ML20205R032

Corrected Pages 4 & 5 of Registry of Radioactive Sealed Sources & Devices Safety Evaluation of Sealed Source for Therapeutic Brachytherapy Seeds.Certificate:NR-569-S-101-S

ML20205R032
Person / Time
Issue date:	04/21/1999
From:	NRC
To:
Shared Package
ML20205R019	List: ML20205R016 ML20205R032
References
SSD, NUDOCS 9904220159
Download: ML20205R032 (2)

Text

l 4

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

No,; NR-569-S-101-S DATE: April 21, 1999 PAGE 4 OF 6

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SOURCE TYPE: Therapeutic Brachytherapy Seeds OUALITY ASSURANCE AND CONTROL:

RSNP used two basic types of radiation detection systems in the assay of seed within 15% accuracy:

1. A fixed-geometry ion chamber is used for rapid counting and assay of seeds required to fill an order or to batch a shipment of irradiated seeds.

2. A Capintec dose calibrator is used to confirm the readings of, and document the perfonnance of the ion chamber assay systam.

To document the performance of the ion chamber, the following tests are performed:

Daily constancy check for reproducibility in measuring a Cs-i 137 tube source, which has been mounted in a plastic rod to assure constant geometry. A log of the results is maintained.

• Quarterly intercomparison study to compare the measurement capabilities of the ion chamber sistam and the dose calibrator. Logs of these tests are maintained.

To calibrate dose calibrators, the following tests are performed:

• Constancy at least once each day prior to assay of seed strengths

• Linearity at installation and at least quarterly thereafter

• Accuracy at installation and at least annually thereafter LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

. The sources shall be distributed to persons specifically licensed by the NRC pursuant to 10 CFR 35.59 and 35.400 sections or equivalent provisions of an Agreement State.

9904220159 990421 PDR RC

• SSD PDR

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

No. .:. NR-569-S-101-S DATE : April 21, 1999 PAGE 5 OF 6 i

l SOURCE TYPE: Therapeutic Brachytherapy Seeds

! l I

l LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont'd)-

. Due to the short half-life of the Gold-198, these sources do not have to be leak tested.

l .

Handling, storage, use, transfer, and disposal: To be

! determined by the licensing authority.

The small size of these sources will require a higher level of accountability during use to prevent source misplacement and loss.

. This registration sheet and the information contained within l

the references shall not be changed or transferred without the written consent of the NRC.

l l

SAFETY ANALYSIS

SUMMARY

Based on our review of information contained within the references cited below, that these seeds are identical to seeds previously deemed acceptable for licensing purposes by the NRC and the States of Texas and Utah, that the high purity gold encased in platinum is inert and the 2.7 day half-life of Gold-198, we continue to conclude that the Model RSNP-Au seeds are acceptable for licensing purpee.;.

Furthermore, we continue to conclude that this source design would be expected to maintain its containment integrity for conditions of use which might occur during uses specified in this certificate.

REFERENCES:

The following supporting documents for the Model RSNP-Au gold seeds are hereby incorporated by reference and are made a part of this registry document.

I

,, April 21, 1999 Edd Johnson Radiation Safety and Nuclear Products P.O. Box 70449 West Valley City, UT 84170 l

Dear Mr. Johnson:

There is a typographical error in the registration certificate, NR-569-S-101-S, dated April 21, 1999. Specifically, in the first bullet on Page 4, the Limitations and/or Other Considerations of Use should read "10 CFR 35.59 and 35.400* Instead of "10 CFR 35.13,35.14 and 35.400."

Please replace Pages 4 and 5 in the certificate with the enclosed one.

If you have any questions, please contact me at (301) 415-5787 or Mr. Ujagar Bhachu at (301) 415-7894.

1

/s/

Seung J. Lee, Mechanical Engineer Materials Safety Branch Division of Industrial and l Medical Nuclear Safety I Office of Nuclear Material Safety l and Safeguards i

Enclosure:

As stated ,

Distribution:

NMSS r/f IMNS r/f Central File SSD-97-80 NE01 DOCUMENT NAME: H:\SJL\NR569101.CP2 Te rective a copy of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure 'N' = No copy OFFICE MSB E NAME SLee f. , /

DATE 04/21/99 OFFICIAL RECORD COPY l

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4

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REGIS.TRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)

No.: NR-569-S-101-S DATE: April 21, 1999 PAGE 5 OF 6 SOURCE TYPE: Therapeutic Brachytherapy Seeds LIMITATIONS AND/OR OTHER CONSIDERNTIONS OF USE (Cont'd)-

l a Due to the short half-life of the Gold-198, these sources do I not have to be leak tested.

l Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.

The small size of these sources will require a higher level i

of accountability during use to prevent source misplecement l and loss.

l

! . This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

i l SAFETY ANALYSIS

SUMMARY

Based on our review of information contained within the references cited below, that these seeds are identical to seeds previously deemed acceptable for licensing purposes by the NRC and the States of Texas and Utah, that the high purity gold encased in platinum is inert and the 2.7 day half-life of Gold-198, we continue to conclude that the Model RSNP-Au seeds are acceptable for licensing purposes.

Furthermore, we continue to conclude that this source design would be expected to maintain its containment integrity for conditions of use which might occur during uses specified in this l certificate.

REFERENCES:

The following supporting documents for the Model RSNP-Au gold '

seeds are hereby incorporated by reference and are made a part of this registry document.

1 l

I

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1 i

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• l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY) j No.: NR-569-s-101-S DATE: April 21, 1999 PAGE 4 OF 6 {

SOURCE TYPE: Therapeutic Brachytherapy Seeds OUALITY ASSURANCE AND CONTROL-i i

l RSNP used two basic types of radiation detection systems in the assay of seed within 15% accuracy:  ;

i

1. A fixed-geometry ion chamber is used for rapid counting and "

assay of seeds required to fill an order or to batch a shipment of irradiated seeds.  !

2. A Capintec dose calibrator is used to confirm the readings l of, and document the performance of the ion chamber assay I system.  !

l To document the performance of the ion chamber, the following tests are performed: l Daily constancy check for reproducibility in measuring a Cs-137 tube source, which has been mounted in a plastic rod to assure constant geometry. A log of the results is maintained.

- Quarterly intercomparison study to compare the measurement capabilities of the ion chamber sistem and the dose calibrator. Logs of these tests are maintained.

To calibrate dose calibrators, the following tests are performed:

Constancy at least once each day prior to assay of seed strengths Linearity at installation and at least quarterly thereafter

• Accuracy at installation and at least annually thereafter LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The sources shall be distributed to persons specifically licensed by the NRC pursuant to 10 CFR 35.59 and 35.400 sections or equivalent provisions of an Agreement State.

,