ML20024J533
| ML20024J533 | |
| Person / Time | |
|---|---|
| Issue date: | 10/17/1994 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL |
| References | |
| SP-94-148, NUDOCS 9410200012 | |
| Download: ML20024J533 (40) | |
Text
. - -
k@i..!d1994 ALL AGREEMENT STATES TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-94-148)
Your attention is invited to the attached correspondence which contains:
INCIDENT AND EVENT INFORMATION.......
PROGRAM MANAGEMENT INFORMATION.......
TRAINING COURSE INFORMATION..........
TECHNICAL INFORMATION................XX OTHER INFORMATION....................
Supplementary information:
The enclosed sealed source and device registry certificates are provided for addition to your catalogues.
If you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CONTACT:
Lloyd Bolling TELEPHONE:
(301) 504-2327 FAX:
(301) 504-3502 INTERNET:
LAB @NRC. GOV IC r
Paul H.
Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated Distribution:
RBangart PLohaus SBaggett, NMSS DIR RF LBolling ALL AS File SSD FILE 9410200012 941037 SP01 PDR STPRC ESQQEN DCD PDR PDR YES NO
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SP-94-148 1.
IL-136-S-339-S AMENDED IN ENTIRETY 10/06/94 (SUPERCEDES IL-136-8-339-8 ISSUED 7/22/92) 2.
CA-321-D-103-G AMENDED PAGE 1, 2,
3 & 4 DATED 8/31/94 3.
NR-385-D-101-E ISSUED 9/30/94 4.
CA-406-S-165-S 9/20/94
- 5. NR-628-S-134-S 9/29/94 1
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9*****g ALL AGREEMENT STATES TRANr.f!ITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-94-148)
Your attention-is invited to the attached correspondence which contains:
INCIDENT AND EVENT INFORMATION.......
PROGRAM MANAGEMENT INFORMATION.......
TRAINING COURSE INFORMATION..........
TECHNICAL INFORMATION................XX OTHER INFORMATION....................
Supplementary information:
The enclosed sealed source and device registry certificates are provided for addition to your catalogues.
If you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CO'ITACT:
Lloyd Bolling TELEPHONE:
(301) 504-2327 FAX:
(3 1) 504-3502 INTERNET:
B IRC.GO
]
% hn Paul H.
Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated i
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ENTIRETY)
NO:
IL-136-S-339-S DATE: October 6, 1994 PAGE: 1 of 6 SOURCE TYPE:
Flood Source i
1 MODEL:
CTR.Q1 Series DISTRIBUTOR:
Amersham Corporation /Medi+ Physics 2636 South Clearbrook Drive Arlington Heights, IL 60005-4692 MANUFACTURER:
Amersham International Plc White Lion Road, Amersham Buckinghamshire, England HP79LL i
ISOTOPE: Cobalt-57 MAXIMUM ACTIVITY: 22 mci, 814 MBq LEAK TEST FRE0VENCY:
6 months PRINCIPAL USE: Medical Reference Source CUSTOM SOURCE:
YES X
NO
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ENTIRETY) tLO:
IL-136-S-339-S DATE: October 6, 1994 PAGE: 2 of 6 SOURCE TVPE:
Flood Source DESCRIPTION:
The sources consist of Cobalt-57 uniformly distributed in a butyl methacrylate polymer, contained in 60 um polyester film bag and encased in 2 mm of polycarbonate.
The Cobalt-57 is mixed with the liquid butyl methacrylate and poured into a bag, made of polyester film, of appropriate size and shape.
Following solidification, the source is encased in a vacuum formed, 2 mm polycarbcnate casing.
The top and bottom halves are ultrasonically welded together.
ihe floca source inserts are 5.5 mm thick and are available in circular and rectangular shapes as follows:
RECTANGULAR FLOOD SOURCES Product Active Overall Active Overall Maximum Code Dimension Dimension Thickness Thickness Activity (mm)
(mm)
(mm)
(mm)
CTR.501 580 X 440 652 x 482 5.5 19 407 MBq 11 mci CTR.601 580 X 440 652 x 482 5.5 19 610.5 MBq 16.5 mci CTR.701 580 X 440 652 x 482 5.5 19 814 MBq 22 mci CTR.801 305 X 440 495 X 355 5.5 19 407 MBq 11 mci CIRCULAR FLOOD SOURCES Product Active Overall Active Overall Maximum Code Diameter Diameter Thickness Thickness Activity (mm)
(mm)
(mm)
(mm)
CTR.201 395 446 5.5 19 407 MBq 11 mci CTR.291 470 522 5.5 19 203.5 MBq 5.5 mci CTR.301 470 522 5.5 19 407 MBq 11 mci CTR.401 600 652 5.5 19 407 MBq 11 mci
. ~
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O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l
(AMENDED IN ENTIRETY) l IL-136-S-339-S DATE: October 6, 1994 PAGE: 3 of 6 SOURCE TYPE:
Flood Source LABELING.
Fixed information is screen printed directly on the polycarbonate cover.
Variable information (e.g. source serial number and activity reference date) is applied by a dry transfer process of plastic letters and numbers
("Letraset") which have an impact adhesive.
The labeling is then sprayed with a clear lacquer.
The following information will appear on all labels:
Caution - Radioactive Material Trefoil Q Check i
Model CTR.Q1 Product Code Serial Number Activity in Curies and Bq Co-57 and activity reference date SCAN OTHER SIDE Amersham or Medi+ Physics DIAGRAMS:
See Attachments A through L.
CONDITIONS OF NORMAL USE:
The flood sources are intended for use at ambient temperatures in nuclear medicine departments within a hospital.
PROTOTYPE TESTING:
The source without its polycarbonate casing has been tested by the manufacturer in accordance with ANSI N542-1977 requirements.
The manufacturer reports a rating of ANSI 77C22322 based on test.results.
EXTERNAL RADIATION LEVELS:
The following dose rate measurements were made using a calibrated R02 dose meter positioned at several distances above the center of each source. All measurements were taken using sources ranging in strength between 8.79 mci to 10.9 mci. The results were extrapolated to determine the appropriate dose rates for 10 mC1, 15 mC1, and 20 mci.
l l
0 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVAlllATION OF SEALED SOURCE (AME,.L." IN ENTIRETY)
~
N_0 :
IL-136-S-339-S..
DATE: October 6, 1994 PAGE: 4 of 6 SOURCE TYPE:
Flood Source CirceTver sources by Product Code Distance CTR.201 CTR.301 CTR.401 Surfwte 683 Sv/hr 461 Sv/hr 311 Sv/hr 68.3 mR/hr 46.1 mR/hr 31.1 mR/hr 5 cn 501 Sv/hr 50.1 398 Sv/hr 263 Sv/hr mR/hr 39.8 mR/hr 26.3 mR/hr 30 cm 68 Sv/hr 63 Sv/hr 60 Sv/hr 6.8 mR/hr 6.3 mR/hr 6 mR/hr 100(tm 9 Sv/hr 8 Sv/hr 10 Sv/hr 0.9 mR/hr 0.8 mR/hr 1 mR/hr Rectangular Sources ty Product Code Distamce CTR.501 CTR.601 CTR.701 CTR.801 Surface 321 Sv/hr 481.5 Sv/hr 642 Sv/hr 770 Sv/hr 32.1 mR/hr 48.1 mR/hr 64.2 mR/hr 77.0 mR/hr 5 cm 275 Sv/hr 412.5 Sv/hr 550 Sv/hr 435 Sv/hr 27.5 mR/hr 41.3 mR/hr 55 mR/hr 43.5 mR/hr 30 cm 55 Sv/hr 82.5 Sv/hr 110 Sv/hr 95 Sv/hr
, 5.5 mR/hr 8.3 mR/hr 11 mR/hr 9.5 mR/hr 100 cm 7
Sv/hr 10.5 Sv/hr 14 Sv/hr 12 Sv/hr 0.7 mR/hr 1.1 mR/hr 1.4 mR/hr 1.2 mR/hr OVALITY ASSURANCE AND CONTROL:
The Co-57 is analyzed in detail for radionuclidic purity using a Ge(Li) detectmr in the 0.01-0.08 MeV energy range and a 3" Nal detector in the 0.08-3.5 MeV energy range. The typical impurities are Co-56 and Co-58.
REGISTRY OF RADI0 ACTIVE SEALED. SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ENTIRETY) fLO:
IL-136-S-339-S DATE: October 6, 1994 PAGE: 5 of 6 SOURCE TYPE:
Flood Source QUALITY ASSURANCE AND CONTROL:
(continued)
The uniformity of distributed Co-57 in the methacrylate matrix is evaluated using a collimated NaI detector. The detector is moved sequentially across the source until the entire useful region of the source has been scanned. The measurement report gives the standard deviation of the results accumulated over the useful region. The acceptable limit is +/- 0.6% and gives an indication of the useful uniformity of the output for this source.
The measurement report includes a flood field image with a color graded map and a reference point for flood field coordinates.
The manufacturer has been manufacturing and distributing these flood sources since 1992.
No reports have been filed for products that are not functioning properly due to workmanship. Additionally, a copy of Amersham /Medi+ Physic's Quality Assurance program is on file with the Illinois Department of Nuclear Safety.
LIMITATIONS AND OTHER CONSIDERATIONS OF USE:
1.
The sealed sources shall be distributed only to specific licensees of the NRC or Agreement States.
2.
At the time of distribution a package insert, Radioactive Source Test Report, and a Radiation Measurement Report will accompany the source.
The Measurement Report will include the output uniformity scan and the actual measured output activity in millicuries.
3.
The surface of the flood source may be cleaned by wiping with a swab moistened with methylated spirits or any normal aqueous solution.
Solvents such as chloroform or methylethyl ketone should not be used.
4.
Handling, Use, Storage, Transfer and Disposal:
Shall be determined by the licensing authority.
5.
This registration sheet and the information contained with the references shall not be changed without the written consent of the Illinois Department of Nuclear Safety.
j 6.
The sources shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
7.
The recommended working life for this source is five years.
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALVATION OF SEALED SOURCE (AMENDED IN ENTIRETY)
NO:
IL-136-S-339-S DATE: October 6, 1994 PAGE: 6 of 6 SOURCE TYPE:
Flood Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data submitted by Amersham Corporation for source design Model CTR.Q1 Series, we continue to conclude that the source design should maintain its integrity for normal conditions of use and accidental conditions which might occur.
REFERENCES:
The following documents for the Amersham Corporation Model CTR.01 Series are hereby incorporated by reference and are made a part of this registry document:
1.
Amersham Corporation application dated February 10, 1992.
2.
Amersham Corporation letters dated February 18, 1992 and July 21, 1992.
3.
Amersham Corporation letters, with attachments, dated May 26, 1992, June 3,1992, July 6,1992, July 28,1994, August 31, 1994, September 15, 1994 and September 26, 1994.
ISSUING AGENCY:
Illinois Department of Nuclear Safety DATE:
b M REVIEWED BY-w
. a@
Daren M. Perrero b,bdk DATE: /O-d~
CONCURRENCE:
i m
/l.(JosephG.Klinger f
NA Ris/i lho Mai Hegulatory Commission does not have the authon!v to regulate the radioactive materialin thb document, and the NRC is not responsible for its conte.t ll is distributed and maintained by NRC as a service to state radiation control agencies.
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Circular Plastic Flood Sources.
Ref. Drawino Numbers SS/SK/DEV 226,242,243,244. 245 i
Dimensions (mm)
CTR.201 CTR.291/
CTR.401 Descriotion CTR.301
'A 446 522 652 Top Tray O,D.
B 394 468 596 Top Tray recess I.D.
C 446 522 326 Castellation radius D
72 84 84 Handle Region E
235 240 240 Radius for castellation F
154 154 154 Wdh of handle straight edge H
42 58 58 Top tray, handle flat KA 52 60 60 KB 26 38 38 Top tray castellations KC 4
10 15 LA 49 57 57 LB 23 32 35 Bottom tray castellations LC 2
8 13 M
71 79 81 Bottom tray handle tray 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED PAGE - AUGUST 31,1994) 110_: CA321D103G QAIE January 27,1977 PAGE: 1 of 4 DEVICE TYPE: Helicc pter Blade Failure Detection Gauge MODEL:
GNI 122XX IBIS (Formerly GND 12200 IBIS)
MANUFACTURER /D!STRIBUTOR:
General Nucleonics Corporation 2807 Metropolitan Place Pomona, CA 91767 SEALED SOURCE MODEL DESIGNATION:
Isotopes Products Laboratory and Amersham Model GNI 12205 ISOTOPE: Strontiun -90 MAXIMUM ACTIVITY: 500 microcuries LE AK TEST FREOUENCY:
Not to exceed 6 months PRINCIPAL USE:
Beta Gauges (E)
CUSTOM DEVICE:
YES X
NO
4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
~
SAFETY EVALUATION OF DEVICE (AMENDED PAGE - AUGUST 31,1994)
NCL: CA321D103G DATE: January 27,1977 PAGE: 2 of 4 DEVICE TYPE: Helicopter Blade Failure Detection Gauge DESCRIPTION:
The device consists of a cylindrical housing typically 5.1" long and 2.75" diameter which contains a bellows, a system ofradial detents for the bellows assembly and an axial rod which houses the activity in the form of an Isotope Products Laboratory or Amersham Model GNI 12205 Annular Beta source.
The distal end of the axial rod terminates in a coaxial disc and the proximal end terminates in a connector attached to the bellows.
The distal end of the housing terminates in a steel reset button. The proximal end of the housing terminates in a base which attaches to the port of a helicopter rotor blade and exposes the proximal end of the housing to the pressurized center of the rotor blade. The interior of the bellows is sealed and maintained at a reference pressure. The bellows is spring loaded against the detents.
In operation, the bellows is held compressed against the detents by the differential between the blade pressure and reference pressure. When the bellows is compressed the source rod is in a retracted position and is shielded by the housing.
If blade pressure fails, the reference pressure in the bellows is no longer sufficient to hold the bellows against the spring. The spring acts to release the detents and the source rod is moved towards the distal end, exposing the source outside the shield.
In this position, a Geiger-Mueller Detector mounted inside the upper fuselage senses the increased radiation field and signals a pressure failure to the cockpit display. In all detectors (GNI Model 122XX-1) a 0.01 microcurie Strontium-90 source is incorporated to provide a bias signal for fail safe operation.
LABELING:
Labeling of each gauge is in accordance with general license requirements.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED PAGE - AUGUST 31,1994)
N O.: CA321D103G DATE: January 27,1977 PAGE: 3 of 4 DEVICE TYPE: Helicopter Blade Failure Detection Gauge PROTOTYPE TESTING:
Testing of this device is performed to meet Military Aircraft Specifications MIL-E-5272C Environmental Testing Aeronautical and Associated Equipment General Specifications for, and MIL-STD-810B Milit.ary Standard Environmental Test Methods for Aerospace and Ground Equipment.
EXTERNAL RADIATION LEVELS:
The 500 microcurie source in the normal (shielded) mode, has a radiation level of 0.8 mR/hr at 3".
In the failure (extended) mode,75 mRfnr is detectable at 12" LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
An instruction manual containing radiation safety instruction and general license conditions is supplied with each gauge.
The manufacturer will perform senices including repair and maintenance. The manufacturer will provide leak test kits for use by the general licensee at six month intervals.
The distribution to general licensees of the device described in this sheet is authorized pursuant to California Radioactive Materials License 3138-70 GL.
REFERENCES:
The following supporting documents for the General Nucleonics Helicopter Blade Failure Detection Gauge, Model GNI 122XX IBIS, is hereby incorporated by reference and is made a part of this registry document.
l.
General Nucleonics letters with attachments dated August 29,1991, April 21,1994, and
, August 18,1994.
l
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED PAGE - AUGUST 31,1994)
EQ: CA321D103G DATE: January 27,1977 PAGE: 4 of 4 DEVIC.E TYPE: Helicopter Blade Failure Detection Gauge DATE:
Aunust 31.1994 REVIEWED BY:
y DATE.
Auaust 31.1994 CONCURRENCE:
A Ak gM ISSUING AGENCY: California Department of Health Senices
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i
4 REGISTRY OF RADIOAC1.T.VE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-385-D-101-E QATg1 September 30, 1994' PAGE 1 OF 2 DEVICE TYPE:
Smoke Detector j
MODEL:
VA-2000 Series 1
i DISTRIBUTOR:
Ventek, Inc.
(formerly Flash Alert) 4137 White Oak Drive P.
O.
Box 43527 Birmingham, AL 35243 MANUFACTURER:
KBM Manufacturing 1
15980 Chaney Thompson Road Huntsville, AL 38503 l
SEALED SOURCE MODEL DESIGNATION:
Amersham Model AMM-1001H 1
ISOTOPE:
MAXIMUM ACTIVITY:
Americium-241-1.0 microcurie (37 kBq)
LEAX TEST FREOUENCY:
Not required i
I PRINCIPAL USE:
(P) Ion Generator, Smoke Detectors CUSTOM DEVICE:
YES X
NO l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
[
NO : NR-385-D-101-E DATE: September 30, 1994 PAGE 2 OF 2 DEVICE TYPE:
Smoke Detector l
DESCRIPTION:
t The VA-2000 series is a combination audio / visual smoke detector for the hearing impaired.
There are two models within the VA-2000 series, the VA-2000P and VA-2000HW.
The only difference between these models is that the VA-2000P is a portable unit which can plug into a common electrical outlet and the VA-2000HW is hardwired.
5
REFERENCES:
The following supporting documents for the VA-2000 Series smoke detectors are hereby incorporated by reference and are made a part of this registry document.
Ventek's letters deted February 8, 1993,-July 8, 1993, June 21, 1994, August 1, 1994, September 13, 1994, and September 21, 1994, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission-Date:
September 30, 1994 Reviewer:
/
hn W.
binski Date:
September 30, 1994 Concurrence:
/ _
" Steven 5.'Baggett a
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s es
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REGISIRY OF RADICACTRE SERLED SOURGS NO DEVIGS SAFEIY EVAUATICN OF SEALED KX1RG LQ,. : CA 406S165S M: September 20, 1994 M-1 of 6 SEALED 9JURG M-Calibration Soarce F0 DEL. 3409 (Capsule # A3409) 1%NUFACIURER/DIFIRIBUIOR:
Isotope Products I.ahoratories 18M tbrth Keystone Street Bu ank, CA 91504 (8'J) 843-7000 197IOPE:
b%XIRN ACTIVITY:
(a)
(boalt 57 (a) 25 millicuries (b)
Gadolinium 153 (b) 75 millicuries LEAK TEST FRBJUENC"f: Six ttrnths PRINCIPAL USE: Calibration source CUSIUi SCURG:
YES X ?O
REGISIRY OF RADIOACTIVE SEAIED SOURCES NO DEVITS SMEIY EVALIATICN OF SEAIED SOURCE E: CA 406S165S DE. Septenber 20, 1994 PNE:
2 of 6 SEALED SOUR TYPE: Calibraticn Source DESCRIPTICN:
'Ihe Model A3409 sealed source is a singly enmrvulated 304 or 304 L stainless steel line source of welded ecostruction with an active polymeric resin ocrrplex matrix.
It has a diameter of 0.25",
an overall length of 10.51", and 0.010" thick walls.
One end has an internal 6-32 thread for handling purposes.
IABELIIU:
'Ihe source is engraved with IPL, nuclide, ncminal activity, and serial number.
Due to the dimensional limitatians, inherent to the source, the standard radiation caution symtol cannot be included.
DIAGRAM:
Drawing Number 3409.
(see sleet 7 of this cbcument)
CQOITIOG OF NORMAL IEE:
This source is intended to be used by trained persannel in a lainratory or clinical environment for checking or calibrating nuclear instrunentation, or to be permanently installed in devices.
This source shauld not be subject to conditians exceeding the test criteria of it's NGI N542-1977 rating.
In ppicular, the source yd not be exposed to tenpeJatures lower than -40 C nor higher than 80 C and external pressures greater that 290 PSI.
PPDIGIYPE TESTI1U:
Prototype sources have undergone testing per ANSI N542-1977 and have been classified as NEI 77C23233 which qualify them for their interded uses(s).
1 REGISIRY OF RADICACTIVE SEMED SOUR S M O DEVICES SAFEIY EVAUATICN OF SEAIED SOURG E: CA 406S165S LA__TJ: Septatter 20, 1994 PlGE:
3 of 6 SEAIED SOURG TYPE: Calibraticn Source EX'IERNAL RADIATICN 1EVEIE-
'Ihe radiatian level of the source will vary with the ccntained radicnuclide and the activity level.
Listed below are radiaticn levels in mr/hr, unless otherwise noted.
Fbr Cb-57 data has been taken frun the table of ga:
factors in the " Radiological Health Handbook" (1970).
Tma
'Ihe relative ga:tma factor for Gd 153 has been calculated fran its garma emission spectrum.
Distance frun source giglide Activity Lgn 30 an 100 on (a)
Cb-57 25 mci 447 mR/hr 23 mR/hr 2.2 mR/hr (b) Gd-153 75 mci 188 mR/hr 9.7 mR/hr 0.9 mR/hr QUALITY ASSURANG MO CINIROL:
P:mram; 'Ihe IPL Quality Assurance Manual details the quality control of these sources frun raw materials to finished product.
'Ihe prcgram is designed to satisfy 10CFR Part 50 (B). 'Ihe program covers drawing ocntrol, purchasing, training, calibraticn recortis, sourte numbering, inccmIng raw materials, assay quality control, leak testing, document ccntrol ccnfirming orders, and pre-production design review.
Activity: Held to 215% of ncminal activity Assay orocedures:
A Chlibrated Icnizatian Chamber is used to neasure the activity of the source.
Radicourity determinaticn: Nuclide purity of 99% is determined by ganTra or alpha spectruretry of the source or the radicnuclide batch.
Leak test orecedures:
Sources are either leak tested according to the "Imrrersicn With Boiling Test" taken frun MEI N5421977 Appendix A A2.1.3, or the imTersicn test frun Appendix to REI N44.2-1973 "American National Standard for Leak Testing Radioactive Brachytherapy Sources." Criteria for acceptance are:
1.0 nCi reTovable leta/ga:rma 0.1 nCi remmrable alpha
o O
REGISTRY OF RADIGACITVE SFAI.ED SOURCES AND DEVICES SAFETY EVAUATIQ1 OF SEALED SOURCE LQ.: CA 406S165S IRTE: September 20, 1994 PAGE-4 of 6 SFALED SCURCE TYPE-Calibration Source LIMITATICNS AND/OR OIRER O2EIDERATICNS OF USE a.
Distribution: These soumes shall be distributed to specific licensees of the NRC or Agreemant States.
b.
Leak Test :
Sources cantaining radioactive mterial in excess of the exenpt quantities listed in Title 17, 30235 ScMle A, shall be leak tested at intervals not gmater than six months.
Such tests mst be capable of detecting 0.005 uCi of ruovable radioactivity, and be performed by specific licensees of the NRC or agrestent states, c.
Use: These soumes am intended to be used by trained persannel in a laboratory enviruirent for checking or calibrating nuclear instzunentation, or to be perranently installed in devices.
These sources should not be subjected to canditians exceeding their respective ANSI N542-1977 ratings.
d.
Handlim:
Renote handling tools and localized shielding struld be used.
e.
Storace: Store in a clean, dry area.
Shieldirrg should be previded as necessary.
f.
Cleanim: Sources nuy be cleaned with alcohol or water with a mild detertjent.
g.
Disposal: Disposal of decayed or otherwise unusable sources nust be mde via the user's authorized radioactivity disposal nethod.
h.
The registration sheet and the infonnation cantained within the mferences shall not be changed witlrut the written omsent of the California Department of Health Services.
SAFETY ANALYSIS SLM%RY:
Based an our review of the information provided, we conclude that Fbdel 3409 is acceptable for licensing purposes.
This series of sources has passed test requirerrents exceeding those of ANSI N.42-1077 for calibration sources, and therefore should be safe for the intended use.
c RB3ISIRY OF RADIOACTIVE SEALED SOURGS AND DEVIGS SAFETY EVAUATICN OF SEAIE SOr RG J
H2: CA 406S165S DME: Septertber 20, 1994 F2GE: 5 OF 6 SEALED SCURG TYPE: Calibration Scurce fe2u<ENCE:
'Ihe following supporting documents for Fbdel 3409 are hereby incorporated by references and are made a part of this registry document.
- 1) Iggi to ANSI N44.2-1973 "American National Standard for IEak Testing Radioactive Brachytherapy Sources."
(
2)
Isotope Products Laboratories Quality Assurance 14anual.
(1993) 3)
IPL letters with enclosures dated June 17, 1994, August 17, 1994 and September 22, 1994.
DATE:
D & 5,)334 REVIEhER:
0 DA'IE:
M Mo[y [$/77t/ CIIGRRENCE:
A
/
J f
. /
k ISSLTIN3 N-California Departnent of Health Services
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REGISTRY OF RADIOACTIVE SEALED SOURCES AN l
SAFETY EVALUATION OF SEALED SOURCE E.Q : CA 406S165S DATE: September 20, 1994 PAGE: 6 OF 6
SEALED SOURCE TYPE:
Calibration Source
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- 6. P ACKAGE AND IDE NTIFY PAR T NUMeER THEREON
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IPL NUCLlDE AcitVITY ISOTOPE PRODUCTS LABORATORIES h FV3 tDN WELD PLUG fo TVBE. BoTH ENDSSERIAL NUMBER BURBANK. CALIFORNIA 91504' i
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE EQ2:
NR-628-S-134-S RAIE:
September 29, 1994 PAGE 1 OF 5 SOURCE TYPE:
Radiographic Source Assembly MODEL:
A58101-8 Source Assembly MANUFACTURER / DISTRIBUTOR:
Amersham Corporation Radiation Products Division (formerly Tech / Ops) 40 North Avenue Burlington, MA 01803 ISOTOPE:
MAXIMUM ACTIVITY:
Iridium-192 240 curies (8.8 TBq)
LEAK TEST FREOUENCY:
6 months PRINCIPAL USE:
(A) Industrial Radiography CUSTOM SOURCE:
YES X
NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.:
NR-628-S-134-S DATE:
September 29, 1994 PAGE 2 OF 5 SOURCE TYPE:
Radiographic Source Assembly DESCRIPTION:
The radioactive Iridium-192 is contained in a single encapsulation sealed by autogenous tungsten inert gas welding in accordance with Amersham's standard source encapsulation procedure approved in their material license 20-18236-01.
The source capsule is fabricated from either Type 304 or Type 304L stainless steel with a minimum wall thickness of 0.030 inches (0.762 mm).
The radioactive material is in the form of solid metallic Iridium-192 (e.g., wafers, pellets, etc.), and is secured within the capsule through the use of metallic springs, spacers, and/or guards.
The internal void volume within the capsule is greater than 0.010 ml.
The source capsule contains a machined area in the form of a step that permits interlocking with a step machined on the source rod.
i This connection is maintained during use since the joined components move within a 0.26" (6.6 mm) diameter guide tube.
The source rod is pinned to an actuating rod located in the Model 616 radiography exposure device.
The overall length and diameter of the source rod containing the source capsule are 2.31" (5.87 i
cm) and 0.250 (0.635 cm) respectively.
This source assembly meets 10 CFR Part 34 equipment requirements.
LABELING:
Each source assembly is etched with the serial numebr and the word " Amersham" or "A".
DIAGRAM:
See Attachments 1 and 2.
CONDITIONS OF NORMAL USE:
The source capsule will be used in environments associated with industrial radiography.
These environs subject the source to extremely harsh environmental use conditions.
This source capsule is approved for use in the Model 616 radiographic ~
exposure device.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.:
NR-628-S-134-S DATE:
September 29, 1994 PAGE 3 OF 5 SOURCE TYPE:
Radiographic Source Assembly PROTOTYPE TESTING:
Prototypes of Model A58101-8 sources were subjected to the prototype tests listed in ANSI N542-1980. They passed the test requirements for a classification of 77C64515.
Additionally, the source capsules passed special form tests as described in 10 CFR 71 and IAEA Safety Series No.
6, 1973.
This source assembly was previously approved as part of the Model 616 device.
The device and source assembly have been in use since 1969 with only one reported incident of failure.
i The failure was the separation of tt.e bottom plate of the exposure device from the shell wher. a Model 616 camera was accidentally dropped from a height of 125 feet (38.1 m).
This plate was tig welded to the shell.
The impact caused the step in the source rod which couples to the source to shear which allowed the source to be dislodged from the device and become exposed.
The device was redesigned to strengthen the welded areas.
EXTERNAL RADIATION LEVELS:
Amersham specifies that the source emits 0.48 R/hr/ curie (1.3 Sv/hr/GBq) at 1 meter.
Thus, the maximum calculated radiation levels for a 240 curie source are:
5 cm from the source 46,080 R/hr (460.08 Sv/hr) 30 cm from the source 1,280 R/hr ( 12.80 Sv/hr) 100 cm from the source 115 R/hr (
1.15 Sv/hr)
OUALITY ASSURANCE AND CONTROL:
Amersham employs a quality control program to insure that each component is manufactured to the specifications furnished to the NRC.
This program complies with the terms and conditions of j
Subpart H, 10 CFR Part 71 and conforms to the American National i
Standards recommendations for quality assurance and control programs.
i j
l 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES s
SAFETY EVALUATION OF SOURCE NO.:
NR-628-S-134-S DATE:
September 29, 1994 PAGE 4 OF 5 SOURCE TYPE:
Radiographic Source Assembly LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The source assembly shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
- The source shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie'(185 Bq) of removable contamination.
Leak tests using Vacuum Bubble Tests techniques shall not
- employ the use of water unless the inner capsule void space 3
is greater than 30 mm.
- The source assemblies shall not be subjected to environmental or other conditions of use which exceed the ANSI-N542 classification of 77C64515.
- Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
In view that these source assemblies exhibit high dose rates, the sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.
- The Model A58101-8 source assembly may only be used in conjunction with the Model 616 exposure device or other devices and uses as specified in a registration certificate issued by the NRC or Agreement State.
- This registration sheet and the information contained in the reference shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, that the Model 616 containing the A58101-8 source was previously deemed acceptable for licensing purposes (source and device were registered together), we conclude that the^Model A58101-8 source capsule is acceptable for licensing purposes.
~
l
. ~ -,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.:
NR-628-S-134-S DATE:
September 29, 1994 PAGE 5 OF 5 SOURCE TYPE:
Radiographic Source Assembly SAFETY ANALYSIS
SUMMARY
(continued):
Furthermore, we conclude that Model A58101-8 would be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Amersham Model A58101-8 source capsule are hereby incorporated by reference and are made a part of this registration document.
- Amersham Corporation's letters September 29, 1994, September 9, 1994, and July 18, 1994, with enclosures thereto.
ISSUING AGENCY:
U.S.
Nuclear Regulatory Commission i
Date:
September 29, 1994 Reviewer:
4 &b Thom s'W Rich
/.
/
Date:
September 29, 1994 Concurrence:
~
/' John W.
Lubinski
REGISTRY OF RADIOACTIVE SEALED SOURCES AND. DEVICES SAFETY EVALUATION OF SOURCE NR-628-S-134-S DATE:
September 29, 1994 ATTACHMENT 1 SOURCE TYPE:
Radiography Source Assembly L
f
?5 A5E lo t-8 a
SOURCE CAPSU LE e
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.:
NR-628-S-134-S DATE:
September 29, 1994 ATTACHMENT 2 SOURCE TYPE:
Radiography Source Assembly
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