ML20247R931
| ML20247R931 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/1983 |
| From: | Steven Baggett, Jonathan Brown NRC |
| To: | |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290244 | |
| Download: ML20247R931 (6) | |
Text
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE' N0': NR-460-S-137-S DATE: JAN 3 1 1983 PAGE 1 0,_F 4 i
DEVICE TYPE: -Tube Source-l MODEL:, Series '6500, 6520 '(former.ly 6D6C) i MANUFACTURER / DISTRIBUTOR: ' Minnesota Mining and Manufacturing ~-
- 3 M Center, I
! St. ' Paul , MN ' 55101 l
l~ .
MANUFACTURER / DISTRIBUTOR:
1 ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 millicuries (see description ,
for color code of nominal activity)
I
, LEAK TEST FREQUENCY: 36 months l*
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l -PRINCIPAL U_SE: (V) General Medical Use l
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1' CUSTOM DEVICE: YES X N0 I
l 9805290244 960126 PDR RC
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l V V REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE N_0 : NR-460-S-137-S DATE: PAGE 2 0F_ 4
, DEVICE TYPEi Tube . Source DESCRIPTION:
This is a doubly encapsulated source. The inner stainless steel capsule contains the cesium-labeled ceramic microspheres. This capsule is sealed by a stainless steel ball pressed in and welded in place. The outer stainless steel capsule is sealsd by a rc pressed fit plug and welded in place. The end of the outer capsule opposite the plug, has an eyelet 0.8 mm- in. diameter. Each tube is then nickel plated. The' tube sources are available to the customer in two lengths. Sources in series 6500 are the standard size tubes, 20'mm/16ng :x 3.05 mm diameter with an active ' length of approximately 14 mm. Series 6520 sources, available to the customer upon special request, are short tubes,16 mm long x 3.05 mm diameter, with en active length of approximately 10 mm.
Each source is color-coded on the eyelet and, according to the nominal activity, examples are listed below:
i l
Color Milligram Radium Equivalent Millicuries of Cesium
! Blue 5 12.5 - 13.4 Green 10 25'.2 --27.7 Yellow 15 37.8 - 41.6 Orange 20 50.4 - 55.4 Red 25 63 - 69.3 Violet 30 75.6 - 83.2 Whi te 35 88.2 - 97.0 1 Black -40 100.8 -111.0 Maximum Activity 199 500
_L_AB EL INGi Each nickel plated tube source is engraved with the nominal activity and serial number, and color-doded on the eyelet end according to the nominal activity.
DIAGRAM:
See attachment.
CONDITIONS OF NORMALEUSE:
The sources are used for intracavitary treatment of cancer, which is accomplished by placing the radioactive source into a device, referred to as an applicator. Sources ;
may be placed in the applicator either before (preloaded) or following (afterloaded) '
insertion of the applicator in the body cavity to be irradiated.
l l I
O REGISTRY .0F< RADI0 ACTIVE SEALED SOURCES AND DEVICES
.O SAFETY EVALUATION OF SEALED SOURCE
'NO:
NR-460-S-137-S DATE: PAGE 3 0F 4 --
JAN 311983 DEVICE TYPE _: Tube Source PROTOTYPE TESTING:
The' sources have.been subjected to various prototype test (s) to demonstrate that te' sources maintain their integrity under stresses of-use and accidents, as described in ANSI N44.1-1973' and ANSI N542-1977. The tests performed on the sources are as folidws:
o Wipe (smear) test' e o' Soak test o Leak (bubble) test o Temperature tested up to 848'C o ~ Impact teste- dr6pped 9 meters onto an unyielding surface o' Percussion test a a 1;45 kg weight was dropped from 1 meter onto the source lying on an unyielding surface No source was found to have lost containment integrity EXTERNAL RADIATION LEVELS:
The manufacturer cylculated the following dose rates from rates provided by NBS: 1 M111irem per Hour Output Activity in Mil 11 curies -
100 cm ?,0 cni 5 cm 3.81 42.3 1,524 11.6 I 8.22 91.3 3,288 25.1 12.2 135.5 4,880 37.2 17.1 140 6,340; 57.1 ,
23.8 264 9,520 72.6 ;
30.5 338.9 12,200 93.0
' Note: The output activity allows for the 5.3% atk nuation through the stainless l steel walls of the source.
QUALITY ASSURANCE AND CONTROL:
i .The manufacturer subjects all sourcer, to quality control tests' prior to their traufer to a licensed recipient.- .These tests consist of leak test; wipe test, ,
assay for radioactivity and soak test. These tests are performed on both the inner and outer capsules. Additionally, each source is visually inspected for workmanship' This quality assurance control program has been previously accepted by the NRC.
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O .
O REGISTRY OF RADI0 ACTIVE SEALED SOURCES- AND DEVICES .I SAFETY EVALUATION OF SEALED SOURCE N_0_: LNR-460-S i l37-S .DATE: J AN 3.1 1983 PAGE 4 0F 4~
DEVICE TYPEi ' Tube Source '
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF.USE:
The source shall be distributed only to specific licensees of the NRC or
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o :
' Agreement States.
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- o. Handling, storage, use, transfer, and disposal: To be determined by the
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licensing authority. Iri view that these sealed sources exhibit high surface dose rates when unshielded, these sealed sources should te handled only by experienced licensed personnel using adequate. remote handling equipment and' procedures.
o The licensing authority will have to obtain details on specific holders
' and any' operational procedures, etc. from the' license applicant' to make a licensing determination.
o; This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data referenced below, we conclude that this source series continues to be acceptable for licensing purposes. Over the past 15 years, 3M Company has distributed thousands of the sources with no incident of source damage and subsequent leakage of radioactive material during the recommended use and recommended handling procedures. We conclude, therefore, that this source series would be expected to maintainitheir containment integrity for the specified uses and the conditions of use applicable to these uses.
REFERENCES:
The following supporting documents for the Model 6500, 6520 series tube sources
- . are hereby incorporated and are made a part of this registry document
o Minnesota Mining and Manufacturing Company application dated May 1,1980 l for the renewal of License No. 22-00057-59MD l
I 0 . Supersede- registry document No. NR-460-S-137-0 dated February 8,.1982 ISSUING AGENCY: . 00S. Nuclear Regulatory Comission Date:
jAN 3 11983 Reviewer: j (h//pf,7pV '
JAN 3 11933
.Date: Concurrence: . u,, , t.
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@ NR-460-S-137-S DATE:
JAN 311983
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20.omm .
--*- 3.hm = \b. Bum : 2.3 m e i ACTWE LEt%TR
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FIGURE 1-2. Schematic Diagram of 3M Cesium-137 Tube 7
Source Series 6520 x
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