Regulatory Guide 6.1: Difference between revisions
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{{#Wiki_filter:February | {{#Wiki_filter:February 1974 U.S. ATOMIC ENERGY COMMISSION | ||
REGULATORY | REGULATORY | ||
DIRECTORATE | DIRECTORATE | ||
OF REGULATORY | OF REGULATORY | ||
STANDARDS | STANDARDS GUIDE REGULATORY | ||
GUIDE 6.1 LEAK TESTING RADIOACTIVE | |||
GUIDE 6. | |||
BRACHYTHERAPY | BRACHYTHERAPY | ||
SOURCES | SOURCES | ||
==A. INTRODUCTION== | ==A. INTRODUCTION== | ||
-Possession and use of brachytherapy sources is | -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0.005 microcurie of radioactivic material on the test sample taken front the source, and that the source be immediately withdrawn from use if the test reveals the presence of 0.005 microcurie or more.This guide describes methods and procedures acceptable tot the Regulatory staff for leak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. | ||
of 10 CFR Part 30.-Rules of General Applicability to 'Licensing | |||
Paragraph (e) of section 30.34 | |||
A standard condition, included in all AEC | |||
==B. DISCUSSION== | ==B. DISCUSSION== | ||
Subcommittee N44-2. Therapeutic Radiology, | 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. | |||
test procedures. | 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. | |||
source disposition. | source disposition. | ||
frequency | frequency ofl leakage testing, records, and personnel qualifications. | ||
The Appendix (which is not a part of" the sl:rrrdard) | The Appendix (which is not a part of" the sl:rrrdard) | ||
describes leakage test met hods wvhich have been I'ulmid | 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. | |||
"Leak | criteria, and recommended practices contained in ANSI N44.2-1973. "Leak Testing Radioactive Brachytherapy Sources"' | ||
con.titute | 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 | 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. | ||
2. Section 7.1 of ANSI N44.2-1973 states that | |||
The leak tests carl be pertor tried 11\USAEC REGULATORY | 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 | 1o the' AEC Regulatory stff of implementing specific parts of the Commission*s regulations. | ||
to delineate techniqtuet used by the staff | 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. | ReguTatory Guides are not subsritutles regulations and c¢,mpliance with them is not required. | ||
Methods and solutions different from those sat out | 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. | Published guides will be revised periodically. | ||
| Line 84: | Line 69: | ||
Comments and suggestion% | Comments and suggestion% | ||
for Irrmtovements in thes guides are encouraged and should be sent to the Secretary of the Commission. | |||
US. Atomic Energy Commission. | US. Atomic Energy Commission. | ||
| Line 91: | Line 76: | ||
D.C. 20545.Attention: | D.C. 20545.Attention: | ||
Chief. Public Proceedings Staff.The guides are issued in the following ten broad divisions: | Chief. Public Proceedings Staff.The guides are issued in the following ten broad divisions: | ||
1. Power Reactors 6. Products 2. Research and Test Reactors | |||
6. | |||
===7. Transportation=== | ===7. Transportation=== | ||
3. Fuels and Materials Facilities | 3. Fuels and Materials Facilities | ||
8. Occupational | 8. Occupational Health 4. Environmental and Siting 9. Antitrust Review S. Materials and Plant Protection | ||
10. General adequateLly pa 'ed I.te4.hini | 10. General adequateLly pa 'ed I.te4.hini | ||
4.ia 11; prqýn mdcd. they. | 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. | 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 | |||
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 | |||
I.l~ I ~tng f seale~md raiidm Ill hi chv | |||
4.. An'Appcmtdi\ | 4.. An'Appcmtdi\ | ||
to. ANSI 'N44.2-' | to. ANSI 'N44.2-' IF7 limsi suggestdCL | ||
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 | ||
ILII. 1 .5 metods C.lo AAI1'il4 | |||
35 Srm')O '~ cyc ippimI. tors% [Ile%% ile Alm~ild lie: taken.1 -mily 110111 surface.,. | 35 Srm')O '~ cyc ippimI. tors% [Ile%% ile Alm~ild lie: taken.1 -mily 110111 surface.,. | ||
ýtiz Ii are | 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 | 34-.) tile SOUtT4cc sutri'. cc. The Stl~icL "ti-facet itsell. II limiud not.1 tic wiped. 51114. this' co uld 4a | ||
====s. | ====s. mis rtiptmmre ==== | ||
4il 11ile thinmc li4.tbra | 4il 11ile thinmc li4.tbra inc 0IO 0 f 0!6.1-2}} | ||
{{RG-Nav}} | {{RG-Nav}} | ||
Revision as of 18:33, 13 July 2018
| 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
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.
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.
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