ML20217C338
| ML20217C338 | |
| Person / Time | |
|---|---|
| Issue date: | 03/09/1998 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bishop W AFFILIATION NOT ASSIGNED |
| References | |
| NUDOCS 9804230271 | |
| Download: ML20217C338 (1) | |
Text
I I
March 9, 1998 l
Mr. William J. Bishop l
V.P. Business Development l
SMV America l
8380 Darrow Road l
Twinsburg, OH 44087 l
l
Dear Mr. Bishop,
This letter is in response to your correspondance dated January 6,1998, and February 18,1998. Your letters do address the deficiencies that we had identified in your application with two exceptions.
l Specifically, (a) prototype testing and (b) the radiation profiles of your Model PS 96 transmission attenuation correction (TAC) source holder (i.e. Items 3 and 12 in NRC letter dated November 4,1997) are still not addressed sufficiently for the reasons discussed below.
L Regarding prototype testing, please note that devices for NRC regiWation must be tested in accordance with applicable industry or consensus standards. We do recognize that the Model PS 96 source holder had been tested to and was found to meet the French standard "D4cret No.86-1103 du 2 Octobre 1986." However, this standard addresses occupational exposure levels for operators of the equipment, while NRC requirements for prototype testing call for structural integrity tests.
For your information, I enclosed a copy of NRC Report No. NUREG-1550, " Standard Review Plan for l
Applications for Sealed Source and Device Evaluations and Registrations." Please note that Section 5.8, Prototype Testing, of the report delineates the information that is needed for approval of your application. Appendix E lists the standards that are customarily used for prototype testing.
Regarding radiation measurements, we do note that you propose to obtain a radiation profile for each source which is to be used in your source holders. In order for us to complete evaluation of your application, we need the radiation profile around the TAC device with the source loaded, and not the I
profile around the source by itself outside the device. Section 7.8, External Radiation Levels, of the NRC report referred to above, provides you further information.
Because of the lack of sufficient data regarding these subjects, we will consider your application abandoned by you until we receive further information from you. This action is without prejudice to the resubmission of a complete application. We will place the drawings and your application in storage for one year from the date of this letter. If you wish to discuss this matter with us, you may call me at 301 415-7904 or Mr. Steven Baggett, Deputy Branch Chief, Materials Safety Branch, at 301415-7273.
l Sincerely, I5I John P. Jankovich, Ph.D., Sr. Engineer 9804230271 980309 Materials Safety Branch PDR ORG NOMA Division of industrial and "N
Medical Nuclear Safety, NMSS
}
Enclosure:
as stated V
Distribution:
NE01g IMNS r/f 97-10 1 @ G.$
DOCUMENT NAME: P:\\SMV.VOD To receive a copy of this document, indicata in the boa:
"C" = Copy without attachment / enclosure
'E' = Copy with attachment / enclosure "N' = No copy OFFICE IMNS
[
l t, IMNS /3 A) 7 NAME JJan,kovidh/lj SBaggett' DATE 02/4/98 02/ W98 OFFICIAL RECORD COPY
)