ML20133F097
| ML20133F097 | |
| Person / Time | |
|---|---|
| Issue date: | 12/06/1996 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20133F058 | List: |
| References | |
| SSD, NUDOCS 9701140065 | |
| Download: ML20133F097 (9) | |
Text
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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE i
(AMENDED IN.ITS ENTIRETY)
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LEL.: NR-0476-S-117-S.
DATE: ' December 6, 1996 PAGE 1 OF 6 SEALED SOURCE TYPE:
Transmission:Line Source
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MODEL:
NES-8412.through NES-8425 MANUFACTURER / DISTRIBUTOR:-
Du Pont Merck Pharmaceuticals Radiopharmaceutical Division 331 Treble Cove Road North Billerica, MA 01862 ISOTOPE:
MAXIMUM ACTIVITY:
Gadolinium-153 1000 millicuries (37 GBq)
LEAK TEST FREOUENCY 6 months PRINCIPAL USE:
(B) Medical Radiography CUSTOM SOURCE:
YES X
NO 9701140065 961230 l
PDR RC
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y REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) i l
HQ.:,NR-0476-S-117-S DATE: December 6, 1996 PAGE 2'OF 6 33ATRn SOURCE TYPE :
Transmission Line' Source l.
DESCRIPTION:
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For'the Models NES-8412 through NES-8424, the sources consist of radioactive.Gd-153 uniformly incorporated into an epoxy matrix.
The Gd-153/ epoxy is contained in a stainless steel or polymer inner tube, then inserted:into a stainless steel outer tube.
Two stainless steel end plugs are epoxy glued onto the ends of the l
outer tube to form the encapsulation.
For the Model NES-8425, l
thel source composition is the same as the other models; however, the NES-8425 differs in that the outer assembly has a 6-32 UNC i
threaded hole in the two capsule end plugs for attachment to a
-source holder.
All sources are stored in centering tubes inside a lead shielded storage tube.
The model number uniquely designates the active length, active diameter and. nominal activity.
The active length and active diameter correspond to the dimensions.of'the inner tube.
The dimension of the inner tube' for models NES-8412 through NES-8424 are: active diameter from 0.06 to 0.18" (1. 52 to 4. 57 mm), active length from 6.0 to 20" (15.24 tc 50.8 cm).
The dimensions of the outer tube are: overall diameter from 0.12 to 0.25" (3.05 to 6.4 mm), overall length from 6.5 to 20.5" (16.51 to 52.07 cm), and minimum plug length is 0.13" (3.3 mm). The dimension of the inner tube for model NFS-8425 are: overall length 10.47 to 10.55" (26.59 to 26.80 cm), threaded hole machined to 0.3" (7.62 mm) in depth with diameter of 0.138" (3. 51 mm), end plug 0.5" (12.70 mm) in length, and overall diameter of end plug is from 0.217 to 0.218" (5.51 to 5.54 mm).
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF SEALED SOURCE l
(AMENDED IN ITS ENTIRETY) l NQ : NR-0476-S-117-S DATE: December 6, 1996 PAGE 3 OF 6 SEALED SOURCE TYPE:
Transmission Line Source LABELING:
Each source is engraved with the model number, isotope, activity, serial number, and month and year of assay.
Each configuration (i.e. activie diameter, active length, nominal activity) will be labeled with a unique model number.
A self-adhesive identification label is affixed to the outside of the lead storage shield.
DIAGRAM:
See attachments 1,2, and 3.
CONDITIONS OF USE:
These sources are designed for use as a component of a medical gamma camera system used in the nuclear medicine department of a hospital or clinic.
Therefore, during normal use the source will be subjected only to controlled conditions suite.ble for humans occupancy.
Extremes in environmental or operating conditions are not expected to exceed normal room temperature and humidity fluctuations.
The useful life of the source is approximately five years.
PROTOTYPE TESTING:
A prototype of the source design was tested in accordance with the specifications of ANSI N542-1977 and the design achieved an ANSI classification of 77C32314.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES j
SAFETY EVALUATION OF' SEALED SOURCE i
(AMENDED IN ITS ENTIRETY)
HQ : NR-0476-S-117-S DATE: December 6, 1996 PAGE 4 OF 6 4
1 SEALPD SOURCE TYPE:
Transmission.Line Source l
1 J
i EXTERNAL RADIATION-LEVELS:
f The characteristic radiation' doses from the sources are listed 4
below:
i Distance Radiation Dose Level j
(cm)
(in.)
(mR/hr/ mci)/(uSv/hr/MBc)
Contact 21 S.25 5
1.97 2.1 0.525 30 11.8 0.6 0.15 i
i The radiation level at the ends of the line source was measured to be 2.4 mR/hr/ mci (0.6 pSv/hr/MBq).
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OUALITY ASSURANCE AND CONTROL:
The sources are to manufactured and distributed under the guidelines of Du Pont Merck Pharmaceutical Company's quality assurance and control program.
The program has been deemed acceptable for licensing purposes by NRC.
A copy of the program j
is on file with the Nuclear Regulatory Commission.
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j LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The sources are to be distributed to persons specifically j
licensed by the NRC or.an Agreement State.
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- The sources shall not be^ subjected to environments which j
exceed their ANSI N542-1977 classification 77C32314.
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r REGISTRY.OF RADIOACTIVE SEALED SOURCES AND DEVICES
' SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
HQ : NR-0476-S-117-S DATE: December 6, 1996 PAGE 5 OF 6 SEALED SOURCE TYPE:
Transmission Line Source 1
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont'd)
- The sources 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.
- Handling, storage, use, tran's fer, and disposal: To be determined by the licensing authority.
- This registration certificate and the information contained within'the' references shall not be changed without the written consent of NRC.
SAFETY ANALYSIS
SUMMARY
Based on review of the Models NES-8412 through NES-8425 sealed sources, and the information and test data cited, we continue to conclude that these sealed sources are acceptable for specific licensing purposes.
Furthermore, we continue to conclude that the sealed sources would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this i
certificate.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES.
SAFETY EVALUATION OF SEALED SOURCE 2
(AMENDED IN ITS ENTIRETY) 4 4
NCL: NR-0476-S-117-S DATE:, December 6, 1996 PAGE 6 OF 6 i
l SEALED SOURCE' TYPE:
Transmission Line Source I
REFERENCES:
i The following supporting documents for the Models NES-8412 through NES-8425 sealed sources are hereby incorporated by 1
reference and are made a part of the document.
- Du'Pont Merck letter dated December 8, 1995, and August 1, l
1996, with enclosures.thereto.
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- Du Pont Merck facsimiles dated May 8, 1996, April 23,.
j 1996, and November 13, 1996, with enclosures thereto.
4 ISSUING AGENCY:
s U.S. Nuclear Regulatory Commission Date: December 6.
1996 Reviewer:
/-
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Jo[E Lubinski i
/
Date: December 6.
1996 Concurrence:
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/$beven L. Baggett l'
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE
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(AMENDED IN ITS ENTIRETY)
ECL NR-0476-S-117-S DATER December 6, 1996 ATTACHMENT 1 i
1 EPOXY SEAL ON GD-153 SOURCE EP0XY MATRIX IN BOTH ENDS STN. STL, OR POLYMER INNER TUBE S TN. S TL.
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6.50 - 20.54 DVERALL LENGTH NES-8412 through NES-8424 Source
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-0476-S-117-S DATE-December 6, 1996 ATTACHMENT 2 30ND ENS PLUG INTO QUTER TUK VliH '3M* e2216 EPOXY GN EQt.AV.) - TYP. SOTH ENDS-CP0Xf TO K FLUSH OR KLOV G3-153 30uRCf EP0XY HATRtX Stk $1L. CUTER TUBC IN IEFLON IN. 4 IUK i
6-32 UNC E 0.3 DCCP 2
STN. STL. END PLUG-TYP. DOTH ENDS q I
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3 ACTIVE LENGTH 267 2 3 MM l
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SREAK SHARP EEE.03 6-32 UNC X.30 DEfP EZN-02 END PLRG (no784ca>
MAf ts 304 STAINLESS STEEL NES-8425 Source
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO.: NR-0476-S-117-S DATE-December 6, 1996 ATTACHMENT 3 seEL3 G/3' DECK MASP
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