ML20248J592
| ML20248J592 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1998 |
| From: | Compton E NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Piorek S AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9806090201 | |
| Download: ML20248J592 (2) | |
Text
,8 p u4 q i!L UNITED STATES
g NUCLEAR REGULATORY COMMISSION I
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WASHINGTON, D.C. 20066-0001 June 3, 1998 Dr. Stanislaw Piorek Motorex, Inc.
Princeton Crossroads Corportste Center 250 Phillips Boulevard Ewing, NJ 08618
Dear Dr. Piorek:
This letter is in response to your lenu.- dated April 18,1998, providing additional information in -
support of your application. However, in order to continue our evaluation of the SIPS Probe, the l
following still needs to be addressed:
l 1.
The NRL relies substantially on p stotype testing to verify that the device will remain operational when subjected to conditions associated with normal handling and use, and will maintain its containment integrity (e g., no loss of byproduct material nor significant -
loss of shielding) with the necessary safety features remaining operable. Metorex has submitted test data verifying cycling testing of the shutter mechanisms. However, Motorex needs to demonstrate that the device will maintain its integrity after being subjected to likely impacts encountered during normal use. The device does not need to remain operational after the impact but there must not be a loss of radioactive material nor significant decrease in shielding. This can be accomplished by subjecting a prototype unit to multiple drops onto a hard surface from the height of the device during normal use. Please provide detailed descriptions of the testing, conditions, and results.
2.
Please clarify Table 2, " Measured Dose Rates For SIPS Probe." Spm:ifically describe
' what the headings mean. For example, in column 2 of the table, what does "Cd closed" "Cd open" mean; was the Fe-55 source shielded or un-shielded? In ceder for us to perform our review, we need complete extemal radiation !avels for the three source combinations with shutter open and closed for each source.
The radiation levels provided in your response were taken with the probe pressed against a 2 mm thick steel plate. This takes in account scattering offects and normai use levels. However, the probe could be accidentally pointed at the user or another individual. Thorofore, please give extemal radiation levels with and without the probe pressed against the steel plate.
- D 3.
Please indicate the location of proposed labels on the probe. In ad jition, describe the matenais, dimensions, and color (s) of the labels..
4.
Plasse describe all radiological safety and protection instructions that are involved in the in-depth training course included with purchase of the device.
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5.
Lastly, please clarify the statement about quality control testing upon completion.
Specifically, confirm that a leak test, shutter test, and radiation survey will be d*
performed prior to distribution.
Please note that it is NRC practice that only prod icts which are essentially identical in design, function, construction, and which vary only in a dimensional capacity, or in the sources used or their application, may be grouped together on a single registration certificate (see NUREG 1556, Vol.3, Section 13.3). The SIPS probe differs in use from the other probes listed in NR-701-D-101-B. Therefore, we intend to register the SIPS probe under its own registration certificate.
Please provide the requested information within thirty (30) days. If you have any questions, please contact me at (301) 415-5799 or Dr. John Jankovich at (301) 415-7904.
Sincerely,
/5 Eric B. Co pton, Engineering Aide Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
lERIAuff SSD-98-43 NE01 DOCUMENT NAME: H:\\ERIC\\COMPLTR\\METOREX.DEF Ta receive e co9y of thle docun.ent. Indicate in the bos: 'C' = Copy without attachment / enclosure
- E' = Copy with attachment / enclosure
l sa NAME ECompton gC JJankovich 6 l SBaggett DATE 6/ / /98 6/ l /98 bi 6/ J /98 OFFICIAL RECORD COPY EC FRF CEidiEB CDPV
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