Regulatory Guide 6.1

Leak Testing Radioactive Brachytherapy Sources

ML13350A237
Person / Time
Issue date:	02/28/1974
From:	US Atomic Energy Commission (AEC)
To:
References
RG-6.001
Download: ML13350A237 (2)

February 1974U.S. ATOMIC ENERGY COMMISSIONREGULATORYDIRECTORATE OF REGULATORY STANDARDSGUIDEREGULATORY GUIDE 6.1LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCESA. INTRODUCTION-Possession and use of brachytherapy sources is anactivity iequirirng a license pursuant to section 30.3,"Activities Requiring License," of 10 CFR Part 30.-Rules of General Applicability to 'Licensing ofByproduct Material." Paragraph (e) of section 30.34 in10 CFR Part 30 provides that the Atomic EnergyCommission may incorporate in any license suchadditional requirements and conditions as it dcemsappropriate or necessary in order to protect health or tominimize danger to life or property.A standard condition, included in all AEC licensesfor possession and use of' sealed brachytherapy sourcesrequires that these sources be periodically leak tested,that the test be capable of detecting the presence of0.005 microcurie of radioactivic material on the testsample taken front the source, and that the source beimmediately withdrawn from use if the test reveals thepresence of 0.005 microcurie or more.This guide describes methods and proceduresacceptable tot the Regulatory staff for leak testingradioactive brachytherapy sources.B. DISCUSSIONSubcommittee N44-2. Therapeutic Radiology, ofthe American National Standards Institute Committeeon Equipment and Materials for Medical RadiationApplications. N44, has developed a standard presentinguniform criteria and test procedures for the evaluationoI radioactive material leakage from sealedbrachytherapy sources. This standard was approved bythe American National Standards Institute (ANSI) onJuly IS, 10373. and dlesignated ANSI N44.2-1973. i The('upies may be obtained from the American NationalSr; inda Wrt I h it tite, I n'., 14.11 30t ro:,dwa y. New York. New YorkIW(118.standard specifies that the sealed radioactivebrachytherapy source should be withdrawn frotm use it( 1) source leakage exceeds the baseline values establishedby repetitive tests indicating degradation tt sotltrceintegrity (Baseline Criterion) Or (2) leakage ofradioactive material equals ur exceeds 5 nanocuries ofradioactive material or, in the case of radium sources. Inant;:urie of radon in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> (Leakage Limit). Thestandard also establishes criteria and procedutres forretests. test procedures. source disposition. frequency oflleakage testing, records, and personnel qualifications.The Appendix (which is not a part of" the sl:rrrdard)describes leakage test met hods wvhich have been I'ulmid tibe acceptable for determining the radioactive leak-age ofsealed brach. therapy sources.C. REGULATORY POSITIONThe requirements. criteria, and recommendedpractices contained in ANSI N44.2-1973. "Leak TestingRadioactive Brachytherapy Sources"' con.titute agenerally acceptable piocedure for complying with trhelicensing conditions applicable to the leak testing ofradioactive brachytherapy sources, subject to thiefollowing:1. In order to be approved for use. brachyltlerapysources should meet certain integrity requirenentls andpass certain tests in addition to the leak test described inthis guide. Manufacturers of medical brachyther:apysources should refer to Regulatory Guide 6.2, "Inlegrityand Test Specifications for Selected BrachythertapySources."2. Section 7.1 of ANSI N44.2-1973 states that theminimum training and experience requirement tio :11lindividual perftorming tire leak tests should le eligibilityfor relevant certification by tire American Board of,Radiology or tire American Board of' Ilealth Physics orequivalent. The leak tests carl be pertor tried 11\USAEC REGULATORY GUIDESRegulatory Guides ate Issued to describe and make available to the publicmethods acceptable 1o the' AEC Regulatory stff of implementing specific parts ofthe Commission*s regulations. to delineate techniqtuet used by the staff inevaluating specific problems or postulated accidents, or to provide guidance toapplicants. ReguTatory Guides are not subsritutles regulations and c¢,mpliancewith them is not required. Methods and solutions different from those sat out inthe guides will be ecceptsble if they provide a besis for the findings requisite tothe issuance or continuance of a permit of lice.ns by the Comntission,.Published guides will be revised periodically. as appropritte. to accommodatecommentsi and to reflect new information or ewperience.Copies ot published guiArý may be obtained by request indicating the divisionsdesired to the US. Atomic Energy Commission. Washington. D.C. 20545.Attention: Oirc..tor of Regulatory Standnrds. Comments and suggestion% forIrrmtovements in thes guides are encouraged and should be sent to the Secretaryof the Commission. US. Atomic Energy Commission. Washington,. D.C. 20545.Attention: Chief. Public Proceedings Staff.The guides are issued in the following ten broad divisions:1. Power Reactors 6. Products2. Research and Test Reactors 7. Transportation3. Fuels and Materials Facilities 8. Occupational Health4. Environmental and Siting 9. Antitrust ReviewS. 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