ML20128Q065

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Tube source.Certificate:NR-460-S-926-S

ML20128Q065
Person / Time
Issue date:	06/25/1985
From:	Steven Baggett, Jonathan Brown NRC
To:
Shared Package
ML20126D741	List: ML20128N478 ML20128N536 ML20128N544 ML20128N574 ML20128Q029 ML20128Q065
References
SSD, NUDOCS 9610180213
Download: ML20128Q065 (8)

Text

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REGISTRY OF RADI0 ACTIVE SEALED SOUR'UES AND DEVICE - 'j

(.

, SAFETY EVALUATION OF SOURCE -

(AMENDED IN ITS ENTIRETY) ~

NO: NR-460-S-137-S -

LATE:

PAGE: 2 of 7 Nb 25

-SOURCE TYPE

/ -n e e dsenc . i,s-Tube Source ' " #' # #" #" ## "

Capsu /c e-nqrucc/ uuM DESCRIPTION:

nominaf acEviq d"# #a nd . stria i

'# #' ~ '#M on Me eye /e + end.

The cesium-137 tube sources consist of two stainless steel caps les, an outer casing and an inner core containing cesium-labeled ce tc microshperes packed along the active length. The inner core sealed

.by two stainless steel balls pressed in and welded in place

• The Outer ^ -

capsyla de eaalad by welding?- Each tube source is then nickel plated.

-engea*!:d Nith the acainsi act.tvity end serial n=ber, cad colcr-coded 4W

-the eylet end eccerding tc the nesfal acthity. '-

Thetubesourcesareavailableintklengths. Sources in series 6500 are 1ength standard of approximately size tubes,14 20m. m long by 3.05 m diameter, with an active

• special request, are .short tubes,16 m long by 3.05 m diameter, andSerie approximately 10 m active length. -

Each source examples are listedisbelow. color-coded on the eyelet and, according toy*the no Color Milligram Radium Equivalunt Millicuries df Cesium

' Blue .

5 .,

Green 12.5 - 13.4 10 Yellow '

15 25.2 --27.7 Orange 37.8 - 41.6 20 Red 50.4 - 55.4 25 Violet 30 63 - 69.3

' White 35 75.6 - 83.2 Bldek 40 88.2 - 97.0 100.8 -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. -

4 9610180213 960216 E 7

PDR RC

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1 REGISTRY OF RADIDACTIVE' SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE l

\

1

> ' (AMENDED IN ITS ENTIRETY)

NO: NR-460-S-137-S DATE:

.g g PAGE: 3 of 7 (

l l SOURCE TYPE: Tube Source L1BELING:

l

) Each nickel plated tube source is engraved with the nominal activity and serial l

number and color-coded on the eyelet end according to the nominal activity.

( DIAGRAM:

j See Attachments 1 and 2.

• I 3

CONDTTIONS OF NORMAL USE:

4

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1 in +r a

• The sources are used for deseescavitary t,reatment of cancer, which is accomplished by placing the radicadtive source into a device, referred to as a

{ applicator.

J Sources may be placed in the applicator either before (preloaded) i or following (afterload) insertion of the applicator in the body cavity to be 1rradiated. i l

4 . j

}

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PROTOTYPE TESTING: .

i The sources have been subjected to various prototype test (s) to demonstrate '

that e5- 4

~

urces shintEin' thki. r'in'tegrity "und'er stresses of use and accidents.

. . . . . . . . . . . . , , .. .,. . ... . s .> . . - . . . .:

as described in ANSI N44.1-1973 and ANSI N542-1977. .The tests performed on th4 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 tnyielding 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 integrityQ) C0hKRet fH187 6 8 7

- - , ~ .7

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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: ~ ~g g j j PAGE: 4 of 7 SOURCE TYPE: Tube Source

. _ EXTERNAL RAD'IATION LEVELS:

The manufacturer calculated the following dose rates from rates provided by NBS:

Millirem per Hour Output Activity in Millicuries 100 cm 30 cm 5 cm 3.81 42.3 @24 11.6

( 8.22 12.2 91.3 491!88 25.1

)

135.5 Q80 37.2 W /r.7 W.ror - C . C ' C n 7,T9 7 57.1 23.8 '264 y20 72.6 30.5 338.9 Ig00 93.0 l

Note: -e%

The output activity allows for the M ttenuation through the stainless steel valls of the source.

QU1LITY 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, 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 work:nanship. This quality assurance control program has been previously accepted by the.NRC.

( '

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~ 72 % 5 i U E R

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'W t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVIC -

SAFETY EVALUATION OF SOURCE I i (AMENDED IN ITS ENTIRETY)

No: NR-460-S-137-S DATE: .

JlfN 2 5 M PAGE: 5 of 7 i

j _ SOURCE TYPE: Tube Source I

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

i l o 4 The source shall be distributed only to specific licensees of the NRC

{ or Agreement States. .

1 s

o Handling, storage, use, transfer, and disposal

To be determined by the

! licensing authority. In view that these sealed sources exhibit high I i

surface dose rates when unshielded, these sealed sources should be handled only by experienced licensed personnel using adequate remote handling equipment and procedures. -

M l

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' ' '

l

\

techniques capable of detecting 0.005 microcurie of removable contamination.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES (Amended in its entirety) 4 NO:. NR-460-S-137-S DATE:

6 of 7 PAGE:

JUN25 1985 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.

eOver the past 15 years, 3M Company has distributed thousands of the sources wit [n e,ncident of source damage and subsequent leakage of radioac

( material during the recommended use and recommended handling procedures. We conclude, therefore, that this source series would be expected to maintain 1

their containment integrity for'the,specified uses and the conditions of use applicable to these uses.

The manuafacture 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

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I, REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVIC

• SAFETY EVALUATION OF SOURCE  !

(AMENDED IN ITS ENTIRETY) 4 NO: NR-460-S-137-S DATE: ym 2 5 M i

PACE: 7 of 7 SOURCE TYPE:. Tube Source  !

ISSUING AGENCY: -

j U. S. Nuclear Regulatory Commissio, Date: -

Reviewer: -

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DE l

( SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY) '

. i

_NO . NR-460-S-137-S OATE:

_ ATTACHMENT 1

. JUrg5-gSS

. 4 ,

.--2.0.0 m m _ 1 l

• 3.3 M M E- -

- \'-3 . $ m m  : j 3m e

. ACTWE LENC,7% ,

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" (/// n/!//// xu s ss s sssss//////////////W////////f/>

s s sss s sssws ss s s d m s 1-(( uss

/8///////////////N/[N////D:,'i.f s s s s ss s s s s su s suss ss ssst '? .* '.;lW 3.05 x- c'

///////)-- -

f -

NY -

l- O . c,.) B to m

-.i.o m m

%7mut.sss sent -

ETEL!L:T I I Mto BALL. CEE\L3ff\ - \g7 '

"5WMLL=ss % Test._

Loccac c.ER%st WCROEPt\ERt=%

Schematic Diagram of Hodified 3M Cesium-137 Source, Series 6500

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e-REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES .

SAFE I EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)

NO. NR-460-S-137-S ' DATE:

g g ATTACHMENT 2 V 4

3M old source design 20.0 wo- [

+ 5.9 v ' -=

\b.B m m a- 2.3 m +

AtrW e tet$5cw

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/ ////////////////////d//////////>

iss sssssss sss ss sss ssssms ss D;;;:Et::::i.:M.:Y-:::

ms s s s sss ms s ms s s, s s s s s 1.T35 SN s' :-s.oe '.;. h f /nrun/A Hun /H/NNNHH/HH/s ,

-o.ss wu - \.o w w wwwtsss sest.

ETEL!lliET

• f l.I mm BALL CEE\OM- \T 3 w A m t. r ,; s = m s e t. Loboeo cERAmc

Vi\C R O S P R E R E S

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.g REGISTRY OF RADI0 ACTIVE SEALED SOURCES Ai40. DEVICES SAFETY EVALUATION OF SEALED SOURCE -

NQ: NR-460-S-169-S DATE:

JAN 311983 PAGE 1 0F 4 4

DEVICE TYPE: Tube Source I

t MODEL: Series 6510, 6570, 6550 (formerly 686G) '

MANUFACTURER / DISTRIBUTOR:

Minnesota Mining and Manufacturing 3 M Center St. Paul, MN 55101 1

MANUFACTURER / DISTRIBUTOR: 1 r l

_IS0 TOPE: Cesium-137 M_AXIMUM ACTIVITY: 500 millicuries (see descript in activity per model) i LEAX TEST FREQUENCY: 6 Months PRINCIPAL USE: (V) General Medfcal Use CUSTOM DEVICE: YES X NO '

00EWL NO. 8 7 6 8 7 0

REGISTRY OF RADI0 ACTIVE SEALED f0VRCES AND DEVI

'[, SAFETY EVALUATION OF SEALED SOURCE N_0,: NR-460-S-169-S DATE:

y 3 .PAGE 2 Of 4 DEVICE TYPE: Tube Source y

DESCRIPTION

j , The miniaturized tube sources are doubly encapsulated stainless steel identic'alregistration refe-ence in construction materials and techniques as the needle source No NR-460-5-151-S. ,

i i

as tubes 19 mm long and 1.65 mm diameter with an i The Heyman afterloading source sortes 6550 are available as miniaturize sources brazed to a 0.9 m stai i

a beve16 d' handle with a screw nless steel wire, the distal end consists of i capsules. lock mechanism for sealing into Heyman afterloading

! _ LABELING: i l

k' Each miniaturized source is engraved with the nominal' activity and serfal num  !

2 4

Theserial and' Heyman~ number.afterloading sources have the. handles with the source n 4

l l

DIAGRAM

j See attachment.

, i CONDITIONS OF NORMAL USE: i The sources are used for intracavitary treatment of cancer, which is accom j by placing the radioactive source into a device, referred to as an applicator.he loaded) insertion of the appitcator in the body cavity to b 4 -

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REGISTRY OF RADI0 ACTIVE SEALE0 SOURCES AND DEVICES

.. ".T.E.

p;:r.m SAFETY EVALUATION OF SEALED SOURCE NO: NR-460-$-169 3 DATE:

n. JAN 311983 PAGE 3 0F 4 DEVICE T_YPE Source .

s- , .

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PROTOTYPE TESTING: -

Tube sources have been subjected to various prototype tests to demonst

' sources maintain their ~1nteg6f ty under stresses of use and accidents, as describ i'n ANSI N44.1-1973 and ANSI N542-1977 The tests per' formed on the sources are as follows: '

o M1pe (smear) test * *

~'!

o Soak test o Leak (bubble) test ~~'!

- ..i o Temperature test up to 848*C . .. . -

o .

o Impact test - dropped 9 meters onto an unyielding surface .

' l Percusi6cn test - 11.45 kg weight was dropped from 1 meter onto the -

source ly16ggon an unyielding surface. -

o .

Be6 ding test - each source was bent over a radius of approximately 3 mm o

90' to the long axis of the source and back again "

(.

L Tensile stress test - a .11.1 kg w&ight was hung from the eyelet end of the source, the other and (needle end) was attached to a permanent fixture ,

o o Soaked in 5% saline solution for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Soaked-in blood'at 140*F for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />!

/ost ~

No sour:cewas ?found to have testrcontdtnment integ61ty EXTERNAL RADIATION LEVELS: - .

The manufacturer calculated the fdllowing dose rates from rates profided by NBSi M1111 rem per hour . Outout Activity in Mil 11 curies 100 cm ,

30 cm 5 cm '

3.81 42.3 1,524 11.6 8.22 41.3 3.288 12.2 135.5 4,880 h,*I2

-43rP'tr.7 23.8 264 W 3r 4.M0 " 7, M a, 57',1 yg g 9,520 30.5 338.9 12,200 93.0 Note:

f off -

The output activity allows for the-GriHNttenuation through the stainless s teel walls of the source. 4

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T CONTR8L N0. 8 7 6 8 7 4

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND O .

s SAFETY EVALUATION OF SE,ALED SOURCE k

NO,: NR-460-S-169-S DATE: ' M 'I ' !E U

,4 oy 4 DEVICE TYPE: Tube Source t

QUALITY ASSURANCE AND CONTROL:

The transfer manufacturer subjects all sources to quality control tests prior to a licensed recipient.

assay for' radioactivity and rate test.These tests consist of leak test, wipe test, inner and outer capsules. Additionally These tests are performed on both the workmanship. each source is visually inspe'cted for by the NRC. This quality assurance con, trol program has bee previousl

_ LIMITATIONS AND/OR OTHER_ CONSIDERATIONS OF_ USE:

o The source Agreement shall States. be distributed only to specific ifcensees of the NRC or o . .

Handling, storage, use, transfer, or disposal: To be determined by the licensing authority.

dose rates when unshieldedIn view that these sealed sources exhibit high surface these sealed sources should be har.:!1ed only by

{2 experienced procedures. licensed person,nel using adequate remote handling equip o

and licensing any operational procedures, etc. from the lice determination.

o  !

shall not be changed or transferred without the writ SAFETY ANALYSIS

SUMMARY

I

}

Based on our review of the information and test data referred below, and th sources have been previously approved for licensing purposes by the NRC, we '

continue to find the tube source acceptable for licensing, that the sources would be expected to maintain their containment integrit specified applicable to uses theseand conditions which might occur during normal operating co uses:

REFERENCES:

The following supporting documents for the Model 6S10, 6570, 6550 sertes tube sources

( are hereby incorporated by reference and are mide a part of this registry documen o .

3M Coropany application dated May 11, 1980, for renewal of Lteense

\

ISSUING AGENCY: j).S. Nuclear Regulatory Commissiona Date: *A _

"d~"' Reviewer: \/

MS7

,g h

Om- ' - - - - # " l

. '. .g: NR 460-S-169-S O o g: JAN 311983 i... ~

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1 2 *

\9.\MM z

+ 4 .7 M M 4

- \1.O MN 1 2,4 MM -* --

ACTWE LE.MGTH i

1

/n'f/ / / / / / / / / / /1 / / / / / / / / / / / / /L // J J //1 // A Y

(' Ol. 't !f *,9.9 ' 6'."

• 1-!,[ffFi':. ./ f: ?(khN

/2 1/ //// 1 / / //1 //f f f /

lG I' / / / J )*f / As//J f / / / /ID a

A_

'-0.42 Mm~ -

- 03 mM I STN EES% "5mE.EL E'YELECT CEs\UM -\S 1 LO*C CER N C vgg% w,,?)

0.7 men B Att.(

,g g m \ t R o 2 P H E 9 t. E s FIGURE 3-1. Schematic Diagram of 3M Cesium-137 Miniaturized

( Tube source ry 095

M: NR-460-S-169-S *

• I 66 MM'MA*~

D_ elf: ?AN 31 E l '

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D

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. +0hm l9.6 M M tt.o wm x l '

ACTWE 5 LENG7H CE%\UM ~ \D I

. 9 * + .42 ,

H  :. STA\MLESS LOAQED CERAt l 280 MM u' wisaL MicPossmunu '-

u -,

i ,

O.1 mm libALL. (t)

Bobum -

%7A\MLESS STEEL '

t

'g,

+ + 0.CbMM

!( .-

y n -

T .

= ,

m ,

L-l l 16 MM -

1 1

%TNtt1PIB% %7 EEL 1

y i r -

t >

s

+ (3.'3 5 m+

t%

FIGURE 3-2.

Schematic Diagram of 3M Cesium-137 Heyman Afterloading Source Q 096

~ . 2. -

- 6 _;es? " N -~~ ~ ariE2i?GlT'ZIEN ~3:I':f' ' '

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es

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND SAFETY EVALUATION OF SEALED SOURCE ,

30: NR-460-S-151-5 OATE: JAN 3 1 1983 PAGE 1- 0F 4 t

t DEVICE TYPE: Needle Source I M: Series 6530y hrmerly 686G) '

MANUFACTURER / DISTRIBUTOR:

Minnesota Mining and Manufacturing 3 M Center St. Paul, MN 55101 I

MANUFACTURER / DISTRIBUTOR: -

h .

ISOTOPE: Cesium-137 MAXIMUM AdTIVITY: 500 millicuries (see descrip for activity per model no.

LEAK TEST FREQUENCY: 6 Months PRINCIPAL USE: (V) Genenal Medical Use' J

CUSTOM DEVICE

_ YES X N0 t

e 4

2 4 m w st e

- - - - - . - - - - - . . - . . = . -- . - - - -

=w3----

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l REGISTRY OF RADIOACTIVE SEALE0 SOURCES AND DEVICES

' SAFETY EVALUATION OF SEA, LEO SOURCE I

(

N_0 : NR-460-S-151-S DATE:

y ,, ,1 g% GE 2g 4 I

_ DEVICE TYPE: Needle Source I

DESCRIPTION: .4 The needle sources are doubly encapsu14ted stainless steel.

the cesium-labeled pressed in and weldedceramic in place. microspheres and is sealed by a statnless steel ba j

overall length triet vats from 1.063 inch to 2.245 inches.The outer capsule is an eyelet and the other a blunt or trocar point.1The series 6530 sources areOn faval' able in either tut i or na tt strength. A high intensity source needle mode

! (6540 listed is also available.) These sources are characterized by length and activi y below:

Milligram Dimensions Active Length Mil 11 curies Model No. Ridium Eauivalent , ln' Millimeters ._. Mil 11 curies <- Cesium -

6530 1.0 6531 27 x 1.65 15 2.52 - 2.9 1.5 34.5 x 1.65 '

• 22.5 6532 2.0 3.78 - 4.35 6533 42 x 1.65 30 5.04 - 5.80 3.0 57 x 1.65 45 F

7.56 - 8.69

, (' 3 6534 6535 0.5 27 x 1.65 15 1.26 - 1.45' 0.75 34.5 x 1.65 22.5 6536 1.0 1.89 - 2.17 6537.

43. x 1.65 30 2.52 - 2.9 1.5 57 x 1.65 45 Q540 10.0

~ 3.78 - 4.35; 22 x 1.65 10 25.2 - 29c /

LABELING:

r-O Because labeled. engraving the needle source might reduce their integrity, the sources ar e not  %

The needle may be identified as to nominal activity by total length. Addit ally, full strength needles are nickel plated and half strength needles are gold plat The storage container is lab'eled in accordance with 10 CFR Part 20.

\ l'nse rf ' s facs >, ced/e source 4r snyesaed wi,% serfs; DIAGRAM ^-

desig na tt need/es '/Aa t so-e MM# #" #

• 3 7 ~ m, M.s m m, See attachment. -

44 mm .an d 37mm /ons re. spec-6&e /y.

3

Dee Ny lCONDITIONS OF NORMAB USE:

6* .

iAtarsh%a '

amu.s 1 The sources are used for;inte=;c:v/it:Wtreatment of cancer which is accomn1 i drue. y plactno the radioactive TourcFgnto a device, referned to as an applicator.

i-Source may be placed in the app 11cator either before (pneloaded) or following (ofterloaded)

{ insertion of the applicator in the body cavity to be irradiated.

O

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o .

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DE SAFETY EVALUATION OF SEACED SOURCE

/ (

I .

NO: NR- 460-S-151 -S DATE: EM 3 ' '3%

1 PAGE 3 _0F 4 DEVICE TYPE: Needle Source

.y PROTOTYPE TESTING:

)

i.

. sources maintain their integrity under stresses o

' in ANSI N44.1-1973 and ANSI NS42-1977.

follows: The tests performed on the sources are as 3

)

o Wipe (smear) test o Soak test o Leak (bubble) test o Temperature test up to 848'c

, o o Impact test - dropped 9 meters onto an unyielding surface Percussion test - a 1.45 kg weight was dropped from 1 meter onto the o

source lying on an unytelding surface, Bending test - each source was bent _ over a radius of approximately 3 mm o 90* to the long axis of the source and back again C^ Tensile stress test - a 11.1 kg weight was hung from the eyelet end of the source, the other end (needle end) was attached to a permanent fixture ~

o o Soaked in 5% saline solution for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> Soaked in blood'at 140*F for 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

No source was found to have test containment integrity EXTERNAL RADIATION LEVELS:

The manufacturer calculated the following dose rates from rates provided by M111 trem per hour Output Activity in Mil 11curi_es.

100 cm 30 cm 5 cm 3.81 42.3 1,524 11.6 '

8.22 41.3 3,288 25.1 12.2 135.5 4,880 37.2

- 4 M e- /r. y i t0 ' ur -6,-640#-- 7.49 57.1-23.8 264 9,520 72.6 30.5 338.9 12,200

• 93.0 f, o Note:

The output activity allows for the-SWI~ attenuation through the stainless s teel walls of the source.

l CONTRGL N0.8 7 6 8 7

\gI l

I

,,, REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED- SOURCE

} {.

M

NR-460-5-151-5 DATE: y. . ,-

,; PAGE.4 0F 4 i

f _ DEVICE TYPE: Needle Source f

00ALITY ASSURANCE AND CONTROL:

, The manufacturer

,to-a subjects all sources to quality control tests prior to their transft license recipient.

4 radioactivity and rate test. These tests consist of leak test, wipe test, assay for capsules. These tests ard performed bn both the inner and outer Additionally, each source i.s visually inspected for workmanship. This

. quality assurance and control program has been previously accepted by the NRC.

t LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

i o Thetessource Sta . shall be distributed only .to: specific licensees of the NRC or Agreement

{

o Handling, storage, use, transfer, and disposal: To be determined by the licensing authori.ty.

! .s..

In view that these sealed sources exhibit high . surface dose rates when unshielded, these sealed sources should be handled only be experienced licensed iT i

personnel using adequate remote handling equ.ipment and procedures.

o

' " ~ ' ' The licensing autnv.Mtj will have to obtain details on specific source 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.

1 SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data referenced below, and that these sources have been previously approved for Itconsing purposes by the NRC, we continue to find the needle source series acceptable for licensing. Furthermore, we conclude j and conditions which might occur during normal operating conditi to these uses.

REFERENCES:

k The following supporting documents for the Model 6530 f ries needle sources i are hereby incorporated by reference and are made a pc t of this registry document: I h o 3M Company application dated May 11, 1980, for renewal of License No. 22-0057-59MD o

Supersedes registry document No. NR-460-S-151-U dated April 1,1972 j i

ISSUING AGENCY: 'U.S. Nuclear Regulatory Commission j

Date; '

Reviewer: '

k' f V

. . mat =u , - -

e i / ~

7 - - .NO

NR-460-S-151-5 DATE: i

agg 3 1 W3 4

?

i

-X L.EMC,7H%

i ,

OEPE.McEMT OM i

i ACT\N\TY RAD \uM EQU)NALENTS IM M\LLIGRAM .

+ 7o7At. t.susm '

5.9im - =  ;

ye Acme t. sues :

s.) m  :

-0.47 w

" %TNNLES STERL

(~ ly - .

~' t

_//c 1\.8;.4::: ~:::'.W::i:G.\:~ :a':~= =

At .-

~ ~ _ .

C . _

i8 n.

-o.7 mm 4 E7ELET O.7 m 95TNMLESS STEEL N@ CEs\uM-\S~T LOADED CERAM\C .

M\CROSPMEREE

(' FIGURE 2-1. Schematic DiagraE of 3M Cesium-137 Needle Source

. @@7

' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

( SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

HQ2: NR-460-S-166-S DATE:- SEP 16199g PAGE 1 OF 5 DEVICE TYPE: Therapeutic Seed Source MODEL: 6702 MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 50 millicuries LEAK TEST FREOUENQ11 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES x NO e'

REGISTRY OF RADIOACTIVE SEALED "S'OURCES AND DEVICES

( SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety) 4 HO2: NR-460-S-166-S DATE: SEP 161988 PAGE 2 OF 5 DEVICE TYPE: t Therapeutic Seed Source DESCRIPTION:

' , The 3M Model 6702 seed contains iodine-125 absorbed on anion exchange resin spheres 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. The rc;in'

-beads are repav=*=d hy = A

== d 4 =eeter gcid ephere. "--

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.

LABELING:

l

~

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. i DIAGRAM: p.tzs on s Esenen, ea o.os m m i Resia -

weisee Tieeneum

\g

() '

4.S a m CONDITIONS OF NORMAL USE:

The 3M Model 6702 sealed source (therapeutic seed) is designed for l use in the interstitial treatment of cancerous tumors. The seeds are designed to withstand normal autoclave temperature and pressure l variations from 1210C at 15 psi to 1380C at 35 psi.

I

1 i . f. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE

( (Amended in its entirety)

NO.: NR-460-S-166-S DATE: - ' ION 'PAGE 3 OF 5 DEVICE TYPE: Therapeutic Seed Source 1 4 PROTOTYPE TESTING:

Prototypes of the Model 6702 sealed' source (seeds) were subjected to tests to demonstrate that the source will maintaln their integrity under stresses of use and accident.

The i

. tests performed were in accordance with ANSI N44.1-1973. 3M i reports that percussion. the prototypes passed the ANSI tests for impact and l

' High temperature test results show that the Model

' ~6702 sealed source retains its. integrity up to temperatures of 2500C. At that temperature, the anion exchange resin breaks down l and releases the iodine. However, the capsule dses. 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 44s/hy gdry heat methods. sources should not be placed in-oeneentmated acifor9 sterilize f ,f3 f, y gg EXTERNAL RADIATION LEVELS: # #

~

External radiation-levels the 3M Company..using filmfrom the Model 6702 were determined by obtdined the following res, badges ults:~ (specified

~ accuracy i 15%) and 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 aci .053 ,

40.0 mci 21.2 OUALITY ASSURANCE AND CONTROL:

The 3M Company conducts the following quality control tests and inspection of the 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 May 1, 1980 application.

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

( SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

I HQt: NR-460-S-166-S DATE: SEP 16 )gy PAGE 4 OF S SEALED SOURCE TYPE: Therapeutic Seed Source LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

A.

' Licensees should observe the 3M Company iistructions for handling and using the I-125 seeds; spec' .'ically these 1

instructions warn t. hat: fer .*/4 /M .s e /u 6ri,, '

Locse4kg /mw j

( l.

Seeds should not be exposed to cencentrated*icid$' #

or sterilized g dry heat methods.

asAng l

2. Seeds should not be autoclaved in plastic tubing l or other plastic containers (only autoclave l compatible materials such as stainless steel, glass, nylon and teflon should be used).

3.

Seeds should not be exposed to temperatures in-S excess of 1380C and pressures in excess of 35 psi.

.. B.

Dose are rates of possible. about 1000 mR/hr at 5 cm. from these sources Personnel monitoring is required by persons using.the sources (extremity monitoring, i.e., ring ~~

dosimeters are suggested) and the source shall be handled only with appropriate handling + equipment.

C.

Sources months. shall be leak tested at intervals not to exceed six The test shall be capable. cf detecting the pressence of .005 microcurie of iodine-125 on the test samples.

D. Handling, Storage, Use, Transfer, and Disposal: Shall be determined by the licensing authority.

E. This regintration sheet and the information contained with the references shall ar;t be changed without the ,

w"itten 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 6702 sealed source is acceptable for licensing purposes. Furthermore, we conclude that this source would be expected to maintain their containment for normal conditions this registration sheet.

of use which might occur during the uses specified in

~

O o .

. )

REGISTRY OF RADIOACTIVE SEALED. SOURCES AND DEVICES

~

SAFETY EVALUATION OF SEALED SOURCE

{ (Amended in its entirety)

&: NR-460-S-166-S W 2 61988 - -

DATE:

PAGE 5 OF 5 SEALED SOURCE TYPE: Therapeutic Seed Source k

REFERENCES:

The following supporting documents for 3M Model 6702

< therpeutic sealed sources are hereby incorporated by references and are made a part of this registry document.

o 3M Company application received March 23, 1979, and application dated May 1, 1980. *

• o 3M Company letters dated May 30, 1979, September

• 12, 1979, February 8, 1980, April 18, 1980, May 8,

( 1980, June 3, 1980, January 11, 1983, July 8, and enclosures thereto. 1988, o Reference also 3M Company Lice'nse No.

22-00657-59MD. - , , , . _ ,

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission j

Date: 6M Reviewer: ,

Date:

Concurrence: O I-

/

.o O /1 // '

i-k CONTROL NO.676 8 f

1

%.)

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES 1 SAFETY EVALUATION OF SEALED SOURCE l

[ (Amended in'its Entirety)

H.Q.a. : NR-460-S-167-S DATE: . EP 161988 p3cg 1 op g DEVICE TYPE: Therapeutic Seed Source k l

MODEL: 6711 MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55101 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 100 millicuries LEAK TEST FREOUENCY:- 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES x NO 9

s n

.' m J

,. _ \U ~

' hfp

i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE

{ (Amended in its Entirety) l NO.: 'NR-460-S-167-S DATE: SEP 161968 PAGE 2 OF 5 1

j DEVICE TYPE: Therapeutic Seed Source k DESCRIPTION:

I rod The 3M Model 6711 seed contains iodine-125 absorbed on a solid I silverMnd 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 l the advancing arc allowing for a solid weld joint. i I

LABELING:

Because of their small size, individual seeds are not h' 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 Matefial", 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: 7.mY, " o.os

. t .f _ t

@, . )rq a=--

\

..y 4

~ s.ome - ~

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 consnercially-available implant tools. These implanters are used solely for source placement and are not designed either,to store or to hold I-125 s

Seeds, as is the case with conventional applicators and cesium-137 sources. The seeds are designed to withstand normal autoclave l temperature and pressure variations from 1210C at 15 psi to 1380C at 35 psi. j I

4 CCMTML NO.8 7 6 8 7 i

i

O o

{'

- REGISTRY OF RADIOACTIVE SEALED . SOURCES AND DEVICES

~

SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

NO.: NR-460-S-167-S DATE: SEP 16 Hus PAGE 3 Or s DEVICE TYPE: Therapeutic Seed Ecurce k

PROTOTYPE TESTING: 1 Prototypes of the Model 6711 sealed source (seeds) were subjected

- to tests to integrity demonstrate under stresses ofthatuse the andsources will maintain their accident.  !

., The tests performed i D# were in accordance with ANSI N44.1-1973. 3M company reports that  !

the prototypes passed the ANSI tests for impact and percussion.

'##" 6 '

'eVi n s /v High temperature test results show that the Model 6702 sealed

>e source retains its integrity up to temperatures of 4000C. At that re/easec/ } temperature 7the an19n avehinge recin breaks dc'.n and releases y ,, g4, the' e

-icdincc^- However, the

,/ iodine at temperatures of about 6000C.

capsule does lose its integrity and leaks

,3,f,,,

3M Company states that the N# Sid^' " sources should not be subjected to temperatures in. excess of 1380C and 35 psi.

• d. -consentxatedPaci In addition, the sources should not be placed in or sterilized -by/ iryt heat methods.

EXTERNAL RADIATION LEVELS:

MSmq i External radiation levels from the Model 6711 were determined by

/#b/'.7 ,

the 3M Company using film badges (speci.fied accuracy 15%) and 0la.ne?' ns obtained the following results:

~

xeccNy eno/a r- Distance from I-125 Measured radiation

,f. the sour;p (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 QUALITY ASSURANCE AND CORTROL:

1 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 l I

inspection, and assay for radioactivity. Complete details of the quality control program are included in the February 8, 1980 application.

{

/

k CONTRiit N0.8 7 6 8 7

- REGISTRY OF RADIOACTIVE SEALED . SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

&: NR-460-S-167-S DATE: SEP 161983 PAGE 4 OF 5 1

SEALED SOURCE TYPE: Therapeutic Seed Source 4 i

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

c o

The sealed sources shall be distributed only to specific licensees of the NRC or Agreement States. i 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 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 C~ . sealed sources exhibit high surface dose rates when unshielded, these sealed sources should be handled only by 3 experienced equipment licensed and personnel procedures. -

using, adequate remote handling 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

4 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.

CONTRet. N0 8 7 6 81

\

REGISTRY OF RADIOACTIVE SEALED. S,0URCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

F_Q,. : NR-460-S-167-S DATE: PAGE 5 OF S 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 i part of this registry document. 1 l

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, i and enclosures thereto. '

I i l

• l l

l l

ISSUING AGENCY:

I U.S. Nuclear Regulatory Commission n

Date: SEP 181990 Reviewer: 'a .

~

AJ Date: { 6 1988 Concurrence: 06 /=o r d36 CONTR9L NO B 7 6 8 7 1

.. as 46 REGISTRY OF RAD 10 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

No.: NR-460-S-167-S DATE: AUG 12133I PAGE 1 OF 5 SOURCE TYPE: Therapeutic Seed Source MODEL: 6711 MANUFACTURER / DISTRIBUTER: Minnesota Mining and Manufacturing 3M Center St. Paul, MN 55144-1000 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 100 millicuries LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES x NO h0 f'

. . M ee 1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

Hot: NR-460-S-167-S DATE: PAGE 2 OF 5 SOURCE 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. The titanium capsule has an outside diameter of 0.8 mm a..d a wall thickness of 0.05 mm. The weld thicknesses located at each end of the capsule average about 0.5 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.

The sealed source labels bear the Medi+ Physics, Inc. logo instead of 3M's. Under an agreement between 3M and Medi+ Physics, Inc.,

3M will continue to manufacture and distribute source Model 6711 for Medi+ Physics, Inc. under 3M's current distribution license from the 3M New Brighton, Minnesota manufacturing plant. 3M will also maintain control of all licensed activities.

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 one dram vial. A label is affixed to the vial stating, " Caution-Radiation Material", isotope, activity range, total activity, assay date, Medi+ Physics logo, and the trefoil radiation symbol.

The label complies with the provisions of 10 CFR 32.72 and 10 CFR 20.203.

DIAGRAM: See 5ttachment 1.

CONDITIONS OF h7RMAL 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

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF SEALED SOURCE '

(Amended in its Entirety) 1 DATE: AUG 121991 l

HQ2: NR-460-S-167-S PAGE 3 OF 5 SOURCE TYPE: Therapeutic Seed Source CONDITIONS OF NORMAL USE: (CoILtM 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 up to 138'C(280*F)  ;

at 35 psi. In addition, the sources should not be placed in concentrated acids or sterilized by dry heat methods.

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 l 6702 sealed source retains its integrity up to temperatures of l 400'C(752*F). At that temperature, the anion exchange resin breaks down and releases the iodine. However, the capsule will not lose its integrity and leak iodine until temperatures reach I about 600*C(1112*F).

EXTERNAL RADIATION LEVELS:

External radiation levels from the Model 6711 were determined by the 3M Company using film badges (specified accuracy 15%) and obtained the following results:

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

i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

, SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

! NO,1 NR-460-S-167-S DATE: EAGE 4 OF 5 1, -

SOURCE TYPE: Therapeutic Seed Source i-OUALITY ASSURANCE AND CONTROL:

j The 3M Company conducts the following quality control tests and inspection of the Model 6711 sealed source prior to distribution:

l visual inspection, initial leak test, and autoclave, x-ray 1 inspection, and assay for radioactivity. Complete details of the quality control program are included in the February 8, 1980 i application.

l

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE

l The sealed sources shall be distributed only to specific  :

licensees of the NRC or Agreement States.

. The licensing authority will have to obtain d2 tails on l specific holders and any operational procedures, etc. from

4. the license applicant to make a licensing determination.  ;

1 i . Licensees should observe the instructions for handling and l l

4 using the I-125 seeds.

. Sources shall be leak tested at intervals not to exceed six ,

months. The test shall be capable of detecting the J presence of 0.005 microcurie of iodine-125 on the test samples.

. 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 the references shall not be changed without the written consent of the NRC.

GS 44 l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)

NO : NR-460-S-167-S DATE: PAGE 5 OF 5 SOURCE TYPE: Therapeutic Seed Source 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 continue to conclude that this source would be expected to maintain its containment for normal conditions of use which might occur during the uses specified in this registration sheet.

i

REFERENCES:

The following supporting documents for 3M Model 6711 therapeutic sealed sources are hereby incorporated by references and are made a part of this registry document.

. Minnesota Mining and Manufacturing Company application received May 1, 1980, for renewal of license No. 22-00057- l 59MD.

l

. Minnesota Mining and Manufacturing Company letters dated  !

July 8, 1988, February 15, 1991, and enclosures thereto.

1 ISSUING AGENCY: i l

U.S. Nuclear Regulatory Commission l AUG 121991 '

" 7*g2Cd61 Date: Reviewer: .

/J AUG 121993 /

Date: Concurrence: /m - -

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety) h: NR-460-S-167-S DATE: U 1 b 19 l Attachment 1 4

g-ISS essertoe 0.04 me en esear ese ,,,,,, ,

h .-1 e.. FA '

g,j (

yf/\ u ==

I = s.0 .. = 1 l

4. s .= r l