Regulatory Guide 6.1: Difference between revisions

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{{Adams
{{Adams
| number = ML003739389
| number = ML13350A237
| issue date = 07/31/1974
| issue date = 02/28/1974
| title = Rev 1, 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 =  
Line 10: Line 10:
| license number =  
| license number =  
| contact person =  
| contact person =  
| document report number = RG-6.1, Rev 1
| document report number = RG-6.001
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 2
| page count = 2
}}
}}
{{#Wiki_filter:U.S. ATOMIC ENERGY COMMISSION  
{{#Wiki_filter:February 1974 U.S. ATOMIC ENERGY COMMISSION
REGULATORY  
REGULATORY
DIRECTORATE  
DIRECTORATE  
OF REGULATORY  
OF REGULATORY  
STANDARDS Revision 1 July 1974 GUIDE REGULATORY  
STANDARDS GUIDE REGULATORY  
GUIDE 6.1 LEAK TESTING RADIOACTIVE  
GUIDE 6.1 LEAK TESTING RADIOACTIVE  
BRACHYTHERAPY  
BRACHYTHERAPY  
Line 24: Line 24:


==A. INTRODUCTION==
==A. INTRODUCTION==
Posses,lion and use of brachytherapy sources is an :ictiNily trequiring a license pursuant to section 30.3, Requiring License," of 10 CFR Part 30, 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 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.


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.
==B. DISCUSSION==
Subcommittee N44-2. Therapeutic Radiology, of the American National Standards Institute Committee on Equipment and Materials for Medical Radiation Applications.


Paragraph
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.
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==
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)
Subcommittee N44-2, Therapeutic Radiology, of the American National Standards Institute Committee
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.
*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.
 
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.


' 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)
criteria, and recommended practices contained in ANSI N44.2-1973. "Leak Testing Radioactive Brachytherapy Sources"'  
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.
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 Appendix (which is not a part of the standard)
The leak tests carl be pertor tried 11\USAEC REGULATORY
describes leakage test methods which have been found to be acceptable for determining the radioactive leakage of sealed brachytherapy sources.
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.


C. REGULATORY
to delineate techniqtuet used by the staff in evaluating specific problems or postulated accidents, or to provide guidance to applicants.
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 1001


===8. USAEC REGULATORY ===
ReguTatory Guides are not subsritutles regulations and c¢,mpliance with them is not required.
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
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,.
,-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:
Published guides will be revised periodically.
Chief, Public Proceedings Staff.  applicants.


Regulatory Guides are not substitutes for regulations and compliance with them is not required.
as appropritte.


Methods and solutions different from those set out in The guides are issued in the following ten broad divisions:
to accommodate commentsi and to reflect new information or ewperience.
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
Copies ot published guiArý may be obtained by request indicating the divisions desired to the US. Atomic Energy Commission.


===7. Transportation ===
Washington.
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
D.C. 20545.Attention:
10. 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.
Oirc..tor of Regulatory Standnrds.


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.
Comments and suggestion%
for Irrmtovements in thes guides are encouraged and should be sent to the Secretary of the Commission.


'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).
US. Atomic Energy Commission.
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.
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


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.
===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


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}}
====s. mis rtiptmmre ====
4il 11ile thinmc li4.tbra inc 0IO 0 f 0!6.1-2}}


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

Revision as of 19:54, 12 October 2018

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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