Regulatory Guide 6.2

Integrity and Test Specification for Selected Brachytherapy Sources

ML13064A083
Person / Time
Issue date:	07/31/1974
From:	US Atomic Energy Commission (AEC)
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References
RG-6.002
Download: ML13064A083 (2)

July 1974U.S. ATOMIC ENERGY COMMISSIONREGULATORYGUIDEDIRECTORATE OF REGULATORY STANDARDSREGULATORY GUIDE 6.2INTEGRITY AND TEST SPECIFICATIONS FOR SELECTED BRACHYTHERAPY SOURCESA. INTRODUCTIONManufacture of brachytherapy sources containingbyproduct material is an activity requiring a licensepursuant to section 30.3, "Activities Requiring License,"of 10 CFR Part 30, "Rules of General Applicability toLicensing of Byproduct Material;" Brachytherapysources manufactured under such license must meetcertain integrity requirements and pass certain tests.Paragraph 32.74(a)(2)(iii) of 10 CFR Part 32, "SpecificLicenses to Manufacture, Distribute, or Import CertainItems Containing Byproduct Material," requires that anapplication for a specific license to manufacture anddistribute brachytherapy sources and devices containingbyproduct material to persons licensed under Section35.14, "Special Licenses for Certain Groups of MedicalUses," of 10 CFR Part 35, "Human Uses of ByproductMaterial," include a description of procedures for, andthe results of, the prototype tests performed to demon-strate that the source or device will maintain its integrityunder stresses likely to be encountered in normal useand accidents. Paragraph 32.74(aX2Xiv) of 10 CFR Part32 requires that the application also include details ofthe quality control procedures which assure that pro-duction sources and devices meet the standards of thedesign and prototype tests. This guide describes integrityrequirements and test specifications acceptable to theRegulatory staff for selected brachytherapy sources.B. DISCUSSIONSubcommittee N44-2, Therapeutic Radiology, of theAmerican National Standards Institute Committee onEquipment and Materials for Medical Radiation Appli-cation, N44, has developed a standard presenting integ-rity requirements and test specifications for selected*Line indicates substantive changes from previous issue.sealed medical sources used in interstitial, intracavitary,and topical therapy. This standard was approved by theAmerican National Standards Institute (ANSI) onAugust 16, 1973, and designated ANSI N44.1-1973.1The standard is limited to the traditional type sourceswith well-established medical uses and does not providestandards for sources used in afterloaded devices. Thethree source type categories covered by the standard aretubes or capsules and needles containing Ra-266, Co-60,or Cs-137, and beta applicators containing either Sr-90or Ra-226. The standard establishes performance testspecifications for temperature, impact, percussion, bend-ing, tensile stress, and puncture. The temperature,impact, and percussion tests, which are the same testsfor classification of a source as "special form" under thetransportation regulations of the Department of Trans-portation and the International Atomic Energy Agencyare applicable to all source types. In addition, thebending test is applicable to interstitial needles, and thetensile stress and puncture tests are applicable to thebeta applicators. According to ANSI N44.1-1973, asource is deemed to pass these tests if it is "free of visualdefects" and "demonstrates leakage of less than 50nanocuries (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 /> inthe case of Ra-226 sources)."The standard also includes a quality control program"to insure that the production units will have the sameintegrity and meet the same requirements as the proto-type units tested pursuant to this standard." The qualitycontrol program further requires that, before transfer,each source be tested and demonstrate leakage of lessthan 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 /> inthe case of Ra-226 sources).]Copies may be obtained from the American" National StandardsInstitute, Inc., 1430 Broadway, New York, New York 10018.USAEC REGULATORY GUIDES Copies of published guides mey be obtained by request indicating the divisionsdesired 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 formethods acceptable to the AEC Regulatory staff of implementing specific parts of inmprovements in these guides are encouraged and should be sent to the Secretarythe 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 compliancewith 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 tothe issuance or continuance of a permit or license by the Commission. 1. Power Reactors 6. Products2. Research and Test Reactors 7. Transportation3, Fuels and Materials Facilities 8. Occupational HealthPublished guides will be revised periodically, as appropriate, to accommodate 4. Environmental arid Siring 9. Antitrust Reviewcomments and to reflect new information or experience. .5. Materials and Plant Protection 10. General C. REGULATORY POSITION,the' requirements and recommended practices con-tained in ANSI N44.1-1973, "Integrity and Test Specifi-cations for Selected Brachytherapy Sources,"1 con-stitute a generally acceptable procedure fordemonstrating the integrity of those medical brachy-therapy sources identified in the standard, subject to thefollowing:1. Section 4.1 of ANSI N44.1-1973 states that non-radioactive prototypes may be substituted for radio-active units in cases where evidence of integrity can beestablished by leakage test methods appropriate tononradioactive sources. The integrity of the source willbe established if the source is tested by a methodcapable of accuratelT' and reliably measuring leakagerates of 1077 atm cm /sec or less for dry air at 250C andfor a pressure differential of one atmospheric against avacuum of 1/100 atmosphere or less, with negativeresults.2. Item 2 in Section 4.1 states that leakage of less thanSO nanocuries from sources subjected to tests describedin Section 4.2 demonstrates retention of integrity afterthe test. Prototype sources subjected to tests describedin Section 4.2 should retain their integrity and leakesentially no radioactive materiaL This will be demon-strated for the purpose of these prototype tests, if leaktests performed both. prior to and after each testdescribed in Section 4.2 indicate removal of less than 5nanocuries in each case.3. To the comiderations described in Section 5.2,"Design Requirements," should be added the possibledeleterious effects on source materials (both radioactiveand nonradioactive) due to the inherent nature of thesource and resulting from radiation damage, chemicaland physical changes (e.g., those resulting in the evolu-tion of gases or changes in density and volume ofcontained radioactive materials), and chemical reactionsbetween source materials.4. Section 5.3, "Materials Specification. and Control,"states that the quality control program shall assure that"substantially the same .... materials .... are incorpo-rated in all production units." (Emphasis supplied.) Allproduction units should be produced with and containmaterials with exactly the same characteristics as theiaterials used in the qualified prototype units.5. Section 5.4 of ANSI N44.1-1973, "AcceptanceTesting," states .that the acceptability of the source shallbe indicated by removal of less than 5 nanocuries of theradioisotope in one of the tests designed to demonstratecontamination of the outer capsule, and it recommendsthat a value not greater than 1/10 of the radioactivitylimit above be chosen as a-production control point andthat no source which exceeds this value be transferredby a manfacturer to a user for use as a brachytherapysource.The acceptability of a source for transfer by amanufacturer to a user for use as a brachytherapy sourceshould be indicated by removal of less than 0.5nanocurie of the radioisotope in one of the testsdesigned to demonstrate contamination of the outercapsule and by presence of a hermetic seal according to aleakage test designed to demonstrate, this situation. Thevacuum leach tests, helium mass spectrometer tests, andKr-85 leak tests2 are acceptable for the purpose ofdemonstrating a hermetic seal.6. Manufacturers of brachytherapy sources should main-tain results of prototype and acceptance tests. The testresults should be expressed in terms of activity measuredand include identification of the test method, instrumen-tatim, and calibration procedures used.7. The Atomic Energy Commission does not licensesources and devices containing Ra-226 and its daughters.Persons licensed by the AEC for byproduct, source, orspecial nuclear material who also possess sources con-taining radium and its daughters must limit the radiationexposu-e from both licensed material and other sourcesof radiation such as radium so that the limits in Part 20are not exceeded (§20.101). Also, many of the Statesand all of the Agreement States do regulate the use ofsources of radium and its daughters. For that reason, theparts of ANSI N44.1-1973 dealing specifically withtesting of sealed radium brachytherapy sources areincluded in this guide, although the AEC has made nodetermination as to their adequacy.2R.G. Neimeyer, "Leak Testing. Encapsulated RadioactiveSources" ORNL-4529, July 1972, available from NationalTechnical Information Service, U.S. Department of Commerce,5285 Port Royal Road, Springfield, Va. 22151.6.2-2