Regulatory Guide 6.1

Rev 1, Leak Testing Radioactive Brachytherapy Sources

ML003739389
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Issue date:	07/31/1974
From:	Office of Nuclear Regulatory Research
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RG-6.1, Rev 1
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U.S. ATOMIC ENERGY COMMISSION

REGULATORY

DIRECTORATE OF REGULATORY STANDARDS

Revision 1 July 1974 GUIDE

REGULATORY GUIDE 6.1 LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES

A. INTRODUCTION

Posses,lion and use of brachytherapy sources is an

ictiNily trequiring a license pursuant to section 30.3,

"*Acltvi*.cs Requiring License," of 10 CFR Part 30,

"Ri*es 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 deems 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 canable of detecting the presence of

0.005 microcurie of radioactive material on the test sample taken from the source, and that the source be immediately withdrawn from use if the test reveals the presence of 0.005 microcurie or more.

Section 35.14, -Specific licenses for certain groups of medical uses," of 10 CFR Part 35, "Human Uses of Byproduct Material," specifies licensing requirements fol certain groups of medical uses of byproduct material.

Paragraph 35.14(b)(5)(i) requires that brachytherapy sources or devices containing byproduct material which are licensed under this paragraph be leak tested as described above.

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

B. DISCUSSION

Subcommittee N44-2, Therapeutic Radiology, of the American National Standards Institute Committee

• Line indicates substantive change from previous issue.

on Equipment and Materials for Medical Radiation Applications, N44, has developed a standard presenting uniform criteria and test procedures for the evaluation of radioactive material leakage from sealed brachytherapy sources. This standard was approved by the American National Standards Institute (ANSI) on July 18, 1973, and designated ANSI N44.2-1973. ' The standard specifies that the sealed radioactive brachytherapy source should be withdrawn from use if

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

or

(2)

leakage of radioactive material equals or exceeds 5 nanocuries of radioactive material or, in the case of iadium sources, I

nanocurie 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 procedures for retests, test procedures, source disposition, frequency of leakage testing, records, and personnel qualifications.

The Appendix (which is not a part of the standard)

describes leakage test methods which have been found to be acceptable for determining the radioactive leakage of sealed brachytherapy sources.

C. REGULATORY POSITION

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

constitute a

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

1.

In order to be approved foi use, brachytherapy sources should meet certain integ,

': requirements and

1 Copies may be obtained from the American National Standards Institute, Inc., 1430 Broadway, Now York, New York

10018.

USAEC REGULATORY GUIDES

Copies of published guides may be obtained by request indicating the divisions desired to the U.S.

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 improvements in these gaides are encouraged and should be sent to the Secretary the Commission's regulations, to delineate techniques ,-ed by the staff in of 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.

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 and Sittng

9. Antitrust Review comments and to reflect new information or experience.

5. Materials and Plant Protection

1

0. General

pass certain tests in addition to the leak test described in this guide. Manufacturers of medical brachytherapy sources should refer to Regulatory Guide 6.2, "Integrity and Test Specifications for Selected Brachytherapy Sources."

2.

Section 6.1 of ANSI N44.2-1973 states that the minimium training and experience requirement of an individual performing the leak tests should be eligibility fot relevant certification by the American Board of Radiology or the American Board of Health Physics or equivalent.

The leak tests can be performed by adequately trained technicians, provided they are supervised by an individual qualified as stated above.

t.

The Atomic Energy Commission does not license and devices containing Ra-226 and its daughters.

'ei sons licensed by the AEC for byproduct, source, or special nuclear material who also possess sources containing radium and its daughters must limit the radiation exposure from both licensed material and other sources of radiation such as radium so that the limits in Part 20 are not exceeded (§20.101). Also.

many of the States and all of the Agreement States do regulate the use of sources of radium and its daughters.

For that reason, the parts of ANSI N44.2-1973 dealing specifically with testing of sealed radium brachytherapy sources are included in this guide, although the AEC has made no determination as to their adequacy.

4.

An Appendix to ANSI N44.2-1973 lists suggested leak test methods. Section A1.2 of the Appendix recommends that all external surfaces of the source be thoroughly wiped with a piece of filter paper or other suitable material. In the case of sealed sources with thin membranous covers such as Sr-90 eye applicators, the wipes should be taken only from surfaces that are in close proximity to the source surface. The source surface itself should not be wiped, since this could cause a rupture of the thin membrane.

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6.1-2