ML20141P245
| ML20141P245 | |
| Person / Time | |
|---|---|
| Site: | 07100551 |
| Issue date: | 01/10/1986 |
| From: | Horndasch A SIEMENS CORP. |
| To: | Mcdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20141P246 | List: |
| References | |
| 26302, NUDOCS 8603190183 | |
| Download: ML20141P245 (1) | |
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January 10, 1986 Office of the Nuclear Material Safety and Safeguard's hhhh U.S; Nuclear Regulatory Commission Washington, D.C.
20555 Attn:
Mr.'C. Mcdonald, Director
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Dear Mr. Mcdonald:
Please find enclosed three sets of documentation that we like to have approved in order to comply with 10 CFR 71 Sub. Part H. Quality Assurance Program.
It contains the following information:
1.
Information for Med. Technician #411 (T2.910.012.01.01.05)
Gammatron 1, 2, 3, R, S and Cs-Gammatron; Work on loaded Gammatron units, dated 3.77.
2.
General remarks and preparatory work for loading and unloading of a Co-60 or Cs-137 source.
Technical information #412 dated 9.77 (T2.910.071.01.01.02) 3.
Gammatron 1, 2,
3, R and Caesa.
Loading and unloading.
Technical information #413 dated 11.77 (T2.910.033.01.01) 4.
Gammatron S65/S80 - Loading and unloading. Technical information #416 dated 5.78 (T2.050.033.03.03.05) 5.
Check of shipping container Model S1747 for Co-60 or Cs-137 sources.
Safety check list for installation.
Technical information #427 (T2.910.036.01.01.05).
Please note that the only teletherapy units sold in the U.S. by SIEMENS MEDICAL SYSTEMS are the Gammatron 3, Gammatron S80 and the Cs-Gammatron.
I hope that this information is sufficient for a quality assurance program.
Should there be any questioris.
lease do not hesitate to contact me.
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DEC 2 0 985 License No. 29-10598-01 Docket No.
30-00368 Control No. 14146 Siemens Corporation X-Ray Division ATTN: Mr. A. Horndasch 186 Wood Avenue South Iselin, New Jersey 08830 Gentlemen:
Please find enclosed the renewal of your NRC Material License.
Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the Region I Material Licensing Section, (215) 337-5239, so that we can provide appropriate corrections and answers.
Please be advised that you must conduct your program involving licensed radioactive materials in accordance with the conditions of your NRC license, representations made in your license application, and NRC regulations.
In particular, please note the items in the enclosed, " Requirements for Materials Licensees."
Please be advised that you are required to submit the quality assurance program included with your June 5,1985, letter to the NRC Office of Nuclear Material Safety and Safeguards for their review. You are advised that 10 CFR 71.16(c) requires that, prior to the use of any Type B package for the shipment of licensed material, each licensee obtain NRC approval of its quality assurance program. The NRC Office of Nuclear Material Safety and Safeguards is responsible for granting this approval. You should direct any correspondence regarding the approval of your quality assurance program to the Director, Office of the Nuclear Material Safety and Safeguards, U. S. Nuclear Regulatory Commission, Washington, D.C.
20555.
The Model S.1747 shipping container is approved in a foreign national competent authority certificate which has been revalidated by the U. S. Department of Transportation. Accordingly, this container may be used only for shipments made to or from locations outside the United States under the general license issued in 10 CFR 71.16. As stated in General Condition VI. of the IAEA Certificate of Competent Authority, the certificate does not apply to a shipment originating and terminating in the United States.
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. 1 Since serious consequences to employees and the public can result from failure to comply with NRC requirements, the NRC expects licensees to pay meticulous attention to detail and to achieve the high standard of compliance which the NRC expects of its licensees.
You will be periodically inspected by NRC. ~A fee may be charged for inspections in accordance with 10 CFR Part 170.
Failure to conduct your program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you. This could include issuance of a notice of violation, or in case of serious violations, an imposition of a civil penalty or an order suspending, modifying or revoking your license as specified in..the General Policy and Procedures for NRC Enforcement Actions,10 CFR Part 2,, Appendix C.
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We wish you success in operating a safe, an,d, eff_ective>-licensed program.
- - Sinc W
hn D. Kinneman, Chief luclear Materials Safety Section A Division of Radiation Safety
-. and Sateguards
Enclosures:
1.
Amendment No. 15 2.
Requirements for Materials Licensees _.
3.
NRC Forms 3 and 313 4.
10 CFR Parts 2, 19, 20, 30,'and'170
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