ML20137R821
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. ,f ** " % t UNITED STATES
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7 ,, . , . NUCLEAR REGULATORY COMMISSION t
i WASHINGTON, D. C. 20555
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M*N/ OCT 2 01983 MEMORANDUM FOR: Regional Administrators Branch Chiefs Division of Fuel Cycle and Material Safety FROM: Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
SUBJECT:
POLICY AND GUIDANCE DIRECTIVE FC 83-20; STANDARD LICENSE CONDITIONS Attached for your use is a revised, up-to-date list of Material Licensing Standard Conditions (Enclosure 1). An explanation of the revisions is included as Enclosure 2. The previous list dated December,1981, is superseded and should be discarded.
In crder to maintain consistency throughout NRC, standard conditions should be used to the maximum extent possible. Any future revisions will be transmitted by memoranda as part of the FC Directive System.
Therefore, proposed revisions to standard conditions or proposed special conditions should be coordinated through Headquarters prior to use.
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Richard E. Cunningham, Director Division of Fuel Cycle and Material Safety
Enclosure:
- 1. Material Licensing Standard Conditions
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Page 1 MATERIAL LINING BRANCI STANPARD CONDITICNS October, 1983 1.B. Licensed material shall be used only at .
1.C. The licensee shall nctify of each operation cerxiucted under this license at a location other than that specified in Iten 2 above when such operation continues for nere than 60 days. The licensee also shall rotify the aforementioned Regional Office upon cessation of such cperation.
2.A. Licensed mterial my be used at and at temporary job sites of the licensee anywhere in the United States.
2.B. Licensed s terial may be used at and at temporary job sites of the licensee anywhere in the United States where the U. S. Nuclear Regulatory Ccrrmission mintains jurisdiction for regulating the use of licensed material.
- 3. Licensed eterial shall be used arrly at tetporary job sites of the licensee anywhere in the United States where the Nuclear Regulatory C& mission maintains jurisdiction for regulating the use of licensed m terial.
- 4. Licensed material may be used anywhere in ._
. The licensee shall emply with the provisions of Title 10, Chapter 1, Code of Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers; Inspections" and Part 20, " Standards for Protection Against Radiation."
6.A. Licensed s terial shall be used by .
6.B. Licensed s terial listed in Item 6 above is authorized fbr use by the followng individual (s) for the materials and uses indicated:
(NAME) (USES) 7.A. Licensed m terial shall be used by, or under the supervision of, .
7.B. Licensed s terial listed in Item 6 above is authorized for use by,
.or under the supervision of, the follcwing individual (s) for the mterials and uses indicated:
Pace 2 7.C. (The folloaing is used in ccnjunction with Standard Condition 7.A.:)
At least one individual named in Condition 12.A. shall be physically present at the authorized place of use whenever licensed e terial is being used.
- 8. Licensed caterial shall be used by, or under the supervisien and in the physical presence of, .
9.A.1.icensei naterial shall be used by, or under the supervision of, individuals designated by .
9.B. The use of licensed caterial in er on hwans shall be by a physician as defined in 10 GR 35.3(b) .
9.C. Physicians designated to use licensed raterial in er en hwans shall neet the training and experience criteria established in Appendix A of Regulatory Guide 10.8 (Revision 1), dated Octcioer 1980.
9.D. The Radiation Protection Officer for the activities authorized by this license iS .
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Oct 1983
3 Paga 3 CEDITICNS lo The following condition is the leak test condition for BRCAD LICENSES and for licenses to persons who fabricate sources.
- 10. A. (1) Each sealed source acquired fran another person and containing licensed naterial, other than Hydrogen 3, with a half-life greater than thirty days and in any fonn other than gas shall be tested for contamination and/or leakage prior to use. In the absence of a certificate fran a transferor indicating that a test has been nude within six nonths prior to the transfer, a sealed source received fran another person shall not be put into use until tested.
(2) Notwithstanding the periodic leak test required by this conditien, any licensed sealed source is exc:pt fran such leak tests
- hen the source contains 100 microcuries or less of beta and/or gar:na enitd.g material or 10 microcuries or less of alpha enitting material.
(3) Except for alpha sources, the periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. The sources excepted fran this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six tronths prior to the date of use or transfer.
B. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage, and ccntamination prior 'to use or transfer as a sealed source. If the inspection or test reveals any construction defects or 0.005 micrccurie or greater of contamination,-
the source shall not be used or transferred as a sealed source until it has been repaired, decontaminated and retested.
C. Each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any fann other than gas shall be tested for leakage and/or contamination at intervals not to exceed six nonths except that each source designed for the purpose of emitting alpha particles shall be tested at intervals not to exceed three nonths. ,
1 D. The test shall be capable of detecting the presence of 0.005 microcurie of l radioactive naterial on the test sample. The test sample shall be taken !
fran the sealed source or fran the surfaces of the device in which the I sealed source is pennanently or senipennanently mounted or stored on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccmnission. 1 E. If the test required by Subsection A. or C. of this ccndition reveals the presence of 0.005 microcurie or nore of renovable contamination, the l licensee shall intnediately withdraw the sealed source fran use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Ccmnission regulations. A report shall be filed within five (5) days of the test with the U. S. Nuclear Regulatory Ca:tnission, Region ,
, describing the equipnent involved, the test results, and the corrective action taken.
l Oct 1983
Paga 4 CCFDITICN 11.
The follcwing condition is the leak test condition for neutren and beta-ga=a sources only.
- 11. A. (1) Each sealed source containing licensed raterial, c&er than Hydrogen 3, with a half-life greater than thirty days arxi in any form other than j gas shall be tested for leakage and/cr contamination at intervals net '
to exceed six ::enths. In the absence of a certificate fran a transferer iMicating that a test has been ::nde within six r:cnths pricr to the transfer, a sealed source received fran another person shall not be put into use until tested.
(2) Notwithstanding the pericdic leak test requi. red by this condition, any licensed sealed source is exerpt fran such leak tests when the source contains 100 microcuries er less of beta and/or ga=a e-itting raterial or 10 ricrecries er less of alpha enitting raterial.
The exceptien in ll.A.(3) may be applied where, in the judgment of the technical reviewer, health and safety will not be carprorised.
(3) The pericdic leak test required by this conditien does not apply to sealed sources that are stored and not being useh. 'Ihe sources excepted fran this test shall be tested for leakage prier to any i l
use er transfer to another person unless they have been leak l tested within si.x ncnths prior to the date of use er transfer.
B. 'Ihe test shall be capable of detecting the presence of 0.005 micrcerie of radioactive naterial on the test sample. The test sample shall be taken fran the sealed source or fran the surfaces of the device in which the sealed source is pe=ranently :rcunted er stored on which one might expect centamination to accur:ulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccmnission. -
C. If the test reveals the presence of 0.005 micrce r ie er r:cre of rarevable contamination, the licensee shall immediately withdraw the sealed source fran use and shall cause it to be decontaninated and repaired er to be disposed of in accordance with Cem tission regulations.
,A report shall be filed within five (5) days of the test with the U. S. Nuclear Regulatory Ccmrission, Region ,
describing the equipment involved, the test results, arxi the corrective action taken.
D. Tests for leakage and/or conta:rination shall be performed by o- by other persons specifically authorired by the Conrission or an Agrement State to perform such services.
Note: Blank in paragraph D may be filled in the "the licensee", the device manufacturer, the source nanufacturer, etc. , or onitted. Nc=nally paragraph D or E, but not both, chould be used.
E. The licensee is authorired to collect leak test samples in accordance with the procedures described in the licensee's for analysis by . Alternatively, leak test sarples may be collected and/or analyzed by other persons specifically authorized by the Ccmnission or an Agreenent State to perforn such services.
Cet 1983
CONDITICES 12.
The following condition is the leak test condition for alpha, neutron, and beta-gamma sources.
- 12. A. (1) Each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any form other {
than gas shall be tested for leakage and/or contamination at intervals l not to exceed six nonths, except r. hat each source designed for the purpose of snitting alpha particles shall be tested at intervals not ,
to exceed three nonths. In the absence of a certificate fran a j
, transferor, indicating that a test has been nude within six nonths prior to the transfer, a sealed source received fran another person shall not be put into use until tested.
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(2) Notwithstaniing the periodic leak test required by this condition, any licensed sealed source is exempt fran such leak tests when the source
,4 contains 100 microcuries or less of beta and/or gamma enitting material or 10 microcuries or less of alpha emitting material.
he exception in 12.A. (3) nay be applied where, in the judgment of the technical reviewer, health' and safety will not be conpranised.
(3) Except for alpha sources, the periodic leak test required by this emdition does not apply to sealed sources that are stored and not being used. Se sources excepted fran this test shall be tested for
't leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or
,'%- transfer.
B. Se test shall be capable of detecting the presence of 0.005 microcurie of radioactive material crt the test sanple. The test sample shall be taken fran the sealed source or fran the surfaces of the device in which the sealed source is permanently nounted or stored on which one might expect b
contanination to a m late. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccmnission.
C. If the test reveals the presence of 0.005 microcurie or nore of renovable ccritanination, the licensee shall- hunediately withdraw the sealed source fran use and shall cause it to be decontaminated and repaired or to be j disposed of in accordance with Cannission regulations. A report shall be filed within 5 days o.f the test with the U. S. Nuclear Regulatory Ccmnission, lbgion ,
, describing the equipnent involved, the test results, and
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the corrective action taken.
D. Tests for leakage and/or contanination'shall be performed by or by other persons specifically authorized by the Cannission or an Agreement State to perform such services.
Note: Blank in parap.g.h D may be filled in with "the licensee", the device manufacturer, the source nanufacturer, etc., or cuitted. Normally paragraph D or E, but not both, should be used.
E. Se licensee is authorized to collect leak test sanples in accordance with the procedures described in the licensee's for analysis by .
Alternatively, leak test sanples nay be collected and/or analyzed by other persons specifically authorized by the Ccmnission or an Agreement State to perform such services.
Oct 1983
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- 4 CONDITICN 13. .
This conditico provides for leak test intervals of three years for certain specified equi;rnent.
- 13. A. (1) Each sealed source shall be tested for leakage and/or contamination at intervals not to exceed three years. In the absence of a certificate from a transferer indicating that a test has been mde within six rrenths prior to the transfer, a sealed source received frcm another person shall not be put into use until tested.
4 (2) Notwithstanding the periodic leak test required by this ccndition, any licensed sealed source is exempt frcm such leak tests when the source contains 100 microcuries or less of beta and/or ca=:a enitting material cr 10 nicrocuries or less of alpha ercitting material.
The exception in 13.A. (3) my be applied where, in the judgment of the technical reviewer, 4
health and safety will not eczuprcmised.
(3) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. W e sources excepted frcm this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six r:enths prior to the date of use or transfer.
B. The test shall be <apable of detecting the presence of 0.005 microcurie of radioactive eterial on the test sar:ple. We test sarrple shall be taken frcm the sealed source or frcm the surfaces of the device in which the sealed source is pennanently mounted or stored on which one might expect c::ntamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccrrmission.
C. If the test reveals the presence of 0.005 microcurie or nere of rerrevable mntamination, the licensee shall W2ately withdraw the sealed source frcm
- use and shall cause it to be decantaminated and repaired or to be disposed of in accordance with Ccmnission regulations. A report shall be filed within 5 days of the test with U. S. Nuclear Regulatory Ccmrission, Region ,
, describiry the equipnent involved, the test results, and the corrective action taken.
D. Tasts for leakage and/or contamination shall be perfonned by or by other persons specifically authorized by the ccrrmission or an Agreement State to perform such services.
Note: Blank in paragraph D may be filled in with "the licensee",. the device mnufacturer, i the source tranufacturer, etc., or crnitted. Normally paragraph D or E, but not both, should be used.
E. Se licensee is authorized to callect leak test samples in accordance with the procedures described in the liceraee's for analysis by . Alternatively, leak test sa:tples may be callected and/or analyzed by other persons specifically authorized by
- the Ccmrission or an Agreement State to perform such services.
Oct 1983
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- 14. Each sealed source containing licensed material to be used outside of a shielded exposure device shall bear a durable, legible, and visible tag pemanently attached to the source. he tag shall be at least one (1) ine:h square, shall bear the conventional radiation symbol prescribed in Section 20.203(a), 10 CFR 20, and a minimum of the following irstructions: ANGER -
PADICACIT/E %TERDJ., - DO NOr FANELE - NOTIFY CIVIL AUTHCRITIES IF EDUND.
Repair or replacanent of tags shall be accanplished by persons specifically licensed by the Cc: mission or an Agreenent State to perfonn this service.
- 15. Each sealed source containing licensed material to be used outside of a shielded exposure device shall bear a durable, legible, and visible tag pennanently attached to the source. W e tag shall be at least one (1) inch square, shall bear the ccnventional radiation symbol prescribed in Section 20.203(a),10 CFR 20, and a minimum of the following instructions: DANGER -
RADIQACTIVE MATERIAL - DO NOT HANDLE - NOTIFY MILITARY AUTIORITIES IF FOUND.
Repair or replacenent of tags shall be acccmplished by persons specifically licensed by the Ccunission or an Agreenent State to perfonn this service.
- 16. Except as specifically provided otherwise by this license, the licensee shall possess and use licensed material described in Itens 6, 7, and 8 of this license in accordance with statenents, representations, and procedures
, or.tained in . The Nuclear Regulatory Ccmnission's regulations shall govern the licensee's statenents in applications or letters, unless the statements are nore restrictive than the regulations.
- 17. Pursuant to the Atanic Energy Act of 1954, as amended, and Title 10, Chapt'er 1, Code of Federal Regulations, Part 70, "Special Nuclear Material",
the licensee is authorized to receive, possess, and use the special nuclear material resulting fran the decay of .
This license shall be deened to contain the conditims specified in Section 70.32(a) of said regulations.
- 18. Sealed sources containing licensed material shall mt be opened.
- 19. Sealed sources containing licensed material shall not be opened or retoved fran their respective source holders by the licensee.
- 20. Sealed sources containing licensed material shall not be opened or renoved !
i fran by the licersee.
- 21. A. Detector cells containing titanium tritide foil shall mly be used in aanjunction with a properly operating tenperature control mechanism which prevents foil tetperatures fran exceeding 225 degrees Centigrade.
B. Detector cells ccntaining scandiun tritide foil shall only be used in conjunction with a properly operating tenperature control mechanism which prevents foil tenperatures fran exceeding 325 degrees Centigrade.
Oct 1983
Page 8
- 22. In lieu of using the conventional radiation caution colors (magenta or purple
'on yellow background) as provided in Section 20.203(a)(1), Title 10, Code of Federal Regulations, Part 20, the licensee is hereby authorized to label detector cells and cell baths, containing licensed material and used in gas chranatography devices, with conspicuously etched or starped radiation caution symbols without a color requirenent.
- 23. A. Each chronatograph detector containing Nickel 63 shall be tested for leakage and/or contamination at intervals not to exceed six nonths.
In the absence of a certificate fran a transferor i:xlicating that a' test has been nede within six nonths prior to the transfer, a detector received fran another person shall not be put into use until tested.
B. The test shall be capable of detecting the presence of 0.005 microcurie of radioactive material en the test sample. The test sanple shall be taken fran the surfaces of the device in which the foil is rounted or stored on which one might expect ccxitamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccmnission.
C. If the test reveals the presence of 0.005 microcurie or core of renovable contamination, the licensee shall innediately withiraw the foil fran use and shall cause it to be decentaminated and repaired or to be disposed of in acmrdance with Connission regulations. A report shall be filed within 5 d:7s of the test with the U. S. Nuclear Regulatory Ccmnission, Region ,
daar -ibing the equipnent involved, the -test results, and the corrective action taken.
Note: Blank in paragraph D may be filled in with "tlie licensee", the device manufacturer, the source manufacturer, etc., or anitted. Normally paragraph D or E, but not both, should be used.
D. Tests for leakage and/or contamination shall be perfonned by or by other persons specifically authorized by the Ccmnission or an Agreement State to perfonn such services.
E. 'Ihe licensee is authorized to collect leak test samples in accordance with the procedures described in the licensee's for analysis by . Alternatively, leak test samples may be collected and/or analyzed by other persons specifically authorized by the Cannission or an Agreement State to perfonn such servicee.
-24. 'Ihe licensee shall report by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the nearest U. S. Nuclear Regulatory Ccmnission Regional Office, loss or potential abandonnent down-hole of any sealed source ccntaining licensed material.
In addition, a written report shall be subnitted within 30 days fbr the lost or abandoned source which shall include infonnation regarding isotope, amount, location, depth, method of innobilization, sealing, placarding, and notations to be placed in public records.
- 25. 'Ihe licensee shall not use licensed material in or on hunan beings or in field applications where activity is released except as provided otherwise by specific condition of this license.
- 26. Experimental animals administered licensed materials or their products shall not be used for hunan consuuption.
- 27. Licensed material shall not be used in or on hunan beings or in products distributed to the public.
Cet 1983 }
Pagm 9
- 28. A. Individuals involved in cperations which utilize, at any one time, more than 100 millicuries of Hydrogen 3 in a non-contained fbrm, other than netallic foil, shall have bicassays performed within one week follcwing a single cperation and at weekly intervals for continuig operations.
Tritium Bioassays - Processors, Dial Painters, Etc.
B. (1) Tritium shall not be used in such a manner as to cause any individual to receive a radiation exposure such that urinary excretion rates exceed 28 microcuries of tritium per liter when averaged over a calendar quarter.
(2) Urinalysis shall be performed at weekly intervals on all individuals who work in the restricted areas of facilities in which tritium is used. If the average concentration of tritium in urine fbr any single individual during a calendar quarter is less than 10 microcuries per liter, urinalysis may be performed on that individual at nonthly intervals for the follcwing calendar quarter and may continue at nonthly intervals so long as the average concentration in the calendar quarter renains belcw 10 microcuries per liter. The urine specimen shall be collected on the same day of the week insofar as possible.
(3) A report of an average concentration in excess of the limit specified in B(1) above for any individual shall be filed, in writing, within thirty (30) days of the end of the calendar quarter with the Office of Inspection and Enforcenent, U. S. Iliclear Regulatory Conmission, Washington, D. C. 20555, with a copy to the appropriate Regional Office.
'Ihe report shall centain the results of all urinalyses for the individual during the calendar quarter, the cause of the excessive concentrations, and the corrective steps taken or planned to assure against a recurrence.
(4) Any single urinalysis which discloses a ccricentration of greater than 50 microcuries per liter shall be reported, in writing, within seven (7) days of the licensee's receipt of the results, to the Office of l Inspection and Enforcenent, U. S. Nuclear Regulatory C:mnission, Washington, D. C. 20555, with a copy to the U. S. Nuclear Regulatory Ccmnission, Region ,
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Civil Defense 1
- 29. Each sealed source containing licensed material to be used outside of a shielded exposure device shall have a durable, legible, and visible tag l permanently attached by a durable rim. The tag shall be at least one (1) inch I square, shall bear a conventional radiation symbol prescribed in Section 20.203(a) of Part 20, and a minimum of the followig instructions: DAIKIER - RADICACTIVE MATERIAL - DO NDP HANDLE - NCTPIPI CIVIL ALTr10RITIES IF EOUND.
l Replacanent of tags and rigs shall be carried o.it by the licensee in accordance with instructions contained in NUAL T PROCEDURES EUR THE USE AND CDNTROL T THE OCD CD V-778 RADIATICN TRAINING SOURCE SET, dated August 1975. ,
Oct 1983
Page 10
- 30. A. Licensed material contained in DCPA Sealed Scur e Sets shall be tested for ' external leakage and/or contamination upon receipt fran another person, except when the licensee receives certification fran the person that the sources had been tested within six (6) renths prior to transfer and found free of surface contamination. Thereafter, sources shall be tested for leakage and/or contamination at intervals not to exceed six (6) months. Records of leak test results shall be maintained by the licensee.
B. The test for leakage and/or ccntamination shall be capable of detecting the presence of 0.05 microcurie of radioactive material on the test sanple.
C. If the test reveals any radioactive material, the licensee shall *Re l immediate action to prevent spread of contamination and within five (5) l days after cc,pletion of the test shall notify the U. S. Nuclear Regulatory l CCmnission, Region .
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D. Imak test of sealed sources in DCPA Sealed Source Sets shall be performed '
by the licensee in accordance with instructions contained in NLAL T l PROCEDURES FOR ' LEE USE AND (INTROL T 'IEE OCD (D V-778 RADIATICN TRAININ3 i SOURCE SEr, dated August 1975.
- 31. Licensed naterial shall be stored except for tauporary storage at locations Miere training ccurses are conducted.-
- 32. iEANK
- 33. BLANK
- 34. BLANK
- Pad % adly - Sealed Sources and Devices - Industrial l
- 35. 'Ihe licensee shall amply with the provisions of Title 10, Chapter 1, Cbde of Federal Regulations, Part 19, " Notices, Instructions and Reprts to Workers; LWons," Part 20, " Standards for Protecticn Against Radiation,"
and Part 34, " Licenses for Radiography and Radiation Safety Esquirenents for Radiographic Operations."
- 36. 'Ihe individuals listed belcw are the only persons authorized by this license to act as radiographers or radiographers' assistants as defined in Section 34.2, 10 CFR 34:
Radiocraphers Radiographers' Assistants i
Oct 1983
Page 11
- 37. A. Prsuant to Sec ica 34.25,10 CFR 34, de licensee is authcrized to perfe' :t tests for leakage er centa:::iratien Of de sealed scur::es au-hcri.:ed by 2is license in acc= dance vid ,ual=es cen =dted in
- 3. Ncewi2 standing the periodic leak test recuired by Secticn 34.25(b),
10 CFR 34, such re:re.i.rement does net apply to radicgraphy scurces that are stored aM not being used. Se scurces excepted fr:m this test shall be tested for leakage price to any use er transfer to a:rther persen unless
' dey have been leak tested witi . six :ents prier to the date of use er transier.
C. Sealed scurces au-1c-ized "cr a use :Ser -ha:. radieg aphy ='- ' ' = -$stad as WTp'ry sc=ces in acecrdance vid Section 34.25 cf 10 CTR 34.
- 38. Se licensee is au hcrized to receive, pcssess, aM use sealed scurces of Iridi=:t 192 cr C balt 60 where de radicac.ivirf exceeds de -ed'-:t amount of .
radicact.ivity specified in Item a cf this license previded:
e A. Such ,:=ssessien does not exceed de q:antir/ per scurce specified in Iten 8 by .cre San 20% for Iridi=:t 192 cr 10% for C balt 60:
3.
Racerds of the licensee show cat no ::cre than the ::axi:::u::: ancent cf radioactivity per scurce specified in Iten 8 cf de license -as crdered f cn de supplier er transferer cf de bypr duct ::atarial: and C. ':he levels cf radia*% for radicgraphic exposure devic 2s and stcrage centai:w.rs do not exceed these spe-d #d ed in Secticn 34.21, 10 CFR 34.
- 39. '1his license does not authorize.de c=:rercial distrihu-4m of exe et cuantities of licensed ::sterial pursuant to Section 30.18, 10 CFR 30, and Section 32.18, 10 CFR 32.
- 40. P=suant to Title 10, C.a=ter 1, Code of Federal Regulations, Part 40, "Danestic Licensing cf Source & terial," the licensee is authcri ed to ;cssess, use,
.ransfer, and i:: pert up to 999 kilegra::s of uranit::: cen-=4 :ed as shieldi.g
- sterda1 in the radicgrachy ex;csure devices and source changers authcrized by this license.
- 41. P=suant to Title 10, C. apter 1, Ccde cf Federal Regulations, Part 40, "Ccmestic Licensing of Source sterial," 2e licensee is aut}crized to possess, ;.se, transfer, and 1.gert the uranit :t centained as shielding ::aterial in the tele cera=y c.i_s authcrized by this license.
- 42. Each source holder and legging teci con-*4-dry radicae -
.aterial shall ;
bear a legible and visible reding. Se ::arking shall bear de conventional i radiation sjntc1 and the folicwi.g w:rding: "1du_x - RADICAC"-'E - IC :CI' E74CT.2 - :CI"'7Y CT.VIL AL'15CFl'"!FS.
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Oct 1983 '
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Paga 12
- 43. The licensee shall not transfer pssession and/or control of materials or products containing licensed material as a contaminant except:
A. By transfer of waste to an authorized recipient:
B. By transfer to a specifically licensed recipient; or C. As provided otherwise by specific condition of this license pursuant to the requirenents of Section 32.11, 10 CFR 32.
- 44. Insta11ht'icn, relocation, renoval fran service, maintenance, repair, ard initial radiation survey of devices containing licensed material and installation, replacenent, and disposal of sealed sources containing licensed material used 1
in devices shall be performed only by or by other persons specifically authorized by the Cannission or an Agreenent State to perform such services.
- 45. Installation, relocation, re cval fran service, maintenance, repair, ard initial radiation survey of containing licensed material shall be perfonned cnly by in accordance with , by the device mnufacturer, or by other persons specifically authorized by the Ccmnission or an Agreenent State to perform such services. Installation, replacenent, and disposal of sealed sources containmg licensed material used in devices shall be perfonned only by the device snufacturer or by other persons specifically authorized by the Connission or an Agreenent State to perfonn such services.
- 45. A. Installation, relocation, renoval fran service, and initial radiation survey of devices containing licensed :taterial shall be performed only by in accordance with , by the device mnufacturer, or by other persons specifically authorized by the Cannission or an Agreement State to perfonn such services. Maintenance ard repair of devices, and installation, replacenent, and disp sal of sealed sources containing licensed mterial used in devices shall be performed only by the device manufacturer or by other persons specifically authorized by the Cannission or an Agreenent State to perfonn such services.
- 46. Maintenance, repair and initial radiation survey of devices ccntaining licensed mterial and installation, replacenent, and disposal of sealed sources containing licensed mterial used in devices shall be perfonned only by
, or by other persons specifically authorized by the Carmission or an Agreement State to perform such services.
46.A. Maintenance or repair of p rtable devices involving renoval of the sealed sources fran the devices or remval or distantling of shielding may be prformed by , the device m nufacturer, or by other persons l specifically authorized by the Ccmnission or an Agreenent State to perform
! such services.
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- 47. 'Ihe licensee shall conduct a physical inventory every six (6) nenths to account for all received and pssessed under the license. The records of the inventories shall be mintained for tao (2) years fran the date of the inventory I for inspection by the Carmission, and shall irclude the quantities and kinds of licensed material, 1ccation of and the date of the inventory.
47.A.The licensee shall conduct a physical inventory every six (6) months to !
account for all received and pssessed under the license.
'Ihe records of the inventories shall be maintained for to (2) years frcm the date of the inventory for inspection 'oy the Carmission, and shall include the quantities and kinds of byproduct material, manufacturer's name and rodel numbers, location of and the date of the inventory.
Note:
Condition 47.A. may be used for fixed gaurge licenses which do not spcify nedel nunbers. See also Condition Nos.1C6 and 107.
Oct 1983
f Paga 13 I
- 48. Detector cells containing licensed material shall not be cpened or the foil j sources removed fran the detector cell by the licensee.
I MR PHARMACY LINJ l
l
- 49. A. The licensee shall perform a test to detect and quantify the activity of molybdenum-99 contamination in each elution of technetium-99m frcm a molybdenum-99/ technetium-99m generator ~and in each extraction or
( separation of technetium-99m fran nelybdenum-99 not contained in a l generator.
B. The licensee shall not distribute technetium-99m for human use if the technetium-99m contains nere than one (1) ricrecurie of nolybdenum-99 per millicurie of technetium-99m er if it contains nere than five (5) ricrocuries of nolybdenum-99 per dose of technetium-99m at the expiration date and i time shown on the package label. The expiration date and time shown on the package label shall be such that the limits above are not exceeded for any l J
single patient dose. The limits for nelybdenum-99 contamination represent maximum values and nelybdenum-99 contarination should be kept l 1
as low as reasonably achievable belcw these limits. l C. The licensee shall establish written procedures for personnel perforning tests to detect and quantify nelybdenum-99 contamination. These procedures shall include all necessary calculations and steps to be taken if activities of nelyMm=-99 in excess of the limits specified in Subitem B. above are detected.
D. Personnel performing tests to detect and quantify nelybdentri-99
- contamination shall be given specific training in performing these tests prior to conducting such tests.
E. 1. The licensee shall naintain for inspection by the Nuclear Regulatory Ccnmission records of the results of each test performed to detect and quantify nelybdenun-99 contamination and records of training given.to personnel performing these tests.
- 2. Records described in Subitem E.1. above shall be raintained for three (3) years folicwing the performance of the tests and the training of personnel.
MR MEDICAL LICENSEES
- 50. A. Notwithstanding the requirenents of Section 35.14(b) of Title 10, Code of Federal Regulations, Part 35, the licensee may possess and use any licensed naterial for which he was authorized and that was in his pssession on January 13, 1975.
B. Licensed material shall be used in accordance with the provisions of Secticn 35.14(b)(c)(e) and (f) of Title 10, Code of Federal Regulations.
C.
Licensed naterial of the types, quantities, and forms specified in Sections 35.31(a) of 10 CFR 35 and 31.11(a) of 10 CFR 31 to be used in accordance with the provisions of (a) and (c) of Section 35.31, 10 CFR 35 and paragraphs (a), (c), and (d) of Section 31.11, 10 CFR 31.
Oct 1983
. Page 14
' 51. 1;eedles er s.aMard radical applica=r cat '= cen-=4ni.g Ccbalt 60 as vire shall not be mened by the licensee unless specifimi'y auth::rized by a ceniitien in dis license.
- 52. Patients c=ntaining C=balt 60, Cesian 137 cr Iridi=n 192 i= plants shall rurain hospi+=14- * =til a scurce ccune and surveys rade vid an a ry%iate raiiatien detection ins =anent indicate dat all i=lants have been rereved. S e results of dese surveys shall be recorded and rain-='ned fer inspection by de C:=r.issien Sr five (5) years San the ti.me the i=lants are rereved.
" S= d ents cen-=in i.g Iodine 131 Sr de treacent of dyrcid ._rci .c=a (cr patients c:n+=".i.T therapeu.ic cuantities of Ccid 198) shall rerain hespi'='4*=4 until the residual activity is 30 millic=ies er less.
- 54. P=suant te Sec-im 20.105(a) of Title 10, C. apter 1, code of Federal Fegulations, Part 20, " Standards Sr Prceecticn ;cainst Fadiatien,".aM in reliance cf statenents, r csi=es and representatiens cade by de licensee in his ,
de Silcwing -=<rdmn radiatien levels are hereby authcriced in d e Silcwing unres= icted areas:
Maximum Radiaticn Level Unrestricted area
- 55. ?=A4me:ive gases as See gas er in solu 4m, to be ad=inistered to 1.=ans, shall be r cred San a supplier *c discibutes de pr. - m indicated Sr hu an use in ac=rdance with de Federa.1 Fecd, .T.:g, and Ccsnetic Act.
- 56. 1bewidstanding de labeling .@ements of Sectics 20.203(f),10 CFR Part 20, (or cc: parable Agreement State reculatiens) de licea.see is autirri ed to receive, pcssess, and use licensed caterial received under de A erican Cc11ege of Pathelegists SA.r. lear Medicine Quality C=.=cl Frw with i=*1ing as pretesed in let.er dated
- 57. "he specifiei ;cssessicn limit includes all licensed raterial ;cssessed by the licensee under dis license whether in stcrage, i,=lanted in patients er otherwise in use.
- 58. Se licensee shall rce receive er transfer in any single transacticn ene (1) grara er ::cre of plutenica 238 ccntained in nuclear-p>ered pace ekers wit} cut notifying the Civisien cf Safeguards, U. S. .'bclear Fg21atcry C:rraissien, Washire cn, D. C. 20555, and, in additien, cc=cleti.m aM discibuting Fern NRC-741 as recuired by Sec,.icn 70.54 cf 10 CFR 70.
- 59. Se licensee shall repert tc de Material Licea. sing Branch, U. S. Nuclear Pegulatcry C:xmtission, Divisicn of Ibel Cycle and Material Safety, Washi.q ,.nn, D. C. 20555, within t entf-hur (24) hcurs of ccc=rence, de death of any nuclear paceraker patient, and any adverse reacticn and/cr malfunc.icn invclvi.z a pacemaker systen,1.cluding de leads. A written reper. giving details cf de adverse reac.icn and/cr ralf=ction shall be subnitted widin dirty (30) days. l Oct 1983 1
Paga 15
- 60. ~he licensee shall repert c de N arial
- icensi.g .t. =nch, ::i'risics cf Fuel Cycle and &terial Saferf, U. S. 2: clear Regulaterf C3=::issien, Mishingten, D. C. 20555, witin ten (10) days, less cf centact wit a r..: clear pacemaker patie=t. I i
j
- 61. "he licensee shall c=ctinue patient fc11cw-up and replacement precedures kr the nuclear --ker durim. the life of the patie:::. Preced=es Sr recoverf and s authericed disp:: sal cf de reelear pacecaker by ret:.._n te de .ee = .=er shall be 611cM u;cn de dea .h cf de patient.
- 62. Fcr a period act to exceed six y (60) days in arf cala+ year, a r_ sit:_:g physician is auther:.ced to use licensed aterial fer ht=en use under de l te=s of $is license, provided de visiti.g physician:
(a) Eas the prier written samissien of the hospital's leitis,. rater and its N i m i Isot.g. es C::rraittee, and 1
(b) Is ster-4"im11y naned as a user en a Nuclear Fegulaterf C:mnission license authcrd d g hunan use, a xi (c) Perims only those ydres kr which he is specifically aut'.criced by a Nuclear Regulatory C:mnission license.
The licensee shall :raintain for inspecticn by de Carr::issien, c= pies of de written pemission specified in subitem (a) above and of the license (s) specified in subiaems (b) and (c) abcve. *hese recer?s shall be enin-=4 ed I kr five (5) years f: on de tire de licensee gran s i_s pe=-issicn under subiten (a) abcve. .
t
- 63. A. Technetit:m-99m separated ' su aclyederum 99 eider by elu-J.cn of a nelybdensn-99/tedretitm-99m generater er by an ex raction process siall be tested to detect and quan,.ify ::clybdenum-99 activity pricr to administration to patients.
B. - te licensee shall net adn".inister technetiun-99m to patients if the technetitm-99m centains :cre dan ene (1) ::'ic ccurie of ::clybde.w99 per
- nillicurie of tednetium-99m er if it cer:tains acre than five (5) microcuries of ::elybderw99 per dcse of technetium-99m at time of administration. The id:::its Sr nelybdenum-99 centarrination represent nximum values anti eclybderun-99 centamination shculd be kept as icw as rassenably achievable belos dese id: nits.
C. The licensee shall establish written ' procedures Sr persennel perfcIri.m tests to detect and quan,.ify ::clybdenum-99 centrinatien. These g Wures shall incitxie all necessarf calcula icns a:xi s eps to be taken if activities of .clybderun-99 in excess of de idrits specified in Subitem B. abcve are detected.
Oct 1983
, Page 16
- 63. centinued D. Persennel perf*W tests to det ctaand q.antify =clybdern::n-99 c::r:: amination shall be given specific trai:iw in pe.' =4 g 2ese tests price to c:rziucting such tests.
E. 1. Se licensee shall rai.~=4 : Sr inspec icn by de m: clear Pegulate:y C::rt::issien racerds of te results of ead test peric=ed to detect a..d T.:r. ify ci :dar n-99 ==rinnien and reccrds Of ~. ini.g 2
qLv-u .c ;eixnnel ;.ari:=i:q 2=ss ~.=s:s.
- 2. Records described in Subitan E.1. abcve shall be cai=:.i.ai Sr tree (3) years 211cwing te perfc=ance cf de tests and de traini.g cf perscrmel.
- 64. ':he 611ceing shall be peu.h.-d caly by persens specifically au.h:: riced by de Carmission er an agreement State t.c perfc::n such services:
A. Installation, relocatien, er re: eval of teletherapy t: nits m=4-iw sources.
B. Scurce exchange.
C. Ar:y .aintenance er recair coeratiens en a teletherapy =it irecivi.g
)
w::k en the scurce drawer, de sht:=ar, er cder edanisa cat ca.:ld exp::se de source, reduce de shielding arcend de scurce, er cargranise the safety .
of de imit and result in fr. creased radianen levels.
- 65. The talederapy facility shall be provided with a systen pe.. itti.g centi =.r.:us observatien of de patient f: =n cutside de treat ent recn dt:ri.g patient i %.tien.
- 66. A. Teletherapy scurces shall be tested Sr leakage at intervals not to exceed six : rents. Rec =rds of test results shall be kapt in tuits of
- nicrce.: ries and ::mintained Sr inspection by de C::nrnissien. In de abserx:e of a cer-4'4cate San a transferer indicating that a test has been ::ade within six trenths prier to 2e transfer, a source received San ancther persen shall net be used t=til tested Sr leakage.
- 3. Se tests shall be sufficiently sensitive to detect 0.05 mi=ccurie of w..aminatien en the test sa:ple.
C. Se test sample shall be taken fran selected accessible surfaces of de teletherapy head. Se selec ed accessible st:rfaces shculd be these st=-faces en which cne :::ight expect centaminatien (if there were to be leakage) t.c acezrulate and shall ine:lt:de de inner si:rface of the rest frequently used treacnent ecnes er beam cc1'4 ating device. Se test sa::=le shall be taken with the scurce in the "eff" position.
Oct 1983
. . Page 17
- 66. D. If the test reveals the presence of 0.05 microcurie or acre of retevable contamination, the licensee shall prc:ptly take action to prevent spread of contamination and shall file a report within five (5) days of the test with the Material Licensing Branch, Division of Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Ca mission, Washington, D. C. 20555, describing the test results and the corrective action taken. A copy of such report shall also be sent to the U. S. Nuclear Regulatory Ca rission, Region ,
- 67. Pricr to initiation of a treatment program, each teletherapy unit shall be equipped with electrical cr mechanical stcps liriting use of the pri:ary beam of radiation so as to ensure cc pliance with Secticn 20.lC5(b), Title 10, Part 20, Code of Federal Regulations, Chapter 1, " Standards for Protection Against Radiation," as evidenced by a radiation survey. Necessary use restrictions shall be fully described in radiation survey reports st mitted in accordance with Condition No. 18.
- 68. A set of written energency instructions shall be posted at the telether$py machine control. Wese instructions shall inform the nachine operator of the procedure to be follcwed should he be unable to turn the machine's pri:rary beam of radiation "off" with the controls outside the treatment rocm.
- 69. A. Access to the teletherapy rocm shall be controlled by a door at each entrance. Such doors shall be normally closed.
B. Each entrance to the teletherapy rocm shall be equipped with an elec-trical interlock systen that will turn the teletherapy machine's prirary beam of radiation "off" inmediately upcn operig of any entrance door.
Se interlock systen shall be connected in such a nanner that the teletherapy machine's primary beam of radiation cannot be turned "on" until all treatment rocm entrance doors are closed and the beam "on-off" control is reset at the control panel.
C. Electrical interlocks on entrance doors to the teletherapy rocm shall be tested for proper operation at least once every six nonths. Fecords of test results shall be maintained for inspection by the Carrrission.
D. In the event of malfunction of any door interlcck, the teletherapy machine control shall be locked in the "off" condition and not used, except as may be necessary for repair or replacement of the interlock systen, until the interlock systen is shown to be functioning prcperly.
Oct 1983
. . Pr.g2 18
- 70. Prior to initiation of a treat.nent program, and subsequent to each installation of a teletherapy source, radiation surveys arxi tests shall be perfonned in accordance with the following:
A. A radiation survey shall be made of:
(i) The teletherapy source housing, with the teletherapy source in the "off" position. 'Ihe =4=m and average radiation levels at one meter fran the teletherapy source in the "off" position shall not exceed 10 milliroentgens per hour and 2 millircentgens per hot:r, respectively.
(ii) All areas adjacent to the treatment rccra with the teletherapy source in the "on" position. 'Ihe survey, except Iten (c), shall be perforned with a phantan in the pri::ary beam of radiation and shall clearly establish:
(a) Tbv. radiation levels in restricted areas are not likely to cause pt:sonnel exposure in excess of the lirits specified in sa. tion 20.101, Title 10, Part 20, Code of Federal Regulations,
,Mpter 1, " Standards for Protection Against Radiation" (10 .~FR 20) .
(b) That quai.'ities of radiation in unrestricted areas do not exceed the '.imiti specified in Section 20.105(b),10 CFR 20.
(c) The intensity of t. e pri: nary beam of radiation at a specified distance fran he teletherapy source.
B. Tests shall be nade to dete. mins prcper cperation of:
(i) Electrical interlock. or entrance doors to the teletherapy treatment roan.
(ii) 'Ihe teletherapy source 'v.n-o.*f" indicators, both at the source housig and on the teleth a r_ machine control panel.
(iii) Electrical or nachanical stc7s #cMM for the purpose of limitdrzg use of the primau.y beam of radiation (restriction of source housing angulation or eleva. ion, carriage or stand travel and operation of the beam "on-off" i.cchanism) .
(iv) The teletherapy treatment timing device.
C. A *eport of the results of the above surveys and tests shall be sent to the Material Licensing Branch, U. S. Nuclear Regulatory Ccmnission, Division of Fuel Cycle and Material Safety, Washington, D. C. 20555, not later than thirty (30) days folleving each installation of a teletherapy sturce. A copy of such report shall be sent to the U. S. Nuclear Regulatory Ccmnission, Region Oct 1983
. . Page 19
- 71. A. Any chang s made in the treat:nent roon shieldig, lccation of the unit within the treat:nent recm, or use of the teletherapy unit that could result in increased radiatien levels in areas cutside the teletherapy treatment rocm shall be evaluated by a radiation survey made in accordance with Condition 18., and reported to the Ccrrisaica within thir*.y (30) days folicwing ccrpletion of the change (s).
- 3. Relocation of the teletherapy unit to a new facility is not permitted withcut pricr approval of the plans aM details by the Ccrrissien.
Folicwing such approval and relocaticn, a radiation survey shall be mde in accordance with condition 18., aM reported to the Ccrrission within thirty (30) days after ccrpletion cf the ::cve. /
- 72. The licensee shall ccnply with the recuirements in Secticns 35.21 thrcugh 35.27, inclusive, of Title 10, Chapter 1, Code of Federal Regulations, Part 35, " Human Uses of Byproduct Material."
GMt% IRRADIA'IORS l 1
- 73. A. Each sealed source containing licensed raterial shall be tested for leakage and/or contamination at intervals not to exceed six ::enths. In the absence of a certificate frcm a transferer indicating that a test has been made within six r:enths prior to the transfer, a sealed source received fran another person shall not be put into use until tested.
B. The test shall be capable of detecting the presence of 0.05 micrcc.:rie of centamination on the test sar:ple. 'Ihe test samples shall be taken frcm apprcpriate accessible surfaces of the device in which the sealed source is pe=nanently or se-dperranently ::cunted er stored. Records of leak test results shall be kept in units of microcuries and raintained for inspectica by the Coimission.
C. If the test reveals the presence of 0.05 micrccurie or r:cre of re:cvable centamination, the licensee shall 1:: mediately withdraw the sealed source l frcm use and shall cause it to be decentaminated and repaired or to be
' disposed of in accordance with Ccmnission regulations. A report shall be filed within 5 days of the test with the U. S. Nuclear Regulatory Ccrtnission,
'egion R ,
describing the equipnent involved, the test results, and the corrective action taken.
D. Tests for leakage and/or contamination shall be perfonned by cr by other persons specifically auth:rized by the Ccrrission or an Agreement State to perfonn such services.
E. The licensee is authorized to collect leak test samples in accordance with the procedures described in the licensee's for analysis by . Alternatively, leak test sarples r:ay be mllected and/or analyzed by other persons specifically authorized by the Ccrrission or an Agreement State to perfcnn such services.
Note: Blank in paragraph D may be filled in with "the licensee", the device I:nnufacturer, the source manufacturer, etc. or onitted. Ncr: ally paragraphs D or E, but not toth, chould be used.
Oct 1983
Paga 20
- 74. Written instructions shall be followed and a copy of these instructions shall be nade available to each individual using or having respnsibility for use of licensed naterial. Any changes in these instructions shall have the prior approval of the Material Licensing Branch, Division of Fuel Cycle and Material Safety, U.S. htclear Regulatory Canmission, Washington, D. C. 20555.
- 75. 'Ihe procedures contained in AD L's instruction nanual for the "Gan=acell "
device shall be folicwed and a copy of this nanual shall be made available !
to each person using or having responsibility for the use of licensed naterial. l
- 76. A. The licensee is authorized to relocate, store, and Estall source units containing naterial licensed above and to perfonn maintenance and repair of the units which do not involve execsure of sealed scurces.
Replacanent and disposal of sealed sources containing licensed naterial l shall be performed only by persons specifically authorized by the l Caumission or an Agreenent State to perform such services. '
B. This license does not authorize repairs or alterations of the irradiator i involving reroval of shielding or access to the licensed naterial excect as provided otherwise by specific condition of this license. Ratoval, replacenent and disp sal of sealed sources shall be performed only by or by other persons specifically authorized by the Cannission or an Agreenent State to perform such activities.
- 77. After installation of the irradiator and Cobalt 60 or Cesitra 137 source and prior to initiation of the irradiation program, a radiation survey shall be conducted to determine the naximum radiation levels in each area adjoining the irradiation roon. A detailed report of the results of the surveys shall be sent to the Material Licensing Branca, Divisicn of Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, not later' than thirty (30) days folloaing installation of the source. A copy of such report shall also be sent to the U. S. Nuclear Regulatory Comission, Region , .
- 78. After installation of the irradiator and Cesium 137 or Cobalt 60 source and prior to initiation of the irradiation program, a radiation survey shall be conducted to d'etermine radiation levels around, above, and belcw the irradiator with the source in the irradiate psition and with the source in the shielded position.
A detailed report of the results of the surveys shall be sent to the Material Licensing Branch, Division of Fuel Cycle and Material Safety, U. S. htclear Regulatory Cannission, Washington, D. C. 20555, not later than thirty (30) days folicwing installation of the source. A copy of such report shall also be sent to the U. S. Nuclear Regulatory Caumission, Region ,
TPMSPORIATION The folicwing condition is to be used in licenses where the licensee (not a comen or centract carrier under regulations published by the Department of Transportation or U. S. Post Office) wants coverage for transprtation of radioisotcpes because his transportation is by air other than civil aircraft.
, Oct 1983
e .
Pago 21
- 79. 'Ihe licensee may transport licensed material or deliver licensed material to a carrier for transport in accordance with the provisions of Title 10, Code of Federal Regulations, Part 71, " Packaging of Radioactive Material for Transport and Transportation of Radioactive Material Under Certain Conditions."
INCLNERATICN The last sentence of this condition may be cnitted or nodified to apply to cituations where the licensee packages his waste residues and transfers then to autMrized recipients for disposal.
- 80. Pursuant to Sections 20.106(b) and 20 302,10 CFR 20, the licensee is authorized to dispose of licensed material by incineration provided the gaseous effluent fran incineration does not exceed the limits specified for air in Appendu B, Table II,10 CFR 20. Ash residues may be disposed of as ordinary waste provided appropriate surveys pursuant to Section 20.201 are made to determine that concentrations of licensed material appearing in the ash residues do not exceed the concentrations (in terms of microcuries per gram) specified for water in Appendu B, Table II,10 CFR 20.
GENERAL LICENSE DISTRIBUTICN - CERTAIN SEALED SOURCES AND DEVICES
- 81. DEIZrED
- 82. No generally licensed device shall be installed by the licensee in such a manner or in such a location that any person could receive nore than 0.5 ren in a calendar year under ordirary circumstances of use.
- 83. 'Ihe licensee shall furnish to each general licensee to whan he transfers a e device pursuant to this license, a copy of Section 31.5,10 CFR 31; Sections 30.34 and 30.51 through 30.63,10 CFR 30; Sections 20.402 and 20.403, 10 CFR 20, and Appendix D, 10 CFR 20.
- 84. Tests of sealed sources for leakage or contamination shall be in accordance with the follocng:
A. 'Ihe conditions of pertinent U. S. Nuclear Regulatory Ccmnission and Agreenent State licenses authorizing the custaner's use and possession of the licensed naterial; B. The procedures described in the application filed by and dated C. 'Ihe sealed source shall not be reroved fran the device. Tests shall be made with the sealed source in the shielded or off condition; D. Prior to collection of test samples, the tester shall survey the area which he will occupy during the sample collection; arx!
E. A report of the results of each test shall be provided the custcmer in units of microcuries.
Oct 1983
~. .
Paga 22
- 85. After installation by the licensee of each device distributed to persons generally licensed pursuant to Section 31.5 of 10 CFR, Part 31, the licensee shall conduct a radiation survey arxi shall assure that the levels of radiation do not exceed those specified in the license authorizing the manufacture or distribution of the installed gauge. The licensee shall furnish the general licensee a copy of the radiation survey rep rt.
- 86. The haraling of radioactive material under this license in the manufacture, installation, dismantling, relocation, and testing of devices shall be performed bl -
- 87. The licensee shall test each device distributed under this license for leakage or contamination of radioactive material and proper cperation of the "on-off" mechanism and indicator, if any, at the time of installation of the device.
- 88. A. Each device distributed under this license shall bear a durable, clearly visible and legible label or labels containing the folicwing or substantially similar statements:
- 1. " Receipt, p ssession, use and transfer of this device are subject to a general license or equivalent and regulations of the U. S. Nuclear Regulatory Ccmnission or an Agreement State."
- 2. "Abandcnnent or disposal prohibited unless transferred to persons specifically licensed by the U. S. Nuclear Regulatory Cm mission or an Agreement State."
- 3. " Operation prohibited if there is indication of failure of or damage to shielding, source containnent or on-off mechanism."
- 4. " Installation, dismantling, relocation, maintenance, repair and testing involving the radioactive material, its shielding or containnent shall be performed by persons specifically licensed by the U. S. Nuclear Regulatory Ctzunission or an Agreement State."
- 5. "'Ihe device shall be tested for radioactive leakage and proper functioning of on-off mechanism and indicator, if any, at installation, at source replacanent, and thereafter at no longer than intervals."
- 6. "Ioss, theft, or transfer of this device and failure of or damage to the shielding, the source containnent or the en-off mechanism nust be reported to the U. S. Nuclear Regulatory Caumission or an Agreement State."
- 7. "This label shall be maintained on the device in a legible condition."
B. Each device distributed under this license shall bear a durable, clearly visible and legible label or labels containing the device model and serial ntsnber, the radiation symbol in colors magenta or purple on a yellow background, the words "CRJfICN, RADICACTIVE MATERIAL" or "DAIK3ER, RADIOACTIVE MATERIAL," the quantity, identity and date of measurement of the radioactive material, and the rane of the distributor of the device.
C. Each label required by this condition shall bear the statement, "Ps oval of this label is prchibited."
oct 1983
Paga 23
- 89. A. The licensee shall report to the Material Licensing Branch, Division of Wel Cycle and Material Safety, U. S. Nuclear Regulatory Ccmnission, all transfers of devices distributed under this license to persons generally licensed under Section 31.5, 10 CFR 31. Such repart shall identify each general licensee by name and address, the type of device transferred, the quantity and type of licensed material contained in the device, and the specific location where each device is installed.
'Ihe report shall be submitted within thirty (30) days after the end of each calendar quarter in which any such device is transferred to a generally licensed person.
B. The licensee shall report to the Material Licensing Branch, Civision of Nel Cycle and Material Safety, U. S. Nuclear Regulatory Ccmission, all transfers of devices distributed under this license to persons generally licensed under Section 31.5,10 CFR 31. Such report shall identify each general licensee by name and address, the type of device transferred, and the quantity and type of licensed naterial contained in the device. 'Ihe report shall be subnitted within thirty (30) days after the end of each calendar quarter in Wiich any such device is transferred to a generally licensed person.
IDK TESTS EUR PLUIOTIIN S0JRCES
- 90. A. Each encaps'ulated plutonium source designed for the purpose of emitting neutron or ganma radiation shall be tested for leakage at intervals not to exceed six (6) nenths. In the absence of a certificate fran a transferor indicating that a test has been made within six (6) months prior to the transfer, a sealed source received fran another person shall not be put into use until tested.
B. 'Ihe test shall be capable of detecting the presence of 0.005 microcurie of alpha contamination on the test sauple. 'Ihe test sample shall be taken fran the source or fran appropriate accessible surfaces of the device in which the sealed source is permanently or senipennanently mounted or stored. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Ccmnission.
C. If the test reveals the presence of 0.005 microcurie or nere of rerovable alpha contamination, the licensee shall innediately withdraw the sealed source fran use and shall cause it to be decontaminated and repaired by a person appropriately licensed to rnake such repairs or to be disposed of in accordance with the Ccmnission regulations. Within five (5) days after determining that any source has leaked, the licensee shall file a report with the 14sterial Licensing Branch, Division of Wel Cycle and Material Safety, U. S. Nuclear Regulatory Ocmnission, Washirston, D. C.
20555, describing the source, the test results, the extent of contamination, the apparent or suspected cause of source failure, and the corrective action taken. A copy of the report shall be sent to the U. S. Rtclear Regulatory Ccranission, Region ,
O:t 1983
_ _ _ _ _ - _ _ _ _ __ -_-_m__-_ _ ._ ______ _
.6 Ptga 24
- 90. centir.ced D. Se periedic leak test requirsi by dis ccnditien does not acply to sealed sources dat are stcred and not beig. used. S e sources exceptsi fr=n this test shall be tested Sr leakage pricr to any use er transfer to another persen unless they have been leak tested vicin six (6) :: ends prior to the date of use er transfer.
1 E. Notwiths- MM de other previsiens of this leak test ccrdition, leak tests are net requirsi en paceakers i:=lanted in experinen-=' anirals previded that a leak .est shall be peric=ned i: =ediately fellcwi.g re eval Of de ;acrakers Sc de ani-a1.
- 91. A. Each plutenian alpha sc=ce shall be tested Sr leakage at ir ervals r:ct to exceed dree (3) :ren d s. In the abserce of a cer.ificate fran a transfer:r i:xiicating that a test has been ::ede wi$in three (3) ::en hs prier to de transfer, a sealed source received ' ancther persen shall net be put into use until, tested. '
- 3. Se test shall be capable of detecting de presence of O.CCS :nicr~- de cf alpha cener.inaticn en the tes. sample. Se test sa:ple sP= be .aken fran ce source er Sem apprecriate accessible s= faces of the device in Wich de sealed scurce is per:anently er seniperanently ::centai er stored. Records of leak test results shall be kept in units of
- nicrocuries and naintained Sr inspec icn by the C= c:Lssicn.
C. If te test reveals de presence of 0.005 :nierec=ie er ::cre cf rencvable alpha centrinatien, de licensee shall i.:nediately wi .hiraw de sealed scurce fran use arxi shall cause it to be decentrinated a:xi :=:-M ed ty a persen wgiately licensed to ::nke such recairs er to be dispesed cf in acc::rdance with the Cs:=:ission regulatiens. Wi.cin five (5) days after decennini.g that arry scurce has leaked, de licensee shall file a regert with the meer da' Licensdrzg Branch, Civisien cf Pael Cycle a:xi
+ter* *' Safety, U. S. Nuclear Regulatcry C=:cissien, Washin:cen, D. C.
20555, describing de source, de test results, de extent of cent.rination,
, . the apparent or suspec.ed cause of scurce failure, arxi de w_..=ctive acticn taken. A copy cf de rescrt sPall be sent to the U. S. ;bclear Regulatcry Carn:issicn, Regicn ,
l D. Se periodic leak test requirsi by this condition dces not apely to sealed sources dat are stcred and net bei.g used. S e scurces excepted f =n this test shall be testai Sr leakage prior to any use er transfer to arecer person unless dey have been leak tested vicin three (3) :: ends pricr to the date of use or transfer.
- 92. Excect fer plutenian centaired in a :nedical device designed Sr 1:xiividual hean acelicatien, no cluteni=n, regardless of S c., shall be deliver =1 to a carrier
~
fhr shipment by " air transper cr trans;crted in an airraft by the licensee except in packages the design of W ich de NRC has specifically acprovai S r transport of plutenian by al.r.
I l
Oct 1983
- = --
i -
[,, ', Paga 25
- 93. The 3.icensee shall file periodic reports as specified in Section 32.
I 10 G R 32.
- 94. A. Each teletherapy roon shall be equipped with a radiation ::enitoring device which continuously ::enitors the teletherapy bean condition and is equipped with a back-up battery power supply for energency cperation.
This device shall energize a visible signal to mke the cperator continuously aware of teletherapy bean condition in order that appropriate energency procedures my be instituted to prevent unnecessary radiation exposure.
Operat.ng procedures shall require daily operational testing of the installed radiation nonitor.
s B. Whenever the continuous radiation r:enitoring device is not operatioral, any person entering the teletherapy roon following an irradiation shall enter with an cperable, calibrated radiatien survey meter and shall determine the beam condition.
- 95. The licensee is authorized to hold radioactive r:aterial with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash provided:
A. Radioactive waste to be dis,tesed of in this manner shall be held for decay a mininum of ten (10) half-lives.
i B. Prior to disposal as normal waste, radioactive waste shall be nonitored i to determine that its radioactivity cannot be distinguished fran l background with typical low-level laboratory survey instranents. All
! radiation labels will be removed or obliterated.
O. Generator columns shall be segregated so that they may be ::enitored separately to ensure decay to background levels prior to disposal.
%. Notwithswvhg other authorizations and requirenent of this license,
, the licensee shall have the cobalt 60 source described in Subitec 7. .
l of this license reteved fran the teletherapy head and returned to the l supplier if the radiaticn levels permitted by condition are exceeded.
t I 97. Notwithstanding the requirements of 10 GR 35.26(a), the licensee
! is authorized to exterzi until the time interval for inspection and servicing of his teletherapy unit.
- 98. Notwithstanding the requirenents of 10 GR 35.24, my perform the duties of the qualifiei expert for t%.se full-calibraticn and spot-check measurements specified in 10 GR 35.21 and 35.22.
I
! 99. Licensed r:eterial shall be used by, or under the supervision of, physicians (as defined in 10 GR 35.3 (b)) who are certified by the American Board of Radiology in Radiology or Therapeutic Radiology and who have been approved by .
9 Oct 1983
Paga 26 100. Radioactive waste ::ay be picked up fran the licensee's c.:stcmers and disposed of in accordance with the procedures, statenents and representations in .
101. A. Radicphannaceuticals dispensed and/or distributed for huran use shall be 1
either:
(i) Repackaged fran prepared radicpharraceuticals that are the subject of an FDA-approved "New Drug Application" (hTA) or for which FDA has accepted a " Notice of Clained Investigational Exe ption for a New Drug" (IND), or (ii) Prepared fran generators and reagent kits that are the subject cf an FDA-apprcved NCA or for which FDA has accepted an IND.
B. bepared radiophannaceuticals for which FDA has accepted an IND and radiophannaceuticals prepared fran generators or reagent kits for whien FDA has accepted an IND shall be dispensed and/or distributed:
(i) In aco:rdance with the directicns provided by the spnsor of the IND, and (ii) Only to physicians who have been accepted by the sponsor of the IND to participate in clinical evaluation of the drug.
'Ihe licensee shall inform in writing. ead physician who participates in an IND evaluation that the physician is responsible to the sponsor of the IND for use of the drug in accordance with protocols established by the sp nsor and for reporting to the sponsor the clinical inferratien obtained thrcugh use of the drug.
102. The licensee shall elute generators and process radioactive material w*.th reagent kits in accordance with instn:ctions furnished by the snufacturer cn the label attached to or in the leaflet or brochure that ac- M es the generator or reagent kit.
103. Reagent kits nay be redistributal to persons licensed pursuant to Section 35.14 and 35.100,10 CFR 35, or under equivalent licenses of Agreement States, for Group III.
104. 'Ihe licensee may use the Calicheck device for doing linearity tests of his dose calibrator provided he folloas the procedures in the Calcorp, Inc., Manual dated March 2, 1982.
105. 'Ihe licensee nay use the Lineator device for doing linearity tests of his dose calibratcr provided he folloas the procedures in the Atanic Products Corporation Lineator Instructions Manual dated June 20, 1983.
Oct 1983
, , Paga 27 Notei Condition 106 may be used for licenses authorizing possession of Kay Ray, AccuRay, Chnart, or IEE fixed gauges, where the nodel rmbers are not specified. The blank should be filled in with the name of the nanufacturer(s) . See also Condition Nos. 47.A and 107.
106. Ebr possession and use in devices which have been evaluated and approved for licensing purposes and authorized for distribution under a license issued by the Nuclear Reculatory Caxtission or an Agreenent State.
Note: Condition 107 may be used as a leak test condition covering a license autMrizing a nu.xture of sealed sources in devices, sane of which require six-nonth leak testing and sane of which require three-year leak testing. See also Condition Nos. 106 and 47.A.
107. A. (1) Each sealed source containing licensed material, other than hydrogen-3, with a half-life greater than thirty days and in any form other than gas shall be tested for leakage and/or contamination at intervals not to exceed six months; except those sealed sources as specified by the manufacturer and specifically autMrized by the Comtission or an Agreenent State may be leak tested at intervals not to exceed three years. In the absence of a certificate fran a transferor indicating
' that a test has been made within six nonths prior to the transfer, a sealed source received fran another person shall not be put into use until tested.
(2 ) Notwithstanding -Jw periodic leak test required by this condition, any licensed sealed source is exerpt fran such leak tests when the source ccntains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha enitting material.
(3 ) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. The sources excepted fran this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six nonths prior to the date of use or transfer.
B. The test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. The test sample shall be taken fran the sealed source or fran the surfaces of the device in which the sealed source is permanently mounted or stored on which one might expect contaminatico to acamlate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Camtission.
C. If the test reveals the presence of 0.005 microcurie or nere of rerovable contamination, the licensee shall inmediately withdraw the sealed source fran use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Ccmnission regulations. A report shall be filed within 5 days of the test with Region , U. S. Nuclear Regulatory C%mnission, describing the equipnent involved, the test results, and the corrective action taken.
(107 continued)
Oct 1983
~ ~
. . . Paga 28 107. (continued)
Note: Blank in paragraph D may be filled in with "the licensee", the device mnufacturer, the source mnufacturer, etc., or anitted. Normally paragraph D or E, but not both, should be used.
D. Tests for leakage and/or contamination shall be performed by cr by other persons specifically authorized by the Comtission or an Agreenent State to perform such services.
E. The licensee is authorized to collect leak test samples in accordance with the procedures described in the licensee's
,for analysis by . Alternatively, leak test sanples may be collected and/or analyzed by other persons specifically authorized by the Comtission or an Agreement State to perform such services.
108. 'Ihis license does not authorize connercial distribution of licensed mterial.
109. This license does not authorize Enssession or use of licensed mterial.
110. This license does not authorize distribution to persons licensed pursuant to Sections 35.14 and 35.100 of 10 CFR Part 35.
Oct 1983
1 ..
q- -
ENCLOSURE 2 i
l Y EXPLANATION OF REVISIONS TO STANDARD CONDITIONS
- 1. Condition Nos. 106 (use condition), 47A (inventory. condition), and 107 (leak test) are added for use in licenses authorizing Kay Ray, Accu Ray, Ohmart, and LFE fixed gauges where model numbers are not specified. These conditions have been used in licenses for over a i
year, but have never been incorporated into the Standard Conditions.
- 2. Leak test condition Nos. 11, 12, 13, 23, 73, and 107, paragraphs D and E, are modified to make it more clear who can collect and analyze leak
- l. test samples. In most cases, D y E should be used, but not both.
l
- 3. Condition Nos. 29 and 30 are modified to reference the current 1975 i FEMA safety manual.
- 4. Condition Nos. 44 and 45 are modified to delete references to leak testing, to avoid. conflicts with leak test conditions.
!' -5. Condition Nos. 44 and 45 are modified to add " removal from service,"
to make it clear whether a licensee can remove a device from service.
- 6. Condition No. 45A is added as a modification to condition No. 45 for cases where a licensee is not authorized to perform maintenance and y repair.
- 7. Condition No. 46A is added to cover maintenance and repair of portable gauges.
- 8. Condition No. 47 is modified to reference " licensed material," so it can be used for Part 40 and Part 70 licenses.
i 9. Conditions Nos. 72 and 97, applicable to teletherapy, are modified to make them consistent with new 10 CFR Section 35.26, published in 1983.
l 10. Condition Nos.108 and 109 are added to prohibit comercial l
distribution, possession, or use of licensed material. These-l conditions are commonly used, but have never been incorporated into the Standard Conditions. .
L 11. Note: A standard condition addressing protection of fixed gauges against environmental conditions is still under development. ;
- 12. Condition 110 makes clear that a distributor may not distritate (An "M0" license is required for this to group) purpose. medical licensees.
i
- 13. Note: References to Regional Offices of Inspection and Enforcement have been deleted from all license conditions. This is consistent with the fact that Regional Offices are no longer part of IE.
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w% WM2MWM@riN- WAlohs Cos'DITICUS Yr , e, w ,' o
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A ,
, '- l, . , , / mI : xfoi OjR;al. :c 11 2 G J y ~ r- :
,i o , , , ,. September, 1979 fu-/' ,g /'1 -
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- /
/ Licensed raterial shall be used only at the licensee's address stated in j f)
L9
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1 .3.
Item 2. above. 4 Va p 19 / uJ > 1 y Licensed raterial shall be used only at .
T.C. 'Ihe licensee shall notify (acprooriate Recional Office of Insoection and Enforcement) of each operation concucted uncer tnis license at a location other than that specified in Item 2 above when such operaticn j4 continues for core than 60 days, 'Ihe licensee also shall notify the aforementioned Regional Office of Inspection and Enforcement upon cessation of such operation. I 2.A. Licensed material may be used at and at
!? te:rporary job sites of the licensee anywnere in the United States.
7.3. Licensed raterial may be used at and at temporary job sites of the licensee anywnere in the United States wnere the
[
> U. S. Nuclear Regulatory Cc:cnission raintains jurisdiction for regulating the i use of licensed raterial.
~5. Licensed material shall be used only at temporary job sites of the g licensee anywhere :.n the UnitM States where the U. S. Nuclear Regulatory
- Comission maintains jurisdiction for regulating the use of licensed material.
- 7. Licensed raterial may be used anywhere in .
- 6. 'Ibe licensee shall ccmply with the provisions of Title 10, Chapter 1, Ccde of Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers; ;
i', ' 7 Inspections" and Part 20, " Standards for Protecti n Against Padiation." j p k 5. Licensed material shall be used by ,
l I~6.3. Licensed material listed in Item 6 above is authorized for use by the !
following individual (s) for the raterials and ust s indicated- .
1 (Name) (Uses) .
} ; ., .
p 7.A. Licensed raterial shall be used by, or under the supervision of,
~
l 7.3. Licensed material listed in Item 6 above is authorized for use by, !
or under the supervision of, the following individual (s) for the raterials and uses indicated:
I (Name) (Uses)
- 8. Licensed raterial shall be used by, or under the suh>ervision and in
[,* the physical presence of, .
7.A. Licensed material shall be used by, or under the suoervision of, p ,
individuals designated by .
_.9.3. The use of licensed material in or on humans shall be by a physician, by, nj <- <~,
ALARA PROGRAM ed' , ,
l (l'.:) 4 . ,G n.,
Aun L4, .t. c n. . n. e t --- _
and Model ALARA Program contained in Appendix 0 of Regulatory Guide 10.8 (Rev. 1),
" Guide for the Preparation of Applications for Medical Prograa,** October 1980. ,
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, .: cot:DITICN 10.
r- se following condition is the leak test condition for broad licenses and for 9
licenses to persons who fabricate sources. ic gy, 1 ff f M r W us
\ 0. A. (1) Each sealed source acquired from another person and containing licensed material, other than Hydrogen 3, with a half-life greater
. than thirty days and in any form o'ther than gas shall be tested for contamination and/or leakage prior to use. In the absence of a p certificate from a transferor indicating that a test has been made within six nonths prior to the transfer, a sealed source received from another person shall not be put into use until tested.
(2) Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exempt from such leak tests when the .
~
7~
source contains 100 microcuries or less of beta and/or gama emitting ---
material or 10 mic,rocuries or less of alpha emitting material.
'~;ne exception in 10.A(3) may be applied where, in the judgment of the technical reviewer, health and safety will not be compromised. .
(3) Except for. alpha sources, the periodic leak test required by this condition does not apply to sealed sources that are stored and
/ not being used. 2 e sources excepted from this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six months prior to the date
. _ . . . . of use or transfer.
B. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage, and contamination prior to use or
/, transfer as a sealed source. If the inspection or test reveals any construction defects or 0.005 microcurie or greater of cont amination, 8( the source shall not be used or transferred as a sealed source until it has been repaired, decontaminated and retested.
C. Each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than' thirty days and in any form other than gas shall be tested for leakage and/or contamination at intervals not 3 to exceed six months except that each source designed for the purpose 7 of enitting alpha particles shall be tested at intervals not to exceed three nonths.
"~
D. %e test shall be capable of detecting the presence of 0.005 microcurie M radioactive material on the test sample. S e test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is permanently or semipermanently mounted or stored on . .
[, which one might expect contanination to accumulate. Records of lkak test results shall be kept in units of microcuries and maintained for' inspection by the Ccmission. 6'. A.s r .v A.ue *
,_ m .u w.
E. If the test required by Subsection A. or C. of this condition reveals the presence of 0.005 microcurie or more of temovable conramination, tne licensee shall inmediately withdraw the sealed source frcm use and shall cause it to be decontaminated and repaired or to ce disposed of in
'*y accordance with Comission regulations. A report shall be filed within five (5) days of the test with the U. S. Nuclear Regulatory Comission, Pegion (type appropriate 3egional Office of Inspectica and Enforcement -
(see list attached), describing the equip ant involved, the test results, and the corrective action taken.
.f* . .e. peu.* 44w 4 *#.. MM aM 8 18 M er$
I e4 ~ s
, s - -
. CCNDITICH 11 kq "j te following condition is the leak test condition for neutron and beta-gamma sources
. only. Section D., which specifies by whom the leak test shall be carried out, may be emitted where it'is inappropriate.
t h
- 11. A. (1) Each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any form other than I
h Iy gas shall be tested for leakage and/or contamination at intervals not to exceed six months. In the absence of a certificate from a transferor indicating that a test has been made within six months orior to the transfer, a sealed source received from another person aall not be put into use until tested. .
2
- . (2) Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exe::pt from stch leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting. material.
Se exception'in 11.A(3) may be applied where, in the judgment of the technical reviewer, health and safety will not be ecxnpromised.
(3) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being.used. Se sources excepted from this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak m tested within six months prior to the date of use or transfer.
. B. Se test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. Se test samplo shall be taken frem the sealed source or from the surfaces of the device in which the sealed source is permanently mounted or stored on sich one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the
- ccomission.
s C. If the test reveals the presence of 0.005 microcurie or more of l
removable contamination, the licensee shall im.ediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Com=ission regulations.
A report shall be filed within five (5) days of the test with the U. S. n: clear Regulatory Co= mission, Region (type appropriate Regional Office of Inspection and Enforcenent - see list attached), describing the
_ equipnent involved, the test results, and the corrective action taken. -
D. Tests for leakage arxl/or contamination shall be performed by or by other persons specifically authorized by the . Commission or an
_ Agreement State to perform steh services.
! p l
V -g ,
,, CCNDITICN 12 lt te 'following condition is the leak test cordition for alpha, neutron, and beta-gamma
~
sources. Section D., which specifies by whom the leak test shall be carried out, may be cnitted where it is inappropriate.
- 12. _A. (1) Each sealed source containing licensed material, other than Hydrogen 3, with a half-life greater than thirty days and in any form other than gas shall be tested for leakage and/or contamination at intervals not to exceed six months, except that ,each source designed for the
- purpose of emitting alpha particles shall be tested at intervals not y to exceed three months. In the absence of a certificate from a p transferor, indicating that a test has been made within six months prior to the transfer, a sealed source received from another person shall not be put into use until tested.
(2) Notwithstanding the periodic leak test required by this condition, any licer. sed sealed ' source is excmpt frcm such leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material.
We exception in 12.A(3) ray be applied where, in the jtdgment of the technical reviewer, health and safety will not be ccepromised.
(3) Except for alpha sources, the periodic leak test required by this
-m cordition does not apply to sealed sources that are stored and not
( )'
being used. Se sources excepted from this test shall be tested for
( _- leakage prior to any use or transfer to.another person unless they have been leak tested within six months prior to the date of use or i -
transfer.
B. Se test shall be capable of detecting the presence of 0.005 microcurie of t
i ra$1oactive material on the test sample. Se test sample shall be taken from the seale:1 source or from the surfaces of the device in which the
! sealed source is permanently mounted or stored on which one might expect I contmination to acctmulate. Records of Icak test results shall be kept in l units of microcuries and maintained for inspection by the Ccemission.
C. If the test reveals the presence of 0.005 microcurie or more of removable
! contamination, the licensee shall immediately withdraw the sealed source i from use and shall cause it to be decontaminated and repaired or to be I disposed of in accordance with C:mmission regulations. A report shall be filed within 5 days of the test with the U. S. Nuclear Regulatory Commission, . .
Region (type appropriate Regional Office of Inspection and Enforccment -
see list attached) , describing the equip ent involved, the test results, l and the corrective action taken.
! D. Tests for leakage and/or contamination shall be perfomed by or by other persons specifically authorized by the Commission or an Igreenent State to perform stch services.
l
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~. . ..
CCNDITICN 13 n -
This coMition provides for leak test intervals of three years for certain specified equipment. ,
- 13. A. (1) shall be tested for leakage and/or contamination ac intervals not to exceed three years. In the absence of a certificate 'from a transferor indicating that a test has been ,
made within six months prior to the transfer, a sealed source received l from another person shall not be put into use until tested.
(2) Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exmpt from such leak tests when the source contains 100 microcuries or less of beta aM/or gamma emitting material or 10 microcuries or less.of alpha emitting .
material.
Se exception in 13.A.(3) may be applied Were, in the judgment of the technical reviewer, health and safety will not be ccrepromised.
- (3) The periodic leak test required by this condition does not apply to sealed sources that are stored and not being used. %e sources excepted from this test shall be tested for leakage prior to any use or transfer to another person unless they have been leak tested within six months prior to the date of use or transfer.
^' "- ****"*'""'*"*5*- 5d '**'t"9 5 "t"' ""' ' a '
(s~
radioactive material on the test sample. Se test sample shall be taken
' from the sealed source or from the surfaces of the device in Wich the sealed source is permanently mounted or stored on 411ch one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Comission.
C. If the tast reveal's the presence of 0.005 microcurie or more of renovable contamination, the licensee shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be dispased of in accordance with Corraission regulations. A reprt shall be filed within 5 days of. the test with the U. S. tbelear Regulatory corriaission, Region (type appropriate Regional office of Inspection and Enforcement - see list attached) , describing the equipent involved, the test results, and the corrective action taken.
D. Tests for leakage and/or contamination shall be performed by - .
or by other persons specifically authoriced by the Commission or an Agreement State to perform su:h services.
r
- 14. "Each sealed source containing licensed material to be used outside of a s j shielded exposure device shall bear a durable, legible, and visible tag permnently attached to the source. The tag shall be at least one (1) inch (N)
'd square, shall bear the conventional radiation symbol prescribed in Section 20.203(a),10 CFR 20, and a minimum of the following instructions: DANGER -
RADICACTIVE MATERIAL - ID NOT HANDLE - tDrIFY CIVIL AUTEORITIES IF EDUND.
Fspair or replacement of tags shall be accer;plished by persens specifically licensed by the Ccmission or an Agreement State to perform this service. ,
~
- 15. Each sealed source containing licensed material .to be used outside of a shielded exposure device shall bear a durable, legible, and visible tag
.M permanently attached to the source. The tag shall be at least one' (1) inch square
- shall bear the conventional radiation . symbol prescribed in Section
~
20.203(a),10 CFR 20, and a minimum of the following instructions: DA!K;ER -
FADICACTIVE MATERIAL - DO Nor EANDLE - POIIFY MILITARY AUT50RITIES IF EDUND.
Papair or replacement of tags shall be acccxrplished by persons specifically licensed by the Cc:nnissica or an Agreement State to perform this service.
l
- 16. Except as specifically provided otherwise by this . license, the licensee i shall possess and use licensed material described in Itca.s 6, ~7, and 8 of ty this license in accordance with statements, representations, and procedures contained in . The' Nuclear Regulatory lf g j p C ission's regulations shall govern the licensee's statements in applications 9 or letters, unless the statenents are core restrictive than the regulations.
1
- 17. Pursuant to the Atomic Energy Act of 1954, as amended, and Title 10, Chapter 1, Code of Federal Fagulations, Part 70, " Domestic Licensing of Special Nuclear Material", the licensee is authori::ed to receive, possess, and use the special
/y>N nuclear material resulting from the decay of . This license
! shall be deeced to contain the conditions specified in Section 70.32(a) of said H)!
regulations.
m, c. a w ,en Ll.a Q 18. Y, Sealed sources containing licensed material shall not be opened.
P-
19.. 6Sealed
. J wsources containing licensed material shall not be opened or removed f from their respective source holders by the licensee.
t F 20. Sealed scurces containing licensed material shall not be opened or removed h
i
~
frca by the licensee,
- 21. A. Detector cells containing titanium tritide foil shall only be used in conjunction with properly cperating temperature control nechanints which prevent foil te::peratures from exceeding 225 degrees Centigrade.
k j B. Detector cells containing scandium tritide foil shall only be used in **
j conjunction with prcperly operating tecperature control mechani=s which i prevent foil temperatures frcxn exceeding 325 degrees Centigrade.
i
~
- 22. In lieu of using the conventional radiation caution colors (magenta or
!f purple on yellow background) as provided in Section 20.203(a)(1), Title 10, Code of Federal Fagulations, Part 20, the licensee is hereby authori::ed to label 4 detector cells and cell baths, containing licensed material and used in gas i chrc=atography devices, with conspicuously etched or stamped radiation caution
[, sy=bols without a color requirerent.
/ \
\ ]
u- .
l L
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\
- 23. A. Each chromatograph detector cell containing Nickel 63 shall be tested for leakage and/or contamination at intervals not'to exceed six (6) months. .
In the absence of a certificate'from a transferor indicating that a test has been made within six (6) nenths prior to the transfer, a detector cell received from another person shall not be put into use until tested.
B. The test shall be ca;iable of detecting the presence of 0.005 microcurie of radioactive material on the test' sample. W e test sample shall be taken from the surfaces of the device in which the Nickel 63 is mounted or stored on which one might expect contamination to accumulate. Records
, of leak test results shall -be kept in units of microcuries and maintained gy for inspection by the Comission. '
,h C. If the test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee shall inraediately withdraw the detector cell from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with Comission regulations. A report shall be
- filed within five (5) days of the test with the U. .S. Nuclear Regulatory Comission, Region (type appropriate Regional Office of Inspection and' 1 Enforcement - see list attached), describing the equipment involved, the test results, and the corrective action taken.
D. Tests for leakage and/or contamination shall be pe'rformed by the licensee or by other persons specifically authorized by the Comiss.on or an Agreement State to perform such services.
./ -
(~ 24. De licensee shall report by telephone within twepty-four (24) hours to the nearest U.S. Nuclear Regulatory Cennission Office of Inspection and Enforcement, r f the loss 'or potential abandonment dowh-hole of any sealed source containing y licensed material. In addition, a written report shall be submitted within
- ,y thirty (30) days for the lost or abandoned source which shall include information
' regarding isotope, amount, location, depth, method of inrobilization, sealing, placarding, and notations to be placed in public records.
- 25. We licensee shall not use licensed material in or on human beings or 1 in field applications where activity is released except as provided otherwise" '~
by specific condition of this license.
~
- 26. Experimental anirals administered licensed materials or their products
- shall not be used for hu=an consu=ption.
T 27. [.icensed raterial shall not be used in or on htnan beings or in products -:
- distributed to the public.
i.
Y l
l
j n _8-'
- Q .
- 28. A. Individuals involved in operations Wich utili::e, at any one time, more than 100 mil 11 curies of Hydrogen 3 in a nort-contained form, other than
, metallic foil, shall have bioassays performed within one week following e a single operation,and at weekly intervals for continuing opera.tions.
Tritiun Bioassavs - Processors, Dial Painters, Etc.
28.' B. (1) Tritiun shall not be used in stch a manner as to cause any individual to receive a radiation exposure stch that urinary excretion rates
, exceed 28 microcuries of tritita per liter een averaged over a calendar quarter.
. (2) Urinalysis shall be performed at wekly intervals on all individuals so wrk in the restricted areas of facilities in sich tritiun is used. If the average concentration of tritiun in urine for any sigle individual during a calendar quarter is less than 10 microcuries per liter, urinalysis may be performed on that individual at monthly intervals for the following calendar quarter and may continue at.
monthly intervals so long as the average correntration in the calendar quarter renains below 10 microcuries per liter. D e urine 6;' specimen shall be collected on the same day of the wek insofar as possible.
s j (3) A report of an average concentration in, excess of the limit specified in B(1) above for any individual shall-be filed, in writing, within thirty (30) days of the end of the calendar quarter with the Office of Inspection and Enforcement, U. S. hbclear Regulatory Comission, Washington, D. C. 20555, with a copy to the Pagional Office of of Inspection and Enforcement. W e report shall contain the results of all urinalyses for the individual during the calendar quarter, the cause of the excessive concentrations, and the corrective steps taken or planned to assure against a recurrence.
(4) Any single urinalysis Wich discloses a concentration of greater than 50 microcuries per liter shall be reported, in writing, within seven (7) days of the licensee's receipt of the results, to the Office of Inspection and Enforcenent, U. S. Nuclear Regulatory Comission, Washington, D. C. 20555, with a copy to the U. S. thelear Regulatory Comission, Region (type appropriate Regional' Office -.
of Inspection and Enforcement - see list attached) .
O
(
v i
i t
. _ . _ . . . . . e p Civil Defense
- 29. Each sealed source containing licensed material to be used outside of a shielded exposure device shall have a durable, legible, and visible tag permanently attached by a durable ring. The tag shall be at least one (1) inch square, shall bear a conventional radiation symbol prescribed in.Section 20.203(a) gy of Part 20, and a minimtra of the following instructions: CANGER - RADIOACTIVE MA17. RIAL - DO tCT HANDLE - NOTIFY CIVIL AlmfCRITIES IF 'EUCND..
Replacement of tags and rings shall be carried otit by the licensee in '
accordance with instructions contained in FROCEDURES AND REUIATIONS FOR THE CARE AND USE CF THE CCD CD V-778 RADIATICN TRAINDIG SCURCE SET, dated
- February 1967. t
- 30. A. Licensed material contained in IEPA Sealed' Source Sets shall be tested for external leakage and/or contamination upon receipt from another person, except een the licensee receives certification from the person that the sources had been tested within six (6) eenths prior to transfer and found free of surface contamination. Thereafter, sources shall be tested for leakage and/or contamination at intervals not to exceed six (6) months. Records of leak test results shall be maintained.by the licensee.
1 B. The' test for leakage and/or centamination shall be capable of detecting the presence of 0.05 microcurie of radioactive material on the test sample.
rA C. If the test reveals any radioactive material, the licensee shall take f immediate action to prevent spread of contamination and within five (5)
(u days after ccrapletion of the test shall notify the U. S. Nuclear Regulatory Comission, Pegion (type appropriate RegionaI Office of Inspection and Enforcement - see list attached) .
D. Isak test of sealed sources in ECPA Sealed Source Sets shall be performed by the licensee in accordance with instructions contained in PROCEDURES AND RMUIATICNS FOR THE CARE AND USE CF THE OCD CD V-778 RADIATION TRAINDS3
+
SOURCE SET, dated February 1967.
- 31. Licensed material shall be stored except for temporary storage at locations were training courses are conducted.
32., (Blank) pv
- 33. (Blank)
~*
- 34. (Blank) h i
i
_ 10 _
( ) Radioarachv - Sealed Sources and Devices - Industrial
- 35. We licensee shall comply with the provisions of Title 10, Chapter 1, Code of Federal Regulations, Part 19, " Notices, Instructions and Reports to Workers; Inspections," Part 20, " Standards for Protection Against Radiation,"
gN and Part 34, " Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations." ,
- 36. We individuals listed below are the only persons authorized by this ,
license to act as radiographers or radiographers' assistants as defined in y Section 34.2, 10 CFR 34:
Radiocrachers Radioarachers' Assistants
- 37. A. . Pursuant to Section 34.25, 10 CFR 34, the licensee is authorized to perform tests for leakage or contamination of the sealed sources authorized by this license in accordance with procedures contained in .
B. Notwithstanding the periodic leak test required by Section 34.25(b),
10 CFR 34, such requirement does not apply to radiography sources that are stored and not being used. The sources excepted from this test shall be tested 9 for leakage prior to any use or transfer to another person unless they have been leak tested within six months prior to the date of use or transfer.
C. Sealed scurces authorized for a use other than radiography shall be tested
/]
as radiography sources in accordance with Section 34.25 of 10 CFR 34.
E/ 33. We licensee is authorized to receive, possess, a'nd use sealed sources of Iridit:1192 or Cobalt 60 where the radioactivity exceeds the maximtm amount of radioactivity specified in Itcm 8 of this license provided:
A. Such possession does not, exceed the quantity per source specified in Item 8 by more than 20% for Iriditn 192 or 10% for Cobalt 60;
,p B. Records of the licensee show that no more than the mximtm amount of radioactivity per source specified in Item 8 of the license was ordered from the supplier or transferor of the byproduct mterial; and C. We levels of radiation for radiographic exposure devices and storage containers do not exceed those specified in Section 34.21, 10 CFR 34.
- 39. bis license does not authorize the connercial distribution of licensed mterial b '- to persons exempt from licensing pursuant to Section 30.18, 10 CFR Part 30. *
- 40. Pursuant to Title 10, Chapter 1, Code of Federal Regulations, Part 40, "Dorrestic -
Licensing of Source Material," the licensee is authorized to rossess, use, transfer, and import up to 999 kilograms of uranitrn contained as shielding P material in the radiography exposure devices and cource changers authorized by this license.
v
( 41. Pursuant to Title 10, Chapter 1, Code of Federal Regulations, part 40, " Domestic
\ s) -
Licensing of Source Material," the licensee is authorized to possess, use, transfer, and imoort the uranium contained as shielding raterial in the F teletherapy unit's authorized by this license.
~
- 42. Each source holder and logging tool containing radioactive material shall bear a legible and visible tarking. The marking shall bear the conventional p u radiation sy bol and the following wording: DANGER - RADIOACTIVE - DO NCrr FADLE - NCTIIIY CIVIL 'AUniCRITIES. , ,
~
- 43. me licensee shall not transfer possession and/or control of caterials or j products ccntaining licensed material as a contaminant except:
I
! g, A A .* By transfer of waste to an authorized recipient; 3
l3/
i t
B. By transfer to a specifically licensed recipient; or i
C. ' 'is provided otherwise by specific condition of this license pursuant l to the requirements of Section 32.11, 10 CER 32.
1
~
- 44. Installation, relocation, raintenance, repair, and initial radiation survey of devices containing licensed caterial and leak testing, installation, replace:ent, and disposal of sealed sources containing lfcensed material used
, in devices shall be performed only by - or by other
,V persons specifically authorized by the Co::aission or an Agreement State to
/7 perform such services, k )
- 45. Installation, initial radiation survey of deviced, relocation, raintenance, repair, and reoval from service of the devices containing licensed material
! and installation, replacement, and disposal of sealed sources containing x licensed raterial used in the devices shall be performed only by or by other persons specifically authorized by the Comission or an Agreement State to perform such services.
~
- 46. Paintenance, repair and initial radiation survey of devices containing licensed caterial and leak testing, installatien, replacement, and disposal
,. of sealed sources containing licensed caterial used in devices shall be t" performed only by or by other persons specifically I authorized by the cc raission or an Agreement State to perform such services.
I
- 47. We licensee shall conduct a physical inventory every six (6) months to account for all received and possessed under the license.
,/
- Tne records of the inventories shall be raintained for two (2) years from the **
date of the inventory for inspection by the Comission, and shall include the quantities and kinds of byproduct caterial, location of sealed sources, and j the date of the inventory.
G j
- 48. Detector cells containing licensed material shall not be opened or the foil sources removed from the detector cell by the licensee.
! I V
e
- u. -
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)
- 49. (For Pharmacy Licenses) .
A. The licensee shall perform a test to detect and quantify the activity of renlybdenum-99 contamination in each elution of technetita-99m from a i .mlyodentn-99/technetitm-99m generator and in each extraction or
- !'b separation of .technetitn-99m from mlybdenum-99 not contained in a generator.
~
B. We licensee shall not distribute for human use technetitn-99m that, at tlie expiration date and time shown on the package label, contains more than one (1) microcurie of m1ybdenum-99 per millicurio of technetitn-99m or mre than five (5) microcuries of m1ybdentn-99 per dose of technetitn-99m. n e expiration date and time shown on the J
3 7, package label shall be such that the limits above are not exceeded for
. anf single patient dose, ne limits for molybdentn-99 contamination represent maximum values and molybdenum-99 contamination should be kept as low as reasonably achievable below these limits.
C. We licensee shall establish written procedures for personnel performing tests to detect and quantify molybdenum-99 contamination. Wese c (;3 procedures shall include all.necessary calculations and steps to be taken if activities of molybdentn-99 in excess of the limits specified in Subitem 3. above are detected.
/%
) D. Personnel performing tests to detect and quantify colybdentn-99
( g j) contamination shall be given specific training in perfoming these tests prior to epnducting such tests.
~
E. 1. Se licensee shall mintain for inspection by the Nuclear Regulatory comdssion records of the results of each test performed to detect and quantify molybdentn-99 contamination and records of training l), given to personnel perfoming these tests.
- 2. Records described in Subitem E.1. above shall be mintained for t o (2) years following the performance of the tests and the training of personnel.
1 m
v e e, b
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)
- 50. A. tbtwithstanding tne requirenentrof Section' 35.14(b)'of Titl410, code of Federal Regulations, Part 35, the licensee may possess and (ne any licensed material for Wich he ms authorized and that es in his possession on Januari 13, 1975.
l E. Licensed material shall be used in accordance with the provisions of
,l [! Section 35.14 (b) (c) (e) and (f) of Title 10, Code of Federal Regulations.
l . .
! C. Licensed material of the types, quantities, and fanns specified in Sections
!- 35.31(a) of 10 CFR 35 and 31.11(a) of 10 CFR 31 ray also be used by j in accordance with the provisions of
- i paragrapns (a) and (c) of Section 35.31,10 CFR 35 and paragraphs (a) ,
(c), and (d) of Section 31.11, 10 CFR 31.
{ 51. bles or standard medical applicator cells containing Cobalt 60 as wire
q
, shall not be opened by the licensee unless specifically authorized by a condition in this license.
I 52. Patients containirq Cobalt 60, Cesiun 137 or Iridiun 192 implants shall remain j hospitalized until surveys made with an appropriate radiation detection
- p m instrunent indicate that all implants have been removed. 'Ihe results of these G~
jg['
surveys shall be recorded and maintained for inspection by the Commission for five (5) years from the time the implants are renoved. .
{W 53.c Patients containirg Iodine 131 for the treatment of thyroid carcinoma or
-Q QA patients containing therapeutic quantities of Gold 198 shall rensin hospitalized
./ until the residual activity is 30 millicuries or less.
p7 xpy h, 54. Pursuant to Section 20.105(a) of Title 10, Chapter 1, Code of Federal l Fegulations, Part 20, " Standards for Protection Against Radiation," and in
- reliance of statements, procedures and representations made by the licensee
! in his , the followirq maximun radiation y levels are herecy autnorized in the follcwing unrestricted areas:
'& t'aximun Radiation favel Unrestricted Area I
- 55. Judioactive gases as free gas or in solution, to be administered to hunans,
@ shall be procured frem a supplier to distributes the product indicated for
! hu.an use in accordance with the Federal Food, Crtg, and Cosnetic kt.
I
~
- 56. tbtwithstand.ng the labeling requirenents of Section 20.203(f),10 CFR Part 20, -*
i6 (or conparaLu Igreement State regulations) the licensee is authorized to l ,, A receive, pcscr,s, and use licensed material received tr. der the American College i of Pathologists Nuclear Itdicine Quality Control Progran with labeling as j propr,ad in letter dated .
L
, *:he specified possession limit inclu$es all licensed material pssessed by the iFC%,57.
,dlicensee under this license Wether in storage, implanted in ptients or g )/p g ) V otherwise in use.
f )
V e
. 1 p~ 58. We licensee shall not receive or transfer in any single transaction one (1)
(V) e
'H
- - gram er m:>re of plutoniu:a 238 contained in nuclear-powered pacemkers without notifying the Division of Safeguards, U. S. Nuclear Regulatory Comission, Washincton, 'D. C. 20555, and, in addition, cocpleting and distributing For:a Nac-741 as required by Section 70.54 of 10 CFR 70.
~
- 59. De licensee shall report to the mterial Licensing Branch, U. S. Uudlear Regulatory Camissien, Division of Fuel Cycle and Material Safety, four (24) hours of occurrence, Washingten, D...uclear C. 20555, within twentyient, and any adverse reaction and/or
, s. W' the death of arr pacemaker pat
! malfunction in'.olving a pacemaker system, including the leads. A written -
l report giving d. tails of the adverse reactipn and/or malfunction shall be subuitted withir thirty (30) days. -. . ._
b j y 60. de licenses. sr.all report to the Material Licensing Brangh, Division of a Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Comission, Washington, D. C. 20555, within ten (10) days, loss of contact with a j
nuclear pacemaker patient.
I~ 61. We licensee shall. continue patient follow-up and replacement procedures for the y nuclear pacccaker during the life of the patient. Procedures for recovery and FlY authorized disposal of the nuclear pacemaket by return to the manufacturer j shall be followed upon the death of the patient.
~
- 62. For a period not to exceed sixty (60) days in any calendar year, a visiting
' . physician is authorized to use licensed mterial for htcan use under the
/5
,'h,9ig/termsofthislicense,providedthevisitingphysician:
k (a) Has the prior written permission of the hospital's Administrator (4 - ' g_ and itsf.edical Isotopes Cormtitteep and
(' (b) Is specifically named as a user on a[Nuclea4 Regulatory Cor::sissionj N ,I license authorizing ht:.an use, and J'
(c) Performs only those procedures for which he is specifically authorized
- g by agelear Regulatory Cormtissionjlicense.
ne licensee shall mintain for inspection by the Cor:raission, copies of the written permission specified in subitem (a) above and of the license (s)
, specified in subitens (b) and (c) above. W ese records shall be maintained 7 for five (5) years from the time the licensee grants its permission under j subites (a) above.
[ 63. A. Technetit:a-99m separated from molybdent:n-99 either by elution of a i molybdenum-99/techn titra-99m generator or by an extraction process shall o be tested to detect and quantify rrolybdent:a-99 activity prior to it" I
adninistration to patients.
j B. We licensee shall not administer to patients technetium-99m containing **
more than one (1) microcurie of trolybdentra-99 per millicurie of technetit:a-99m or more than five (5) microcuries of r:ulybdenu:n-99 per dose of technetit:a-99m at time of administration. We limits for molybdentra-99
! contamination represent mximum values and relybdent:a-99 contamination L_ should be kept as low as reasonably achievable below these limits.
O)
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E
,- . . - G3. C. 22 licensee shall escablish written procedurcs for personnel performing tests to detect and quantify nelybdenum-99 contamination. %ese procedures shall include ,all necessary calculations and steps to be taken D if activitie of eclybdan=-99 in excess -of the lhits spccified 'in ~~
Subitem B. above are detected.
D. Personnel-performing tests to detect and quantify molybdenum-99 contamination shall be given specific training in perforeting these tests prior to conducting such tests.
[ E. 1.
^
We licensee shall maintain for inspection by the Nuclear Regulatory.
Co.-etission records of the results of each test performed to detect and quantify molybdenum-99 contamination and records of training
, ' given to personnel performing these tests.
- 2. Records described in Subitem E.1. above shall be maintained for two (2) years following the performance of the tests and the training of personnel.
Teletheraov -
' 64. n e following shall be performed cnly by persons specifically authorized by the Cocutission or an Agreement State to perform such services:
A. Installation, relocation, or removal of teletherapy. units containing sources.
'[ B. Source exchange.
C. Any maintenance or repair operations on a teletherapy unit involving work on the source drawer, the shutter, or other mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in increased radiation levels.
d;., 65. We teletherapy facility shall be provided with a syste permitting continuous
- observation of the patient from outside the treattent roem during patient irradiatien.
1
{~~~ 66. A. Teletherapy sources shall be tested for leakage at intervals not to i
4 exceed six conths. Records of test results shall be kept in units of microcuries and maintained for inspection by the Co:mtission. In the
,)D absence of a certificate from a transferor indicating that a test has been cade within six cenths prior to the transfer, a source received from another person shall not be used until tested for leakage. .
B. We tests shall be sufficiently sensitive to detect 0.05 microcurie of lQ contamination on the test sacple.
C. Se test sample shall be taken from selected accessible surfaces of the gg teletherapy head. W e selected accessible surfaces should be those surfaces
- g on which one might expect contamination (if there were to be leakage) to accumulate and shall include the inner surface of the rest frecuently * * '
used treatment cones or beam collimating device, ne test sangle shall be taken with the source in the "off" position.
~'
D. If the test reveals the presence of 0.05 micrecurie or more of removable contaminatten, the licenses shall promptly take action to prevent spread 4.
of contamination and shall file a report within five (5) days of the test t
l
- gU with the Material Licensing Branch, Division of Puel Cycle and Material Safety, U. S. Nuclear Regulatory Comission, Washington, D. C. 20555, describing the test results and the correctivo action taken. A copy of such report shall also te sent to the U. S. Nuclear Regulatory Comission, Oq" Region (type appropriate Regional Office of Inspection and Enforcement -
see list attached).
.' T 67 Prior to, initiation of'a treatment program, cach teletherapy uni't shall be 0 equipped with electrical or mechanical stops limiting use of the primry beam
-.i of radiation so as to ensure ccepliance with Section 20.105(b), Title 10,
-[ 'b Part 20s Code of Federal negulatienc, Chaptar 1, " Standards for Protection
\ ~,) Against Radiation," as evidenced by a radiation survey. Necessary use restrictions shall be fully described in radiation survey reports submitted in accordance with Condition No. 18.
~
- 63. A set of written emergency instructions shall be posted at the teletherapy machine control. These instructions shall inform the machine operator of the procedure to be followed should he be unable to turn the mehine's primary beam of radiation "off" with the controls outside the treatment room.
- 69. A. Access to the teletherapy room shall be centrolled by a door at each Q,,
entrance. Such doors shall be normily closed. '
h l g.L ,
B. Each entrance to the teletherapy room shall be equipped with an elec-r trical interlock system that will turn the teletherapy mchine's primary i u i' L , beam of radiation "off" irrediately upon opening of any entrance door.
@j 2e interlock system shall be connected in such a manner that the j[4 h i teletherapy machine's primary beam of radiation cannot be turned "on" l.
until all treat =ent room entrance doors are closed and the beam "on-off" centrol is reset at the control panel.
l I~ C. Electrical interlocks on entrance doors to the teletherapy room shall lW be tested for proper operation at least once every six months. Records I
~
of test results shall be maintained for inspection by the Comission.
c D. In the event of mlfunction of any door interlock, the teletherapy machine
- 'i control shall be locked in the "off" condition and not used, ex' cept as my be necessary for repair or replacer.ent of the interlock system,
(,x} until the interlock system is shown to be functioning properly.
C/ 70. Prior to initiation of a treat =ent program, and subsequent to each installation
, of a teletherapy source, radiation surveys and tests shall be performed in i # accordance with the following:
A. A radiation survey shall be mde of:
(i) ne teletherapy source housing, with the teletherapy source in the "off" position. Se mximum ard average radiation levels at one meter from the teletherapy source in the "off" position shall not exceed 10 millircentgens per hour and 2 milliroentgens per hour, respectively.
- (ii) All areas adjacent to the treatment room with the teletherapy source I
6 in the "on" position. The survey, except Item (c), shall be j performed with a phantem in the primry beam of radiation and shall
! clearly establish:
(a) Wat radiation levels in restricted areas are not likely to cause l personnel exposure in excess of the limits specified in i
a_ Section 20.101, Title 10, Part 20, Code of Federal Regulations, i Chapter 1, " Standards for Protection Against Radiation)
~,
- v. .
. 70. continued f3 . .
k Ic# (b) ihat quantities of radiation in unrestricted areas do not exceed the limits specified in Section 20.105(b),10 CFR 20.
v (c) We intensity of the primary beam of radiation at a specified distance from the teletherapy source. ,
B. Tests shall be made to determine proper operation of:
.A (i) Electrical interlocks on entrance doors to the toletherapy '
j treac:ent room. -
(ii) We teletherapy source "on-off" indicators, both at the source j
'4 housing and on the teletherapy eachine control panel.
-l (iii) Electri' cal or mechanical stops installed for the p2rpose of l . limiting use of the primary beam of radiation (restriction of
'j
- source housing angulation or elevation, carriage or stand travel l , and operation of the beam "on-off" mechanism).
l , in'aik We t* letherapy treatment timing device.
p'{I ..j- (iv)
C. A report of the results of the above surveys and tests shall be sent to the Material Licensing Branch, U. S. Nuclear Regulatory Cccmission, Division of Fuel Cycle and Material Safety, Washington, D. C. 20555, not later than thirty (30) days following each installation of a teletherapy Ichy, source. A copy of such report shall be sent to the U. S. Nuclear C/ ' Regulatory Commission, Region (type appropriate Regional Office of Inspection and Enforement - see list attached) .
- 71. A. Any changes made in the treatment room shielding, location of the unit within the treat =ent room, or use of the teletherapy unit that could result in increased radiation levels in areas outside the teletherapy
.# f treatment room shall be evaluated by a radiation survey made in accordance with condition 18., and reported to the Ccemission within thirty (30) days follcwing completien of the change (s) .
B. Relocation ~of the teletherapy unit to a new facility is not permitted without prior approval of the plans and details by the Comission. Following
, such approval and relocation, a radiation survey shall be made in accordance
'# with Condition 18., and reported to the Comission within thirty (30) days after completion of the cove. ,,
- 72. Each teletherapy machine shall be fully inspected and serviced during source replace.ent or at intervals not to exceed five (5) years, whichever comes first, to assure proper functionirg of the cource exposure mechanism.
his inspection and servicing must be perfonred by persons specifically
- , authorized to do so by the U. S. Nuclear Regulatory Comission or an Agreement l
State, and a report of the inspection and servicing must be kept on'f!le for 3 review by the comission's Cffice of Inspection and Enforcement.
L_...
p v
I
Ga=a Irradiators . '
n * *
( [ 73. A. Dach realed cource containing licensed mterial shall be tested for leakage
\/ ,
and/or contamination at intervals not to exceed six renths. In the absence l1 pl i
of a certificate from a transferor indicating that a test has been mde within six months prior to the transfer, a sealed source received from .
!b another person shall not be put into use until tested.
i B. te test shall be capable of detecting the presence of 0.05 microcurie f of contamination on the test sample. D e test samples shall be taken from appropriate accessible surfaces of the device in which the sealed ldd s source is permanently or semipermnently munted or stored. Records of.
T leak test results shall be kept in units of microcuries and maintained for i'
inspection by the Comission.
~~
C. If the test reveals the presence of 0.05 microcurie or more of removable
' contamination, the licensee shall imediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be
'g ,_ disposed of in accordance with Comission regulations. A report'shall
< f'
- be filed within 5 days of the test with the U. S. Nuclear Regulatory Comission, Region (type appropriate Regional Office of Inspection and Enforcement - see list attached), describing the equip::ent involved, the test results, and the corrective action taken.
~~
D. Tests for leakage and/or contamination shall be performed by y?p or by other persons specifically authorized by the Comission or an Agreement State to perform such services.
(*/ 74. Written instructions ,
shall be followed and a copy of these instructions shall be made available to each individual using or having responsibility for use of licensed material. Any changes in f these instructions shall have the prior approval of the Material Licensing Branch, Division of Fuel Cycle and K3terial Safety, U.S. Nuclear Regulatory Ccmission, Washington, D. C.
- 20555.
- 75. De procedures contained in AECL's instruction tunual for the "Garmacell _ "
p device shall be followed and a copy of this nsnual shall be mde available
- p to each person using or having responsibility for the use of licensed mterial.
- 76. A. W e licensee is authorized to relocate, store, and install source units containing cuterial licensed above and to perform raintenance and repair i h, %' y' of the units which do not involve exposure of sealed sources. Replacceent and disposal of sealed sources containing licensed material shall be
,/ performed only by persons specifically authorized by the Comission or ,,
an Agreement State to perform such services.
B. nis license does not authorize repairs or alteratiens of the irradiator involving reroval of shielding or access to the licensed mterial except Y as provided otherwise by specific condition of this license. Removal, replacement and disposal of sealed sources shall be performed only by or by other persons specifically authorized by the cocnission or an ujrcecent State to perform such activities.
im
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v I
r~ 77. Af ter installation of the irradiator and Cobalt 60 orTesium"137' source and r('
['N) -
prior to initiation of the irradiation program, a radiation survey shall be conducted to detemine the maximum radiation levels .in each area. adjoining the irradiation room. A detailed report of the results of the surveys shall be
- sent to the Material Licensing Branch, Division of Fuel Cycle and Material f/ Safety, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, not later f than thirty (30) days following installation of the source. A copy of such report shall also be sent to the U. S. Nuclear Regulatory Connission, Region (type appropriate Regional Office of Inspection and Enforement -
see 1ist attached) . ,
- 78. After installation of the irradiator and Cesitm 137 or Cebalt 60 source and prior to initiation of the irradiation ' program, a radiation survey shall be conducted to detemine radiation levels around, abave, and below the irradiator with the source in the irradiate position and with the source in the shielded position.
A detailed report of the results of the surveys shall be sent to the Material
,) Licensing Branch, Division of Ebel Cycle and Paterial Safety, U. S. Nuclear 4* Regulatory Ccanission, Washington, D. C. 20555, not-later than thirty (30) days. following installation of the source. A copy of such report shall also
, be sent to the U. S. Nuclear Regulatory Commission, Region (type appropriate l Regional Office of Inspection and Enforement - see list attached).
I j TRANSPORTATION I
l ne follewing condition is to be used in licenses where the licensee (not a common or contract carrier under regulations published by the Department of n Transportation or U. S. Post Office) wants coverage for transportation of radio-
) isotopes because his transportation does not occur in interstate or foreign (V correrce or the transportation is by air other than civil aircraf t.
h A[f4 9. De licensee may transport licensed traterial or deliver licensed material.
to a carrier for transport in accordance with the provisions of Title 10,
.fp, g @ /, Code of Federal Regulations, Part 71, " Packaging of Radioactive Material g for Transport and Transportati'on of Fadioactive Material Under Certain 1 Conditions."
INCINERATICH 2 e la entence of this condition may be omitted or modified to apply to situations where the licensee packages his waste residues and transfers then to authorized recipients for disposal.
[;
- 80. Pursuant to Sections 20.lC6(b) and 20.302,10 CFR 20, the licensee is authori:ed to dispose of licensed ruterial by incineration provided the gaseous f
effluent from incineration does not exceed the limits specified for al" in .
, ,J/ Appendix B, Table II, IU CFR 20. Ash residues may be disposed of as ordimry waste
> provided appropriate surveys pursuant to section.20.201 ara.made to detemine that concentrations of licensed material appearing in the ash residues do not exceed the concentrations (in tems of microcuries per gram) specified for water in Appendix B, Table II,10 CFR 20.
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. __ GENERAL LICENSE DISTRIBUTION - CERTAIN fEALED SOURCES AND DE7 ICES i e
)81. (Pravious Condition 81. no longer in use.) , ,
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- 82. No generally licensed device shall be installed by the licensee in such a ranner or in suen a location that any person could receive core than 0.5 rem
/ in a calendar year under ordinary circumstances of use.
- 83. D e licensee shall furnish to each general. licensee to whom he transfers a device pursuant to this license, a copy of Section 31.5,10 CER 31;
- yy sections 30.34 and 30.51 through 30.63,10 CIR 30; Sections 20.402 and -
j 20.403, 10 CFR 20, and Appendix D., 10 CFR 2G.
4 I 84. Tests of sealed sources for leakage or contamination shall be in accordance with the following:
A. The conditions of pertinent U. S. Nuclear Regulatory Cotraission and l
Agreement State licenses authori::ing the customer's use and possession of the licensed raterial; B. The procedures described in the applicalion filed by and dated sf C. The sealed source shall not be removed from the device. Tests shall be
!F made with the sealed source in the shielded or off condition; i )) D. Prior to cr,llection of test sam.ples, the tester shall survey the area which he will occupy during the sample callec$ ion; and E. A report of the results of each test shall be provided the customer in units c.: microcuries.
- 85. After installation by the licensee of each device distributed to persons generally licensed pursuant to Section 31.5 of 10 CFR, Part 31, the licensee shall conduct a radiation survey and shall assure that the levels of radiation
[ (.o not exceed those specified in the license authorizing the manufacture or distribution of the installed gauge. The licensee shall furnish the general
- licensee a copy of the radiation survey report.
.~~~,86. We handling of radioactive raterial under t.".is license in the mnufacture, l J installation, dismantling, relocation, and testing of devices shall be performed
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4 T' y 87. *:he licensee shall test each device distributed tnder this license for leakage or contamination of radicactive material and proper operation of the "en-off" mechanisa and indicator, if any, at the time of installation of the device.
- 88. A. Each device distributed under this license shall bear a durable, clearly visible and legible label or labels containing the following or -
substantially similar statements.
P 1. " Receipt, possession, use and transfer of this device are subject to a general license or equivalent and regulations of the i
U. S.1.bclear Regulatory Cocnission or an Agreement State."
i
- 2. "Abandement or dispsal prohibited unless transferred to persons specifically licensed by the U. S.- 1bclear Pagulatory Commission or an Agreement State."
~-~
- 3. " Operation prohibited if there is indication of failure of or damage to shielding, source contairment or on-off mechanim."
- 4. " Installation, distantling, relocation, maintenance, repair and O
testing involvirg the radioactive caterial, its shielding or (j) x contair=ent shall be perfomed by persons specifically licensed by the U. S. t.bclear Regulatory Ccanissior} or an Agreement State."
- 5. " Device shall be tested for radioactive leakage and proper functioning of on-off mechanisn and indicator, if any, at installation, at source replacenent, and thereafter at no lorger than
, . intervals."
t
- 6. "Ioss, theft, or transfer of this device and failure of or damage to the shielding, the source centsiment or the on-off mechanism t must be reparted to the U. S. !.bclear Regulatory Cocnission or an
{ Agreenent State."
L. --
l B. Each device distributed under this license shall bear a durable, clearly
, visible and legible label or labels containing the device model and 7# serial nteber, the radiation synbol in colors magenta or purple on a yellow background, the wrds "CAlfrICN, FADICACTIVE MATERIAL" or "PANGER, - .
PADICACTIVE MATERIAL," the quantity, identity and date of measurement l of the radioactive material, and the nane of the distributor of the. device.
L 7p C. Each label required by this cordition shall bear the statement, " Removal of this label is prohibited."
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- 89. A. We licensee shall report to the Material Licensing Branch, Divisich of l Puel Cycle and Material Safety, U. S. Nuclear Regulatory Comission, all i transfers of devices distributed under this license to persons generally n licensed under Section 31.5,10 CER 31. - Such' report shall identify each
' general licensee by name hnd address, the type of device transferred, and the quantity and type of licensed material contained in the device, and
[ the specific location where each device is installed.. S e report shall be submitted within thirty (30) days after the end of'each calendar quarter in which any such device is transferred to a generally licensed person.
B. We licensee shall report to the Material Licensing Branch, Division of Fuel Cycle. and Material Safety, U. S. Nuclear Regulatory Comission, all transfers of devices distributed under this license to persons generally licensed under Section 31.5,10 cm 31. Such report shall identify each, general.
licensee by name and address, the type of device transferred, and the quantity and type of licensed material contained in the device. Se
.. report shall be submitted within thirty (30) days after the end of each calendar quarter in which any such device is transferred to 4 generally licensed person.
LEAK TESTS FOR P!DIONIUM SOURCES I 90. A. Each encapsulated plutonium source designed for the purpose of emitting-neutron or game radiation shall be tested for leakage at intervals not to exceed six (6) months. In the absence of a certificate from a transferor
- indicating that a test has been made within six *(6) months prior to the -
1 transfer, a sealed source' received from another person shall not be put into use until tested.
B. We test shall _be capable of detecting the presence of 0.005 microcurie W e test sample shall be taken of fromalpha contamination the source on. the test or from appropriate sample. 51e, surfaces of the device in accessil which the sealed source is permanently or semipermanently mounted or t
stored. _ Records of leak test results shall be kept in units of microcuries and maintained for inspection by the Commission.
. C. If the test reveals the presence of 0.005 microcurie or more of removable" -
l alpha contmination, the licensee shall immediately withdraw the sealed
- j .
source from use and shall cause it to be decontaminated and repaired by
~
P a person appropriately licensed to make such repairs or to be disposed of in accordance with th4 Comission regulations. Within f,1ve (5) days after determining that any source has leaked, the licensee ~shall file a i
report with the Material Licensing Branch, Division of Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Commission, Washington, D. C.
20555, describing the source, the test results, the extent of contamination, the apparent or suspected cause of source failure, and the corrective i action taken. A copy of the report shall be sent to the U. S. Nuclear **
_: Regulatory Comission, Region (type appropriate Regional Office of Inspection and Enforcement - (see list attached).
D. %e periodic leak test required by this conditir.m does not apply to
- sealed sources that are stored and not being used. S e sources excepted
. ; from this test'shall be tested for leakage prior to any use or transfer I
'l to another person unless they have been leak tested within six (6) months prior to the date of use or transfer.
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[~N 90. continued * *
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U E. thtvithstanding the other provisions of this leak test condition, leak
[, e tests are not required on pcenakers implanted in experimental animals provided that a leak test shall be performed immediately following removal of the pcemakers frcxn the animal.
- 91. A. Each plutoniun alpha source shall be tested for leakage at intervals not to
' exceed three (3) months. In the absence "of a certificate from a transferor
[ . indicating that a test has been made within three (3) months prior to the transfer a sealed source received frem another person shall not be put into j r/ use until tested.
- 1 l B. te test shall be capable of detecting the presence of 0.005 microcurie of i al@.a contamination on the test sample. We test sample shall be taken
- from the source or from appropriate accessible surfaces of the device in I
which the sealed source is permanently or semipermanently mounted or stored.
I Records of leak test results shall be kept in mits of microcuries and maintained for inspection by the Commission.
C. If the test reveals.the presence of 0.005 microcurie or more of removable ii al@.a contamination, the licensee shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired by I
a person appropriately licensed to make su::h repairs or to be disposed of in accordance with the Commission regulations. Within five (5) days after determinirx; that any source has leaked, the licensee shall file a
.(O ") report with the Material Licensing Branch, Division of Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Cc;;raission, Washington, D. C.
20555, describing. the source, the test results, the extent of contamination, the apparent or suspected cause of source failure, and the corrective action taken. A copy of the report shall be sent to the U. S. Nuclear
' Regulatory Comission, Eegion (type appropriate Regional Office of Wien and Enforcerent - (see list attached) .
i D. Se periodic leak test required by this condition does not apply to sealed j sources that are stored and not being used. Se sources excepted from this l test shall be tested for leakage prior to any use or transfer to another j person tnless they have been leak tested within three (3) months prior to the date of use or transfer.
~
- 92. Except for plutonitra contained in a medical device designed for individual htracn
.t application, no plutoniun, regardless of form, shall be delivered to a carrior for shipent by air tranzport or transprted in an aircraft by the licensee -.
i except in packages the design of Milch the URC has specifically approved for
- transprt of plutoniun by air.
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- 93. De licensee ~ shall file an annual report as specified .in Section 32. _,
10 CIR Part 32.
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ri[ "We licensee is authorized to hold radioactive material with a physical I half-life of less than 65 days for decay-in-storage before dispasal in d // F/
ordinary trash provided:
A. Effected radioactive waste shall be held for decay a minimtm of ten M (10) half-lives.
$ Prior to disposal as normal waste, radioactive waste shall be monitored B.
to determine that its radioactivity cannot be distinguished from background with typical low-level laboratory survey instruments. All radiation labels will be removed or obliterated.
C. Generator colunns shall be segregated so that they may be monitored se1arately 5 to ensure decay to bakground levels prior to disposal."
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- 94. A. Each teletherapy rc<n shall be equipped with a radiation ronitorirg / # 3 2/ f device which continuously monitors the teletherapy beam condition and 1 is equipped with a back-up battery power supply for ecergency operation.
_ __ p. ' Ibis device shall energize a visible signal to maks1j6herator continuously {
aware of teletherapy betra condition in order that appropriate amargency j procedures may be instituted to prevent unnecessary radiation exposure.
\ Operating procedures shall require daily cperational testirg of the ;
installed radiation ronitor. ,
i l
B. hhenever the continuous radiation ronitorirg device is not operational, !
any person enterirg the teletherapy rocm followirg an irradiation shall enter with an operable, calibrated rtdiation survey meter and shall determine the beam condition.
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, m Region I Regional Office of Inspection and Enforcenent
. U. S. Nuclear Regulatory Coc:nission
.. 631 Park Avenue ,
i - King,of Prussia, Pennsylvania 19406
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i Region II Regional Office of Inspection and Enforcenent j - U. S. Nuclear Regulatory Consnission i 101 Marietta Street, Suite 3100 l Atlanta, Georgia _30303 4
j Region III Regional Office of Inspection and Enforcement U. S. Nuclear Regulatory Commission
. 799 Roosevelt Road
! Glen Ellyn, Illinois 60137 l
l l Region IV Regional Office of Inspection and Enforcemnt
! U. S. Nuclear Regulatory Cormnission 611 Ryan Plaza Drive, Suite 1000 Arlington, Texas 76012 l Region V Regional Office of Inspection' and Enforcenent
- U. S. Nuclear Regulatory Ccmmission l 1990 N. California Blvd., Suite 202 ,
Walnut Creek, California 94596 i
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.-'81 NOV 13 A9 omce or Twa pnesIDENT
- MDE o once.sy .McKEin Senow Uwe Ne i)NC Jas~'
pia sn-son November 5, 1981 Secretary U.S. Nuclear Regulatory Comission . . . _ _
k Washington, D.C. 20555 Attn: Chief, Docketing & Service Branch -35
Dear Sir:
Reference is made to 10CFR 35.23 (a) of the U.S. Nuclear Regulatory Connission Rules and Regulations which states that " Full calibration measurements required by para. 35.21 shall be perfonned using a dosimetry system that has been calibrated by the National Bureau of ^,
Standards or by a Regional Calibration Laboratory accredited by the American Association of Physicists in Medicine. The dosimetry system (m) shall have been calibrated within the previous two years and after any servicing that may have affected system calibration."
(f The National Bureau of Standards (NBS) and the accredited Regional Calibration Laboratories (RCLs) are able to calibrate a limited number of instruments each year. With the advent of the referenced NRC regulation the waiting period for instrument calibration has increased and at present is about six months. It is probable that the waiting period will become longer as more instruments are due for calibrations.
In order to aleviate this situation, the American Association of Physicists in Medicine (AAPM) reconnends a longer interval between * ' '
calibrations, provided that suitable dosimetry system verification checks are 'chrried out as outlined in the attached Appendix. Specifically, the AAPM recommends the following to the NRC:
- 1. Grant variances to licensed teletherapy users who are not able to have instruments calibrated within the two year period.
- 2. Modify the referenced regulation 10CFR 25.23 (a) and regula-tion 35.25 (a), as outlined in the attached Appendix, in accordance with the " Expedited Procedure 'or Handling Certain Petitions for Rulemaking" published in 46FR35486 relative to 10CFR 2.802 (e).
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The Aeooctenon's Sc enti nais are MEDICAL PHYSICS and PHYSICS IN MEDICINE AND 380 LOGY Moment Society of the American institute of Physics w_
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2 l N U.S. Nuclear Regulatory Com.
November 5, 1981 Page 2
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! Should you so desire, representatives of the AAPM will be pleased ;
' to meet with appropriate NRC staff to discuss this-petition. !
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Sincerely yours, '
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i Colin G. Ortor., Ph.D. 1 l President !
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Enclosures -
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Appendix & Suggested Amendment of 10CFR 35.23 (a) and 35.25 (a)
Para 35.23 (a):
Full calibration measurements required by para 35.21 shall be perfomed using a dosimetry system that has been calibrated by the National Bureau of Standards (NBS) or by a Regional Calibration Laboratory (RCL) accredited by the American Association of Physicists in Medicine (AAPM). The dosimetry system shall have been calibrated within the previous two years and after any servicing that may have affected system calibration. As an alternative, the dosimetry system -
shall be calibrated every four years; an independent cobalt-60 intercomparison shall be made midway (+ 6 months) in the period; and (O
suitable records shall be kept to prove constancy of the dosimetry
"' ) system.
Independent cobalt-60 intercomparisons shall be sponsored by a professional organization, such as a chapter of the AAPM, the Radiological Physics Center (RPC), or a regional Center for Radiological Physics (CRP). Such intercomparisons shall not provide a calibration factor for the dosimetry system but wiTT provide a check to determine that the existing calibration factor is valid. If such a dosimetry system intercomparison demonstrates that the calibration factor appears to have changed by more than 2%, then the dosimetry syster shall b,e . ,
recalibrated at the NBS or an RCL.
Constancy of dosimetry system perfomance shall be verified before and after calibration by the NBS or an RCL, before and after a dosimetry system intercomparison, and at least quarterly thereafter, or prior to the use of a dosimetry system if the interval is greater.
A cobalt-60 teletherapy source, with a jig for positive positioning of the ionization chamber, or a shielded Strontium-90 or other long-lived radioactive source, may be used for such constancy checks.*
The time of irradiation shall be long compared to the time required to start and stop an irradiation. Corrections shall be made for radioactive source decay, and ambient temperature and pressure; t
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(./ *A compact constancy checker shall not be used for dosimetry system intercomparisons, f The Assoclasson s Scientific Joumelo are MDICAL PHYS 6CS and PHYSICS IN MDeCINE AND StoLOGY Momewt Society of the Amortcen institute of Physics L .--3
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1 OFRCE OF THE PRES 40ENT U oncosoey s' "Se Esi 7me Yec
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attention shall be paid to possible errors in source or chamber positioning, collimator geometry, and timers. For field instruments changes or fluctuations of + If, are normal.
Records of (1) full calibration measurements under para 35.21 and (2) dosimetry system intercomparisons using Co-60, and (3) constancy checks of the dosimetry sys, tem used to make these 'neasurements under para 35.23, shall be preserved for at least five years after comple-tion of tre full calibration.
R3tionale: .-
The AAPM considers it essential to maintain high standards of -
J calibration for dosimetry systems used in the calibration of tele-therapy units. Since the capacity of the NBS and RCLs is limited, an alternative method has been suggested to maintain these high standards while reducing the load on the calibration laboratories.
Members of the AAPM are almostinvariably the physicists responsible for the calibration of teletherapy units.
The specific issues involved are the need to insure high accuracy in the calibration of teletherapy units and, within the capabilities of the calibration laboratories, to assure that dosimetry systems provide this accuracy. The recommendations made above are to change -- -
the requirement for dosimetry system calibrations every two years by the NBS or an RCL, to an alternative of requiring a calibration every four years with a dosimetry system intercomparison midway in the period and constancy checks throughout the four year period.
The current rule could result in the use of a defective dosimetry system for a period as long as two years if, for example, it was damaged in transit or an error was made in the calibration. It is difficult, on short notice, to collect data showing that instrument calibrations stay constant over periods of many years. A number of qualified physicists who calibrate instruments and machines, believe that an initial calibration with proper constancy checks and dosimetry system intercomparisons would provide a better way to assure proper dosimetry system accuracy, than a new calibration every two years. Rationale for a longer period between calibrations was included in the IAEA " Manual of Dosimetry in Radiotherapy" in (m) v 1970. A recent publication by Karzmark (1980) reported on constancy checks and intercomparisons for periods up to 14 years. For integrated The Aaaa**=nong Scionsfic Joumale are MEDICAI. PHYSICS and PHYSICS IN MEDICINE ANO SIOLoGY Momiser Society of the Amortceninstitute of Physice -
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(misn-son dose data, the average standard deviation for six field instraments was 0.79%. Shalek et al (1981) reported on intercomparisons and calibrations with several different dosimetry systems. The results presented indicated that reliability of the dosimetry system or chamber calibration factor provided by the NBS or an RCL was unrelated to the number of years since calibration. The current rule is unduly burdensome because the calibration facilities of the NBS and RCLs are limited and at present there is a backlog of about six months.
REFERENCES Massey, John B., IAEA Technical Report No.110. " Manual of Dosimetry in Radiotherapy", p. 26, 1970.
Karzmark, C.J., "Concerning radiotherapy standard dose meter calibration" Med. Phys. 7, 574-5, 1980.
Shalek, R.J. , Humphries, L.J. and Hanson, W.F. , "The American Association of Physicists in Medicine Regional Calibration Laboratory System", Proceedings of a Meeting on Traceability for Ionizing Radiation Measurements, NBS Special Publication 609, in press,1981. - - -
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slightly lower standard of accuracy, the calibration services of the M ANU AL OF "o"a rr ia a rai=ias i='er torie ~ *a ' "s raea = "ma -ha*
will be used by most radiotherapy centres and are of adequate accuracy.
anuncy d a anbnHon bta ned by the Inhnique d ocHmi 3,53 DOSIMETRY IN RADIOTHERAPY or, particularly, by a postal dose intercomparison service is very de- -
e ' pendent on the experience of the workers and the amount of effort expended.
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d lLilliC2l gtlidC [of (C5 ting and (2libf2 tins C(luj!iment . used only to obtain temporary calibration factors pending a calibration hv USCd in CXICin2l bC2m ifC2tfDCnt5 a rit andardizing laboratory.
3.3.3.2. Frequency of calibration it is desirable that the dosemeter should be calibrated by the standard-izing laboratory at intervals of about two or three years. This is particu- !
larly necessary for radiation qualities of less than 3 mm Cu llVT where Jolin B. M255Cy changes in the chamber which are not detected by radioactive check .
(section 3. 5. 2) can affect the calibration. For seCo calibratsonC the interval may be longer if the radioactive eneck shows no significant change.
Department of l'hysics, in the intervals between calibrations ,6ests (which are detailed in Christle llospital and llott Hadium Institute section 3. 5) must be performed to confirm that no gross change in sensi-withington, Manchester, United Kingdom tivity and therefore in calibration f actor (Kr ) is occurring. In this con-nection regular radioactive standard checks (section 3. 5.2) are imperative.
If any of the tests raise doubts, a calibration may have to be repeated before the two-yearly period is over. -
- 3. 4 SI'ECIAL RIQUIREMENTS FOlt LOW-VOLTAGE X-RAYS (GilEN?.
pubhshed on behalf of the gggygg 6.o rrnational Atomic Energy Agency, the World llealth Orgamzation it has already been commented that it is important to choose an and um ionization chamber that is suitable for the quality range of interest. "I his l'an American Health Organization is particularly so for low-voltage X-rays. The normal type of thimble chamber la acceptable down to about I mm Al IIVT but below this the wall thickness needs to be very small in order to be sure that the chamber is measuring the radiation properly. For this range of quality - the so-called Grenz-ray range -it is usual to use a parallel plate chamber with a very thin f ront wall or even no wall at all.
The calibration of such a chamber also calls for special care and it should he done at approximately the same exposure rate as that to be measured since it is difficult to achieve full saturation at the high dose rates encountered.
INTEftNATIONAL ATOMIC ENEHGY AGENCY 3. 5 CAlt U AND htAINTENANCE OF TIIE DOSEMETEll y VI EN N A , 1970 The instructions given in the manufacturer's handbook accompanying the dosemeter should be studied and followed. The user must check that the instrument is behaving in a sensible manner. Dosemeters, although snoderately rugged, are sensitive scientific instruments and should ho treated as such. In the event of any inisbehaviour, no mpt should be 9 .
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made to danmantle the instrument (especially the chas a repair unless the user is sure of his competence.
nd to attempt eferable tu
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- 9;e COMMUNICATIONS (A) v Concerning radiotherapy standard dose meter is cause for investigation, repair and possible recali-meter calibration bration. A sudden, inexplicable calibration factor shift for a treatment unit should make the calibration dosemeter One suggestedt and one existing2 guideline in the centrol suspect.
of radiation for radiotherapy treatment require that mea- Less frequent calibration is appropriate where some re-surement of the output of the therapy beam'shall be per- dundant method of assuring constancy ofionization chamber !
formed with a measurement instrument, the calibration of response is provided. One redundant method would be to have j w hich is directly traceable to national standards of exposure two or more completely independent ionization chamber j or absorbed dose and which shall have been calibrated within sy' stems. Another method is to assess chamber response i the preceding two years. The two year requiremer t is ap- constancy by using a long lived isotopic standard in re. !
propriate in many circumstances. However, in some cir- peatable geometry. We have done this for a number of Vic. I ctmstances,it may be unnecessarily short and hence, add to torcen, Baldwin Farmer, and Farmer ionization chambers, inconvenience'and patient care costs. using a 2 milligram, shielded radium source) having a fixed A method which provides frequent, local calibration cylindrical geometry. Closely fitting, cylindrical Lucite constancy checks may well be preferabic to a mandatory but sleeves are placed betwcen the chamber and source to ensure less frequent and more inconvenient assessment as provided geometrical repeatability for these constancy checks. It is by distant calibration facilities. Certainly, where obvious important to note that such close. geometry measurements damage has occurred, such as from dropping a chamber, are valid for constancy checks, but it is inappropriate to in-immediate recalibration is warranted. The presence of sig- tercompare chambers with such a source, since significant nificant c!cctrical leakage in the secondary standard dose inaccuracies could result.
b-( 1 TAsLEI. Summarv-ionization chambers constaner measurements with radium sources. -
Dase meter Dates No. Percent chamber model(s) Senal No. Scale of data Mean standard and usage chamber descr. reading . data points value deviation Victorcen model 570 g900 100 R red Integrated 100 R 1967-80 37 7.08 0.47%
type III chanebers #477 100 R blue dose 100 R 1967-80 37 7.19 0 63%
secondary standard Keithicy 602. (Coulombs) serial #47024A farmer :3pe 2505/3 # 3439 Labeled mte- 3 x 10-' 1977-80 4 1.23 1.68%
(carbon) chamber red grated 3 x 10-8 1977-80 4 1.25 0.45%
secondary standard dose 3 x 10-' 1977-80 4 - 1.24 0 r,8%'
victorcen model 570 # 454 100 R red Inte- 100 R 1967-79 30 6 44 0.72%
type 121 charr.bers . grated field instrument # 10051 100 R blue dose 100 R 1974-80 15 6.76 0.90%
D & K #1 dose meter Dose 1969-80 7 5 86 4 05%
baldwin farmer
- 616905 - rate <[1000 100 R R 1969-80 6 5.90 0 88%
model F chamber . 10 R 1969-80 9 5.60 0.76%
Geld instrument inte- 1000 1 1969-80 10 5.73 0.96%
grated 1001 1969-80 25 5 68 0.95%
dose 10I 1 % 9-80 11 5 62- 0.91%
D & K # 2 dose meter Dose 1000 R 1969-76 5 5.98 3 81%
baldwin farmer # 80805l4 - rate 100 R 1969-77 8 5.88 3.06%
model F charaber 10 R 1969-77 10 5 99 3 06 % -
neld instrument Inte- 10001 1975 80 10 5.67 0.86%
grated 1001 1975 80 25 5 69 0 67%
dose 10 1 1975-80 10 5.62 1.20%
D&K#2 Inte- 1003I 1977-80 7 5.59 0 77%
grated 1977-80 5.57 0.62%
[i %
I farmer type 2505/3 (carbon) chamber
- 1741 -
dose 100 1 101 1977-80 7
7 5.55 0.97 b Geld instrument Keithley 602. (coulon bs 3 x 10-' 1977 80 4 I.202 0 59%
senal # 47013A 3 x 10-8 1977-b0 4 1.215 0 363 farmer t3pe 2505/3 #3399 1.a beled intes 3 x 10-' 1977 80 4 1.197 0 $2%
(carbon) chamber blue dose Geld instn. ment l
574 Med. Phys. 7(5). SeptJOct.1980 0094 2405/80/050574 02501.20 @ 1980 Am. Assoc. Phys. Med. 574
vn .
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Communleations
) ,.575 575 Table I summarites our constancy measurements for nine from $_100 to $1000 depending on their estent. Hence,if the ioniz2 tion chambers using the 2 mg Ra source for periods of interval between calibrations could be extended toYour or five time extending to 14 years. The standard c4viatbn for the years, a significant cost saving would accrue and instruments three secondary ic.sation standard chambers listed is 0.68%, would be less frequently subject to damage during transit.
a value well within the *2% accuracy associated with our it would seem appropriate, in this event, to require that national laboratory standardization. If our esperience is suitable constancy assurance procedures be carried out at relevant. then the two year requirement would appear too defined times during the interim. Howeser, the two Scar re-restrictive for 'some circumstances. Where redundant quirement could remain an option.
methods are available, a longer interval appears warra nted, Acknow/cdgment: We are indebted to Dr. L. J. Humphries coupled with prompt recalibration if sudden changes and Dr. R. L oevinger for helpful discussions.
occur.
We have had esperience with six Geld instrument ioniza-
'suggesied staie aerutationi ror Coniros or R nd.ai.on (SSRCR). Bur of i tion chambers a hich are intercompared with our secondary Radiol Health, Ociot>er,1978. F 8. C. 2. m I
standard instruments for various quality radiations in ap. % clear Regulaion Cornrnisuon. Fed Reg 44.1724 No 5- Wnda),
propriate geometries (see Table 1). Here, the average of the l'a 8 I'79 standard deviations wsing the 2 mg Ra source is 1.07% if we ^
' ' ' , " (* C. Rust, Arn J of Roenigeno; Radiat. Ther. and include both dose and dose rate data for the two D & K in- Nuc Med.114, is t.1972.
struments.' If only integrated dose data are included, the I average standard deviation is reduced to 0.79% s value close C. J. Karzmark to that of our secondary standard dose meters. Radiological Physics Section We suggest that the views and experience of a wider con. Department of Radiology stituency be sought on the question of calibration frequency. Stanford University of Medicine At current prices, calibration services typically vary in cost Stanford. California W303 e
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v THE AMERICAN A55CC!ATION OF PHYSICISTS IN PEDICINE'S REGIONAL CALIBRATICN LASORATORY SYSTC4 Rooert J. Shalek. Leroy J. Humphries and William F. Hanson Physics Depart. ment
-The University of Texas System Cancer Center M. D. Aneerson Hos;ttal and Tumer Institute Houston. Texas Three Regional Calibration Laboratories have been established primarily for the disse 61n.ition of national radiation standards for radiation therapy. The National Eureau cf Standards together with the regional laboratories have a calitration capacity in rough ecuilibrium with the demaed. However. if all instrument users had field instruments calibrated regularly the demand might exceed present calibration capacity. Various data are adduced to
~ demonstrate that comercially available field instruments can maintain cattbraticas for periods longer than the generally reccmended 2 year interval.
Introduction cedures between the Naticnal Buresu of Stan.
dards and the regional laboratories. The It is estir.ated that there are 1322 ra i- distribution of work load bet een the labora-atton theracy facilities in the United States tories and the types of instrueents now used snc that a mini: cum of IC57 field f astruments as field instruments will be discussed. In recuire calib*ation in order to service these addition. the frequency of calibration of facilities [1]. At present the National field instruments uses for the calibratten ~
surasu of Standards eslibrates less than 100 of radiation therapy nchines will de con-field instrv=e9ts per year. In order to close sidered from the view of wnat is occurrin; the gap bet een need and calibration caoacity, and what may oe required for the satisfactory ._
it was suggested that secondary radiation use of the instruments, stardardi:ing laboratories de established just as seconcary laboratories exist for the dis- The.information cerives frcri Task G*oup sa*.ination of ele:trical and other standards. 43 reports, frern a Re;cet of the Commi* tee on Roter: Leevinger of the National Sureau of Radiation Calibration *:4eds in Therapy of tne Stancards re:oren:ec that the Are ican A:erican Association of Phys! cists in we cietne Association of f*1ysicists la we dicine (AAPw) (L. Lanzl. Chair-r.an) [1]. from the ocertting seco*e ;Pe actreditin; agercy for the estab. experierce of the '8 D. Anderson RCL. and frcm lisreent of Regieral Calibraticn Laborat: ries data collected by the Radic1cgical Physics (RCL)(P]. The AAPw tecested tre suggestion Center (RPC). The latter organi:ation reviess in 1973 and :;ointed Task Grous *) of the Patiati:n Theracy C mit;ee to estseltsh radiation measurements anc calculittens re-lating to radiation therapy at institutions
- riteria for tr.e ir.ttiation and ::eration of par'.icipating in inteeinstttutional c* fecial t*e laderatortes, to review to314:ations for trials and thus nas the op;crt:.nity for cb.
latc*atory a::recitaticn. to select labcra- serving the c:eration of field instruments by t:rits are to c cticue in the supervisicn of the user.
the labc*at:*ies.,
To date, three Regicnal Calitettion Recuireeents For inc *,0eestion of La:crat: ries have been accredites b/ tne aAPr* .
Recional caisora: ;n ts,ces:3r.es These facilities a*e 1ccated at t'eacrial Sloan.
Xettering Cancer Ceater (MSK) in Saw York. The s;ecific re;uirements (cr coerstien The Unive*sity of Tevas 5 /stem Csncer Center of an RCL are presently being revie ed by a M. 3. Ancersen Hospital and Tumor Institute subcc inittee of Task Groue e) [3], t is (M in Housten. anc Victcreen [nstrument likely that the 2CLS will be re: vireo to pro-Division (VICJ in Cleveland. It pas :een ee. vide instr.: rent :alitr tiens t=at egree ith c ~ ended that at least cr.e additional #CL the nattenti sta*.dar:s to witnin tne limits
- e esta Ms'r ed.st a :istaa:e froa tae :trer specifiet in Tatie !. These over:11 *equire.
la:cratories(1]. tents will recla:e : resent s:eti'tc rt:uf et.
.ents u;cn varicus steps in t.*e :alibratice In tre discussion re*e. 5::-e of the re- 'rocess. In *nis ;a:e* orb insterentt f:r sui *e ae ts ar: :a:::ilities :( tre regiera! the cahora* ion of tn+rapy acmes =til se
% 14toest: ries will :, ::nsicered ::getner .ith CC"5IC'P'1-en 431catien of t e cuality issursr.ce oro.
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Table ! Table !!!
Propcsed Criteria for Calibration Agreement Radiation Beam Qualities Available Between . at N85 and the RCLs (1980) an RCL and N85 X' Ray (HYL/kV)
. s5Co X ray M 88C0 *Filt.
0.03-2.78 m A1/10-100 kVcp L Reference-class instruments . NBS ' Yes 1.6m A1 3.2m Cu/60-250 kVcp M suitable for cattbration of other 20.51' 21.0 instruments to a precisten of 0.1% 4.2m Al-5.2m Cu/50-250 kVcp H~
0.07-2.4rrn A1/20-100 kVp L MDA Y's 2.07: A13.0m Cu/75 250 kVp M Field-class instruments 0.03-1.95m A1/10- 60 kVp L suitable f'or therapy beta 21.0% 22.0 MSK Yes 3.0mn Al-2.1m Cu/60-250 kVcp M calibration 0.9-1.6mm A1/50- 75 kVp L 2.8m Al-3.2m Cu/60-250 kVcp M
' Field-class instrcents suitable 25,0*
for diagncstic 4-ray calibration :5.01 .
- Filtration: Light, L; Moderate, M; Heavy H Field-class instrurents suitable .
NBS also calibrates at 8 8'Cs energy for hesita physics survey 210*. 210".
measurerents ,
Table IV ..
5 Table 11 RCL Measurerent Assurance Tests by NBS -
Secondary Standard Instru entation at the MDA RCL Medien Energy x pay (b1 Ceviation(8) Co Year RCL Mein e tc1 Mar Deviation (*)
Exposure Standards:-(:;35 calibration biennially)
Shenka-Wyct:f f, 3.6cc. 0.25m AE wall MDA *1 3 -4 -3 Ezradin Mcdel A-3. 3.6ce, 2.54m AE wall +4 -1 1976 M3K +2 1 VictS een Mocel 415A. 2cc. 2 mil sylar windcw -7 -11 +1 VIC 2 Nucleir Enter; rises Mocel 2561 (NPt. Seconeary Standard). 0.3cc, 0.5m gra; nite wall MDA -5 -- -5 -1 1977 MSK -3 -- 3 +3 Capacitance Standa*es: (NB5 traceable calibra- v1C +2 3 +8 +2 ti:n bfeanially)
- General Radie Type la04-A, 1000 pF General Radio Type 1404 B. 100 SF , 1978 -
WIC +3 2 +6 +1 Voltage Stancar:s: (+%$5 tracesole calibra-tion tiennially) MOA -5 2 -8 +2 Keithley Mccel 240A, Regulated HY supply, 1979 M5K : +2 4 +9 -1 0 to 1.2kV VIC 6 4 -12 -4
- 0ata Precisica Mc:e1 3500. Si digit, 0 H Oata Precisten Model' 245, Als digit. O'11
+Eppley Model 100. Sta.ncard Cell (a) Deviation: Parts per thousand
-((RCL/N35)-1] x 1000 (b) 60-250ky; 1.36m Al to 3.2 rn Cu Hvts
! Other ROL Instruments:
tef tniey **ccel 502 electr:re ers (c) One sta-carc ceviation Keit31ey 2:e1251 picoa :eee source l Taylcr "::e1 120c' aree:ic tar-reter gntere:reariser *nste, en
' Fisner 4:e1 15-043A t9erecreter, I to 51'C, 8 1976: Shonka 3cm ton c.as:er p o,1+ fety, 1977: U cto een 202 8 4155 9tecer i al.cinire: ylar -snsmissi:n : et:r :34.:e, 1973: ';IL ese-ete :- s-e
- Mar:e*
- ( 1379
- PT4 1:J2 30-329 c*a :e*
l ommem
%s , . . .
.a . '
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- I *
) In Table !!, the equipment employed at Directly Traceable to NBS (v the MCA RCL is listed. This equipment is comreccially available and for the mest part The first definition of ditectly tuccable ca:able of perf:r ning with a reproducibility appeared in the 1971 protocol of the AAPM of 0.1".. The range of beam qualities avai1* Scientific Comittee on Radiation Dosimetry able for cattbaration at NS5 and at each RCL (SCRAD)[4]asfollows,"forthepurposesof are shown in Table !!!. this protocol, an instrument with a calibration factor directly tracesole to the National The ionization chambers maintained as Bureau of Standards has been calibrated either secondary standards by an RCL are calbrated at NBS or against a reference instrueent which at MSS at least' biennially fer each calibration has itself been calibrated at N35.* Robert energy offered by an RCL. Cther instruments Loevinger of NSS has proposed that the defini-such as standard capacitor, standard voltage tion of d4tet,tfrf tucz.tble be tigntened 45 .
cell, berceeter, themomether and voltmeter follows(5]. A field htturcat w4th a ca44-have calibrations documented as traceable to hition pctct due Cly tucc.iblc to the N35. In addition M5 circulates a Chamber or Nathn:4 Sate:2 of Staninda b4 teen cati-desieeter system with undisclosed calibration btated egchat.the ection:L attir. iud maintahed annually to eacn RCL for calibration. The re- at ABS es epinat a accendzy 44.ndaid m2&-
suits from four years of these measurement tshed at a Regun.tl C:Libutun tacot. stew.
assurance tests are shown in Table IV. In each Implicit in this definition is the recognition year tne calibration at cobalt-60 and the mean that a necendasy afetad.ud is more than a re-of the calitrations in the x-ray range were ference-class instru: ent calibrated at NBS be.
within the criteria defined in. Table !. In two cause of the cuality assurance recuirements isolcated x-ray cases. the deviation from the placed upon an RCL by the AAFM.
national stacard exceeded the 1: prescsed for reference-class instruments, however, the wofst case was only 1.2* The Frecuency M Calitratien of helo Instruments Table V s$cws the distribution of instru-rent calibraticis amceg the varicus laboratories. The Nuclear Regulat:ry Cmissicn recuires Cata ceres from t=o scurces, tre questicnnaries that licencees ef cc: alt-60 telethera;y units circulate: ty :Pe Lanzl comittee [1] and frca perform calibrations with dosimetry systems ~
ex RCL records. 30*. of tne res;encers to the calibrated by NBS or an RCL witnin the pre-( ) Lanzl comittee cuestionnaire had calibrations vious two years (5]. Sorne states and other ,
(u) feca N35 ce an RCL. Although tae werd icghr.it a:; ears in the pare of the secondary laterato .
ries, instri.: ents co e for calibratien to the agencies recuire annual recalibration. A time period of two years bet.een calibrations of field instreents accords reasonably well RCLs from distant parts of the ccuntry and sc*e with current practices as sr.cwn in Table VI.
foreign countries.
Table VI
- Table V Frecuency of secsrin; a calibration abcratory of Last Calibration From Lanzl Re03rt Frem MA RCL Cata and RCL herkload
" '"C7 Laborat:ry Res:encents O) #!nstruments N 9"CY IY'I g) ~
- 7/78 - 6/79 b* * - *
<1 3 0.5 9 33 29 135 b -
1 2 30 1
1.5 32 MC RCL 21 102 3 13 2 IS 4 7 2.5 4 MSc RCL 21 65 4 4 5 3 v!C RCL 15 75 6 4 3.5 3 7 2 4 1 Manufacturer 20 - 8 2 cr other >8 3 (a) vcer of res ent ents to tris Average tire: 2.5 year 1.5 year
- vestien was 52h s ter o' raciett.eracy cente-s is Mean tire 1.5 year 1.~ ir a::r:m e n eiy 1,222.N
- # 'I"*' ***C ' *"
/ (b) Fre. PCL reports ol ~&.e :et.ee :al4rsticas by
( )
v en instimen
LW a
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v The median time indicated by resocndents to various instruments in holding their calibra-the Lanz 1 questionnaire [1] or ssers of the ,
tion appears to be comparable as is shown in MDA RCL is approximately 1.5 years. Despite Table VII. 'Here RPC interccmparisons with in-the agreement between the practices of users struments w'iich had calibrations from N35 or and the federal regulation, the frequency of an RCL show ro great difference acccrding to calit, ration necessary for field instruments is instrument type. The lapsed time between the worth consideration. Information to be calibration of the instrument and the inter-addressed here suggests that the time period comparison with RPC was a median 13 months for between the calibrations of field in'struments Victoreen R. Meters and 10 months for Farmer could be longer than two years if suitab!e type instruments. In tables whicM follow. no other tests upon the instrument are perfonned , dtstinction is made between different types of by the user. instruments.
Curing visits to institutions to review In Table VIII. the results of RPC inter-measurements and calculations relating to comparisons are shcwn according to calibration radiation theracy, the RPC u} gally makes an source before 1976 and after 1916. It is interexparisco in air in a Co beam between clear that prior to 1976 instrutents which were the institution's field instrument and the RPC calibrated by a manufacturer or had an uncertain instrument. Since Septemoer.1970 the RPC calibration history (other) were suspect; af ter -
instrument cenststed of one of several Farmer 1976 few instruments with suspect calibrations chamters and a Keithley 602 electroreter. As were found regardless of the methed of cali-an indication of RPC precision, seventy-five bration; however, there are not enough manu-constancy checks over a three-year period facturer or other calibrations af ter 1976 to using the RPC field instrunent showed a stan- demonstrate a Conclusive improvetent. .It is dard deviation of 0.4* for individual measure- noteworthy that field instrteents intercom-1%. where pared with other instruments which were cali-
=tsts with a maximum deviation gSr checker brated at NB% or an RCL appear to have cali-bCo irradiater or a coeurcial bration factors which are not significantly wastheradiationsource(7], In some inter-exparisons prior to Septem:er 1970. the RPC less reliable than those calibrated by NSS or used a Farrer Secondary Standard model 2502 an RCL. P.any of these instru-ents were an electrometer and cha* er that showed a stan- institution's inster.ent for everyday use which -
% dard deviation of 0.7" for individual has been compared to the institution's standard measureeents in 17 measurements over a two- instrument Calibrated at hBS or an RCL. Prior ,
year period [7} - to about 1976, intercoccaris:n with the insti.
tution's ca. amber was usually made only when the In Figure 1 a bar graph indicates the RPC differed by more td n h in the calibration ty;es of chambers the institutions visited by of a therapy machine. Af ter tnat time inter-the RPC e*oloyed curing various two-year inter. comparisons were.made whenever the institution's instrument was available during revie- visits.
vais fres 1953 to 1979. It is clear that Thus some bias in the direction of causing Far ea-ty;e ent-ters are teing used more and t*at Act:reen R#eters are being used less as the earlier data to accear less coesistent has been introduced by RPC procedures, time ogsses. However, the stability of the s- Table VII
- mm Intercomparison of the RPC instru ent with s - -
C Ir m t.
instruments calibrated at $25 or N an RCL. disti 5 uisnie; the type
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Neoer of.
j j i Intarcom. "a an RPC/ inst eI *I >3%(DI
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0.014 Victoreen 57 1.000 1 l
j= R Meters 0
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! Far er type 56- 1.000 0.009 s ;
I
- chambers l
l I
0.033 i
1 -
ne ion l sn nn L a m.
U sn ,,
Other 10 1.016 l' w or c:wwa a) Ord stancard te 41stiC6
[ Timeb n=ter :f :ta-ter inter:::pris::a perf--et tyre ??:. ty :mr. f:r "u :ree b) Vter of cha-ters w :p; t, wnese f act:r differed fr71 cre 23n g, I,
?-leters. ;. :: Tar:er m e ::L :ers act f:r
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Properly maintained therapy field instru- calibrations relative to that cetermined in the cents appear to maintain their calibration original calibration. The mautmum deviation factors over lon9 periods of time. The time seen in the cattbrations was 0.3%.
since instrument calibration does not seem to play a role in the raliability of the chamber Forty-two other chambers were calibrated Calibration factor as seen in RPC intercom- twice by MCA RCL since 1976. The tire interval parisons in Table IX. These instruments were between calibrations varied from one to three calibrated at 1865 or an RCL and thus ' started . years. The results are shown in Figure 2. The witn a calibration directly traceable to NBS. mean ratio between the new and original call-Further data on long tem stability of instruments comes from the MCA RCL. Table X Table IX shows data on 5 chambers which ha. e been cali-brated by PCA RCL 3 ti.nes or more since 1976. Intercotparison of the RPC instrunent with The checks indicate the year of initial call- institution's instru.ent as a function bration and the values are the ratio of the of the time since instrument was calibrated calibration factor determined in subsecuent at N85 or an RCL Table vlII Time since Number of
- calibration In te rcom- P'e an ' Ntt-ber Intercorparison of the RPC instrument (months) parisens RPC/ inst. ok3I >3%
with institution's instrurents '.
calibrated by various labcratories 0 - 12 60 1.003 0.018 2 Nun:eer
- of Mean 13 - 24 29 0.997 0.010 0 Calibration Intercem- RPC/ Nw; ses.rce cari sens Inst. eI "I >3 t 25 - 36 10 0.996 0.008 0 ;.
37 - 48 10 1.008 0.016 0 Inst..wrenta ced.4brated 6cione 1974 .
1.001 0.017 49 - 60 1 0.990 0 hSS 29 1 0.020 >60 3 0.993 0.021 0 RCL 35 1.003 1 Comparec to a) One standard deviation.
3 ekg* 5 b) Ne:ter of instruments with calibration 0.00 0 f actor dif fering frca RPC by more than 3%.
20 1.005 er RCL .-
Cha ber Table X sanufacturer 45 1.016 0.030 13 0.031 Repeated Calitratiens by NOA RCL Cther 25 1.009 6 (new calibration fa:ter)/, .. .
fr.aca-en.ts c:246tu*ed in 1974 ct LtC44 (original calibration factor)
Dosimeter '76 '77 '78 '79 '80 NBS "9 1.000 0.009 0 40 0.999 0.011 0 K-F / .999 .999 .999 1.000 aCL K-F / 1.000 0.999 Ccecared to chamber cali- K-F / 1.002 brated at NSS 1,.000 cr 8~L 24 0.998 0.019 1 F / 0.999 1.002 Cham:er wanufacturer 4 1.017 0.053 1 vict R / 0.999 1.000 i
i Other 5 1.005. 0.014 'O K-F Far er 0.6 c: graphite crancer with teithley zedel EC2 or 516 electrc eter l
a) Cee stardard deviaticn. F - Far er 0.6 ce gracnite cht-ber i
- ) :e:er er inst-.ee-ts otn :aneranen Vict 4 - Victcreen Sce'l 131 ch8c *r with rect:r efffecte; reca the ;*: by.cre todel 570 ele:trfeter 7,n 3; i
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bration factors was 1.002 with a standard tain about his current calibration. However,
. deviation of 0.3t. A maximum deviation of 0.M if the user is confident of his instrument was seen in three chambers. There was no differ- calibration. a recalibration according to a ence between the results for VictoretN R Meters time schedule is usually not welcome. since and Farmer tyce' instruments. '
there is risk to the instrument in transport and the absence of the instrument may be a seri-The KA RCL cata indicate that instrumerts ous inconvenience. In addition, the cost of are even more sticle and reliable than indicated calibration is sometimes a problem.
by the RPC data above. These differences stem from several factors including: the RPC data are frors field intercom 4 prisons with field in. Techniciues Available to Assure stroents, the institution may be using the in. Reliability of Assicrec strument idi a different r.anner from that ein.
- Calibration Factors played by the calibrating laboratory, or the instrument say have been modified since cali- Since therapy field instruments appear to bration. Although the data indicate good long maintain their calibration . factors over extend-team stability, there are two 0.6cc Farmer ed periods of time, the instrument user can chambe s (with nylon thiebles), belonging to maintain confidence in his instru ent calibra-the autPors, each of which Mave expertenced. tion through periodic constancy checks. Grant, uremplained changes in calibration of 1 to 2*. et al. [7] discuss the use of a cobalt-60 theracy unit or a strontium-90 constancy check ;
source device to perform routine checks on :
04scussien of the Time Between the performance of the instrurec'. Botn tech-Calibrations of Fielo ins:*uwents niques ap; ear cor!; arable. The80Sr data are reproduced in Figure 3. showing all checks to -
If kBS and each RCL presently in operation be within + 1* of the mean.
we-e to calibrate 85 inst urients per year, the IC57 instruments requiring calibration [1] Another important constancy check pro. ,
~~
could on the average be calibrated every 3.1 cedure is an intercomparisen with instruments
\ years. If another RCL was activated the from other institutions that have cham:ers average tire bet =eti calibrations could be 2.5 calibrated by NES or an RCL. Table XI sheds yeges. Mc=ever, there are a numter of cali* the results of interccmprisons carried out in
. brations re';uired following re; air of instru- conjunction with meetings of Southwest. Midwest ments or purchase of new instrueents. The fact and Missourt Valley chapters of the AAFM that the average time between calibrations by .(B.9.10]. These inte cocaprisons uncovered an ins tution at the CA RCL is 1.5 years erroneous factors on two Chacers whose fac-sug;es tnat some institutions or individuals tors were frem cuestionacle sources and may be eLerly conscientious in calibration of verified sus ected ;roblems alth two RCL calf-instruments = nile. others allow longer perioos trated chameers. Pertoalc intercorparisons of cf time between calibrations of their instru- several chamber electro eter systems (last 5 ments.
lines of Table XI) again de*onstrate the long Fr:m the instrument user's view, an instru-ment calibration is esse 9tial if he feels uncer- It is imoortant to rere*ber that any
. calibr4tien laboratory can previce an errorecus calibratica factor and that instruments may 0.994 - eean = 1.002
- a= .003 0.996 n = 42 -
2a.08%
0.993 - . ..
ne= CF .* ,. ... . .
UTc'7 1.000 --- , .,- - - - . . . - .- - . *. . - - - - - - - - - " . . .
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jgam7 1.cc2 ________
1.004 ---------
i g l 1.006 -- I suf Frequency a u w Tir m 2: Sin:cre :f ne is:13 Of the ta'it-sti: .
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a sutz st.ent tslitrs*.1:r. *e;ssiv, to :ts: L"?
- T sa sign: v*e the :heur :si tet ;r "it.aly E*ithle? U G:G7 878
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undergo change during transport. A pnysicist questionnaires and have their instruments should therefere challenge, in every way cattbrated regularly have calibrations at a pessible, any calibration factor obtained mean interval of about 1.5 years. However, from from NSS and an RCL. These challenges can an estimate of potential users and the current include; comparing the new f actor with the old capacity of NB5 and 3 RCLS it is suggested that facter, a constancy check on the instrument be- only one calibration every three years would be fore and after calibratioc, and intercomparison possible for each user if all of the instruments wita other instruments calibrated at 385 or an were calibrated at the same interval.
RCL.
Data from various fources support the conclusion that corcerical field instruments Conclusiens and Recomendations - ~ are capable of maintaining their calibrations for many years. It is suggested here that there The Regional Calibration Laboratories be a reconsideration of the time interval be-appear to be sucessfully filling an u portant tween calibration required by federal or state need in the radiological cornunity. The users policy. If a user who has a calibration factor of therapy field instruments who respond to directly tractable to NS$ verifies tre constancy of this instrument monthly by measurements on.
a cobalt 60 irradiator or strontium-90 constancy Table !! checker and if he verifies the instrument con-stancy at least every two yeses by an intercom.
Inte-c rparison of Chambers with partson with other instruments with calibrations a 2eference Chamber that had ,
directly traceable to N35, it snould be possiole teen Recently Calibrated
- to space calibrations'at N35 or an RCL to peri-by N35 or an RCL(a) ods of 3 to 5 years. The user would always use the factor assigned by N85 er an RCL and e ploy fine since Calibration the monthly constancy checks and biennial inter-Last .
Factor comparison checks as indications for recalibra.
Calibration Tyse of Calibrated Institution / tion of his instrument when consistent discreo-(weths) Cosireter by reference ancies of Zi are found in the checks. This .-
suggestion seems warranted by the performance 40 F-K RCL 1.000 characteristics of the available instruments '
~
33 Vict R RCL 1.001 if couoted with reliable checks and adequate
( 36 \fet R 7 1.042 5bI documentation.
J4 Cap RCL 1.001 31 Vict R RCL 0.981 ICI 25 F-K RCL 0.998 Refereaces 21 vict R RCL 0.996 18 T-Cao RCL 0.980 ICI [g] Lanz!, L. H. (Principal Investicator) Report 15e FK RCL 0.993 of the Comittee en Calibration Needs in 7- Vict R RCL 0.997 Therapy of the berican Association of 1* Cao RCL 1.003 Physicists in Medicir.e. Chicago, Illinois 1 F-K RCL 0.994 (1979).
? EG&C-K ? 1.C27 IDI
? F-K Inter- 0.994 E23 Rosenfeld, M. (Chairran). Task Group f 3
.comoarison of the Merican Ass:ctation of Physicists 4 0.998(d) in Medicire. It has been recomended that "
I4 E*" c ar son 0.998 the regional laboratories be renaced.
20 . 1.CC0 Accredited Cesiretry Calibratten Latoratory 19 0,994(d) (ADCL), but the AAM has not as yet approv.
33 F-K Inter. 0.993 ed the name change.
comc M son F-K, Far er 0.6cc chamter with Keitnley [3] McCarthy W. A., Chair an of Sutccmittee of Task Group #3 of tne Merican Association nedel 602 or 616 electrometer of Physicists in **edicine. Report in draft Vict 2; Victcreen model 621 or 131 charter with model 570 electremeter (private co m nication).
Cap; Capintec model 192 chamte with model 192: electretteter b'l Scientific Cemittee on Radiation D:simetr* '
El&3; EC&G mcdel 525 A :haecer (5CRAO) of the derican Association of a) Cata fron varioJs regional chanters pnysi61sts in yeescine. apr;tecal for the of tre AAP" [7,8,9}. Costret7 of X- arc 04 es tay Beats nitn b) The easter factor in use for these two w aximum treraits teneen 0.5 and 50 va v."
cra :e-s .as of uranc n or cuestionamie bys ~we e 313I 16 gg71): 379 396.
origtn.
e ht n Leevinger R., ES, Seivate Gnunication.
e s) re sa e institutisn on severai [6] 7,,,,g , , g,
{ccasiens.
8,1975 h
~
E
. - . . . - . . . . - _ ~ - - ~ ~ . ~ _ _ - - . . - _ . . . . - . . . . . - _ . . .
.s'v'
..g.
V U Grant !!!, W., Cundiff, J., Hans:n, W.,
i Gagnen, W., and Shalek, R.,-Calibration l Instrumentation used by the AAPM Radiolog- i l
l ical Physics Center. Mej( e P$ys 3, p. 353-4, (1976).
Southwest chapte'r of AAPM (Huch)tes. L. J.)
unpublished data.
') Missouri Valley chapter of AAPM (Purdy J. A.
and Felman, A.) unpublished data.
l Midwest enapter of AAPM (Mrejsa, A. F.)
j unpublished data. .
I This wr su:perted in part by DHEW NCI grant CA 10953. i J
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AGENDA
(^\ January 21, 1982 NRC Willste Bldg NRC-NBS discussion of AAPM petition to amend 10 CFR 35.23(a) on calibration requirements for teletherapy licensees.
- Introductions
- Conference-call phone connections to NRC consultants:
i Dr. Peter Almond - M.D. Anderson, Houston Dr. Edward Webster - Mass. General Hosp., Boston
- Dosimetry system calibration backlog
- AAPM recommendations for:
]
a Longer interval between full calibrations
- Dosimetry system verification
[ . Suggested method of intercompar' isons 0ther methods
. Constancy checks
. Discussion I
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