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{{Adams
{{Adams
| number = ML081140471
| number = ML13064A083
| issue date = 07/01/2008
| issue date = 07/31/1974
| title = Integrity and Test Specifications for Selected Brachytherapy Sources
| title = Integrity and Test Specification for Selected 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-6004
| document report number = RG-6.002
| document report number = RG-6.002, Rev 2
| package number = ML081140456
| document type = Regulatory Guide
| document type = Regulatory Guide
| page count = 4
| page count = 2
}}
}}
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION
{{#Wiki_filter:July 1974 U.S. ATOMIC ENERGY COMMISSION
July 2008 Revision 2REGULATORY GUIDE
                                REGULATORY
  OFFICE OF NUCLEAR REGULATORY RESEARCH
                                DIRECTORATE OF REGULATORY STANDARDS
    REGULATORY GUIDE 6.2 (Draft was issued as DG-6004, dated December 2007)
                                                                                                                                GUIDE
INTEGRITY AND TEST SPECIFICATIONS FOR SELECTED BRACHYTHERAPY SOURCES
                                                                  REGULATORY GUIDE 6.2 INTEGRITY AND TEST SPECIFICATIONS FOR SELECTED BRACHYTHERAPY SOURCES


==A. INTRODUCTION==
==A. INTRODUCTION==
This guide directs the reader to the type of information acceptable to the U.S. Nuclear Regulatory Commission (NRC) to evaluate the integrity and test specifications for selected brachytherapy sources.  The manufacture of brachytherapy sources containing byproduct material requires a license pursuant to Title 10, Section 30.3, "Activities Requiring License," of the Code of Federal Regulations (10 CFR 30.3) (Ref. 1).  Brachytherapy sources manufactured under such a license must meet certain integrity requirements and pass certain tests. The regulation at 10 CFR 32.74(a)(2)(iii) (Ref. 2) requires that an application for a specific license to manufacture and distribute brachytherapy sources and devices containing byproduct material include a description of the procedures for, and results of, prototype tests performed to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents. Additionally, 10 CFR 32.74(a)(2)(v) requires that the application also include details of quality control procedures to ensure that production sources and devices meet the standards of the design and prototype tests.
sealed medical sources used in interstitial, intracavitary, and topical therapy. This standard was approved by the Manufacture of brachytherapy sources containing                                   American National Standards Institute (ANSI) on byproduct material is an activity requiring a license                                 August 16, 1973, and designated ANSI N44.1-1973. 1 pursuant to section 30.3, "Activities Requiring License,"                             The standard is limited to the traditional type sources of 10 CFR Part 30, "Rules of General Applicability to                                  with well-established medical uses and does not provide Licensing of Byproduct Material;" Brachytherapy                                        standards for sources used in afterloaded devices. The sources manufactured under such license must meet                                     three source type categories covered by the standard are certain integrity requirements and pass certain tests.                                 tubes or capsules and needles containing Ra-266, Co-60,
Paragraph 32.74(a)(2)(iii) of 10 CFR Part 32, "Specific                                or Cs-137, and beta applicators containing either Sr-90
Licenses to Manufacture, Distribute, or Import Certain                                or Ra-226. The standard establishes performance test Items Containing Byproduct Material," requires that an                                 specifications for temperature, impact, percussion, bend- application for a specific license to manufacture and                                 ing, tensile stress, and puncture. The temperature, distribute brachytherapy sources and devices containing                               impact, and percussion tests, which are the same tests byproduct material to persons licensed under Section                                  for classification of a source as "special form" under the
35.14, "Special Licenses for Certain Groups of Medical                                transportation regulations of the Department of Trans- Uses," of 10 CFR Part 35, "Human Uses of Byproduct                                    portation and the International Atomic Energy Agency Material," include a description of procedures for, and                               are applicable to all source types. In addition, the the results of, the prototype tests performed to demon-                                bending test is applicable to interstitial needles, and the strate that the source or device will maintain its integrity                           tensile stress and puncture tests are applicable to the under stresses likely to be encountered in normal use                                 beta applicators. According to ANSI N44.1-1973, a and accidents. Paragraph 32.74(aX2Xiv) of 10 CFR Part                                  source is deemed to pass these tests if it is "free of visual
32 requires that the application also include details of                               defects" and "demonstrates leakage of less than 50
the quality control procedures which assure that pro-                                  nanocuries (nCi) (10 nanocuries of radon in 24 hours in duction sources and devices meet the standards of the                                 the case of Ra-226 sources)."
design and prototype tests. This guide describes integrity requirements and test specifications acceptable to the Regulatory staff for selected brachytherapy sources.                                        The standard also includes a quality control program
                                                                                      "to insure that the production units will have the same integrity and meet the same requirements as the proto-


This regulatory guide endorses the methods and procedures for integrity and test specifications of selected 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==
 
type units tested pursuant to this standard." The quality control program further requires that, before transfer, Subcommittee N44-2, Therapeutic Radiology, of the                                 each source be tested and demonstrate leakage of less American National Standards Institute Committee on than 5 nanocuries (1 nanocurie of radon in 24 hours in Equipment and Materials for Medical Radiation Appli- the case of Ra-226 sources).
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.
cation, N44, has developed a standard presenting integ- rity requirements and test specifications for selected
 
                                                                                      ]Copies may be obtained from the American" National Standards
This guide was issued after consideration of comments received from the public.
*Line indicates substantive changes from previous issue.                                Institute, Inc., 1430 Broadway, New York, New York 10018.
 
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.
 
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. ML081140471.
 
Rev. 2 of RG 6.2, Page 2 Since the initial publication of Regulatory Guide 6.2 in 1974, the NRC has revised the requirements for the medical use of byproduct materials in 10 CFR Part 32, "Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Material," and 10 CFR Part 35, "Medical Use of Byproduct Material" (Ref. 5), to implement a risk-informed, performance-based approach to regulation.  Volumes 3 and 9 of NUREG-1556 incorporate this revised approach.


This regulatory guide contains information collections covered by 10 CFR Parts 32 and 35 that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0001 and 3150-0010, respectively. 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.
USAEC REGULATORY GUIDES                                      Copies of published guides mey be obtained by request indicating the divisions desired to the US. 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    inmprovements in these guides are encouraged and should be sent to the Secretary the Commission's regulations, to delineate techniques used by the staff in          o1f the Commission, U.S. Atomic Energy Commission, Washington, D.C. 20545.


==B. DISCUSSION==
evaluating specific problems or postulated accidents, or to provide guidance to    Attention: Chief, Public Proceedings Staff.
As part of its redesign of the materials license program, the NRC has 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 describes how to file a request with the NRC for radiation safety evaluation and registration of sealed sources and devices containing byproduct material.  It also lists the applicable regulations and industry standards as well as the policies affecting evaluation and registration.  Volume 3 contains administrative procedures to be followed, information on how to perform the evaluation and how to prepare a registration certificate, and the responsibilities of the registration certificate holder.  In addition, it is designed to provide the reviewer of such requests with guidance, information, and materials necessary to perform a complete and thorough evaluation of the submittal.
applicants. Regulatory Guides are not substitutes for regulations and compliance with them is not required. Methods and solutions different from those set out in    The guides are issued in the following ten broad divisions:
  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                       


Volume 9 of NUREG-1556 provides guidance for licensing under 10 CFR Part 35. It contains information that is intended to assist applicants with the preparation of license applications for the medical use of byproduct material.  In particular, it describes the types of information needed to complete NRC Form 313, "Application for Materials License," and the series of forms under NRC Form 313A, "Training and Experience and Preceptor Statement."  Volume 9 provides an overview of the types of licenses issued by the NRC and the commitments and responsibilities that a licensee must undertake.  In addition, it identifies the applicable regulations, the process for filing a license application, and the contents of applications for different types of medical uses of byproduct material.  Because of the wide variety in the types of medical uses of byproduct material, Volume 9 contains indicators to alert applicants to information pertinent to particular types of medical uses.
===6. Products===
                                                                                        2.  Research and Test Reactors           


Volume 9 of NUREG-1556 includes a discussion of the NRC's criteria for evaluating a medical use license application.  Complementary guidance on inspection procedures for inspections of medical use licensees is contained in documents available at the NRC's web page on the medical use of byproduct material (Ref. 6) (http://www.nrc.gov/materials/miau/med-use-toolkit.html
===7. Transportation===
).    In addition, Volume 9, like 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 (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, Rev. 2 of RG 6.2, Page 3 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
                                                                                        3, Fuels and Materials Facilities        8. Occupational Health Published guides will be revised periodically, as appropriate, to accommodate          4.  Environmental arid Siring              9. Antitrust Review comments and to reflect new information or experience. .                               5.  Materials and Plant Protection        1


====s.     ====
===0. General===
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, 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==
==C. REGULATORY POSITION==
This regulatory guide endorses the method described in Volumes 3 and 9 of NUREG-1556 as a process that has been found acceptable to the NRC for meeting the regulatory requirements for integrity and test specifications for selected brachytherapy sources.
materials with exactly the same characteristics as the iaterials used in the qualified prototype units.
 
==D. IMPLEMENTATION==
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.
,the' requirements and recommended practices con- tained in ANSI N44.1-1973, "Integrity and Test Specifi-            5. Section 5.4 of ANSI N44.1-1973, "Acceptance
                                                  1 cations for Selected Brachytherapy Sources,"            con-      Testing," states .that the acceptability of the source shall stitute a generally acceptable procedure for                       be indicated by removal of less than 5 nanocuries of the demonstrating the integrity of those medical brachy-              radioisotope in one of the tests designed to demonstrate therapy sources identified in the standard, subject to the        contamination of the outer capsule, and it recommends following:                                                        that a value not greater than 1/10 of the radioactivity limit above be chosen as a-production control point and
1. Section 4.1 of ANSI N44.1-1973 states that non-                that no source which exceeds this value be transferred radioactive prototypes may be substituted for radio-              by a manfacturer to a user for use as a brachytherapy active units in cases where evidence of integrity can be          source.


Rev. 2 of RG 6.2, Page 4 REFERENCES
established by leakage test methods appropriate to nonradioactive sources. The integrity of the source will              The acceptability of a source for transfer by a be established if the source is tested by a method                manufacturer to a user for use as a brachytherapy source capable of accuratelT' and reliably measuring leakage            should be indicated by removal of less than 0.5 rates of 107 7 atm cm /sec or less for dry air at 25 0 C and      nanocurie of the radioisotope in one of the tests for a pressure differential of one atmospheric against a          designed to demonstrate contamination of the outer vacuum of 1/100 atmosphere or less, with negative                  capsule and by presence of a hermetic seal according to a results.                                                          leakage test designed to demonstrate, this situation. The vacuum leach tests, helium mass spectrometer tests, and Kr-85 leak tests 2 are acceptable for the purpose of
1. 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
2. Item 2 in Section 4.1 states that leakage of less than          demonstrating a hermetic seal.


1  2. 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
SO nanocuries from sources subjected to tests described in Section 4.2 demonstrates retention of integrity after          6. Manufacturers of brachytherapy sources should main- the test. Prototype sources subjected to tests described          tain results of prototype and acceptance tests. The test in Section 4.2 should retain their integrity and leak              results should be expressed in terms of activity measured esentially no radioactive materiaL This will be demon-            and include identification of the test method, instrumen- strated for the purpose of these prototype tests, if leak          tatim, and calibration procedures used.


3. NUREG-1556, Volume 3, "Consolidated Guidance about Materials Licenses:  Applications for Sealed Source and Device Evaluation and Registration," U.S. Nuclear Regulatory Commission, Washington DC, most current date and revision.
tests performed both. prior to and after each test described in Section 4.2 indicate removal of less than 5            7. The Atomic Energy Commission does not license nanocuries in each case.                                          sources and devices containing Ra-226 and its daughters.


2  (http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)   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.
Persons licensed by the AEC for byproduct, source, or
3. To the comiderations described in Section 5.2,                  special nuclear material who also possess sources con-
"Design Requirements," should be added the possible                taining radium and its daughters must limit the radiation deleterious effects on source materials (both radioactive          exposu-e from both licensed material and other sources and nonradioactive) due to the inherent nature of the              of radiation such as radium so that the limits in Part 20
source and resulting from radiation damage, chemical                are not exceeded (§20.101). Also, many of the States and physical changes (e.g., those resulting in the evolu-           and all of the Agreement States do regulate the use of tion of gases or changes in density and volume of                  sources of radium and its daughters. For that reason, the contained radioactive materials), and chemical reactions          parts of ANSI N44.1-1973 dealing specifically with between source materials.                                           testing of sealed radium brachytherapy sources are included in this guide, although the AEC has made no determination as to their adequacy.


(http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/)    5. 10 CFR Part 35, "Medical Use of Byproduct Material," U.S. Nuclear Regulatory Commission, Washington, DC.
4. Section 5.3, "Materials Specification. and Control,"
states that the quality control program shall assure that          2 R.G. Neimeyer, "Leak Testing. Encapsulated Radioactive
"substantially the same .... materials .... are incorpo-           Sources" ORNL-4529, July 1972, available from National rated in all production units." (Emphasis supplied.) All            Technical Information Service, U.S. Department of Commerce, production units should be produced with and contain                5285 Port Royal Road, Springfield, Va. 22151.


6. Medical Uses Licensee Toolkit, U.S. Nuclear Regulatory Commission, Washington DC, NRC Web site: (http://www.nrc.gov/materials/miau/med-use-toolkit.html
6.2-2}}
).                                                       
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.}}


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Latest revision as of 08:26, 20 March 2020

Integrity and Test Specification for Selected Brachytherapy Sources
ML13064A083
Person / Time
Issue date: 07/31/1974
From:
US Atomic Energy Commission (AEC)
To:
References
RG-6.002
Download: ML13064A083 (2)
v • d • e


July 1974 U.S. ATOMIC ENERGY COMMISSION

REGULATORY

DIRECTORATE OF REGULATORY STANDARDS

GUIDE

REGULATORY GUIDE 6.2 INTEGRITY AND TEST SPECIFICATIONS FOR SELECTED BRACHYTHERAPY SOURCES

A. INTRODUCTION

sealed medical sources used in interstitial, intracavitary, and topical therapy. This standard was approved by the Manufacture of brachytherapy sources containing American National Standards Institute (ANSI) on byproduct material is an activity requiring a license August 16, 1973, and designated ANSI N44.1-1973. 1 pursuant to section 30.3, "Activities Requiring License," The standard is limited to the traditional type sources of 10 CFR Part 30, "Rules of General Applicability to with well-established medical uses and does not provide Licensing of Byproduct Material;" Brachytherapy standards for sources used in afterloaded devices. The sources manufactured under such license must meet three source type categories covered by the standard are certain integrity requirements and pass certain tests. tubes or capsules and needles containing Ra-266, Co-60,

Paragraph 32.74(a)(2)(iii) of 10 CFR Part 32, "Specific or Cs-137, and beta applicators containing either Sr-90

Licenses to Manufacture, Distribute, or Import Certain or Ra-226. The standard establishes performance test Items Containing Byproduct Material," requires that an specifications for temperature, impact, percussion, bend- application for a specific license to manufacture and ing, tensile stress, and puncture. The temperature, distribute brachytherapy sources and devices containing impact, and percussion tests, which are the same tests byproduct material to persons licensed under Section for classification of a source as "special form" under the

35.14, "Special Licenses for Certain Groups of Medical transportation regulations of the Department of Trans- Uses," of 10 CFR Part 35, "Human Uses of Byproduct portation and the International Atomic Energy Agency Material," include a description of procedures for, and are applicable to all source types. In addition, the the results of, the prototype tests performed to demon- bending test is applicable to interstitial needles, and the strate that the source or device will maintain its integrity tensile stress and puncture tests are applicable to the under stresses likely to be encountered in normal use beta applicators. According to ANSI N44.1-1973, a and accidents. Paragraph 32.74(aX2Xiv) of 10 CFR Part source is deemed to pass these tests if it is "free of visual

32 requires that the application also include details of defects" and "demonstrates leakage of less than 50

the quality control procedures which assure that pro- nanocuries (nCi) (10 nanocuries of radon in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in duction sources and devices meet the standards of the the case of Ra-226 sources)."

design and prototype tests. This guide describes integrity requirements and test specifications acceptable to the Regulatory staff for selected brachytherapy sources. The standard also includes a quality control program

"to insure that the production units will have the same integrity and meet the same requirements as the proto-

B. DISCUSSION

type units tested pursuant to this standard." The quality control program further requires that, before transfer, Subcommittee N44-2, Therapeutic Radiology, of the each source be tested and demonstrate leakage of less American National Standards Institute Committee on than 5 nanocuries (1 nanocurie of radon in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in Equipment and Materials for Medical Radiation Appli- the case of Ra-226 sources).

cation, N44, has developed a standard presenting integ- rity requirements and test specifications for selected

]Copies may be obtained from the American" National Standards

  • Line indicates substantive changes from previous issue. Institute, Inc., 1430 Broadway, New York, New York 10018.

USAEC REGULATORY GUIDES Copies of published guides mey be obtained by request indicating the divisions desired to the US. 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 inmprovements in these guides are encouraged and should be sent to the Secretary the Commission's regulations, to delineate techniques used by the staff in o1f the Commission, U.S. Atomic Energy Commission, Washington, D.C. 20545.

evaluating specific problems or postulated accidents, or to provide guidance to Attention: Chief, Public Proceedings Staff.

applicants. Regulatory Guides are not substitutes for regulations and compliance with them is not required. Methods and solutions different from those set out in The guides are issued in the following ten broad divisions:

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

7. Transportation

3, Fuels and Materials Facilities 8. Occupational Health Published guides will be revised periodically, as appropriate, to accommodate 4. Environmental arid Siring 9. Antitrust Review comments and to reflect new information or experience. . 5. Materials and Plant Protection 1

0. General

C. REGULATORY POSITION

materials with exactly the same characteristics as the iaterials used in the qualified prototype units.

,the' requirements and recommended practices con- tained in ANSI N44.1-1973, "Integrity and Test Specifi- 5. Section 5.4 of ANSI N44.1-1973, "Acceptance

1 cations for Selected Brachytherapy Sources," con- Testing," states .that the acceptability of the source shall stitute a generally acceptable procedure for be indicated by removal of less than 5 nanocuries of the demonstrating the integrity of those medical brachy- radioisotope in one of the tests designed to demonstrate therapy sources identified in the standard, subject to the contamination of the outer capsule, and it recommends following: that a value not greater than 1/10 of the radioactivity limit above be chosen as a-production control point and

1. Section 4.1 of ANSI N44.1-1973 states that non- that no source which exceeds this value be transferred radioactive prototypes may be substituted for radio- by a manfacturer to a user for use as a brachytherapy active units in cases where evidence of integrity can be source.

established by leakage test methods appropriate to nonradioactive sources. The integrity of the source will The acceptability of a source for transfer by a be established if the source is tested by a method manufacturer to a user for use as a brachytherapy source capable of accuratelT' and reliably measuring leakage should be indicated by removal of less than 0.5 rates of 107 7 atm cm /sec or less for dry air at 25 0 C and nanocurie of the radioisotope in one of the tests for a pressure differential of one atmospheric against a designed to demonstrate contamination of the outer vacuum of 1/100 atmosphere or less, with negative capsule and by presence of a hermetic seal according to a results. leakage test designed to demonstrate, this situation. The vacuum leach tests, helium mass spectrometer tests, and Kr-85 leak tests 2 are acceptable for the purpose of

2. Item 2 in Section 4.1 states that leakage of less than demonstrating a hermetic seal.

SO nanocuries from sources subjected to tests described in Section 4.2 demonstrates retention of integrity after 6. Manufacturers of brachytherapy sources should main- the test. Prototype sources subjected to tests described tain results of prototype and acceptance tests. The test in Section 4.2 should retain their integrity and leak results should be expressed in terms of activity measured esentially no radioactive materiaL This will be demon- and include identification of the test method, instrumen- strated for the purpose of these prototype tests, if leak tatim, and calibration procedures used.

tests performed both. prior to and after each test described in Section 4.2 indicate removal of less than 5 7. The Atomic Energy Commission does not license nanocuries in each case. sources and devices containing Ra-226 and its daughters.

Persons licensed by the AEC for byproduct, source, or

3. To the comiderations described in Section 5.2, special nuclear material who also possess sources con-

"Design Requirements," should be added the possible taining radium and its daughters must limit the radiation deleterious effects on source materials (both radioactive exposu-e from both licensed material and other sources and nonradioactive) due to the inherent nature of the of radiation such as radium so that the limits in Part 20

source and resulting from radiation damage, chemical are not exceeded (§20.101). Also, many of the States and physical changes (e.g., those resulting in the evolu- and all of the Agreement States do regulate the use of tion of gases or changes in density and volume of sources of radium and its daughters. For that reason, the contained radioactive materials), and chemical reactions parts of ANSI N44.1-1973 dealing specifically with between source materials. testing of sealed radium brachytherapy sources are included in this guide, although the AEC has made no determination as to their adequacy.

4. Section 5.3, "Materials Specification. and Control,"

states that the quality control program shall assure that 2 R.G. Neimeyer, "Leak Testing. Encapsulated Radioactive

"substantially the same .... materials .... are incorpo- Sources" ORNL-4529, July 1972, available from National rated in all production units." (Emphasis supplied.) All Technical Information Service, U.S. Department of Commerce, production units should be produced with and contain 5285 Port Royal Road, Springfield, Va. 22151.

6.2-2


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