ML20249A318
| ML20249A318 | |
| Person / Time | |
|---|---|
| Issue date: | 06/12/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bishop W AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9806160306 | |
| Download: ML20249A318 (2) | |
Text
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UNITED STATES g
j' NUCLEAR REGULATORY COMMISSION l;
e WASHINGTON, D.C. segeH001
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June 12, 1998 l
' Mr. William J. Bishop V.P. Business Development SMVAmerica 8380 Darrow Road I
Twinsburg, Ohio 44067 L
Dear Mr. Bishop:
L This letter is in response to your application dated March 7,1997, and subsequent correspondence requesting registration of the Transmission Attenuation Correction (TAC)
Source Holder Model PS 96.' We continue evaluation of your request with the information which
. you have provided in your letters dated March 12,1998, and April 6,1998. However, in order to complete our evaluation, the following additional information is necessary:
1.
Since the TAC device could be used with' one attachment arm as well as with two, please indicate that every attachment arm, either in the one arm or the two arm l
configuration, will be equipped with the appropriate labels that are included in the
-]
p application.
L 2.
In your letter dated January 6,1998, you indicated that two labels will be used: one to show model number, worial number, SMVs name, etc.; the other to show the isotope, activity, date and trefoil symbol. The sample label showed SMVs address in France as L
manufacturer. ' Please indicate to the user an address for SMV in the United States. You L
may choose to show the U.S. address on the first label; to add another label indicating the SMV America's address as distributor; or any other means of identifying a contact for the user in the U.S. However, please note that all labels are needed on every arm, as discussed above, in case the device is used in a single arm configuration.
l 3.
Regarding prototype testing, please demonstrate that if the device, the source holder or the transport container were to be dropped from operating height, they would continue to l
provide appropriate radiation protection. The provisions of the applicable requirements, p
i.e 10 CFR 32.210(c), specify that prototype testing is to provide reasonable assurance L
that the radiation safety properties of the device are adequate under the condition that i
the device is likely to encounter. Please note that the equipment need not be.
operational after a drop accident, but must maintain its radiation protection function.
4.
Please describe the quality assurance inspections you will perform as distributor in the
- U.S. upon receiving the devices from the manufacturer in France. The shielding l
property of one unit may be different from another due to manufacturing variability. As
. your application indicated, the devices will be loaded at the hospitals where they are to be used. Therefore, please indicate how you assure that the radiation level (e.g.
j radiation profile) of the of the sources, transported directly to the user by the source
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O supplier, is within the specified limits for each unit.
9906160306 990612 POR RC 880 PDR j
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June 12, 1998 2
5.
In your application, you have provided information regarding occupation exposure of the operators while using the TAC device with patients. Please provide the estimated dose to the operator when performing the following special operations: loading, unloading, leak testing, and changing filters.
- 6.
Please make corrections regarding the identification of the source as Gd-153 instead of -
Tc-99 in the TAC User's Manual (Chapter 2, and p. 5-1) as well as on the label drawing (Drawing No. ETl01003084/Rev. A).
l Please provide the requested information within thirty (30) days. If we do not receive the I
L requested information within thirty (30) days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application. If you have any questions, please contact me at (301) 415-7904 or Mr.'
' John Lubinski at (301) 415-7868.
Sincerely, (orig, signed by)
John P. Jankovich, Ph.D., Sr. Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards -
Distnbution:
NE01k SBaggett IMNS r#
SSD-98-38 GSD File # NR-1048-D-101-S -
DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\104810.Df2 To recehe e sepy of thle doeuenent, indioote in the box: "C' = Copy without ettschment/ enclosure
- E' = Copy with attachment / enclosure
- N* = No copy
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lDATE 06/1498 UC 06/ 2398 OPP CIAL RECORD COPY i
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