ML20247R917
| ML20247R917 | |
| Person / Time | |
|---|---|
| Issue date: | 06/25/1985 |
| From: | Steven Baggett, Jonathan Brown NRC |
| To: | |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290242 | |
| Download: ML20247R917 (20) | |
Text
_ _ _ _ - _ - _ _ _ _ _ _ _ _ _ _
[ .Qy, REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO. NR-460-S-137-S DATE: 'JLII 2 5 125 PAGE: 1 of 7 SOURCE TYPE: Tube Source MODEL: Series 6500, 6520 (formerly 6D6C)
MANUFACTURER / DISTRIBUTOR:
Minnesota Mining and Manufacturing 3M Center St. Paul, MN- 55101 ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 mil 11 curies LEAK TEST FREQUENCY: 36 months PRINCIPAL USE: (V) Ceneral Medical Use CUSTOM SOURCE: YES Y NO 9805290242 960126 PDR RC l SSD PDR q.jgl 7\ i \i2
I L
l O O l REGISTRY OF RADI0 ACTIVE SEALED SOURCES ANO DEVICES SAFETY EVALUATION OF SOURCE (AMENDEDINITSENTIRETY)
NO: NR-460-S-137-S DATE: PAGE: 2 of 7 5 25 % '
, SOURCE TYPE: Tube Source l DESCRIPTION:
l The cesium-137 tube sources consist of two stainless steel capsules, an outer casing and an inner. core containing cesium-labeled cernic microshperes packed along the active length. The inner core is sealed l
by two stainless steel balls pressed in and welded in place
- The outer j capsule is sealed by welding. Each tube source is then nickel plated, j engraved with the nominal activity and serial number, and color-coded on i
the eylet end according to the nomial activity.
The tube sources are available in tow lengths. Sources in series 6500 are standard size tubes, 20 m long by 3.05 m diameter, with an active length of approximately 14 m. Series 6520 sources, available only upon l
special request, are short tubes,16 m long by 3.05 m diameter, and approximately 10 m active length. .
Each source examples is color-coded are listed below: on the eyelet and, according to the nominal activity, i Color Milligram Radium Equivalent M1111 curies df Cesium l l
Blue 5 Green 10 12.5 - 13.4 !
Yellow 15 25.2 --27.7 !
Orange 20 37.8 - 41.6 1 Red 25 50.4 - 55.4 I Violet 30 63 - 69.3 White 35 75.6 - 83.2 81dek 40 88.2 - 97.0 l 100.8 -111.0 l Maximum Activity 199 500
- ' NOTE:
i 3M made this design change in 1985. The previous design use
-only one stainless ball to seal the end on the inner capsule.
Both designs will be marketed by 3M until the stock of the old '
design is depleted. Attachment 2 shows the old design. -
e
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ . _ _ . __ . _ . . _ _ _ _ _ _ _ . . _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ . . _ _ _ _ i
l-O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE l (AMENDED IN ITS ENTIRETY)
! NO: NR-460-S-137-S DATE: .g g' PAGE: 3 of 7 l
SOURCE TYPE: Tube Source l
LABELING:
I Each nickel plated tube source ic engraved with the nominal activity and serial number and color-coded on the eyelet end according to the nominal activity.
DIACRAM:
l 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 (afterload) insertion of the applicator in the body 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, l as described in ANSI N44.1-1973 and ANSI N542-1977. The tests performed on the I sources are as follows:
o Wipe (smear) test
[ o Soak test o Leak (bubble) test o Temperature tested up to 848*C .
o Impact test - dropped 9 meters onto an unyielding surface o Percussion test - a 1.45 kg weight was dropped from 1 meter onto the source lying on an unyielding surface i No source was found to have lost containment integrity
- i J
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: Mgj PAGE: 4 of 7 SOURCE TYPE: Tube Source EXTERNAL RADIATION LEVELS:
The manufacturer calculated the following dose rates from rates provided by NBS:
Millirem per Hour Output Activity in Mil 11 curies 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 17.1 140 6.840 57.1 23.8 -264 9.520 72.6 30.5 338.9 12.200 93.0 Note: The output activity allows ~for the 5.3% attenuation through the stainless steel walls of the source.
QUALITY ASSURANCE AND CONTROL:
The manufacturer subjects all sources to quality control tests prior to their l.
- transfer to a licensed recipient. These tests consists of leak test, u!pe l 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.
- f. i o______________ i
O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: JUN 2 5 E PAGE: 5 of 7 SOURCE TYPE: Tube Source LIMITATIONS AND/OR 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 surface dose rates when unshielded, these sealed sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures.
.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 This registration 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.
)
I i
u _ . _ _ _ . _ _ ,_ _ .._ _ _ .._ .. .- . ,
O O
! l l
! REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF-SEALED SOURCES l
(Amended in its entirety)
NO: NR-460-S-137-S DATE:
g PAGE: 6 of 7 SOURCE TYPE: Tube Source I SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data referenced below, we
. conclude that this source series continues to be acceptable for licensing purposes. Over the past 15 years, 3M Company has distributed thousands of the sources with no incident of source damage and subsequent leakage of radioactive material during the recommended use and recommended handling procedures. We 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.
j The manufacture conclude that the integrity of the new design surpasses the old design.
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:
o Minnesota Mining and Manufacturing Company application dated May 1, 1980 for renewal of License No. 22-00057-59MD o Supersede registry document No. NR-460-S-137-S dated April 7, 1985 b
O O REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S- DATE: M)tt25 Y PAGE: 7 of 7 SOURCE TYPE: Tube Source ISSUING AGENCY:
U. S. Nuclear Regulatory Comission Date: Reviewer: 2 /
Date: JUN 2 5 N Concurrence: y iq , L.p.
U
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E_-----------_--------- - - _ _ - - - - _ - - _ - - - - - - - _-- -_
1 O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO. NR-460-S-137-S ~ DATE: ATTACHMENT 1 JUW2 5-@5 20.Omm :
-*- S.9 MM "
\b. bum : 2.3e ACitNE LEt%Tw l f//
/ ////////////////////W/////////d ss sssssss us ss sss s sss ns ss s s x, ,
E T
l sms
}:l;.'f .
4 :': .' '..' ':'.* i'-:' .4 ;: 1. . '.; ;;i f.::d:(
s s s s ss ss s s ss. s s s; s.0s mm
//A' //////////////A(//N//////////A ssss sssm i on.
g
/ 1 O.93 mm -i.0 m m
%'TNhlE% TsTEEL '
ETELET :
II mm BALL CEstuto- \g t
- E t M M L E s erm % T e s t Lo8cto c.ERmt, i WCRO%PMERE% I
- . l 1
. Schematic Diagram of Modified 3M Cesium-137 Source, Series 6500 E- _ - - - - - - - - - _ - _ - - - - - -_-- - - - - - - _ - - -- ---- ------------ - --- ----- - --- - d
11 O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO. NR-460-S-137-S DATE:
$g ATTACHMENT 2 3M old source design l
1 l
20.0mm :
, i
+ h.D M M C
\D.DMM W 2.3 Mkh e !
AC'TWE LEt4E.TW '
[L I^
f// ////////////////////s(////// ////) A
/ ss sssssssus sssss ssssms ss ss - 3 y T 1
[ X;:.94 :?':i..:lW.:n::.% -l;'.'.hi r'.%fs x s.Os sm s s s s s ss ss s s ss. xss sssss N
//M///////////////N//} f//////////A yy h
[ '
O.93 mm -\,0 m m
%'TNkuli:ii35 E' TEEL E T El.Eii!T l.\ mm BALL CE%\Oto - \%"'I "5tMMLtiis!!!, *ib" TEEL L.OADED CERNMC WCROSP%ERE!!Se
7- .
! O O l
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY) l
.NO. NR-460-S-137-S DATE: ]Rjl 2 5 1925 PAGE: 1 of 7 SOURCE TYPE: Tube Source l
MODEL: Series 6500, 6520 (formerly 6D6C) I MANUFACTURER / DISTRIBUTOR:
l Minnesota Mining and Manufacturing i
! 3M Center J l
St. Paul, MN 55101 l
l.
I l
ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 mil 11 curies l
l LEAK TEST FREQUENCY: 36 montha i
! PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES )( NO l
I l
l I
1 4._ _,
V 4
i REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO. NR-460-S-137-S DATE: M 2 5 125 ' PAGE: 1 of 7 SOURCE TYPE: Tube Source MODEL: Series 6500, 6520-(formerly 6D6C)
MANUFACTURER / DISTRIBUTOR:
Minnesota Mining and Manufacturing- )
3M Center.
St. Paul, MN '55101 i
ISOTOPE: Cesium-137 MAXIMUM ACTIVITY: 500 millicuries LEAK TEST FREQUENCY: 36' months PRINCIPAL-USE: (V) General Medical Use.
CUSTOM SOURCE: YES X NO l
l' j
i 1
l i
r 1 A G V .V REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES I
SAFETY EVALUATION OF SOURCE i (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: PAGE: 2 of 7 .-
~
JUN 2 5 1!Nl$ '
SOURCE TYPE: Tube Source DESCRIPTION:
The cesium-137 tube sources consist of two stainless steel capsules, l an outer casing and an inner core containing cesium-labeled cermic microshperes packed along the active length. The inner core is sealed by two stainless steel balls pressed in and welded in place
- The outer capsule is sealed by welding. Each tube source is then nickel plated, engraved with the nominal activity and serial number, and color-coded on the eylet end according to the nomial activity. '
The tube sources are available in tow lengths. Sources in series 6500 are standard size tubes, 20 m long by 3.05 nun diameter, with an active length of approximately 14 m. 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 examples is color-coded are listed below: on the eyelet and, according to the nominal activity, ,
Color Milligram Radium Equivalent Millicuries df Cesium Blue 5 Green 10 12.5 - 13.4 Yellow 25.2 --27.7 15 Orange 20 37.8 - 41.6 4 Red 25 50.4 - 55.4 Violet 30 63 - 69.3 White 35 75.6 - 83.2 Black 88.2 - 97.0 40 100.8 -111.0 Maximum Activity 199 500
- NOTE:
3M made this design change in 1985. The previous design use only one stainless ball to seal the end on the inner capsule.
Both designs will be marketed by 3M until the stock of the old design is depleted. Attachment 2 shows the old design.
l
O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: . M h 5 g' PACE: 3 of 7 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 (afterload) insertion of the app 11cator in the body 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:
o Wipe (smear) test o Soak test o- Leak (bubble) test o Temperature tested up to 848'C o Impact test - dropped 9 meters onto an unyielding surface o 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 l
)
4 E 1 O O i
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE
___ (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S DATE: -Q g j PAGE: 4 of 7 SOURCE TYPE: Tube Source EXTERNAL RADIATION LEVELS:
1 The manufacturer calculated the following dose rates from rates provided by NBS:
Millirem per Hour Output Activity in Millicuries I 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 17.1 140 6.840 57,1 23.8 264 9.520 72.6 30.5 338.9 12.200 93.0 l I
Note: The output activity allows for the 5.3% attenuation through the ;
stainless steel walls of the source.
1 QUALITY ASSURANCE AND CONTROL:
The manufacturer subjects all sources to quality control tests prior to their transfer to a licensed recipient. These tests consists 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.
__________ __ D
% Lwwk; 6s ,, ;i.:;;. .a., ;n.u _
J-p ,
/
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
~
J[jf 2 5 W 5'of-7 ~
1- -NO: NR-460-S-137-S. DATE: P GE:
SOURCE TYPE: Tube Source.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
.o . The source shall be distributed only to specific licensees of the NRC l
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 surface dose rates when unshielded, these sealed sources should be handled only by experienced licensed personnel.using adequate remote handling equipment and procedures.
.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 This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the hTC.
o The source shall be leak tested at three (3) year intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
l l'
l I
I o _ _ 1 ___- __ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
- i. 1
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES (Amended in its entirety)
NO: NR-460-S-137-S DATE: PAGE: 6 of 7 1955 SOURCE TYPE: Tube Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data referenced below, we conclude that this source series continues to be acceptable for licensing purposes. Over the past 15 years, 3M Company has distributed thousands of the sources with no incident of source damage and subsequent leakage of radioactive material during the recommended use and recommended handling procedures. We 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.
The manufacture conclude that the integrity of the new design surpasses the old design.
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:
o Minnesota Mining and Manufacturing Company application dated May 1, 1980 for renewal of License No. 22-00057-59MD o Supersede registry document No. NR-460-S-137-S dated April 7, 1985 l
t L __ _ __ _ _ _ _ _ _ _ _ _ . . _ _ _ _ . . . _ . _ _ ___ _ . _ _ _ _ _ _ _ _
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE
( __ _ , (AMENDED IN ITS ENTIRETY)
NO: NR-460-S-137-S- DATE: ym 2 5 Y PAGE: 7 of 7 SOURCE TYPE: Tube Source l
_ ISSUING AGr.NCY:
- U. : S. Nur. lear Regulatory Cotmnission l
/ /
Dater' Reviewer: N JUN 2 5 25 Dar.e :
< concurrence: y L. q- . L .[' .
i
/
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l t .. . _ _ _ _______ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ - - - - - __ . - . - - - - - .
O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
NO. NR-460-S-137-S ' DATE: ATTACHMENT 1 aurz5 #5
+
20.0mm *
-*- 3.hm =
\b.B m m : 2.3 m -
x.
AC TWE LENG,"T%
\
C/' ///////////////////N/////H/H) ^
/ ss sssuss ss s s s sss s s s s .s s ss ss . s g, T
(}l,l-l} -l'[-[-)}[:f;[*1-lllll:z.'[kN S.O 5 y ,
//A'///////////////N//N//////////A h O.*as em -).0 m m
=sTAmtsen, siest -
ETELET Ii mm BALL CE%\um-- Y:!rf
=3TA m t s g g, en,ts g t LOM>EO C.ERAtou .,
VhCRO%PRER4lriin E
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. Schematic Diagram of !;odified 3M Cesium-137 Source.
Series 6500 L
~
'O. O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE
'(AMENDED IN ITS ENTIRETY) 1 NO. NR-460-S-137-S DATE:
5g ATTACHMENT : 2 1
3M old source design ;
- \
20.Otam : i i
+ S.') um = \b. bum : '2.3 m *-
AC.TWE LEtirTW f/' ////////////////////4(////// ////)
/ ss r
sssssss ss s ss sssssss w J, .. .. .... .. .. .t. :.
.. .. ., n. . . .. A. .
s ss ss
. . . . ~. . . . . - 3 T^ I 8 . . . ....:.. r..~ + \ S.05 sms s s s sss sss s ss- sss s s s s s s sN N gy 1
//M///////////////N//M//////////4 1
{f O.tB MM si A m us:sss si e s t
-\.0 m m ETELEET i.i mm BALL C E t \uto -\=!rT s,Amtese, g,sst Lokomo c.eemme, V%CROs98%ERETs