ML20248L260
| ML20248L260 | |
| Person / Time | |
|---|---|
| Issue date: | 05/29/1998 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Demke T AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9806110047 | |
| Download: ML20248L260 (2) | |
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION L1 WASHINGTON, D.C. 20ee6 4001 N...,,/
l May 29, 1998 l
Thomas A. Demke, D.D.S.
GE Medkr* Systems 3000 N. s:.!andview Blvd., W-641 Waukesha, WI 53188
Dear Dr. Demke:
This letter is in response to your letter dated March 19,1998, providing additional information in support of your application. However, in order to continue our evaluation of your application, the following still needs to be addressed:
1.
The NRC relies substantially on prototype 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. Specifically, GE Medical Systems needs to demonstrate that the device will maintain its integrity after being subjected to repeated cycling and likely impacts during use.
Cycle testing must demonstrate that the device will remain operation after the expected number of cycles over the years of use of the device (stated as 10 years in your application). This can be accomplished by subjecting a prototype unit to the expected number of cycles a device may encounter during its useful life.
GE Medical Systems may demonstrate the device will withstand likely impacts encountered during 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 shieldirg. This can be accomplished by subjecting a prototype unit to multiple drops on to a hard surface from the height of the device during normal use.
2.
Due to the location of the mechanical indicator, if the source holder were to become stuck or an LED were to fail there would be a tendency for the operator to look at this indicator by putting his or her bcdy into the beam. Therefore, please provide an estimate of the dose an operator might receive based on the dose rates and length of time spent in the beam. In addition, provide justification for the location of the indicator
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and/or indicate what measures would be needed to remedy this problem (e.g. mcving g
the location of the indicator, implementing administrative methods including surveying the area to determine if source is shielded).
3.
Please describe the quality control functions (e.g., audits of DBA and/or inspections or products performed by GE Medical Systems) that will be implemented by GE Medical Systems to verify that DBA is manufacturing and distributing the products in accordance with GE's application.
Please note that we are still in the process of evaluating your request that certain information be withheld from public disclosure. This issue will be addressed in a separate letter.
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9806110047 990529 PDR RC Q[
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May 29, 1998 l '9..,
- t Please' provide the requested information within thirty (30) days. If you have any questions,-
please contact me at (301) 415-7868 or Mr. Eric Compton at (301) 415-5799.-
Sincerely, petwicignd W John W. Lubinski, Mechanical Engineer Materials Safety Branch Division of Industrial and _
Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
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k DOCUMENT NAME: H:\\ERIC\\COMPLTR\\GEMED.DEF T) esee6ve a sepy of thle document, indicate in the bos: 'C' - Copy without attachment / enclosure
- E" = Copy with ettschment/ enclosure
- N' = No copy OFFICE MSB lr MSBJA l l
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NAME ECompton rc JLubinkki i
DATE 05/ 1 /98 05/z? /98 1
OFFICIAL RECORD COPY
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