ML20149L088
| ML20149L088 | |
| Person / Time | |
|---|---|
| Issue date: | 02/13/1996 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gregoire M NORDION INTERNATIONAL, INC. |
| References | |
| SSD, NUDOCS 9602230234 | |
| Download: ML20149L088 (2) | |
Text
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- a UNITED STATES s
j NUCLEAR REGULATORY COMMISSION t
WASHINGTON, D.C. 20665-0001
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February 13, 1996 Marc Gregoire Nordion' International, Inc.
447 March Road P.O. ' Box 13500 Kanata, Ontario, Canada K2K 1X8
Dear Mr. Gregoire:
This letter is in response to your application dated October 17, 1995, requesting registration of the Model C-337 radiography source assembly.
We i
are in the process of evaluating your request.
However, in order to continue our evaluation, the following information is necessary:
1.
Your application indicates the source assembly will be used with the Amersham 660B exposure device.
Please provide a complete listing of all other equipment (e.g. Amersham 660A, AE, BE, source changers) with which the source assembly will be used.
Please include the maximum source activity for each combination.
2.
Please provide a drawing, including dimensions, tolerances, and materials of construction, of the male connector that will be used with the source assembly and specification for swaging the connector to the drive cable, 3.
Please provide details of construction of the inside of the source capsule.
The details should include materials of construction and minimum void space within the capsule.
4.
Please verify that all Model C-337 source assemblies will be manufactured under the provisions of the quality assurance program submitted, and approved by NRC, in accordance with 10 CFR Part 71, Subpart H.
5.
Please indicate how Nordion verified that the Amersham exposure device, when incorporating a Model C-337 source assembly, will meet the following requirements specified in 10 CFR or ANSI N432-1980:
5.1 The coupling between the source assembly and control cable cannot become disconnected if cranked outside the guide tube.
5.2-The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. (10 CFR 34.20(c)(1))
5.3 The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. (10 CFR 34.20(c)(2))
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M. Gregoire 5.4 When the exposure device is locked, it shall not be possible to remove the cource assembly from the exposure device or to move the shielding so as to expose the sealed source.
(ANSI N432-1980, section 5.1.2.1) 5.5 It shall not be possible to operate the lock unless the source assembly is in the fully shielded position.
l (ANSI N432-1980, section 5.1.2.4) 5.6 It shall not be possible to remove the source assembly through the back of the exposure device even when the exposure device is unlocked. (ANSI N432-1980, section 5.1.2.5)
.6.
Please indicate how Nordion verified that source changers, when incorporating a Model C-337 source assembly, will meet the following requirement: " Source changers must provide a system for assuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the device cable to or from a source assembly."(10CFR34.20(c)(9))
7.
Your application indicates that a large amount of cycling using the Amersham controls was performed prior to starting the endurance: test.
Please provide the approximate number of cycles.
In addition, your.
application indicates that since neither the source nor male connector enter the drive cable sheaths, the wear cannot be attributed to the source assembly.
Please provide additional information to justify this statement.
3s.
Please provide the requested within 30 days.
If you have any' questions,.
4 please contact me at (301) 415-7868 or Mr. Steven Baggett at'(301) 415-7273.
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Sincerely, t
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Original Signed by ~
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John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety.
Office of Nuclear Material Safety and Safeguards Distribution:
SSSS Staff SCDB r/f SSD-95-110 NE01 DOCUMENT NAME: C:\\ FILES \\SSDS\\NR220111.DEF Ts,eoelva a copy of ttde deemnent, Indicate in the box: 'C" = Copy without attachment / enclosure
- E" = Copy with attachment / enclosure
- N" = No copy
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DATE 021/J/96
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