ML20155C908
| ML20155C908 | |
| Person / Time | |
|---|---|
| Issue date: | 03/16/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Piorek S AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20155C764 | List: |
| References | |
| SSD, NUDOCS 9811030049 | |
| Download: ML20155C908 (48) | |
Text
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UNITED STATES p
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j NUCLEAR REGULATORY COMMISSION WASHlHGTON, D.C. 20655-0001 o
March 16, 1998 Dr. Stanislaw Piorek Vice President, Research and Product Development Metorex, Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618
Dear Dr. Piorek:
This letter is in response to your application dated October 16,1997 requesting to add Model Nos. A3895-1 and A3895-2 sources and the Model SIPS x-ray fluorescence analyzer probe to Registration Certificate #NR-701 D-101-B. We have completed an initial evaluation of your request. However, to continue our evaluation, the following information is necessary for the SIPS probe:
/1.
Please submit complete and detailed engineering drawings including dimensions, tolerances, materials of construction, and assembly methods (screw, welds, etc.).
Describe how sources are held in place as well as the mechanical operation of the shutters. In your response, please also include technical specifications for the material of the "kapton" foil.
2.
Please specify the leak test frequency for the Model SIPS probe.
/3.
Provide the conditions of use of this product. Give details on the useful or expected life of the product, temperature ranges, humidity levels, expected shock or vibrations, or other extremes.
4.
Please provide results of prototype testing that demonstrates the effectiveness of the containment, shielding, and the safety features under both normal and likely accidental conditions of handling, storage, use, and disposal of this Please provide the tests and procedures used. Also, provide details on t e drop, i act, and temperature testing associated with transportation of the product.
5.
Please provide radiation profiles for each possible mode of operation (including readings for all sources in shielded positions) at distances of 5,30, and 100 cm both with and without cap. Also, please demonstrate the safety criteria of 10 CFR 32.51 are met including dose scenarios for all activities the user will perform with the device.
6.
Details of Quality Control (QC) and Quality Assurances (QA) were not reported in your application. Please describe what measures are taken to ensure that your product is manufactured and distributed in accordance with the representations made in your application. For measures regarding quality assurance, please see Regulatory Guide 6.9 enclosed for your information.
9011030049 981029
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2.
Safety instructions were not included in your application. Please provide instructions involving the operation, maintenance, calibration, damage / failure, specific warnings, leak testing, and radiation surveys of the product.
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/The following information is hs~arrf67th'e Model A3895-1 and A3895-2 sources: sfr c errcn.
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Please specify in which of the devices, that are listed in Registration Certificate #NR-701-D-101-B, the new sources will be used.
2.
Provide complete information on the radiation profiles of all the devices that the sources will be used in.
Because of the limited information provided in your letter dated October 16,1997, we are closing this action at this time and will take no further action until we receive a comolete application without reference to previous submissions. We have enclosed documents NUREG-1550; NUREG-1556, Vol. 3; and Regulatory Guide 6.9 for your use. These documents provide guidelines for preparing a complete application. We would suggest you may also obtair, the services of a consultant b assist in co.npleting the applicaticn. If you have any questions, please contact me at (301) 415-7904, or Mr. Steven Baggett at (301) 415-7273.
Sincerel,
lS i John P. Jankovich, Ph.D., Sr. Engineer Sealed Source Safety Section l
Medical, Academic, and Commercial Use Safety Branch Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
as stated Distribution:
IMNS r/f SSD-97-64 NE01 SSD File # NR-701-D-101-B P:\\NR701101.DEF DOCUMENT NAME:
o recobre e copy of this document, Indicate in the box: 'C* = Copy without attachtrent/ enclosure
- E' = Copy with attachment / enclosure N* =
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