ML20196C182
| ML20196C182 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/1986 |
| From: | Steven Baggett, Stephen Bell NRC |
| To: | |
| Shared Package | |
| ML20137U384 | List: |
| References | |
| SSD, NUDOCS 9906230351 | |
| Download: ML20196C182 (6) | |
Text
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDCOPY) 1 l
NO: NR-136-S-255-S DATE:
PAGE:
1 of 6 gg i
SOURCE TYPE:
Brachytherapy Source MUDEL:
CDC.T1 MANUFACTURER / DISTRIBUTOR:
Amersham Corporation 2636 South Clearbrook Drive Arlington Heights, IL 60005 ISOTOPE:
MAXIMUM ACTIVITY:
Cesium-137 80 millicuries LEAK TEST FREQUENCY:
6 months PRINCIPAL USE:
(V) General Medical Use CUSTOM DEVICE:
YES X_NO l
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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDCOPY)
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NO:.NR-136-S-255-S DATE:
PAGE:
2 of 6 JUN BI M
-SOURCE TYPE:
Brachytherapy Source l
DESCRIPTION:
The Model CDC.T1 brachytherapy tube sources will contain up to 80 mil 11 curies of Cesium-137. They are constructed and packaged as follows:
Cesium-137 as chloride is dry mixed with zirconium phosphate and sintered at high temperature. The resultant mixture is a highly insoluble high melting point powder which can be used to " powder load" narrow bore tubes.
The powder is loaded into a piece of narrow bore 316L tubing which has had a cap brazed onto one end to seal it. After loading, the other end is sealed with a cap by brazing.
The outer capsule is also manufactured from 316L stainless steel.
1 The inner capsule is loaded into the outer and then a plug is tig welded in to complete the seal. Finally, the weld region is machine polished to ensure that there are no uneven sections. The overall dimensions of.these tubes are:
External Length 20 m (maximum) 15 m (nominal)
Active Length Diameter 2.65 m Wall Thickness 0.46 m (minimum)
Each source is packed individually in a glass specimen tube. This specimen tube is supported in a lead container which has an appropriate shielding thickness. -The lead container is supported in a sealed can by the use of expanded polystyrene packing pieces and the can is similarly supported in an outer transport carton. This packaging has.been tested and conforms with the l
requirements of the U.S. DOT for Type A packaging. The packaging is not i
designed for re-use or for permanent storage.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDCOPY) gg,%
PAGE: 3 of 6 N0:
NR-136-S-255-S DATE:
SOURCE TYPE:
Brachytherapy Source LABELING:
The source is permanently engraved with the following information:
A unique serial number The product code An activity code Space restrictions prevent the addition of further information.
The specimen tube in which each source is stored is labeled with the following ini nmation :
The manufacturer's name Theisotope(Cesium-137)
The words " Caution-Radioactive Material" The intermediate container (sealed can) is labeled in accordance with the requirements of Section 32.74, 10 CFR 32.
.The outer container is marked in accordance with requirements of the U.S. DOT for Type A Container.
DIAGRAM:
A sketch of the assembly is shown below.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDCOPY)
N0: NR-136-S-255-S DATE:
J312 3 M6 PAGE: 4 of 6 SOURCE TYPE:
Brachytherapy Source CONDITIONS OF NORMAL USE:
The Model CDC.T1 sources are specifically for medical use and exclusively for use in a medical environment. The sources are used either in applicators (e.g.,
Fletcher-Suit or Heyman applicators for intracavitary use) or, on occasion, for direct interstitial implantation in the treatment of various forms of cancer.
They are not expected to be subjected to excessive extremes of temperature, physical shock, or to corrosive environments.
PROTOTYPE TESTING:
Amersham Corporation provided test data on the Model CDC.T1 source design showing that the sources have been tested according to the requirements of ANSI N542 (1977) and achieved a performance rating of C64344.
In addition, the sources have been tested according to the requirements of ANSI N44.1 and ANSI N44.2-1973 for brachytherapy sources and passed the specified temperature, drop and percussion tests.
EXTERNAL RADIATION LEVELS:
Amersham Corporation states that a cesium source with a content of 10 millicuries might be expected to generate dose rates as follows:
Distance Dose Rate 5 cm 1300 mR/hr 30 cm 38 mR/hr 100 cm 4 mR/hr l
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NO.S 7 hl REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED COPY)
NO:
NR-136-S-255-5 DATE:
PAGE:
5 of 6 M23 @
SOURCE TYPE:
Brachytherapy Source QUALITY ASSURANCE AND CONTROL:
Amersham Corporation states that all materials used in the fabrication of this product are checked against suppliers specifications prior to manufacture.
Finished sources are checked for freedom from leakage and contamination by bubble, wipe and immersion testing. Removable activity must be less than 0.005 microcurie before the source can be released. The customer is provided with a certificate documenting the leak test and the radiation emission measurements.
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
The sources shall be distributed only to persons specifically licensed by the NRC pursuant to Sections 35.13 or 35.14 and 35.100 of Title 10, Code of Federal Regulations, Part 35 or equivalent provisions of Agreement State Regulations.
The source shall be leak tested at six month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
The sources shall not be subjected to environmental or other conditions of use which exceed the test specifications for selected brachytherapy sources contained in ANSI N44.1, N44.2-1973.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
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l REGISTRY.OF. RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDCOPY)
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NO: NR-136-S-255-S DATE:
PAGE:
6 of 6
~ SOURCE TYPE:
Brachytherapy Source B
SAFETY ANALYSIS SUMARY:
Based on our review of the information and test data contained in the references cited below, and that the increase in source length does not adversely affect the intagrity rating of the source, we conclude that the Model CDC.T1 brachytherapy source design is acceptable for licensing purposes.
Furthermore, we conclude that the Model CDC.T1 sources would be expected to maintain their containment intergrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
j The following supporting document for the Model CDC.T1 brachytherapy source is hereby incorporated by reference and is made a part of this registry document:
Amersham Corporation's letter dated October 28, 1983 and November 19, 1985 with enclosures thereto..
Supersedes registration document dated June 19, 1984.
ISSUING AGENCY:
i U. S. NUCLEAR REGULATORY COMMISSION M 2 3'196
-$ ', j 7
DATE:
REVIEWER:
.p-DATE:
Jt3( 3 $ M CONCURRENC :
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