ML20128N544
| ML20128N544 | |
| Person / Time | |
|---|---|
| Issue date: | 06/23/1980 |
| From: | Singer B, Wright E NRC |
| To: | |
| Shared Package | |
| ML20126D741 | List: |
| References | |
| SSD, NUDOCS 9610160424 | |
| Download: ML20128N544 (4) | |
Text
. - - . . - . - . . . - .- ...- .-.. - - - - . . . - . . - .. ,. . . . . . . - . - , -
O~ REGISTRY OF RADI0 ACTIVE SEALED SCURCES AND DEVICES -
SAFETY EVALUATION OF SEALED SOURCE (Amended in11ts entirety) i.
NO.: NR460S167S DATE: June 23, 1980 PAGE 1 0F 4 SEALED SOURCE TYPE: Therapeutic Seed Source MODEL: 6711 i
f1At:UFACTURER/CISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center -
! St. Paul, MN 55101 i
e f!ANUFACTURER/ DISTRIBUTOR:
IS0 TOPE: Iodine-125 MAXIMUM ACTIVITY: 62 millicuries i
j (G _/ .
e
! )
i
- ' LEAK TEST FREQUENCY: 6 months
- 1 i
I PRINCIPAL USE: General Medical Use i
j CUST0ft SOURCE: YES X N0 l l i
)
!' l i
LO 1
1 9610160424 960216 PDR
~~
RC
- SSD PDR
h O V U i
O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)
NO.: NR460S167S DATE: June 23, 1980 PAGE 2 0F 4 SEALED SOURCE TYPE: Therapeutic Seed Source DESCRIPTION:
The 3M Company Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule ..iich is sealed by tungsten-inert-gas weld at each end of the capsule.
LABELING:
Because of their small size, individual seeds are not labaled. The seeds are supplied as a group of seeds with an activity within a stated range on the assay date, are packaged in a 1 dram vial, onto which is affixed a label stating,
" Caution-Radioactive Material," isotope, activity range, total activity, assay date, manufacturer logo, and the trefoil symbol.
DIAGRAM: UNNU" (08 a*
I '
g o.s == ( ) , o.s ..
4
- 3.omm -
c 4.S mm 2 l
CONDITIONS OF NORMAL USE. l The 3M Company 6711 sealed source (therapeutic seed) is designed for use in the ,
interstitial treatment of cancerous tumors. The seeds are designed to withstand i normal autoclave temperature and p -sure variations from 121 C at 15 psi to 138 C l at 35 psi.
PROTOTYPE TESTING: .
Prototypes of the Model 6711 sealed source (seeds) were subjected to tests to i 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 paragraphs 4.2.2 and 4.2.3. 3M Company reports that the prototype passed the ANSI C tests for impact and percussion. High temperature test results show that the Model f
. _ . _ . ~ . _ m. . . . _ _ _ . _ _ _ _ _ _ _ _ _ . . _ . _ _ _ _ _ . _ _ _ _ _ __
l.
0 O l
l REGISTRY 0F RADI0 ACTIVE SEALED SOURCES AND DEVICES A$ndNN$e?tikY N0.: NR460S167S DATE: June 23, 1980 PAGE 3 0F 4 SEALED SOURCE TYPE: Therapeutic Seed Source PROTOTYPE TESTING (CONT'D):
6711 sealed source retains-its integrity up to temperatures of 400'C. 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 600 C.
3M Company states that the sources should not be subjected to temperatures in excess i
of 138*C and 35 psi. In addition, the sources should not be placed in concentrated acids or sterilized by dry heat methods.
EXTERNAL RADIATION LEVELS:
External radiation levels from the Model 6711 was determined by the 3M Company using film badges (specified accuracy : 15%). Results are:
i O- I-125 Seed Average Dose Rates (mr/hr) i l
l Activity At 5 cm At 30 cm l Model 6711 0.1 mci (comp) 2.5 0.053 Model 6711 40.0 mci (comp) 1000 21.2 '
QUALITY-ASSURANCE AND CONTROL:
The 3M Company conducts the following quality control tests and inspection of the Model 6711 sealed sources prior to distribution: visual inspection, initial leak test, second 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 application. '
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
A. Licensees should observe the 3M Company instructions for handling and using ;
the-I-125 seeds; specifically these instructions warn that: ;
- 1. ' Seeds should not be exposed to. concentrated acids.
, 2. Seeds should not be autoclaved in plastic tubing or other plastic containers (only autoclave compatible materials such as stainless steel, glass, nylon and teflon should be used).
j Q 3. Seeds should not be exposed to temperatures in excess of 138'C and
- pressures in excess of 35 psi.
4
O Q I
'Q REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEV!CES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety) fi0. : NR460S167S DATE: June 23, 1980 PAGE 4 0F 4 SEALED SOURCE TYPE: Therapeutic Seed Source LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE (CONT'D):
C. Leak Testing: Six month intervals -- The test shall be capable of detecting the presence of 0.005 microcurie of iodine-125 on the test samples.
D. Handling, Storage, Use, Transfer, and Disposal: To be determined by the licensing authority.
REFERENCES:
The following supporting documents for the therapeutic sealed sources are hereby incorporated by reference and are made a part of this registry document:
o 3M Company application received February 8,1980, and application dated May 1, 1980.
o 3M Company letters dated April 18,1980, May 8,1980, June 3,1980, January 11, 1983, and enclosures thereto, o Reference also 3M Company License No. 22-00057-59MD.
o Supersedes registry document dated June 23, 1980.
Date June 23, 1980 Reviewed By /s/
Earl G. Wright Date June 23, 1980 Concurrence /s/
Bernard Singer ISSUING AGENCY:
U.S. Nuclear Regulatory Comission
_ __ _ _ _ . . . _