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{{Adams
{{Adams
| number = ML081140467
| number = ML13350A237
| issue date = 07/01/2008
| issue date = 02/28/1974
| title = Leak Testing Radioactive Brachytherapy Sources
| title = Leak Testing Radioactive Brachytherapy Sources
| author name =  
| author name =  
| author affiliation = NRC/RES
| author affiliation = US Atomic Energy Commission (AEC)
| addressee name =  
| addressee name =  
| addressee affiliation =  
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Orr M/RES/415-6373
| contact person =  
| case reference number = DG-6003
| document report number = RG-6.001
| 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:February 1974 U.S. ATOMIC ENERGY COMMISSION
July 2008 Revision 2REGULATORY GUIDE
REGULATORY
  OFFICE OF NUCLEAR REGULATORY RESEARCH
DIRECTORATE
    REGULATORY GUIDE 6.1 (Draft was issued as DG-6003, dated January 2008)
OF REGULATORY  
LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES
STANDARDS GUIDE REGULATORY  
GUIDE 6.1 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.  Possession and use of brachytherapy sources is an activity requiring a license pursuant to Title 10,
-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0.005 microcurie of radioactivic material on the test sample taken front the source, and that the source be immediately withdrawn from use if the test reveals the presence of 0.005 microcurie or more.This guide describes methods and procedures acceptable tot the Regulatory staff for leak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.
Section 30.3, "Activities Requiring License," of the Code of Federal Regulations (10 CFR 30.3) (Ref. 1). 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:  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.
==B. DISCUSSION==
Subcommittee N44-2. Therapeutic Radiology, of the American National Standards Institute Committee on Equipment and Materials for Medical Radiation Applications.


The NRC revised the requirements for the medical use of byproduct materials, found in 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 agency's 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.
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 N44.2-1973.


This guide was issued after consideration of comments received from the public.
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 hours (Leakage Limit). The standard also establishes criteria and procedutres for retests. test procedures.


Regulatory guides are issued in 10 broad divisions C1, 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 Hea lth; 9, Antitrust and Financial Review; and 10, General.
source disposition.


Electronic copies of this guide and other recently issued guides are available through the NRC's public Web site under the Regulatory Guides document collection of the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML081140467.
frequency ofl 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 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.


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


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.  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.
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
==B. DISCUSSION==
1o the' AEC Regulatory stff of implementing specific parts of the Commission*s regulations.
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.
to delineate techniqtuet used by the staff in evaluating specific problems or postulated accidents, or to provide guidance to applicants.


Volume 9 of NUREG-1556 includes a discussion of the NRC's 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
ReguTatory Guides are not subsritutles regulations and c¢,mpliance with them is not required.


===7.      ===
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,.
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
Published guides will be revised periodically.
(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 agency's 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


====s.      ====
as appropritte.
NUREG-1556 is available electronically through the Electronic Reading Room on the NRC's 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 NRC's 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, 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.


==C. REGULATORY POSITION==
to accommodate commentsi and to reflect new information or ewperience.
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==
Copies ot published guiArý may be obtained by request indicating the divisions desired to the US. Atomic Energy Commission.
The purpose of this section is to provide information to applicants and licensees regarding the NRC's 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 NRC's 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.
Washington.


Rev. 2 of RG 6.1, Page 4 REFERENCES
D.C. 20545.Attention:
1. 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
Oirc..tor of Regulatory Standnrds.


1  2. 10 CFR Part 35, "Medical Use of Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
Comments and suggestion%
for Irrmtovements in thes guides are encouraged and should be sent to the Secretary of the Commission.


1 
US. Atomic Energy Commission.
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/)   
Washington,.
4. NUREG-1556, Volume 9, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses," U.S. Nuclear Regulatory Commission, Washington DC, most current date and revision.
D.C. 20545.Attention:  
Chief. Public Proceedings Staff.The guides are issued in the following ten broad divisions:
1. Power Reactors 6. Products 2. Research and Test Reactors


2   (http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)   
===7. Transportation===
3. Fuels and Materials Facilities
8. Occupational Health 4. Environmental and Siting 9. Antitrust Review S. Materials and Plant Protection
10. General adequateLly pa 'ed I.te4.hini
4.ia 11; prqýn mdcd. they. are sUperv 3Ld. bv'.in iiidlividuaI
qcualfled as % k h~I hle Atoirpc vI~ .irgy Coinmuitsion does viki'11. license.4113~4'~'md d!.iv~ .iainni i16-2126 anb d its. iuichiels Peri'lsicelmsen.d he i: ALC mrh rodi.iMtri l"IL I .expo3 311 C'.13 vim lLh i au 1 w juaic ri 'al and .di 431111 radia~l lini oth cm.~ve a~~ir~t til lipiuII in at Gir wit .1 §I 2)0. 1.44Le 0 1~l ) I.Al.tilol (p1 t t iL State and all oi t' 4 til Agicentm States do i4.QIZI to 11I the m~ ' i 4ll t mll~'i 'iin I, t.d telit.1 0 1' 1 .h i'&mt ile~ 4jft~t of. ANSI N~ 44.2~ d~lm'.p~ifm.iII
I.l~ I ~tng f seale~md raiidm Ill hi chv tlerampy stilLi rces are im 4Iude.d it Iltis Luide. althotigh the~ AE C has3 Made 110 detmertiblatImn tts to theiri ldempilaiv.A
4.. An'Appcmtdi\
to. ANSI 'N44.2-' IF7 limsi suggestdCL
ILII. 1 .5 metods C.lo AAI1'il4 jpmi Ltivil~tll meilds. thatit dl li? iilC of thIlc & tc131.4. 1 I lit rou~h fl uped ~ ti 11' .4.peeo -t ter1.1 p4 -allot (it o the 9PC3 ibi In SuLii I ~.4 3co e ld .1 tcL S. ewithi tillu it icnib 1a nfill iS.t CVefs1''suidi
35 Srm')O '~ cyc ippimI. tors% [Ile%% ile Alm~ild lie: taken.1 -mily 110111 surface.,.  
ýtiz Ii are Ili close Iir0\3im~llf
34-.) tile SOUtT4cc sutri'. cc. The Stl~icL "ti-facet itsell. II limiud not.1 tic wiped. 51114. this' co uld 4a


1  All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRC's 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 NRC's 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 NRC's 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 NRC's 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) 553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.}}
====s. mis rtiptmmre ====
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Revision as of 00:08, 15 July 2019

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)
v • d • e


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 N44.2-1973.

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"'

con.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 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.The guides are issued in the following ten broad divisions:

1. Power Reactors 6. Products 2. Research and Test Reactors

7. Transportation

3. Fuels and Materials Facilities

8. Occupational Health 4. Environmental and Siting 9. Antitrust Review S. Materials and Plant Protection

10. General adequateLly pa 'ed I.te4.hini

4.ia 11; prqýn mdcd. they. are sUperv 3Ld. bv'.in iiidlividuaI

qcualfled as % k h~I hle Atoirpc vI~ .irgy Coinmuitsion does viki'11. license.4113~4'~'md d!.iv~ .iainni i16-2126 anb d its. iuichiels Peri'lsicelmsen.d he i: ALC mrh rodi.iMtri l"IL I .expo3 311 C'.13 vim lLh i au 1 w juaic ri 'al and .di 431111 radia~l lini oth cm.~ve a~~ir~t til lipiuII in at Gir wit .1 §I 2)0. 1.44Le 0 1~l ) I.Al.tilol (p1 t t iL State and all oi t' 4 til Agicentm States do i4.QIZI to 11I the m~ ' i 4ll t mll~'i 'iin I, t.d telit.1 0 1' 1 .h i'&mt ile~ 4jft~t of. ANSI N~ 44.2~ d~lm'.p~ifm.iII

I.l~ I ~tng f seale~md raiidm Ill hi chv tlerampy stilLi rces are im 4Iude.d it Iltis Luide. althotigh the~ AE C has3 Made 110 detmertiblatImn tts to theiri ldempilaiv.A

4.. An'Appcmtdi\

to. ANSI 'N44.2-' IF7 limsi suggestdCL

ILII. 1 .5 metods C.lo AAI1'il4 jpmi Ltivil~tll meilds. thatit dl li? iilC of thIlc & tc131.4. 1 I lit rou~h fl uped ~ ti 11' .4.peeo -t ter1.1 p4 -allot (it o the 9PC3 ibi In SuLii I ~.4 3co e ld .1 tcL S. ewithi tillu it icnib 1a nfill iS.t CVefs1suidi

35 Srm')O '~ cyc ippimI. tors% [Ile%% ile Alm~ild lie: taken.1 -mily 110111 surface.,.

ýtiz Ii are Ili close Iir0\3im~llf

34-.) tile SOUtT4cc sutri'. cc. The Stl~icL "ti-facet itsell. II limiud not.1 tic wiped. 51114. this' co uld 4a

s. mis rtiptmmre

4il 11ile thinmc li4.tbra inc 0IO 0 f 0!6.1-2


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