ML20199F581
| ML20199F581 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1999 |
| From: | Bhachu U NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Doruff M AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9901210357 | |
| Download: ML20199F581 (3) | |
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January 19, 1999 If you have any questions, please contact rne at (301) 415 7894.
Sincerely, Original signed by Ujagar Bhachu Ujagar S. Bhachu, Mechanical Engineer Materials Safety Branch Division of Industrial and Medica 1 Nuclear Safety Office of Nuclear Material Safety And Safeguards j
Distribution:
SSSS r/f SSD-98-96 NEO1 IMNS r/f NMSS r/f NRC Central File h
DOCUMENT NAME: P:\\NYAM To receive a copy of this document, indicate in the box: "C" L Cap wth attachrientlenclosure "E" - Copy with attachment / enclosure
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NAME USBhachu 11 4 CT$adbald l' DATE 01/ff/99 01/T/99\\ '
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OFFICIAL RECORD COPY i
1, O '3 b b 9901210357 990119 PDR RC SSD pop
January 19, 1999 4
Mr. Mark A. Doruff, CHP Director, Environment and Safety Regulatory Affairs i
Nycomed Amersham 26236 South Clearbrook Drive 4
Arlington Heights,IL 60005
Dear Mr. Duff:
We have received your application dated October 28,1998, which requested an amendment to registration certificato IL-136-S-255-S You have indicated that you wish to change the location from which these sources will be distributed to your South Plainfield, New Jersey location. Since i
New Jersey is not an Agreement State, the registration of the source is being reassigned to the NRC. Therefore, NRC staff will perform a new complete safety evaluation to ensure that the source meets all NRC regulatory requirements. We have performed a cursory review of the application and the review has indicated we need the following additional information and clarifications to continue with our review:
1.
Please submit a copy of an FDA 510K form or pre-market approval from FDA.
2.
Although Drawing VZ-1271/4E, contains much of the information necessary for our review, certain additional details are needed. Please provide a more complete description of the source capsule, including a complete package of engineering drawings. The drawings should show the overall source capsule with all dimensions, specification of materials and the construction of the assembly of the source with all parts labeled. The only specific dimensions related to source wall thickness is the aggregate thickness of the two side walls. Please include descriptions of all dimensions of the inner walls. Please include the weld filler material specifications, diameter and details of any chamfer on the end cap and the dimensions of the eyelet shown on drawing VZ-1271/4E, and depth of laser-etched, " engraving," or " electro-etched" labels, with tolerances. Also, please state whether the prototype you tested was labeled and/or etched in accordance with coding you specified in your application.
3.
The description in the draft registration certificate you provided referred to an overall maximum length. Please explain if this refers to source manufactured to dimensions or tolerances other than those indicated on drawing VZ-127-1271/4E or drawings l
requested in item 2 of this letter, or to a nominal value with a range. If to a range of sizes, it may be necessary to assess prototype testing to assure sufficient applicability of g,0 similar test data.
4.
Please submit details about the conditions of use of the source. We are specifically interested in operating temperature ranges, vibration conditions, and potentially harsh environments. A description of possible or potential accident conditions is also needed.
Further your application stated that the source should not be subjected to long term exposure to materiais such as plastics which might degrade due to radiation exposure
'O and create corrosive agents, but stated that the shipping materials include plastic sleeves. Although the description stated that the Type A packages are not intended for use for long term storage, the instructions booklet you enclosed with the application did not address this issue, nor instruct the user to transfer the source from shipping container on a particular time frame, nor did the application address sources prepared but not shipped. Please demonstrate that use of the described shipping container does not create a corrosive environment, or otherwise cause the source to be subjected to conditions outside the stated parameters, which precludes storage in a corrosive environment.
5.
Correct labeling of the source is important to ensure persons near the source are aware of the radiation hazard. Although, we recognize that the source is less than 3mm in diameter, please indicate pursuant to 17 CFR 32.74 why you believe the source is too small to provide a small radiation caution symbol (trefoil).
6.
Prototype testing of a source should demonstrate the source's durabHity. You stated that the source attained a classification of C64444 in accordance with ANSI N542-1977, that classification standard does not specifically provide classification for brachytherapy sources, and instead refers to an information basis only to ANSI N44.1. That standard includes an impact Test, the conditions of which are different from those stated in ANSI N542-1977 or its successor standard ANSI N44.6-1997. As such, the acceptance criterion in ANSI 44.1 was not clearly met by the tests described in your application.
Please demonstrate how tests you performed will relate to applicable drop and impact test requirements. Please demonstrate that under likely conditions of use and foreseeable accident conditions, no leakage of radioactive material will occur.
7.
As a part of your application you did not provide a copy of AEA Technology OSA'S quality control and assurance program, nor state specifically the ISO 9001 version and the date or the certification. Instead, the application stated the internal Quality Assurance Manual and date. Please submit information regarding the U.S. program for verification of he source manufacturer's adherence to the quality assurance manual or a quality contrsi program used for the manufacturing and d%:ributing the source.
Please provide details regarding the manufacturing facility 4 certification pursuant to ISO 9001 or NUREG 1556 Vol. 3, which you stated you used in preparation of the application, should prove helpful in meeting our requirement.
Please submit you application in daplicate within 30 days from the receipt of this letter, being certain to address the major areas of concern cited herein.
i
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