Regulatory Guide 6.1: Difference between revisions

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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                                                           July 2008 Revision 2 REGULATORY GUIDE
{{#Wiki_filter:February 1974 U.S. ATOMIC ENERGY COMMISSION
                            OFFICE OF NUCLEAR REGULATORY RESEARCH
                                REGULATORY
                                        REGULATORY GUIDE 6.1 (Draft was issued as DG-6003, dated January 2008)
                                  DIRECTORATE OF REGULATORY                                 STANDARDS
                                  LEAK TESTING RADIOACTIVE
                                                                                                                                GUIDE
                                  BRACHYTHERAPY SOURCES
                                                                  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.
standard specifies that the sealed radioactive brachytherapy source should be withdrawn frotm use it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
"Activities Requiring License," of 10 CFR Part 30.                                      integrity (Baseline Criterion) Or (2) leakage of
-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
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.


Possession and use of brachytherapy sources is an activity requiring a license pursuant to Title 10,
minimize danger to life or property.                                                    The Appendix (which is not a part of" the sl:rrrdard)
Section 30.3, Activities Requiring License, of the Code of Federal Regulations (10 CFR 30.3) (Ref. 1).
                                                                                        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.
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:
requires that these sources be periodically leak tested, that the test be capable of detecting the presence of
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.
0.005 microcurie of radioactivic material on the test                                                     


The NRC revised the requirements for the medical use of byproduct materials, found in
==C. REGULATORY POSITION==
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.
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:
 
This guide was issued after consideration of comments received from the public.
 
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;
9, Antitrust and Financial Review; and 10, General.
 
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.
 
NRC criteria for evaluating a medical use license application which includes the use of radioactive sources for brachytherapy.
 
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.
 
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.


==B. DISCUSSION==
==B. DISCUSSION==
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.
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.


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.
equivalent. The leak tests carl be pertor tried 11\
                                                                                      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.


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 35.67.
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.


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
the Commission*s regulations. to delineate techniqtuet used by the staff in           Attention: Chief. Public Proceedings Staff.
(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 requirements.


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
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:
11555 Rockville Pike, Rockville, MD; the mailing address is USNRC PDR, Washington, DC 20555;
                                                              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,.
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 2
the issuance or continuance of a permit of lice.ns by the                                2.  Research and Test Reactors           


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


==C. REGULATORY POSITION==
===8. Occupational Health===
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.
                                                                                        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.


==D. IMPLEMENTATION==
adequateLly          pa'ed      I.te4.hini 4. ia11;    prqýn mdcd.    they. are                            I.l~ I ~tng f seale~md raiidm Ill
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.
                                                                                                    '.p~ifm.iII                                        hi chv tlerampy sUperv 3Ld. bv'.in iiidlividuaI qcualfled                as % k        h~                stilLi rces are im 4Iude.d it Iltis Luide. althotigh the~ AE C has3 Made 110 detmertiblatImn tts to theiri ldempilaiv.A
        I hle Atoirpc vI~      .irgy d!.iv~
          .4113~4'~'md          .   iainni Coinmuitsion does viki'11.license i16-2126 i:he ALC mrh anbd its. iuichiels rod


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.
====i. iMtri====
                                                                                          4.. An'Appcmtdi\ to. ANSI 'N44.2-' IF7 limsi suggestdCL
                                                                                                  ILII.


Rev. 2 of RG 6.1, Page 3
1      .5metods C.lo                AAI1'il4                jpmi
                                                                                                                                                                                  0IO
Peri'lsicelmsen.d                                                                  l meilds. thatit dl li?
                                                                                              Ltivil~tll                              iilCŽ          of thIlc            1
                                                                                                                                                                      & tc131.4.


REFERENCES
"IL.I        expo3      C'.13 vim
1. 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, U.S. Nuclear Regulatory Commission, Washington, DC.1
                            311            lLh        1 w i au      juaic ri'al    and .       I lit rou~hfl uped ~ ti              11'.4.peeo -t ter1.1   -allot (ito the p4 ibi        9PC3 I ~.4 3co e                    ldIn SuLii tcLewithi
2. 10 CFR Part 35, Medical Use of Byproduct Material, U.S. Nuclear Regulatory Commission, Washington, DC.1
                                                                                                                                                        .1    S.       tillu di  431111 radia~l        lini    othcm.~ve                        til a~~ir~t CVefs1''suidi 35 Srm')O '~
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/)
                                                                                            it icnib 1a nfill iS.t                              cyc ippimI. tors%[Ile lipiuII      in at            Gir wit                      .1§I2)0.01.44Le
4. NUREG-1556, Volume 9, Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Medical Use Licenses, U.S. Nuclear Regulatory Commission, Washington DC,
                                                                        1~l
  most current date and revision.2 (http://www.nrc.gov/reading-rm/doc- collections/nuregs/staff/sr1556/)
                                                                          )    I.Al.       %%  ile    Alm~ild lie: taken.1 - mily 110111 surface.,. ýtiz Ii are Ili tilol (p1    t t iLState and all oi t'til4 Agicentm States do                              close Iir0\3im~llf    34-.)tile SOUtT4cc sutri'. cc. The Stl~icL "ti-facet i4.QIZI to 11I them~ ' i mll~'i   4ll t        'iin I,               t.d  telit                  II limiud not.1 tic wiped. 51114. this' could itsel
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.
====l.   mis====
                                                                                                                                                                  4as.


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)
.10      1'      1 i'&mt    .hile~      4jft~t of. ANSI    N~ 44.2~        d~lm            rtiptmmre 4il 11ile thinmcli
  553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.


Rev. 2 of RG 6.1, Page 4}}
===4. tbrainc===
                                                                                                                                                                                  0f
                                                                                                                                                                                  0!
                                                                                      6.1-2}}


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Revision as of 00:23, 20 March 2020

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

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

"Activities Requiring License," of 10 CFR Part 30. integrity (Baseline Criterion) Or (2) leakage of

-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

10 CFR Part 30 provides that the Atomic Energy 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 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.

minimize danger to life or property. The Appendix (which is not a part of" the sl:rrrdard)

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.

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

C. REGULATORY POSITION

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:

B. DISCUSSION

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\

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

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:

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,.

the issuance or continuance of a permit of lice.ns by the 2. Research and Test Reactors

7. Transportation

3. Fuels and Materials Facilities

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.

adequateLly pa'ed I.te4.hini 4. ia11; prqýn mdcd. they. are I.l~ I ~tng f seale~md raiidm Ill

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