). ;
- ity requirernents and test specifications for selected 3
Copies rnay be obtained from the Amerun Nauoru! Standards
'Lme mdicates substantrve chanaen from previousissue. Insutute, Inc.,1430 Broadosy New Wrk, New York 10018.
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4 C. REGULATORY POSITION materials with exactly the saane characteristics as the materials used in the quahGed prototype units.
I 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. "Acecptance cations for Selected Brachytherapy Sources,"3 con- Testing." states that the acceptabihty of the sourec shall stitute a generally acceptable procedure foi 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 m the standard, subject to the contamination of the outer capsule, and it recommends followmg: that a value not greater than 1/10 of the radioactivity limit above be chosen as a production control point and that no source which exceeds this value be transferred I. Section 4.1 of ANSI N44.1 1973 states that non.
radioactive prototypes may be substituted for radio. by a manfacturer to a user for use as a brachytherapy active units in cases where evidence ofintegrity can be source.
estabheed by leakage test methods appropriate tc nonradioactive sources. The integrity of the source wilj The acceptability of a source for transfer by a m estabhaed if the source is tested by a method manufacturet to a user for use as a brachytherapy source t.Ac of accuratel and reliably measuring leakage should be indicated by removal of less than 0.5 unesof104 atm cm /sec or less for dry air at 25'C and nanoeurie of the radiol,otope m one of the tests for a pressure differential of one atmospheric agamst a designed to demonstrate contamination of the outer vacuum of 1/100 atmosphere or less, with negathe capsule and by presence of a hermetic seal according to a results. leakage test designed ta 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 Secuon 4.1 states that leakage ofless than demonstrating a hermetic seal.
50 nanoeunes from sources subjected to tests described m 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 essentially no radioactne material. This will be demon- and include identification of the test methoci,instrumen.
g strated for the purpose of these prototype tests,ifleak tation and calibration procedures used.
tests performed both prior to and after each test d described in Section 4.2 mdicate removal of less than 5 7. The Atomic Er.ergy Commission does not license nanoeuries in each case. sources and devices containing Ra 226 and its daughters Persons licensed by the AEC for byproduct, source, or 3.To the considerations 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 deleterioas effects on source materials (both radioactive exposure from both licensed material and other sources and nonradioactive) due to the inherent nature of the of radiation such as radium so that the limitsin Part 20 source and resulting from radiation damage, chemical are not exceeded (l20.101). Alm, 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 chanFes in denuty and volume of sources of radium and its daughters. For that reason, the contained radioactive materials), and chemical reactions parts of ANSI N44.11973 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 lic3P .,la ted Radioactive substantially the same . . . . materials . . . . are incorpo- Sources" ORNL 4529. July 1972, ass &ble from National rated in all production units."(Emphasis supplied.) All Technical information Service. U.S. Department of Commerce, production units should b<. produced with and contain $285 Port Royal Road, Springfield Va. 22151.
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