Regulatory Guide 6.1: Difference between revisions

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{{#Wiki_filter:February 1974 U.S. ATOMIC ENERGY COMMISSION
{{#Wiki_filter:February 1974 U.S. ATOMIC ENERGY COMMISSION
                                REGULATORY
REGULATORY
                                  DIRECTORATE OF REGULATORY                                 STANDARDS
DIRECTORATE OF REGULATORY STANDARDS
                                                                                                                                GUIDE
GUIDE
                                                                  REGULATORY GUIDE 6.1 LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES
REGULATORY GUIDE 6.1 LEAK TESTING RADIOACTIVE BRACHYTHERAPY SOURCES


==A. INTRODUCTION==
==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0.005 microcurie of radioactivic material on the test sample taken front the source, and that the source be immediately withdrawn from use if the test reveals the presence of 0.005 microcurie or more.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 N44.2-197
===3. 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
standard specifies that the sealed radioactive brachytherapy source should be withdrawn frotm use it
      -Possession and use of brachytherapy sources is an                              ( 1) source leakage exceeds the baseline values established activity iequirirng a license pursuant to section 30.3,                                by repetitive tests indicating degradation tt sotltrce
( 1) source leakage exceeds the baseline values established by repetitive tests indicating degradation tt sotltrce integrity (Baseline Criterion)  
"Activities Requiring License," of 10 CFR Part 30.                                      integrity (Baseline Criterion) Or (2) leakage of
Or  
-Rules of General Applicability to 'Licensing of                                        radioactive material equals ur exceeds 5 nanocuries of Byproduct Material." Paragraph (e) of section 30.34 in                                  radioactive material or, in the case of radium sources. I
(2)  
10 CFR Part 30 provides that the Atomic Energy                                          nant;:urie of radon in 24 hours (Leakage Limit). The Commission may incorporate in any license such                                          standard also establishes criteria and procedutres for additional requirements and conditions as it dcems                                      retests. test procedures. source disposition. frequency ofl appropriate or necessary in order to protect health or to                              leakage testing, records, and personnel qualifications.
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. 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"'
co


minimize danger to life or property.                                                   The Appendix (which is not a part of" the sl:rrrdard)
====n. titute a====
                                                                                        describes leakage test met hods wvhich have been I'ulmid ti A standard condition, included in all AEC licenses                              be acceptable for determining the radioactive leak-age of for possession and use of' sealed brachytherapy sources                                 sealed brach. therapy sources.
generally acceptable piocedure for complying with trhe licensing conditions applicable to the leak testing of radioactive brachytherapy sources, subject to thie following:
1.


requires that these sources be periodically leak tested, that the test be capable of detecting the presence of
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."
0.005 microcurie of radioactivic material on the test                                                     
2.


==C. REGULATORY POSITION==
Section 7.1 of ANSI N44.2-1973 states that the minimum training and experience requirement tio
sample taken front the source, and that the source be immediately withdrawn from use if the test reveals the                                        The requirements. criteria, and recommended presence of 0.005 microcurie or more.                                                  practices contained in ANSI N44.2-1973. "Leak Testing Radioactive Brachytherapy Sources"'                         con.titute a This guide describes methods and procedures                                      generally acceptable piocedure for complying with trhe acceptable tot the Regulatory staff for leak testing                                    licensing conditions applicable to the leak testing of radioactive brachytherapy sources.                                                     radioactive brachytherapy sources, subject to thie following:
: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 fo*r 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.


==B. DISCUSSION==
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.
1. In order to be approved for use. brachyltlerapy Subcommittee N44-2. Therapeutic Radiology, of                                  sources should meet certain integrity requirenentls and the American National Standards Institute Committee                                    pass certain tests in addition to the leak test described in on Equipment and Materials for Medical Radiation                                        this guide. Manufacturers of medical brachyther:apy Applications. N44, has developed a standard presenting                                  sources should refer to Regulatory Guide 6.2, "Inlegrity uniform criteria and test procedures for the evaluation                                and Test Specifications for Selected Brachythertapy oI radioactive material leakage from sealed                                            Sources."
brachytherapy sources. This standard was approved by the American National Standards Institute (ANSI) on                                    2. Section 7.1 of ANSI N44.2-1973 states that the July IS, 10373. and dlesignated ANSI N44.2-1973. i The                                  minimum training and experience requirement tio :11l individual perftorming tire leak tests should le eligibility for relevant certification by tire American Board of,
        ('upies    may be obtained from the American National                          Radiology or tire American Board of' Ilealth Physics or Sr; inda Wrt Ih                    30t ro:,dwa y. New York. New York it tite, I n'., 14.11 IW(118.


equivalent. The leak tests carl be pertor tried 11\
Attention: Chief. Public Proceedings Staff.
                                                                                      Copies ot published guiArý may be obtained by request indicating the divisions USAEC REGULATORY GUIDES                                      desired to the US. Atomic Energy Commission. Washington. D.C. 20545.


Attention: Oirc..tor of Regulatory Standnrds. Comments and suggestion% for Regulatory Guides ate Issued to describe and make available to the public            Irrmtovements in thes guides are encouraged and should be sent to the Secretary methods acceptable 1o the' AEC Regulatory stff of implementing specific parts of      of the Commission. US. Atomic Energy Commission. Washington,. D.C. 20545.
The guides are issued in the following ten broad divisions:


the Commission*s regulations. to delineate techniqtuet used by the staff in          Attention: Chief. Public Proceedings Staff.
===1. Power Reactors ===


to evaluating specific problems or postulated accidents, or to provide guidance and c¢,mpliance applicants. ReguTatory Guides are not subsritutles fo*r regulations                in The guides are issued in the following ten broad divisions:
===6. Products===
                                                              from those sat out with them is not required. Methods and solutions different the findings requisite to the guides will be ecceptsble if they provide a besis for                                1. Power Reactors                        6. Products Comntission,.
2. Research and Test Reactors  
the issuance or continuance of a permit of lice.ns by the                                2. Research and Test Reactors          


===7. Transportation===
===7. Transportation===
                                                                                        3. Fuels and Materials Facilities      
3. Fuels and Materials Facilities  


===8. Occupational Health===
===8. Occupational Health===
                                                                                        4. Environmental and Siting             9. Antitrust Review appropritte. to accommodate Published guides will be revised periodically. as                                        S. Materials and Plant Protection       10. General commentsi and to reflect new information or ewperience.
4. Environmental and Siting  
9. Antitrust Review S. Materials and Plant Protection  
1
 
===0. General===
 
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Revision as of 00:17, 11 January 2025

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 N44.2-197

3. 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"'

co

n. 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 fo*r 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

1

0. General

adequateLly pa 'ed I.te4.hini4.ia 11;

prqýn mdcd. they. are sUperv 3Ld. bv'.in iiidlividuaI qcualfled as % k h~

I hle Atoirpc vI~

.irgy Coinmuitsion does viki'1

1. license

.4113~4'~'md d!.iv~

.

iainni i16-2126 anb d its. iuichiels Peri'lsicelmsen.d he i:

ALC mrh rod

i. iMtri l

"IL I .

expo3

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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

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'iin I,

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