ML20248A152
| ML20248A152 | |
| Person / Time | |
|---|---|
| Issue date: | 07/22/1990 |
| From: | Steven Baggett NRC |
| To: | |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290301 | |
| Download: ML20248A152 (9) | |
Text
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11' ;C.P.R. 225-3t&O2 001 i
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
PAGE; NO. NR-460-S-137-5 DATE: J(jg22 W I of 7 SEALED SOURCE TYPE: Tube Source MODEL: Series 6500, 6520 (formerly 6D6C) i MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 millicuries LEAK TEST FREQr'NCY: 36 months i
PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES X NO
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. REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-5-137-S DATE: JUN t t 1990 PAGE: 2 of 7 SEALED SOURCE TYPE: Tube Source DESCRIPTION:
The cesium-137 tube sources consist of two stainless steel capsules, an outer casing and an inner. core containing cesium-labeled ceramic microshperes packed along the active length. The inner core is sealed by two stainless steel balls
, pressed in and welded in place.* The welded inner core is placed inside an outer capsule engraved with nominal activity and serial number, and color-coded on the eyelet end.' Each tube-source is then nickel plated.
The tube. sources are'available in two lengths. Sources in series 6500 are standard size tubes, 20 mm long by 3.05 mm diameter, with an active length of approximately 14 mm. Series 6520 sources, available only upon special request, are short tubes, 16 mm long by 3.05 mm diameter, and approximately 10 mm active length.
Each source is color-coded on the eyelet and, according to the nominal activity, examples are listed below:
Color Milligram Radium Equivalent M1111 curies 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 White 35 88.23.- 97.0 Black 40 100.8 -111.0 Maximum Activity 199 500
- NOTE:. 3M made this design change in 1985. The previous design used only one
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stainless ball to seal the end on the inner capsule. -Both designs l will be marketed by SM until the stock of the old design is depleted.
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" Attachment 2 shows the old design.
P he Os-137 tube source strengths listed above are " standard" activities. As the sources decay below the nominal activity, however, they fall into a "non- standard" activity category. The strengths of both the " standard" and "non-standard" activity sources are documented in the calibration Certificate accompanying the sources at the time of distribution.
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-v ee REGISTRY OF RADIOACTIVE SEALE0 SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-5 DATE: JUN t t 1990 PAGE:_ 3 of 7 SEALED SOURCE TYPE: Tube Source LABELING:
Each nickel plated tube source is engraved with the nominal activity and serial number and color-coded on the eyelet end according to the nominal activity, DIAGRAM:
See Attachments 1 and 2.
CONDITIONS OF NORMAL USE:
The sources are used for intracavitary treatment of cancer, which is accomplished by placing the radioactive source into a device, referred to as a app 11cator. Sources may be placed in the.a plicator either before (preloaded) or following (afterload) insertion of the applicator in the body cavity to be i irradiated. l PROTOTYPE TESTING:
The sources have been subjected to various prototype test (s) to demonstrate that l the sources maintain their integrity under stresses of use and accidents, as l described in ANSI N44.1-1973 and ANSI N542-1977. The tests performed on the '
l sources are as follows:
- Wipe (smear) test
- Soak test
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- Leak (bubble) test l
- Temperature tested up to 848'C l
e Impact test - dropped 9 meters onto an unyielding surface
- Percussion test - 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.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: Jt}H t t 1990 PAGE1 4 of 7 )
SEALED SOURCE TYPE: Tube Source EXTERNAL RADIATION LEVELS:
l The manufacturer calculated the following dose rates from rates provided by NBS:
M1111 rem per Hour Output Activity in Millicuries 100 cm 30 cm 5 cm 3.81 42.3 1,524 11.6 8.22 91.3 3,288 25.1 12.2 135.5 4,880 37.2 18.7 208 7,492 57.1 i 23.8 264 9,520 72.6 30.5 338.9 12,200 93.0 l
Note: The output activity allows for the 2% attenuation through the
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l stainless steel walls of the source.
- QUALITY ASSURANCE AND CONTROL:
The manufacturer subjects all sources to quality control tests prfor to their transfer to a licensed recipient. These tests consist of leak test, wipe test, nsay for radioactivity and soak test. These tests are performed on both the inner and outer capsules. Additionally, each source is visually inspected for
- i workmanship. This quality assurance control program has been previously accepted by the NRC.
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4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l (AMENDED IN ITS ENTIAETY)
NO: NR-460-S-137-S DATE: JUN 2 21990 PAGE: 5 of 7 SEALED SOURCE TYPE: Tube Source LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
o The source shall be distributed only to specific licensees of the NRC or Agreement States.
o Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that these sealed sources exhibit high sur- ,
face dose rates when unshielded, these sealed sources should be handled j only by experienced licensed personnel using adequate remote handling i equipment and procedures, !
l 9 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. d i
o This registrat, ion sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
o The source shall be leak tested at three (3) year intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
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At time of distribution of both " standard" and "non-standard" activity Cs-137 sources, a calibration Certificate will accompany the shipment which shows for each source the actual measured output activity in millicuries of Cs-137 and the calculated milligram radium
( equivalent Os-137 activity.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES (Amended in its entirety) ,
l NR-460-S-137-5 DATE: PAGE: 6 of 7 NO: JUH 211990 SEALED SOURCE TYPE:- Tube Source SAFETY ANALYSIS
SUMMARY
1 Based on our review of the information and test data referenced below, we continue to conclude that this source series continues to be acceptable for specific licensing purposes. Over the past 20 years, 3M Company has distributed thousands of the sources with one incident of source damage and ,
subsequent leakage of radioactive material during the recommended use and recommended handling procedures. We continue to conclude, therefore, that this source series would be expected to maintain their 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: 1 l
Minnesota Mining and Manufacturing Company application dated May 1, 1980 l o l for renewal of License No. 22-00057-59MD o 3M Company letter dated July 24, 1989 with enclosures thereto.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: JUN 21 1990 PAGfl 7 of 7 SEALED SOURCE TYPE: Tube Source I'
ISSUING AGENCY 1
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21 M Reviewer: [b 37 #b Date: <
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Date: JUN ?f icon .
Concurrence:
11/02/90 .
26 C. P. R. 225-3t4-02 008 r
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDINITSENT!RETV)
DATE: 22 1990 ATTACHMENT 1 N0j, 0 NR-460-S-137-S
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11/02/90 227 C.P.R. 225-3N-0 009 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO: WR 460-S-137-5 g g ,, g ATTACHMENT 2 3M old i;ource design c' =
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June 14, 1990 i MEMORANDUM FOR: William Adam Material Licensing Section, i Region III FROM: Steven Baggett Medical, Academic and Commercial Use Safety Branch, NMSS
SUBJECT:
SSD TECHNICAL ASSISTANCE REQUEST DATED 10/13/89-3M's REQUEST FOR RENEWAL OF LICENSE {
1 NUMBER 22-00057-59MD, CONTROL # 87687 '
Based on the information provided by the applicant, we have i revised the Registry sheets for the brachytherapy sources.
Please find enclosed copes of the registration certificates for those sources that 3M will continue to distribute. Certificates for those sources that are being discontinued will be forthcoming. '
Please forward a copy of the enclosed registration certificates to the licensee and request that they read over the certificates and notify us immediately if there are any errors.
If you have any questions please call me at FTS 492-0542.
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Steven <Baggett Medical, Academic and Commercial Use Safety Branch, NMSS
Enclosure:
Registration Certificate numbers ,NR-460-S-137-Si NR-460-S-151-S NR-460-S-166-S NR-460-S-167-S NR-460-S-169-S l
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