ML20210H329
| ML20210H329 | |
| Person / Time | |
|---|---|
| Issue date: | 07/15/1997 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Basinger D HAUNI RICHMOND, INC. |
| Shared Package | |
| ML20210H287 | List: |
| References | |
| SSD, NUDOCS 9708130404 | |
| Download: ML20210H329 (2) | |
Text
_
y-c tP"%
p
-h
?'&
UulTED STATES -
j' j
NUCLEAR REGULATORY COMMISSION I e WASHINGTON D.C. 20586 4001
\\,w..../
July 15,1997 Darrell Basinger Hauni Richmond, Inc.
2800 Charles City Road Richmond,VA 23231
Dear Mr. Basinger:
This is in reference to your application dated December 9,1996, and the responses to our letter 9ted May 3,1996. Based on our review of your appi:aation, further information is required to" continue the review. Therefore, please provide the following information or clarifications:
1.
Page 1 (Section 1) of your application indicates that the device model number is E44 9260 and the device type is SU-1. Please indicate the model number of the device as it will appear on the label on the device.
2.
Page 3 (Section 1) of application references drawing E409300-500-4-B. However, you l
included drawing E409300-500-4-C in your application. Please either provide drawing L
E409300-500-4-B or verify drawing E409300-500-4-C is the correct drawing.
l 3.
Please verify that the ON/OFF indicators on the device are visible during use of the device.
4.
Your application states that the labeling w!!! indicate that the device contains 20 mci of strontium-90. Please verify that all devices will contain the maximum x:uantity (20 mci) or verify that the label will reflect the actual quantity of strontium-90 contained in the device.
5.
Please verify that Hauni Richmond will be identified on the device labeling. The sample label provided only includes LNI.
6.
Section 3.10.1 (page 13) states that the maximum ambient temperature to which the scanner would be subjected is 60*C. Section 3.11.1 (page 14) states that the heating chamber test maximum temperature is 40'C. Please explain why the testing to a maximum temperature of 40*C should be considered adequate.
7.
Section 1.6 (page ) includes a recommended working life of the source of 10 years.
Secticn 3.3 (Tab 2, Page) states the source has a recommended working life of 15 years. Also, there is no expected life of the device specified. Please clearly state the working life of the source and provide information on the working life of the device.
8.
Tab 4 of the application includes radiation profiles for the device. However, information provided is unclear, may contradict itself, and includes ir. formation concerning radiation profiles for the Model 2314-0-00 DS. Therefore, please provide a revised listing of the radiation profiles.
9708130404 970808 PDR RC SSD PDR g,
e A,
D. Basinger 2
July 15,1997 In addition, this section references a " protective covering" for the device. Please provide details of this covering including its purpose, whether the labeling is visible when the covering is in place, and the effects of the covering on the radiation profiles.
9.
In the " Customer Responsibilities With Respect To The Gauge Operations And Maintenance" section of the application (tab 13), it indicates that any worker would not be expected to receive a dose in excess of 2 mR in any one hour. On page 11 (Section 3.6) of the application it indicates that no individual should receive more than 0.5 rem / year. On page 13 (Section 3.10.2) of the application it indicales an estimated dose of 6 mrem would result to operating personnelin one year. Please clarify the relationship of the above statements.
Also, please verify that on page 13 (Section 3.10.2), the second sentence of the second paragraph should read "The scatter radiation in the direction of the operating personnel is 0.06 mretruhr(0.6aSv/hr)."
10.
TI,e procedures for leak testing (included in tab 2, Section 4.2, page 24) indicate that the source holder needs to be removed from the device. Please provide justification for removing the source holder in lieu of leak testing the area around the source holder since removal of the source holder would expose the user to increased radiatian levels.
11.
Section 4.1 (Tab 2, Page 22) and Section 4.3 (Tab 2, Page 25) of the Technical Information document entitled " Certification for Nuclear Scanning Unit" (Tab 2, page 25) l include statements that use the terms " authorized personnel only" and "specifically authorized person " Please provide the definitions of these statements and indicate whether these refer to persons specific licensed by NRC or an Agreement State. In addition, please commit to modify the terms in the document based on the information you provide us.
Please provide the requested information within 45 days. If you have any questions, please contact me at (301) 415-7868 or Mr. Steven Baggett at (301) 415-7273.
Sincerely John, Lubinski, Mechanical Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of indust:ial and Medical Nuciear Safety Office of Nuclear Material Safety and Safeguards Distribution:
SSSS r/f SSD-96-116 NE01 TO'Brien, OSP DOCUMENT NAME: C:\\ FILES \\SSDS\\HAUNIDEF.LTR To receive a cor of this document indicate in the bos: "C" = Copy without attachmentienclosure "E* = Copy with attachment /encicsure
- N' = No copy OFFICE ' IMAB g l
l j
l NAME JLubir%ki/jl DATE 07/15/97
~
OFFICIAL RECORD COPY
,