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 1974 U.S. ATOMIC ENERGY COMMISSION

REGULATORY

DIRECTORATE OF REGULATORY STANDARDS

GUIDE

REGULATORY GUIDE 6.1 LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES

A. INTRODUCTION

-Possession and use of brachytherapy sources is an activity iequirirng a license pursuant to section 30.3,

"Activities Requiring License," of 10 CFR Part 30.

-Rules of General Applicability to 'Licensing of Byproduct Material." Paragraph (e) of section 30.34 in

10 CFR Part 30 provides that the Atomic Energy Commission may incorporate in any license such additional requirements and conditions as it dcems appropriate or necessary in order to protect health or to minimize danger to life or property.

A standard condition, included in all AEC licenses for possession and use of' sealed brachytherapy sources requires that these sources be periodically leak tested, that the test be capable of detecting the presence of

0.005 microcurie of radioactivic material on the test sample taken front the source, and that the source be immediately withdrawn from use if the test reveals the presence of 0.005 microcurie or more.

This guide describes methods and procedures acceptable tot the Regulatory staff for leak testing radioactive brachytherapy sources.

B. DISCUSSION

Subcommittee N44-2. Therapeutic Radiology, of the American National Standards Institute Committee on Equipment and Materials for Medical Radiation Applications. N44, has developed a standard presenting uniform criteria and test procedures for the evaluation oI

radioactive material leakage from sealed brachytherapy sources. This standard was approved by the American National Standards Institute (ANSI) on July IS, 10373. and dlesignated ANSI N44.2-197

3. i The

('upies may be obtained from the American National Sr; inda Wrt I h it tite, I n'., 14.11

30t ro:,dwa y. New York. New York IW(118.

standard specifies that the sealed radioactive brachytherapy source should be withdrawn frotm use it

( 1) source leakage exceeds the baseline values established by repetitive tests indicating degradation tt sotltrce integrity (Baseline Criterion)

Or

(2)

leakage of radioactive material equals ur exceeds 5 nanocuries of radioactive material or, in the case of radium sources. I

nant;: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). The standard also establishes criteria and procedutres for retests. test procedures. source disposition. frequency ofl leakage 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 ti be acceptable for determining the radioactive leak-age of sealed brach. therapy sources.

C. REGULATORY POSITION

The requirements.

criteria, and recommended practices contained in ANSI N44.2-1973. "Leak Testing Radioactive Brachytherapy Sources"'

co

n. titute a

generally acceptable piocedure for complying with trhe licensing conditions applicable to the leak testing of radioactive brachytherapy sources, subject to thie following:

1.

In order to be approved for use. brachyltlerapy sources should meet certain integrity requirenentls and pass certain tests in addition to the leak test described in this guide. Manufacturers of medical brachyther:apy sources should refer to Regulatory Guide 6.2, "Inlegrity and Test Specifications for Selected Brachythertapy Sources."

2.

Section 7.1 of ANSI N44.2-1973 states that the minimum training and experience requirement tio

11l individual perftorming tire leak tests should le eligibility for relevant certification by tire American Board of, Radiology or tire American Board of' Ilealth Physics or equivalent.

The leak tests carl be pertor tried 11\\

USAEC REGULATORY GUIDES

Regulatory Guides ate Issued to describe and make available to the public methods acceptable 1o the' AEC Regulatory stff of implementing specific parts of the Commission*s regulations. to delineate techniqtuet used by the staff in evaluating specific problems or postulated accidents, or to provide guidance to applicants. ReguTatory Guides are not subsritutles fo*r regulations and c¢,mpliance with them is not required. Methods and solutions different from those sat out in the guides will be ecceptsble if they provide a besis for the findings requisite to the issuance or continuance of a permit of lice.ns by the Comntission,.

Published guides will be revised periodically. as appropritte. to accommodate commentsi and to reflect new information or ewperience.

Copies ot published guiArý may be obtained by request indicating the divisions desired to the US. Atomic Energy Commission. Washington. D.C. 20545.

Attention: Oirc..tor of Regulatory Standnrds. Comments and suggestion% for Irrmtovements in thes guides are encouraged and should be sent to the Secretary of the Commission. US. Atomic Energy Commission. Washington,. D.C. 20545.

Attention: Chief. Public Proceedings Staff.

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