ML20128N478
| ML20128N478 | |
| Person / Time | |
|---|---|
| Issue date: | 09/16/1988 |
| From: | Steven Baggett, Stephen Bell NRC |
| To: | |
| Shared Package | |
| ML20126D741 | List: |
| References | |
| SSD, NUDOCS 9610160402 | |
| Download: ML20128N478 (5) | |
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y D Q REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE I (Amended in its Entirety) l
,SEP 161988 HQi.: NR-460-S-167-S DATE1 p3gg 1 op g DEVICE TYPE: Therapeutic Seed Source MODEL: 6711 MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 1
ISOTOPE: MAXIMUM ACTIVITY: l Iodine-125 100 millicuries LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES x NO l
l 9610160402 960216 PDR RC
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- 0 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE '
(Amended in its Entirety) l l
NO.: NR-460-S-167-S DATE: .SEP 161M8 PAGE 2 OF 5 DEVICE TYPE: Therapeutic Seed Source
- DESCRIPTION
The 3M Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule which is sealed by plasma-arc welds at each end of the source capsule.
l The titanium capsule has an outside diameter of .8 mm and a wall thickness of .05 mm. The weld thicknesses located at each end of the capsule average about .5 mm.
Plasma-Arc Welding allows for higher welding speeds with
, greater energy concentration and deeper and narrower welds.
During Plasma-Arc Welding the molten metal reforms behind the advancing arc allowing for a solid weld joint.
4 L&BELING:
Because of their small size, individual seeds are not labeled. The seeds are supplied as a group of seeds with an i activity within a stated range on the assay date and are packaged in a 1 dram vial. A label is affixed to the vial stating, " Caution-Radiation Material", isotope, activity range, total activity, assay date, manufacturer logo, and the trefoil radiation symbol. The label complies with the provisions of 10 CFR 32.72 and 10 CFR 20.203.
DIAGRAM: *[.S/,*(([** o.os ==
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---- t o m. f' c 4.5 mm CONDITIONS OF NORMAL USE:
The 3M Model 6711 sealed source (therapeutic seed) is designed for use in the interstitial treatment of cancerous tumors. The i placement of I-125 Seeds in tissue, which takes place in surgery, is facilitated by the use of one of several commercially-available implant tools. These implanters are used solely for source placement and are not designed either to store or to hold I-125 Seeds, as is the case with conventional applicators and cesium-137 sources. The seeds are designed to withstand normal autoclave temperature and pressure variations from 1210C at 15 psi to 1380C at 35 psi.
o o 1 . 1 1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE j (Amended in its Entirety) 1 HQ,,: NR-460-S-167-S DATE1 .SEP 1619N PAGE 2 OF 5 e DEVICE TYPE: Therapeutic Seed Source i DESCRIPTION 1 The 3M Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule which is sealed by plasma-arc welds at each end of the source capsule. The titanium capsule has an outside diameter of .8 mm and a wall thickness of .05 mm. The weld thicknesses located at each end of the capsule average about .5 mm. Plasma-Arc Welding allows for higher welding speeds with greater energy concentration and deeper and narrower welds. During Plasma-Arc Welding the molten metal reforms behind the advancing arc allowing for a solid weld joint. l LABELING: . Because of their small size, individual seeds are not labeled. The seeds are supplied as a group of seeds with an activity within a stated range on the assay date and are packaged in a 1 dram vial. A label is affixed to the vial stating, " Caution-Radiation Material", isotope, activity range, total activity, assay date, manufacturer logo, and the trefoil radiation symbol. The label complies with the provisions of 10 CFR 32.72 and 10 CFR 20.203. DIAGRAM: die',[rY == b
... py ws as..
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r 4.s .. = CONDITIONS OF NORMAL USE: The 3M Model 6711 sealed source (therapeutic seed) is designed for use in the interstitial treatment;of cancerous tumors. The placement of I-125 Seeds in tissue, which takes place in surgery, is facilitated by the use of one of several commercially-available implant tools. These implanters are used solely for source placement and are not designed either to store or to hold I-125 Seeds, as is the case with conventional applicators and cesium-137 sources.- The seeds are designed to withstand normal autoclave temperature and pressure variations from 1210C at 15 psi to 1380C at 35 psi.
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'. . O O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety) l HQt: NR-460-S-167-S DATE: SEP 161Ns pgag 3 op 5 DEVICE TYPE: Therapeutic Seed Source l PROTOTYPE TESTING:
Prototypes of the Model 6711 sealed source (seeds) were subjected to tests to demonstrate that-the sources will maintain their integrity under stresses of use and accident. The tests performed were in accordance with ANSI N44.1-1973. 3M company reports that the prototypes passed the ANSI tests for impact and percussion. High temperature test results show that the Model 6702 sealed source retains its integrity up to temperatures of 4000C. At that temperature, the anion exchange resin breaks down and releases the iodine. However, the capsule does lose its integrity and leaks iodine at temperatures of about 6000C. 3M Company states that the sources should not be subjected to temperatures in excess of 1380C and 35 psi. In addition, the sources should not be placed in concentrated acids or sterilized by dry heat methods. EXTERNAL RADIATION LEVELS: l External radiation levels from the Model 6711 were determined by 1 the 3M Company using film badges (specified accuracy 15%) and j obtained.the following results: j Distance from I-125 Measured radiation the source (cm.) Seed Activity levels (mR/hr) ! 5 0.1 mci 2.5 40.0 mci 1000.0 30 0.1 mci 0.053 40.0 mci 21.2 OUALITY ASSURANCE AND CONTROL: The~3M Company conducts the following quality control tests and inspection of the Model 6711 sealed source prior to distribution: visual inspection, initial leak test, and autoclave, x-ray inspection, and assay for radioactivity. Complete details of the quality control program are included in the February 8, 1980 l application. l 1
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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-167-S DATE: SEP 16198$ PAGE 4 OF 5 SEALED SOURCE TYPE: Therapeutic Seed Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: o The sealed sources shall be distributed only to specific licensees of the NRC or Agreement States. 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 Licensees should observe the 3M Company instructions for 4 handling and using the I-125 seeds. o 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. o This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC. SAFETY ANALYSIS
SUMMARY
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 Model 6711 sealed source is acceptable for licensing purposes. Furthermore, we conclude that this source would be expected to maintain their containment for normal conditions of use which might occur during the uses specified in this registration sheet. M
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Q Q REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety) HQ2: NR-460-S-167-S DATE: PAGE 5 OF 5 SEALED SOURCE TYPE: Therapeutic Seed Source
REFERENCES:
The following supporting documents for 3M Model 6711 therpeutic sealed sources are hereby incorporated by references and are made a part of this registry document. o Minnesota Mining and Manufacturing Company application received May 1, 1980, for renewal of license No. 22-00057-59MD. o 3M Company letter dated July 8, 1988, and enclosures thereto. ISSUING AGENCY: U.S. Nuclear Regulatory Commission rm Date: SEP 161990 Reviewer: s ' 'a cF
.o Date: SEP 161988 Concurrence: 0 5u.( ,o d 3 //
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