ML20217R138
| ML20217R138 | |
| Person / Time | |
|---|---|
| Issue date: | 04/18/1990 |
| From: | Steven Baggett, Thomas Rich NRC |
| To: | |
| Shared Package | |
| ML20217R141 | List: |
| References | |
| SSD, NUDOCS 9805140155 | |
| Download: ML20217R138 (7) | |
Text
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a REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO,:
NR-460-S-801-S DATE: APR 1B 1GG0 PAGE 1 OF 6 i
l SEALED SOURCE TYPE:
Needle Source MODEL:
6540 Series, 6530, 6531, 6532, 6533 l
MANUFACTURER / DISTRIBUTOR:
Mint?esota Mining and Manufacturing 3M Center St. Paul, MN 55144-1000 f
ISOTOPE:
MAXIMUM ACTIVITY:
Cesium-137 500 millicuries (see description for activity per model)
LEAK TEST FREOUENCY:
6 Months ERINCIPAL USEL- (V) General Medical Use CUSTOM SOURCE:
YES x
NO l
i 9805140155 900418 i
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ2:
NR-460-S-801-S DATE:
APR 181990 PAGE 2 OF 6 SEALED SOURCE TYPE:
Needle Source DESCRIPTION:
The' needle sources are doubly encapsulated stainless steel.
The inner capsule contains the cesium-labeled ceramic microspheres I
and is sealed by a stainless steel ball pressed in and welded in place.
The outer capsule is sealed by welding and has an overall length that varies from 1.063 inches to 2.245 inches.
One end of the needle has an eyelet and the other a blunt or trocar point.
The series 6530 sources'are available in either full or half i
strength.
A high intensity source needle model 6540 is also available.
These sources are characterized by~ length and activity as listed below:
Dimensions Active Length Cesium-137 Activity Model No.
(millimeters)
(millicuries)
(millicuries) 6534 27 x 1.65 15 1.26 -
1.45
{
6535 34.5 x 1.65 22.5 1.89 -
2.17 6536 42 x 1.65 30 2.52 -
2.9
)
3 6537-57 x 1.65 45 3.78 -
4.35 6540 22 x 1.65 10 25.2
- 29.
LABELINQ:
The needles are labeled with a unique serial number.
The first two characters of the eight digit serial number identify the 1,
manufacturer (3M), the middle four digits form a unique serial
. number, and the last two characters are used to designate the ilength. The code designations for length are:
1 g'
JV
. Code Length
~
mm LD 57.
mm J
rm U
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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES fjAFETY EVALUATION OF SEALED SOURCE NO :- NR-460-S-801-S DATE:
ApR 1 8 Kl00 PAGE 3 OF 6 SEhLED SOURCE TYPE:
Needle Source LABELING (CONT.):
Additionally, full strength needles are nickel plated and half strength needles are gold plated.
The storage container is labeled in accordance with 10:CFR Part 20.
DIAGRAM:
i See attachment 1 CONDITIONS OF NORMAL USE:
The sealed sources are used for interacavitary 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) orLfollowing (afterloaded) incertion of the applicator in the body cavity to i-be irradiated.
The sources are subjected to environments typically found in hospitals'or research labs.
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PROTOTYPE TESTING:
Sealed sources,- Series 6530 were tested in accordance with ANSI N542-1977.
The sources achieved an ANSI classification of 77C65444.
Sealed sources were also tested to the bending test, impact test, and tensile stress test, prescribed in ANSI-N44.1.
The sources maintain their integrity and met the ANSI-N44.1 requirements.
o 9
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ2:
NR-460-S-801-S DATE:
APR 18 120 PAGE 4 OF 6 SEALED SOURCE TYPE:
Needle Source EXTERNAL RADIATION LEVELS:
The manufacturer calculated the following dose rates from rates provided by NIST:
Millirem per hour Outside Activity 100 cm 30 cm 5 cm (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 18.8 208.4 7,501 57.1 23.8 264.4 9,520 72.6 30.5 338.9 12,200 93.0 i
Note:
The output activity allows for the 1.0% attenuation through the stainless steel walls of the source.
QUALITY ASSURANCE AND CONTROL:
The manufacturer has submitted an acceptable quality assurance and control program and is on file with the Medical, Academic, and Commercial Use Safety Branch.
The manufacturer subjects'all sources to quality control tests prior to-their transfer to a license recipient.
These tests consist of leak test, wipe test, assay for radioactivity and output rate test.
These tests are performed on both the inner and outer capsules.
Additionally, each source is visually inspected for workmanship.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
o The. sealed source shall be distributed only to those persons specifically licensed by the NRC or an Agreement State.
o The source capsules shall not be subjected to I
environmental or other. conditions of use which exceed the ANSI N542 classification of 77C65444.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE APR 18 1990 HQt:
NR-460-S-801-S DATE:
PAGE 5 OF 6 SEALED SOURCE TYPE:
Needle Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (CONT.):
o The source shall be leak tested intervals not to exceed six months.
The te'st shall be capable of detecting the presence of 0.005 microcurie of the radionuclide on the test samples.
o REVIEWER NOTE:
The licensing authority will have to obtain details on specific operational procedures (i.e. cleaning-a source to avoid radiation exposure) from the license applicant, to make a licensing determination.
o Handling, Storage, Use, Transfer, and Disposal:
To be 1
determined by the licensing authority.
In view that these
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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.
i SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below and the claimed ANSI N542 classification, we continue to conclude that'3M's models 6530 Series and 6540 sealed sources are i
acceptable for licensing purposes.
'Furthermore, we continue to 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.
I l
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3-O REGISTRY OF RADIOACTIVE SEALED' SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l
1990 lib.:
NR-4 6 0 -S-8 01-S DATE:
PAGE 6 OF 6 s
SEALED SOURCE TYPE:
Needle Source l
REFERENCES:
h sThe following supporting documents for the Model 6530, 6540 L
Series needle sources are hereby incorporated by reference and l
are made a part of this registry document:
o 3M Company's application dated May 11, 1980,,for renewal of License No. 22-0057-59MD, with enclosures thereto.
o 3M's letters dated November 16, 1989, March 27, 1990, with enclosures thereto.
4 ISSUING AGENCY:
U.S.
Nuclear Regulatory Commission APR 181990 Date:
Reviewer:
,!1erN4
'M d</
APR 1 S 1990 "f_";,Mg)
Date:
Concurrence:.c
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O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NR-460-S-801-S DATE:
APR 181990 ATTACHMENT 1
-M LEMG7HS DEPEMDEMT OM Ac7\\NiTY IN M\\LLt GR AM RAD \\um EQU\\NALENTS c
-M TOTAL LEMGTH-
=
I 5.9 MM r
- %m\\w \\ cusu -
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-0.47 MM STAINLES STEEL d
h x s s s s s s s s s s -,
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-0.7 mm ENELET O.7 MM BALLC2.)
- ~ 07 mmes et
'CADED CERAM\\C M\\CROSPMERES i
Schematic Diagram of 3M Cesium-137 Needle Source
.