ML20212G134
| ML20212G134 | |
| Person / Time | |
|---|---|
| Issue date: | 11/04/1997 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Vernon P AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9711060041 | |
| Download: ML20212G134 (3) | |
Text
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NUCLEAR REGULATORY COMMISSION s
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WASHINGTON, D.C. 2066Hooi l
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November 4, 1997_
Mr. Phil Vemon SMV America 8380 Darrow Road Twinsburg, OH 44087
Dear Mr,
Vernon:
This letter is in response to your application dated March 7,1997 requesting registration of the Model PS 96 sourceholder. We are in the process of evaluating your request. However, in order to continue our evaluatio7, the following information is necessary:
q 1.
Please clarify the relationship between SMV America and SMV intemational (France) regarding who actually manufactures the device?
2.
The engineering drawings provided in your application did not include dimensions, tolerances, or proper parts labeling. Please provide conventional engineering drawings showing dimensions and tolerances. A parts list, including the materials of construction (with material desigraation, if applicable), should accompany the drawings. There is no need to remake design drawings that the manufacturer r n tready have; English translation, handwn. ten next to the corresponding French 13., is acceptable.
3.
The prototype testing report from Labortoire Central des industries Electriques (LCIE) refers to a French standard, Decree No. 861103 (October 2,1986). Since we are not familiar with this standard, you will need to provide a copy, with English translation.
a 4.
Section 4.1, Conditions of Use, did not address the expected life of the device.
S.
No assembly methods are discussed in Section 4.2, Detcils of Construction. Please describe the various assembly methods (ie screws, welding, adhesives, etc.) employed in device construction.
1 6.
Section 4.2.3.5 discusses the collimator and the narrow linear beam of radiation G
emerging from the emitter. The dimensions of this beam are not specified here.
However, in Section 3.3.1 of the LCIE report, some dimensions are given for the beam.
Please clarify the dimensions of the radiation beam emerging from the emitter. Also, identify the adhesive used to hold the lead collimator together, and demonstrate technically that the adhesive will not be detrimentally affected by exposure to radiation.
Furthermora, the radiation profile in the LCIE report, made reference to Figures 1-6 on page 8, which is missing. Page 8 will need to be included with this report.
7.
' No dimensions are given for the copper filter discussed in SecUon 4.2.3.6 of your application. The engineering drawings, with proper dimensions and material designatiori, may suffice. Additionally, details as to attaebing the copper filter to the emitter should also be described (See item 5).
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2 8.
Section 4.3, Labeiing: the label should include the model number, serial number, isotope, activity, distributor's name, date of assay, trefoil symbol, and the word's
' CAUTION-RAD!OACTIVE MATERIAL." An additional label containing limiting -
conditions of use or other information necessary for safe use of the product may also be used. Please show the locations of alllabel(s), and indicate the material and method of mounting the label (s) to the device. In addition, i'. is nut clear whether the trefoil s/mbol ~
is properly used; the LCIE report indicstes that the trefoil symbol is green, when it should be magenta, purple, or black. Please refer to 10 CFR 20.1901 and confirm that the symbol meets the requirements of this section. 'A diagram of the labelis suggested.
- 9.
In Section 4.6.2, Maximum Dose Rate to an Operator, the maximum patient load is stated to be 10 patients per day. However, the LCIE report lists the maximum number of patients to be 20 per day. Please clarify what the maximum patient load is expected.
10.
In your response please address the issue that corrosion between different materials is unlikely to occur, considering the device maybe exposed to high humidity (up to 95%)
conditions? Without a parts lists and material specifications for the components, we cannot determine materials compatibility.
11.
Please note, that leak-testing of the source assembly is not to exceed six months. Leak test intervals of longer than six months require sufficient justification that the longer intervals is warranted. Please provide a determination that the sources are acceptable for an extended leak test interval. The provisions of 10 CFR 32.51(b) describe the information that you need to provide.
12.
The SMV Quality Control Plan provided is too general, During the fabrication, the quality assurance measures must be implemented to ensure that devices meet the design specifications and prototype tests. At a minimum, the quality assurance program needs to ensure that: the materials of construction and the final assembly meet the design specifications; the final product is leak tested; a final radiation profile is performed; and a test that verifies the product operates as intended, including all safety functions, is performed. Additionally visual and mechanicalinspection of components should be performed on finished products at a regular basis.
13.
Section 3.2 of the LCIE report indicates that 5 red emergency stop switches are to be activated by hand to shut down the camera and Section 3.3 refers to an audib!e darm that signals if the shutter is manurtly opened. These safety measures are not addressed in the main application. Please, delineate these safety measures in more detail.
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i t Please provide the necessary information within 30 days. I h:ve enclosed copies of the Standard Review Plan for Applications for Sealed Source and Device Evaluations and
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Regislations' (NUREG 1550) and Regulatory Guide 6.9 regarding qualdy assurance programs t
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to aid you in preparing your response. If you have any questions, please contact me at (301) 415 7904 or Mr. Steven Baggett at (301) 415 7273.
Sincerely, I*e l r
John P. Jankovich, Ph D. Senior Engineer
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Medcol, Academic, and Commercial Use Safety Branch Division ofindustrial and Medtal Nuclear Safety, NMSS
Enclosures:
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