ML20149L273
| ML20149L273 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/1996 |
| From: | Thomas Rich NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Roughan C AMERSHAM CORP. |
| References | |
| SSD, NUDOCS 9602260060 | |
| Download: ML20149L273 (2) | |
Text
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UNITED STATES g
i NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D.C. 20066 4001 I
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February 23, 1996
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Cathleen Roughan Amersham Corporation 40 North Avenue Burlington,'MA 01803 F
Dear'Mrs. Roughan:
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.This letter is in response to your letter dated January 18, 1996, requesting registration of collimators. We have reviewed your application and find that l
there.is insufficient prototype tests and supporting documentation to approve j
this equipment as meeting the requirements of 10 CFR 34.20.-
4 No information was provided to support that the above items have been tested and passed the endurance test requirements listed in American National i
. Standard N432: " Radiological safety for the Design and Construction of Apparatus for Gamma' Radiography" (ANSI N432-1980). As you are aware, 10 CFR 34.20 incorporates the ANSI standard into the regulations.
Under Section 8.9.1, it states, "The endurance test requires demonstration that the gamma radiography system will remain operational after 20,000 cycles." It then lists the equipment and procedures for performing the endurance test.
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The ANSI standard defines the gamma radiography system as, "All components necessary to make radiographic exposures, including the exposure device, i
source assembly, control, and other components associated with positioning the source such as source guide tubes, exposure head, and collimators, if used."
It is clear from the definitions, that collimators are part of the radiography system and that prototypes are to be endurance tested.
In order for us to continue our evaluation we need the following:
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1)
Endurance test results for the endurance test prescribed in Section 8.9, e
ANSI N432-1980, for each collimator that Amersham plans to manufacture l
and distribute and any that Amersham has sold in the past that they want to register on behalf of their customers.
In lieu of testing _each collimator, you may provide an engineering analysis that. demonstrates that these collimators would likely pass the endurance' test if they were tested.- The analysis must be based on a 4
similar design (e.g.~, source stop) that has been tested in accordance with the standard.
Your engineering analysis, at a minimum, must compare the tested design.against the other collimator~ designs and address'the effects of the materials of construction (i.e., wear resistance, strength, corrosion properties), the wall thickness, the length (i.e., resistance), any bends within the collimator including the maximum bend. angles and the minimum bend radii over which the bends will be produced (curvature), and any other properties that would have an effect on the outcome of the endurance test.
In addition, please provide operational history for each collimator design that has not been subjected to the endurance test.
T 9602260060 960223 i
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s 2)
In your letter you stated that you have enclosed drawings for the collimators that allow the source to come in direct contact with the sealed source. We did not receive these drawings with the package.
Please provide these drawings and a generic drawing for future i
collimator designs which show the minimum and maximum specifications, including the length, minimum wall thickness, inside diameter of hole j
and its shape, length and design (e.g., curvature, location), and j
materials of construction.
4 3)
Please provide the procedures that Amersham will follow for future designs to ensure that they meet the appropriate tests and are designed j
within the specifications of the drawing to be provided in item (2).
4)
An explanation on how the components will be labeled.
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5)
The conditions of use and likely environments that these items will be subjected to during use (i.e., temperature, pressure, humidity, impact, puncture).
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6)
You also stated in your letter that you have attached a cross reference table which indicates which collimator can be used with the various 4
j devices. We did not receive this list and request that you provide us a copy.
Please provide the requested information as soon as possible.
If you have any questions, please contact me at (301) 415-7893 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, Thomas W. Rich, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch 3
Divition of Industrial and j
Medical. Nuclear Safety i
Office of Nuclear Material Safety And Safeguards i
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Distribution:
SSSS Staff SCDB r/f SSD-96-05 NE01 $
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