ML20154R733
| ML20154R733 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/1998 |
| From: | Samson Lee NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Cook R AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9810270169 | |
| Download: ML20154R733 (4) | |
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UNITED STATES s
j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066 4001
\\***!**p8 October 23, 1998 l
Mr. Ronald Cook Advanced Gauging Technologies, LLC 8323 Big Walnut Road, Suite 100 Westerville, OH 43082 9467
Dear Mr. Cook:
This letter Is in response to your application dated March 3,1998 requesting registration of a gamma gauging device, model AGT 400 Source Head, under the provisions of 10 CFR 32.210.
We have evaluated your request and found that additional information and clarification is necessary before we can continue our review. We would suggest you review this letter and arrange a meeting with us to discuss the information needed to resubmit your application. We have truncated our review and will continue our evaluation upon receipt of a revised application.
SEALED SOURCE DESCRIPTION 1.
Section 2.0, " SEALED SOURCE DESCRIPTION," of your application stated that the ANSI Classification for Amersham AMC.19 is C64444. The sealed source and device registration certificate for the model AMC.19 shows an ANSI N542-1977 Classification of C64344. This rating still exceeds the ANSI N542-1977 requirement for gauges of C43232, we would suggest you correct this in your application.
DEVICE DESCRIPTION / CONSTRUCTION 1.
"Please submit complete and detailed engineering drawings including dimensions, specifications, tolerances, materials of construction for the source holder and the source housing. Specifically, Indicate the means to prevent inadvertent human access to the source.
2.
Provide installation specifications for "O" and fixed' frames to the level of detail you provided for the "C" frame.
3.
The sh. utter status window in the source housing top cover should have a label to define if the shutter position is open or closed. Please submit such a label or explanation as why you don't think it is needed.
4.
Provide the criteria for locating the source head shutter position lights on to the "C","O",
and fixed frames.
5.
What designed safety systems or administrative controls will be applied to ensure that the process material passing through opening will not damage the source housing?
9810270169 901023 PDR RC SSD PDR
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R.- Cook LABELING 1.
- Aluminum has been found to be easily corroded in corrosive environments, therefore, stainless steel might be a better choice of material. Please provide the justification if you want to continue to use aluminum or indicate a more durable material for the label.
2.
Describe placement and means of attachment (including material and locations) and lettering sizes of the labels (Figs. 4A through 4E are for radiation profiles, not for the label, as stated in the application).
3.
Provide a description or drawing of labeling to be applied to devices used under a specific license.
4.
Certain information is missing from the general license labeling. Specifically, the statement saying "This label shall be maintained on the device in a legible condition." is missing. Please provide a justification that the print on the labeling will remain on the device in a legible condition during the conditions of use of the device.
CONDITION OF USE 1.
Describe the environmental conditions which the device will be subjected to during normai use and likely accident conditions. Normal use and likely accident conditions should include those experienced during use, handling, storage, and transportation, such as corrosion, vibration, impact, puncture, compressive loads, explosion, flooding, poor air quality, excessive high or low temperatures, and cycling of the on/off mechanism.
-2.
A critical safety feature of your device is the shutter return spring. Demonstrate that this spring will operate without failure for the intended life of the device if not, what is the radiation consequences to the user if the shutter fails to return to the fully shielded position and at what frequencies would this occur?
PROTOTYPE TESTING / HISTORICAL USE 1.
Using the assumption, we estimated that there will be more than 300,000 shutter operations during 15 year life time of the device. Provido the basis for concluding that the device is expected to operate safely for 15 years. Your original justification based on the 1 year simulated shutter testing (20,000 operations) is not acceptable.
2.-
For the drop test, a.
Provide the adequacy of height of 1.2 meters. The height should represent the actual source head location. For the fixed frame, it might be higher than 1.2
- meters, b.
We don't agree that the parallel to the ground orientation drop test is the most vulnerable scenario. The test should represent the most severe condition such as a corner drop. Please justify your choice of orientation for the drop test and the height used.
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R. Cook -
i 3.
This refers to your ANSI N538 Device designation. We' assumed that you completed the
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test in accordance with the conditions as defined in ANSI N538. If not, please provide the test procedures and results for the temperature test.
RADIATION PROFILES 1.
What is the activity used for the dose rate profiles?
2.
For the generally licensed items,10 CFR 32.51 requires that the applicant submit 1
sufficient information about the product to provide reasonable assurance that (1) the device can be safely operated by persons not having training in radiological protection, (2) under ordinary conditions of handling, storage, and use of the device, the byproduct j
material contained in the device will not be released or inadvertently removed from the 1
device, and it is unlikely that any person will receive in 1 year a dose in excess of 10 l
percent of the annual limits specified in 10 CFR 20.1201(a), and (3) under accident i
conditions (such as fire and explosion) associated with handling, storage, and use of the
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device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in Column IV of the table in 10 CFR 32.24. Please provide the maximum dose to users under ordinary and likely accident conditions and the assurance the.t the device can be used by persons I
without training per 10 CFR 32.51.
3.
What is the maximum air gap? A range of 2" and 12" is specified in the section 1.e of
. Radiation Safety Information, however, up to a 24" air gap is provided in the radiation profiles.
QUALITY ASSURANCE 1.-
Quality Control (OC) and Quality Assurances (QA) Information provided is not sufficient to adequately evaluate the program. The following information are missing: (1) the materials of construction and the final assembly meet the design specifications; (2) the assembly method; and (3) dimensions and tolerances. Refer to Regulatory Guide (RG)
. 6.9 (enclosed) for guidance on what are considered essential elements of an adequate QA and OC program. Please resubmit revised applicable sections of AGT's manual of
" Radiation Safsty Policies and Procedures." and compare them against RG 6.9.
INSTALLATION 1.
Provioe any special procedures that need to be followed when this device is installed at
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the user's facility. These should include the verification of the integrity of the mounting and whether any special attachments are needed.
2.
Provide the likely doses to persons mounting the device if installation is to be performed by the customer.
SAFETY INSTRUCTIONS
-1.
Provide the Site Survey Form used by your technicians to document infield radiation measurement taken around the installed gauges.
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s R. Cook ACCOMPANYING DOCUMENTATION 1.
Provide copies of regulations governing use and transpot'ation of the product and a ~
listing of regulatory authorities who license possession and u:9 of the pro'Juct for general distribution.-
Enclosed are RG 6.9 and NUREG 1556, Vol. 3 for your references. Please note that no further review action will be performed until we receive a resubmitted application containing the information and clarifications requested above. If you have any questions, please contact me at (301) 415-5787 or Mr. Steven Baggett at (301) 415-7273. Please contact me to arrange a' meeting.
Sincerely,
/s/
Seung J. Lee, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated cc: SKimberley, LFDCB Distribution:
SSD-98-36 NE0d File Center DOCUMENT NAME: C:\\SJL\\AGT8.DEF T2 receive a cop' of thle document, Indicate In the box: "C' = Copy without attachment / enclosure "E' = Cop t with attachment / enclosure 'N' = No copy OFFICE MSB lE MSB s l
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l NAME SLee 6//
SBagg6tt l
DATE 10/23/98 10/ t4/98 l
OFFICIAL RECORD COPY o r n, c. e-
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