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{{Adams
{{Adams
| number = ML081140467
| number = ML003739389
| issue date = 07/01/2008
| issue date = 07/31/1974
| title = Leak Testing Radioactive Brachytherapy Sources
| title = Rev 1, Leak Testing Radioactive Brachytherapy Sources
| author name =  
| author name =  
| author affiliation = NRC/RES
| author affiliation = NRC/RES
Line 9: Line 9:
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Orr M/RES/415-6373
| contact person =  
| case reference number = DG-6003
| document report number = RG-6.1, Rev 1
| document report number = RG-6.001, Rev 2
| package number = ML081140455
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 4
| page count = 2
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION  
{{#Wiki_filter:U.S. ATOMIC ENERGY COMMISSION  
July 2008
REGULATORY  
 
DIRECTORATE OF REGULATORY STANDARDS
Revision 2 REGULATORY GUIDE
Revision 1 July 1974 GUIDE
 
REGULATORY GUIDE 6.1 LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES
OFFICE OF NUCLEAR REGULATORY RESEARCH 
 
REGULATORY GUIDE 6.1 (Draft was issued as DG-6003, dated January 2008)
 
LEAK TESTING RADIOACTIVE  
BRACHYTHERAPY SOURCES  


==A. INTRODUCTION==
==A. INTRODUCTION==
This guide directs the reader to methods and procedures acceptable to the staff of the U.S. Nuclear Regulatory Commission (NRC) for leak testing radioactive brachytherapy sources.
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.


Possession and use of brachytherapy sources is an activity requiring a license pursuant to Title 10,
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  
Section 30.3, Activities Requiring License, of the Code of Federal Regulations (10 CFR 30.3) (Ref. 1). 
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.
The requirements in 10 CFR 35.67, Requirements for Possession of Sealed Sources and Brachytherapy Sources (Ref. 2), state, in part, that the sources are to be periodically leak tested and that the test be capable of detecting the presence of 185 becquerel (Bq) (0.005 microcurie (Ci)) of radioactive material in the sample.  The regulations also require that the source be immediately withdrawn from use if the test reveals the presence of 185 Bq (0.005 Ci) or more of removable contamination.


This regulatory guide endorses the methods and procedures for leak testing radioactive brachytherapy sources contained in the current revisions of NUREG-1556, Volume 3, Consolidated Guidance about Materials Licenses:  Applications for Sealed Source and Device Evaluation and Registration (Ref. 3), and NUREG-1556, Volume 9, Consolidated Guidance about Materials Licenses: 
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.
Program-Specific Guidance about Medical Use Licenses (Ref. 4), as a process that the NRC has found to be acceptable for meeting the regulatory requirements.


The NRC revised the requirements for the medical use of byproduct materials, found in
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.
10 CFR Part 35, Medical Use of Byproduct Material, to implement a risk-informed, performance-based approach to regulation. Volume 3 of NUREG-1556 provides information on applying for sealed source and device evaluation and registration, while Volume 9 of NUREG-1556 provides information on the The NRC issues regulatory guides to describe and make available to the public methods that the NRC staff considers acceptable for use in implementing specific parts of the agencys regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in reviewing applications for permits and licenses.  Regulatory guides are not substitutes for regulations, and compliance with them is not required.  Methods and solutions that differ from those set forth in regulatory guides will be deemed acceptable if they provide a basis for the findings required for the issuance or continuance of a permit or license by the Commission.


This guide was issued after consideration of comments received from the public.
This guide describes methods and procedures acceptable to the Regulatory staff for leak testing radioactive brachytherapy sources.


Regulatory guides are issued in 10 broad divisionsC1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting; 5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health;
==B. DISCUSSION==
9, Antitrust and Financial Review; and 10, General.
Subcommittee N44-2, Therapeutic Radiology, of the American National Standards Institute Committee
*Line indicates substantive change from previous issue.


Electronic copies of this guide and other recently issued guides are available through the NRCs public Web site under the Regulatory Guides document collection of the NRCs Electronic Reading Room at http://www.nrc.gov/reading-rm/doc- collections/ and through the NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML081140467.
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 hours (Leakage Limit). The standard also establishes criteria and procedures for retests, test procedures, source disposition, frequency of leakage testing, records, and personnel qualifications.


Rev. 2 of RG 6.1, Page 2 NRC criteria for evaluating a medical use license application which includes the use of radioactive sources for brachytherap
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.


====y.     ====
==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.


Licensees must perform leak testing of sealed sources (e.g., calibration, transmission, and reference sources) or brachytherapy sources in accordance with 10 CFR 35.67.  Appendix Q to Volume 9 of NUREG-1556 provides an example procedure that is an acceptable method of performing the leak testing.
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.


This regulatory guide contains information collection requirements covered by 10 CFR Part 35 that the Office of Management and Budget (OMB) approved under OMB control number 3150-0010.
USAEC REGULATORY GUIDES
Copies of published guides may be obtained by request indicating the divisions desired to the U.S.


The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
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.


==B. DISCUSSION==
evaluating specific problems or postulated accidents, or to provide guidance to Attention: Chief, Public Proceedings Staff.
As part of its redesign of the materials license program, the NRC consolidated and updated numerous guidance documents for material licenses into the multivolume NUREG-1556.  Various volumes in the NUREG-1556 series provide current, program-specific guidance on testing, licensing, decommissioning, and terminating materials licenses.


Volume 3 of NUREG-1556 provides applicants with guidance on how to submit a request to the NRC for a safety evaluation or registration of a sealed source. It also provides reviewers of such requests with the information and materials necessary to determine that the products are acceptable for registration and certification purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.
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.


Volume 9 of NUREG-1556 includes a discussion of the NRCs criteria for evaluating a medical use license application. Appendix Q, Model Leak Test Program of Volume 9, contains procedures for leak testing of brachytherapy sources that the NRC has found to be an acceptable method of demonstrating compliance with the requirements of 10 CFR 35.6
===1. Power Reactors ===


===7.     ===
===6. Products ===
2. Research and Test Reactors


Many of the volumes of NUREG-1556 also contain appendices that include (1) copies of necessary forms, (2) sample applications and completed examples for different types of applications, and  
===7. Transportation ===
(3) examples of the types of supporting information, such as implementing procedures that the applicant may need to prepare. The NRC is placing added emphasis on conducting its regulatory activities in a risk-informed and performance-based manner. This approach is intended to be less prescriptive and to allow licensees the flexibility to implement the agencys regulations in a manner that is more specific to their needs yet still meets the regulatory requirements.  By supplying examples, the NRC seeks to provide information to meet the needs of applicants for licensure, without being prescriptive. Guidance in the NUREG represents one means of complying with NRC regulations and is not intended to be the only means of satisfying the regulatory requirement
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.


====s.     ====
5. Materials and Plant Protection
1


NUREG-1556 is available electronically through the Electronic Reading Room on the NRCs public Web site, at http://www.nrc.gov/reading rm/doc collections/nuregs/staff/sr1556.  Copies are also available for inspection or copying for a fee from the NRCs Public Document Room (PDR) at
===0. General===
11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555;
telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov.  In addition,


Rev. 2 of RG 6.1, Page 3 copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800; or from the National Technical Information Service (NTIS), at 5285 Port Royal Road, Springfield, VA 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.
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.


==C. REGULATORY POSITION==
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.
This regulatory guide endorses the method described in Volumes 3 and 9 of NUREG-1556 as a process that the NRC has found to be acceptable for meeting the regulatory requirements for leak testing of radioactive brachytherapy sources.


==D. IMPLEMENTATION==
The leak tests can be performed by adequately trained technicians, provided they are supervised by an individual qualified as stated above.
The purpose of this section is to provide information to applicants and licensees regarding the NRCs plans for using this regulatory guide.  The NRC does not intend or approve any imposition or backfit in connection with its issuance.


In some cases, applicants or licensees may propose or use a previously established acceptable alternative method for complying with specified portions of the NRCs regulations.  Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for license applications, license amendment applications, and amendment requests.
t.


Rev. 2 of RG 6.1, Page 4
The Atomic Energy Commission does not license and devices containing Ra-226 and its daughters.


REFERENCES
'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.


1.
many of the States and all of the Agreement States do regulate the use of sources of radium and its daughters.


10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, U.S. Nuclear Regulatory Commission, Washington, DC.1
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.
 
2.
 
10 CFR Part 35, Medical Use of Byproduct Material, U.S. Nuclear Regulatory Commission, Washington, DC.1 
 
3.
 
NUREG-1556, Volume 3, Consolidated Guidance about Materials Licenses:  Applications for Sealed Source and Device Evaluation and Registration, Washington DC, U.S. Nuclear Regulatory Commission, most current date and revision.2  (http://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1556/) 


4.
4.


NUREG-1556, Volume 9, Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses, U.S. Nuclear Regulatory Commission, Washington DC,
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.
most current date and revision.2   (http://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1556/) 
 
1 All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRCs public Web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/.  Copies are also available for inspection or copying for a fee from the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD;
the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209;
fax (301) 415-3548; and email PDR@nrc.gov.
 
2 The multivolume NUREG-series report listed herein was published by the U.S. Nuclear Regulatory Commission.


These volumes are available electronically through the Electronic Reading Room on the NRCs public Web site, at http://www.nrc.gov/reading-rm/doc-collections/nuregs/.  Copies are also available for inspection or copying for a fee from the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and email PDR@nrc.gov.  In addition, copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800, or from the National Technical Information Service (NTIS), at 5285 Port Royal Road, Springfield, VA 22161, online at http://www.ntis.gov, by telephone at (800)
L
553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.}}
6.1-2}}


{{RG-Nav}}
{{RG-Nav}}

Latest revision as of 02:10, 17 January 2025

Rev 1, Leak Testing Radioactive Brachytherapy Sources
ML003739389
Person / Time
Issue date: 07/31/1974
From:
Office of Nuclear Regulatory Research
To:
References
RG-6.1, Rev 1
Download: ML003739389 (2)
v • d • e


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.

1. Power Reactors

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.

L

6.1-2


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