ML20247R865
| ML20247R865 | |
| Person / Time | |
|---|---|
| Issue date: | 01/28/1991 |
| From: | Steven Baggett NRC |
| To: | |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290232 | |
| Download: ML20247R865 (8) | |
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
][hi NR-460-S-137-S DATE: PAGE 1 OF 6 JAN 2 81999 l
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TsEALED SOURCE TYPE: Tube Source i
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MODEL: Series 6500, 6520 (formerly 6D6C) l MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 l
l l ISOTOPE: MAXIMUM ACTIVITY:
! Cesium-137 500 millicuries l (See description for activity per model)
LEAK TEST FREOUENCY: 36 months i
l PRINCIPAL USE: (V) General Medical Use l
CUSTOM SOURCE: YES X NO l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
NO.: NR-4 6 0-S-13 7 -S DATE: 'JAN 2 81991 PAGE 2 OF 6 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 microspheres 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 Milliaram Redium Eauivalent Mil 11 curies of Cesium-137 Bluo 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 88.2 - 97.0 Black 40 100.8 -111.0 Max. Act. 199 500 The cesium-137 tube source strengths listed above are " standard" activities. As the sources decay below the nominal activity, however, they fall into a "non-standard" ectivity 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.
- NOTE: 3M made this design change in 1985. The previous design used only one stainless ball to seal the end on the inner l capsule. Both designs will be marketed by 3M until the stock of the old design is depleted. Attachment 2 shows the old design.
O O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQt: NR-460-S-137-S DATE: 28139) PAGE 3 OF G 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 applicator. Sources may be placed in the applicator either before (preloaded) or following (afterloaded) insertion of.the applicator in the bcdy cavity to be irradiated.
PROTOTYPE TESTING:
The sources have been subjected to various prototype test (s) to demonstrate that the 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 follows:
. Wipe (smear) test Soak Test a
Leak (bubble) test
- Temperature tested to 848'C
+
Impact test - dropped 9 meters onto an unyielding surface j + Percussion test - a 1.45 kg weight was dropped from 1 meter L onto the source lying'on an unyielding surface i
No source was found to have lost containment integrity.
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O O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQt: NR-460-S-137-S DATE: JAN 2 81991 p3os 4 or s SEALED SOURCE TYPE: Tube Source EXTERNAL RADIATION LEVELS:
The manufacturer calculated the following dose rates from rates provided by NIST:
Millirem per Hour 100 cm 30 cm 5 cp Outout Activity in Millicuries 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 23.8 264 9,520 72.6 30.5 338.9 12,200 93.0 Note: The output activity allows for the 2% attenuation through the stainless steel walls of the source.
OUALITY ASSURANCE AND CONTROL:
The manufacturer subjects all sources to quality control tests prior to their transfer 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 LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The sealed sources shall be distributed only to specific l licensees of the NRC or Agreement States.
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- At time of distribution of both " standard" and "non-standard" activity Cesium-137 sources, a calibration Certificate will accompany the shipment which shows for each source the actual measured output activity in millicuries of cesium-137 and the calculated milligram radium equivalent cesium-137 activity.
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.
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O O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQ2: NR-460-S-137-S DATE: JAN 2 8199l PAGE 5 OF 6 l
SEALED SOURCE TYPE: Tube Source i
I LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
+ Handling, Storage, Use, Transfer, and Disposal: Shall be determined by the licensing authority. In view that these sealed sources exhibit high surface dose rates when unshielded, these sealed sources should be handled only by
' experienced licensed personnel using adequate remote handling equipment and procedures.
+ This registration sheet and the information contained with j the references shall not be changed without the written t
consent of the NRC.
l l + The source shall be leak tested at three (3) year intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
I SAFETY ANALYSIS
SUMMARY
i Based on our review of the information and test data cited below, the past history of the source design, we continue to conclude that 3M Models, Series 6500, and 6520 tube sources are acceptable for licensing purposes. Furthermore, we conclude that these sources would be expected to maintain their containment for normal conditions of use which might occur during the uses specified in this registration sheet.
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REFERENCES:
! The following supporting documents for 3M Models Series 6500, and 6520 tube sources are hereby incorporated by references and are
, made a.part of this registry document.
+ Minnesota Mining and Manufacturing Company application dated May 1, 1980, for renewal of license No. 22-00057-59MD.
+
3M Company letter dated July 24, 1988, November 6, 1990, and enclosures thereto.
O O ,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
HQ.,_ : NR-460-S-137-S DATE: PAGE 6'OF 6 JAN 2 81991 SEALED SOURCE TYPE: Tube Source ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: 2 8 7997 Reviewer: #4 fV/ bb
/
Date:
JAN 2 81991 Concurrence: .
,2/. #ag V V/
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f O o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 3AFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
EOO2 ,: NR-460-S-137-S DATE: JAN 2 81991 Attachment 1
- 20.0 mm =
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O O RE'GISTRY OF RADIOACTIVE SEALED SOURCES AND DE SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety) h: NR-460-S-137-S DATE:
DAN 2 8199{ Attachment 2 3M old source design l
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