Text

Package of Documents Re Registry of Radioactive Sealed Sources & Devices
	ML20140H420
Person / Time
Issue date:	10/16/1985
From:	; NRC
To:	;
Shared Package
ML20140H417	List: IA-85-666, Package of Documents Re Registry of Radioactive Sealed Sources & Devices; ML20140H413; ML20140H420;
References
	FOIA-85-666 NUDOCS 8510220144
	Download: ML20140H420 (105)
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f('!! REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: CA40651050 DATE: January 18, 1972 PAGE 1 0F 3-SEALED SOURCE TYPE: X-Ray Fluorescence Sources MODEL: AN 55, AN 57, AN 109,~AN 125, AN 241 NANUFACTURER/ DISTRIBUTOR: Isotope Products, Inc.

1800 N. Keystone Street Burbank, CA 91506-MANUFACTURER / DISTRIBUTOR:

ISOTOPE: Iron MAXIMUM ACTIVITY: 100 millicuries c

Cobalt-57 100 millicuries

. Cadmium-109 100 millicuries Iodine-125 200 millicuries Americium-241 50 millicuries LEAK TEST FRE0VENCY: 6 Months PRINCIPAL USE: X-Ray Fluorescence CUSTOM SOURCE: YES X NO

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d- REGISTRY OF RADI0 ACTIVE SEALFD SOURCES AND DEVICES.

SAFETY EVALUATION OF SEALED SOURCE NO.: CA406S105U DATE: January 18, 1972 .

PAGE 2 0F 3 -

SEALED SOURCE TYPE:- X-Ray Fluorescence Sources DESCRIPTION:

i

Maximum Activity Isotope: Model Designation: '(mC1) Normally Used*' -

i I ron.-55 AN 55 series ** 100 !

. Cobalt-57 AN 57 series 100

( Cadmium-109 AN 109 series 100 t i

Iodine-125 AN 125 series 200 i Americium-241 AN 241 series 50

, For special purposes, a greater amount may be required.

l.

- following' digits indicate nominal activity in millicuries. Thus "AN 55-100" would indicate 100 millicuries of iron-55.

~

These sources are annular, and are of various sizes. They are usually furnished to customers in holders of various designs. Construction of the sources is as follows:

i AN 55: Elemental iron is el'ectro-deposited and diffusion bonded on a nickel disc. '

t A beryllium sheet about 0.005" is then placed over the nickel disc and l, sealed in position by epoxy resin.

I AN 57: Cobalt-57 distributed within aluminum cermet wire received from i Radiochemical Centre is placed in a 304L stainless steel tube, with a i wall thickness of about 0.009", which is sealed at the ends by fusion I welding.

i

! AN 109 Elemental cadmium is electro-deposited on a silver wire, which is then

] placed in aluminum tubing, with a wall thickness of about 0.005", which j is sealed at the ends by cold welding.

~

! AN 125: Iodine-is electro-deposited on copper wire, which'is then placed in aluminum tubing, with a wall thickness of about 0.005", which is sealed l at the ends by cold welding.

AB 241: Americium-241 distributed within ' aluminum cermet wire received from Radiochemical Centre is placed in a 304L stainless steel tube, with a

. wall thickness of about 0.009", which is sealed at the ends by fusion 5

welding.

- _ . . . . , . . . . . . _ . . . _ , , . _ . . , _ _ , . . , . , , _ . , , . , _ _ , . ~ . . , , . _ . . . , . _ . _ _ . . _ _ _ . . ,.. _ . _ ___ _ . -

m J' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVIDES SAFETY EVALUATION OF SEALED SOURCE NO.: CA406S105U DATE: January 18, 1972 PAGE 3 0F 3 -

SEALED SOURCE TYPE: X-Ray Fluorescence Sources LABELING:

Source holders are labeled as to kind and amount of radioactive material, date of

, assay, and serial number.

PROTOTYPE TESTING:

The manufacturer and distributor performs prototype tests of the various models to determine adequacy of the sources to withstand normal environments to which X-ray fluorescent sources are exposed. He certifies that sources enc'apsulated in stainless steel naet the requirements for "special form material" as defined by 49 CFR 173.398. Healsocertifiesthagepoxyresinusedinthesourceswasfoundto be adequate after testing to 3 x 10 rads.-

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LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:

Normal leak test intervals are recommended (6 months for beta-gamma, and 6 months or less for alpha sources). These sources are inherently relatively delicate.

Before licensing one of these sources for any purpose other than as an X-ray fluorescence source, an evaluation should be made to determine adecuacy of the source for environmental conditions which might be encountered by it.

ISSUING AGENCY:

l California Department of Public Health '

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i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR169S136U DATE: August 01, 1972 PAGE 11DF 2 SEALED SOURCE TYPE: Ganna X-Ray _ Fluorescence Sources M00Eli C-283 MANUFACTURER / DISTRIBUTOR: Atomic Energy 'of Canada, Ltd.

Commercial Products P. O. Box 93 Ottawa, Canada MANUFACTURER / DISTRIBUTOR:

ISOTOPE: Gadolinium-153 MAXIt4UM ACTIVITY: 20 mil 11 curies Cadmium-109 20 mil 11 curies Iodine-125 40 millicuries.

LEAK TEST FRE0VENCY:

PRINCIPAL USE: X-Ray Fluorescence CUSTOM SOURCE: YES X NO J

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION GF SEALED SOURCE NO.: NR169S136U DATE: August 01, 1972 PAGE 2 0F 2 SEALED SOURCE TYPE: Gamma X-Ray Fluorescence Sources I

DESCRIPTION:

The AECL Model C-283 source isJconstructed of an aluminum cylinder 0.425 inches in diameter by 1/4 of an inch in -length. The capsule contains the radioactive material and an aluminum cover approximately 0.06 inches thick and is sealed with epoxy sealant Stycast 2762. The outer wall thickness is approximately 50 mils and 4

the end window thickness is 16 mils. An aluminum capsule liner ring is inserted

within the capsule to define either a 0.28 inch or 0.20 inch active source diameter j for the window.

, The radioactive material consists of gadolinium-153 absorbed on resin beads, cadmium-109 deposited by electrolysis on a silver foil disc 0.323 inches in diameter by 0.02 inches thick, or iodine-125 absorbed by evaporation onto 15/20 mesh 4

charcoal chips or beads.

PROTOTYPE TESTING:

The source has been tested and classified in accordance with ANSI N5.10-1968 as C33334.

~

OUALITY ASSURANCE AND CONTROL:

i 1 The manufacturer performs both destructive and nondestructive tests on the source.

i Weld quality is checked by destructive means. Each source is checked for leakage by a hot liquid bubble test within 7 days of shipment and each source is checked i for contamination by dry smearing the source. Activity limits for smears are i 0.0005 microcurie on the capsule. Prior to leak testing, the sources are i decontaminated by ultrasonic means.

l ISSUING AGENCY:

U.S. Atomic Energy Corm 11ssion r

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-S-135-5 DATE: JUN 12 EG4 PAGE 1 0F 6 SOURCE TYPE: Gamma / Photon Source MODEL: C-281 MANUFACTURER / DISTRIBUTOR: Atomic Energy of Canada, Ltd.

413 March Road P.O. Box 13500 Kanata, Ontario Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 3 Curies Cadmium-109 0.2 Curies Gadolinium-153 1 Curie Ytterbium-169 5 Curies Thulium-170 5 Curies Tellurium-125m 0.5 Curies LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (T) Other CUSTOM DEVICE: YES X No

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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES 4 SAFETY EVALUATION OF SOURCE

! (Amended in Entirety) 1-l NO.: NR-169-S-135-S DATE: JUN 12 M ~

PAGE 2 0F 6 l

! SOURCE TYPE: Gamma / Photon Source

{ DESCRIPTION:

i j The AECL.C-281 source and holder assembly is designed to hold an AECL C-235 j capsule (refer to Registration No. NR-169-S-161 S). It is a cylindrical brass ;

) holder 1.47 inches long and 5/8 of an inch 0.D. The inner capsule (AECL l l C-235) is held in place by an "0" ring screw. It has a removable end cap which provides approximately 1/4 of an inch of brass shielding. The assembly can be !

1 procured with an optional AECL model C-284 filter assembly containing a 2 mil !

thick tin filter. !

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J j LABELING:

t l The inner capsule is engraved with AECL, the nuclide, model number, and the ,

] source serial number. The outer source holder is engraved with AECL, the "

} nuclide, the model number, and the source serial number.

! DIAGRAM:

See attached drawings.

CONDITIONS OF NORMAL USE:

I i These sour,ces would normally be incorporated in laboratory testing equipment l such as bone mineral analyzers, etc. The use would normally be in clinical !

] laboratory, industrial or other research laboratory environments under standard

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j condition of temperature and pressure. ;

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety) c

NO.: NR-169-S-135-S DATE: JUN 121984 PAGE 3 0F 6 I SOURCE TYPE: . Gamma / Photon Source !

PROTOTYPE TESTING:

Same as for C-235/C-236 gamma sources. By certificate dated.May 24, 1972, the

manufacturer claims a classification of C34334 for the model C-235 inner j capsule in accordance with standards established by ANSI Committee N43-3.

EXTERNAL RADIATION LEVELS:

i j

j The manufacturer state's that a source containing 3 Ci of iodine-125 would be !

l expected to register the following readings: '

I (a) at 12 inches from the top surface of source C-235 = 2.9 R/h, l

)

j (b) at 12 inches from the top surface of source / holder assembly C-281 e l through the unobstructed window and with shipping cap removed I j - 215 R/h, !

4 l

(c) at 12 inches from the top surface of source / holder assembly C-281, i l foil filter C-284 installed and with shipping cap removed = 1.3 R/h, !

j (d) in contact with the side of source / holder assembly C-281, foil

] filter C-284 and shipping cap installed = approximately 100 mR/h.

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i iI REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety).

NO.: NR-169-S-135-S DATE: JUN 12 084 PAGE 4 0F 6 SOURCE TYPE: Gamma / Photon Source QUALITY ASSURANCE AND CONTROL:

The manufacturer performs both destructive and nondestructive tests on the source. Weld quality is checked by destructive means. Each source is checked for leakage by a hot liquid bubble test within seven days of shipment, and each source is checked for contamination (both inner and outer capsules) by dry smearing the source. Activity limits for the smears are 0.005 microcurie on the inner capsule and 0.0005 microcurie on the outer capsule. The smear test is repeated after seven days or more and within seven days of shipment.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data contained in the references cited below, we conclude that the Modal C-281 source design continues to be acceptable for licensing purposes. The basic source design was originally approved for licensing purposes by the U.S. Atomic Energy Commission in 1972, for the use of a inaximum of one Curie of iodine-125. The increased maximum activity of 3 Curies of iodine-125 and the use of the additional radionuclides and their respective maximum activities listed in this certificate are not expected to have a deleterious effect on the source containment. Therefore, we conclude that the Model C-281 sealed sources would be expected to maintain their containment integrity for normal conditions of use and accident conditions which might occur during uses specified in this certificate.

's t :o REGISTRY OF RADIOACTIVE SEALED SOURLES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-S-135-S DATE: JUN 12 E04 PAGE 5 0F 6 SOURCE TYPE: Gamma / Photon Source LIMITATIONS AND/OR CONSIDERATION OF USE:

o The source shall be distributed only to persons specifically licensed by the NRC or Agreement States, o The source shall be leak tested at six month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.

o Handling, storage, use, transfer, and disposal: To be determined by the lira, sing authority, o The source shall not be subjected to environmental or other conditions of use which exceed the performance standard classification C34334 contained in ANSI N5.4, 1968.

l o This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

REFERENCES:

The following supporting documents for the Model C-281 sources are hereby incorporated by reference and are made a part of this registry document:

l l

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

N3.. NR-169-S-135-S DATE:

JM 121984 PAGE 6 0F 6

REFERENCES:

o Letters dated January 24, 1984, February 2, 1984, and April 4, 1972, and enclosures there'o.

o U. S. Atomic Energy Commission registration sheet dated August 1, 1972.

Date Reviewed b , f, )?) . Smw y.

G V Date 7/[d Concurrence p d '-'s [ v,o ( F ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

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

NO.: NR-169-5-135-5 DATE: DUN 12 ATTACHMENT t

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b b REGISTRY'0F RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE ,

NO.: NR-169-S-161-S DATE: JUN Jg g PAGE 1 0F 7 SOURCE TYPE: Gamma / Photon Source MODEL: C-235/C-236 MANUFACTURER / DISTRIBUTOR: Atomic Energy of Canada, Ltd.

l 413 March Road l P.O. Box 13500 j Kanata, Ontario

. Canada X2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:

l 4

lodine-125 3 Curies

) Cadmium-109 0.2 Curies Gadolinium-153 1 Curie Ytterbium-169 5 Curies '

! Thulium-170 5 Curies I Tellurium-125m 0.5 Curies -

i

) LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (T) Other

) CUSTOM DEVICE: YES X NO l

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-169-S-161-S DATE: JUN 12 IIB 4 PAGE 2 0F 7 i

SOURCE TYPE: Gamma / Photon Source DESCRIPTION:

1

The Model C-235 inner capsule may be placed in a model C-236 cylindrical brass holder 1.343 inches long and 5/8 inch 0.D. The walls of the holder are approxi-i mately 0.025 inch thick. The inner capsule is held in the C-236 holder by 1

i brazing a 2 mil thick tin filter over the source holder opening and pressing a f 0.2 inch diameter by 0.187 inch long brass brush into place. The holder is equipped with a brass end cap which provides approximately 1/4 inch of brass sheilding.

I '

Model C-235 Inner Capsule o Iodine-125 absorbed into a 0.08 inch diameter spherical bead is encapsulated in a 1 inch long 316L stainless steel and aluminum capsule with a 0.124 inch 0.D. and a 20 mil wall. A spacer is used to position the charcoal or zealite bead at one end of the source rod and a stainless steel plug is welded in place to seal the capsule.

Additional radionuclides may be incorporated in this inner capsule in a similar manner. ;

1 o Cadmium-109 is absorbed on ion exchange medium or electrodeposited t i

as metallic cadmium on a suitable substrate such as silver, gold, l platinum or nickel.

o Gadolinium-153 is absorbed on ton exchange medium or as a pressed

, pellet of gadolinium oxide. '

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'$ ha REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-159-5-161-S DATE: PAGE 3 0F 7 JUN 12 EW4 SOURCE TYPE: Gamma / Photon Source DESCRIPTION (. J:

o Ytterbium-169 is absorbed on ion exchange medium or as a pressed pellet of ytterbium cxide or as a pellet of metallic ytterbium.

~

o Thulium-170 is absorbed on ion exchange medium or as a pellet of 2

metallic thullum.

2 o Tellurium-125m is absorbed on ion exchange medium or as a pressed pellet of tellurium oxide, i LABELING:

The inner capsule is engraved with "AECL, I-125 (or other radionuclide) and C-235," and the source serial number. The outer source holder is engraved with "AECL, I-125 (or other radionuclide), C-206" and the source serial number.

DIAGRAM:

I See attached drawings of inne capsule assembly and outer source holder.

CONDITIONS OF NORMAL USE:

These sources would normally be incorporated in laboratory testing equipment such as bone mineral analyzers, etc. The use would normally be in clinical laboratory, industrial or other research laboratory environments under standard conditions of temperature ard pressure.

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( b REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-169-S-161-S DATE: JUN 121984 PAGE 4 0F 7 SOURCE TYPE: Gamma / Photon Source i PROTOTYPE TESTING:

By certificate dated May 24, 1972, the manufacture claims a classification of C 34334 for the Model C-325 inner capsule in accordance with standards established by Committee N43-3.

EXTERNAL RADIATION LEVELS:

The following are previously submitted radiation levels for the C-235/C-236 model. (Refer to certificate No. NR 1695 156S and letter dated July 7, 1970.)

The inner capsule loading was 200 mci Iodine-125.

(a) 9 6.0 in from the top surface of the capsule (C235), with a 200 mci content (Iodine-125) = 730 mRh I

(b) @ 6.0 in from the top surface of the capsule (C236), with a 200 mci content, through the unobstructed window and with the shipping cap removed = 410 mRh (c) All conditions described in (b) but with 0.002 in. tin foil F

insert in the window, = 250 mRh (d) All conditions described in (c) but reading taken through the side of the capsule (C236 has a brass wall approximately 0.25 in thick), = negligible, in the region of 2 mRh

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES 4 SAFETY EVALUATION OF SOURCE NO.: NR-169-S-161-S DATE: JUN 121984 PAGE 5 0F 7 SOURCE TYPE: Gamma / Photon Source .

QUALITY ASSURANCE AND CONTROL:

, The manufacturer performs both destructive and nondestructive tests on the source. Weld quality is checked by destructive means. Each source is checked for leakage by a hot liquid bubble test within seven days of shipment, and each source is checked for contamination (both inner and outer capsules) by i dry smearing the source. Activity limits for the smears are 0.005 microcurie -

on the inner capsule and O. 005 microcurie on the outer capsule. The smear test is repeated after seven days or more and within seven days of shipment.

i 4

SAFETY ANALYSIS

SUMMARY

t Based on our review of the information and test data contained in the referen- f I

ces cited below, we conclude that the Model C-235/C-236 source design is acceptable for licensing purposes. The basic source design was originally i

, approved for licensing purposes by the U. S. Atomic Energy Commission in 1969 for the use of a maximum of 500 millicuries of iodine-125, and more recently fi registered under registry number NR-169-5-156-S. The increased maximum activity ,

of 3 curies of iodine-125 and the use to the additional radionuclides and !

their respective maximum activities listed in this certificate are not expected i

to have a deleterious'effect on source containment. Therefore, we conclude that the Model C-235/C-236 sealed sources would be expected to maintain their :

containment integrity for normal conditions of use and accident conditions which might' occur during uses specified in this certificate.

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a REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE o

NO.: NR-169-S-161-S DATE: JUN 12 Eg4 PAGE 6 0F 7 SOURCE TYPE: Gamma / Photon Source LIMITATIONS AND/OR CONSIDERATION OF USE:

1 o The source shall be distributed only to persons specifically licensed by the NRC or Agreement States.

!I o The source shall be leak tested at six month intervals using techniques capable of. detecting 0.005 microcurie of removable contaimination.

o Handling, storage, use, transfer, and disposals to be determined by the licensing authority.

o The source shall not be subjected to environmental or other conditions of use which exceed the performance standard classification C34334 ,

contained in ANSI N5.4, 1968. ,

i o This registration sheet and the information contained within the

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

REFERENCES:

t r l The following supporting documents for the model C-235/C-236 sources are hereby incorporated by reference and are made a part of this registry document:

i

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o Atomic Energy of Canada, Limited letters dated January 24, 1984, and

February 2, 1984, and enclosures thereto.

- . , _~ . _ _ . . _ - . - . . - _

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J REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO.: NR-169-5-161-S DATE: JUN 121984 PAGE 7 0F 7 SOURCE TYPE: Gamma / Photon Source l

REFERENCES:

j o NRC Registration Certificate No. NR-169-S-156-S, dated November 20, 1979.

Date Reviewed Ipeth //[ /Itw , ,

y/ i Date Concurrence

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ISSUING AGENCY

! U.S. Nuclear Regulatory Commission 4

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1N3HH3V11V N613 I N0l' :31VO S-191-S-691-8N :~0N N-

i. L 33800S 30 NOI1V0lVA3 A133VS

-]

.o 3 .,

t REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

, SAFETY EVALUATION OF SEALED SOURCE NO.: NR169S158U DATE: November 20, 1979 PAGE 10F 2 V -

i SEALED SOURCE TYPE: Sealed Source l

MODEL: C-265 i

MANUFACTURER /DISTRIBUTdR: Atomic Energy of Canada, Ltd. i Commercial Products ,

P. O. Box 93 !

j - Ottawa, Canada '

j MANUFACTURER /CISTRIBUTOR:

.p ISOTOPE: - Iodine-125 MAXIMUM ACTIVITY: 500 mil 11 curies Gadolinium-153 100 millicurie,s '

f i

LEAK TEST FREQUENCY:

PRINCIPAL USE: Industrial Radiography CUSTOM SOURCE: YES X NO

D i

i t

l 1 ---va-e,w-an -g-e-r.+y e e t----w+r-+gwi-w se -e- -AM -

+rm-e -e-gw 9 r-Tm'F-w my-M r- v-v e-tp =--*-9-~e+ rwa v= e'< p w m-r y-g9%,rg- -y,p- y-Sww,rp- 9%r, 9-w yg w ,w,y y py y <

(t REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR1695158U DATE: November 20, 1979 PAGE 2 0F 2 SEALED SOURCE TYPE: Sealed Source DESCRIPTION:

The Model C-265 source contains a maximum of 500 millicuries of iodine-125 in the form of Na! absorbed on charcoal or zeolite beads or a maximum of 100 millicuries of gadolinium-153 as GdCl absorbed on resin beads. The source consists of an annular aluminum body and body cover and is sealed with stycast 2762 epoxide sealant. The annular body measures 1.50 inches in diameter by 0.25 inches high and contains an annular grove 0.015 inches deep into which the radioactive material is placed. Minimum thickness is 0.020 inches.

LABELING:

Sources are engraved with; AECL, I-125 or Gd-153, C-265 and a serial number.

PROTOTYFE TESTING:

Tests conducted by the manufacturer indicate the source may be classified as C33334 under the specifications established by ANSI.

REFERENCES:

i Date November 20, 1979 Reviewed By /s/

Earl G. Wright l Date November 20, 1979 Concurrence /s/

Joseph M. Brown, Jr.

ISSUING AGENCY:

U.S. Nuclear Regulatory Comission L-------___---___----_-_--------------------

'~ \c REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-S-157-5 DATE: JUN 12 564 PAGE 1 0F 6 SOURCE TYPE: Gamma / Photon Source MODEL: C-324 MANUFACTURER / DISTRIBUTOR: Atomic. Energy of Canada, Ltd.

413 March Road P.O. Box 13500 '

Kanata, Ontario Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 3 Curies Cadmium-109 0.2 Curies Gadolinium-153 1 Curie Ytterbium-169 5 Curies Thulium-170 5 Curies Tellurium-125m 0.5 Curies LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM DEVICE: YES X NO l

l 1

( \'

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE I (Amended in Entirety) t i

NO.: NR-169-S-157-5 DATE: JUN 121984 PAGE 2 0F 6 !

SOURCE TYPE: Gamma / Photon Source '

DESCRIPTION:

i The model 324 sealed source is for use as a Gamma / Photon source for general medical use such as for bone mineral analysis. The radionuclide, for example, I iodine-125 which is absorbed into irregularly shaped charcoal chips or zeolite i beads, is encapsuiated in a 316 L stainless steel and aluminum capsule. The capsule is 0.384 inch long, 0.155 inch'of which is aluminum. The overall diameter is 0.114 inch. A stainless steel plug is welded in place to seal the ;

capsule. Minimum wall thickness of the source 0.015 inch. The C-234 sealed i source is identical in design and construction (overall divisions excepted-the C-324 is smaller in physical size) to the AECL sealed source model C-23b.

Additional radionuclides instead of iodine may be incorporated as follows: E o Cadmium-109 is absorbed on ion exchange medium or electro deposited as metallic cadmium on a suitable substrate such as silver, gold, !

platinum or nickel.

i o Gadolinium-153 is absorbed on ion exchange medium or as a pressed !

pellet of gadolinium oxide.

o Ytterbium-169 is absorbed on ion exchange medium or as pressed pellet of ytterbium oxide or as a pellet of metallic ytterbium.

_: c o Thulium-170 is absorbed on ion exchange medium or as a pellet of

. metallic thulium.

i l

( ..I t

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-S-157-S DATE: PAGE 3 0F 6 JUN I 2 EE4 SOURCE TYPE: Gamma / Photon Source DESCRIPTION (cont.):

o Tellurium-125m is absorbed on ion exchange medium or as pressed pellet of tellurium oxide.

LABELING:

The capsule is engraved on its stainless steel cylindrical surface with "AECL",

"I-125" (or other radionuclide), and serial number as specified in characters 0.045 inch high X 0.005 inch maximum depth.

DIAGRAM:

See attached drawing.

CONDITIONS OF NORMAL USE:

This model source is for bone mineral analysis. The use would typically be in a clinical laboratory environment under standard conditions of temperature.

PROTOTYPE TESTING:

The source 3s certified by the manufacturer to meet the ANSI standards under a classification of 68C 34334.

l l

.. 7 . - - - . _ _ . - - , ,. ,

( (l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

- SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-5-157-S DATE: PAGE 4 0F 6 JUN J2 @

SOURCE TYPE: Gamma / Photon Source EXTERNAL RADIATION LEVELS:

Refer to AECL Model C-235.

QUALITY ASSURANCE AND CONTROL:

The manufacturer performs both destructive and nondestructive tests on the source. Weld quality is checked by destructive means. Each source is checked for leakage by a hot liquid bubble test within seven days of final packaging, and each source is checked for contamination by smearing the source. Activity limits for the smears are 0.0005 microcurie. The smear test is repeated after seven days or more with an activity limit of 0.005 microcurie.

LIMITATIONS AND/OR CONSIDERATION OF USE:

o The source shall be distributed only to persons specifically licensed by the NRC or Agreement States.

o The source shall be leak tested at six month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.

o Handling, storege, use, transfer, and disposal: To be determined by the licensing authority.

o -The source shall not be subjected to environmental or other conditions of use which exceed the performance standard classification C34334 contained in ANSI N5.4, 1968.

l I

l

( (.

f REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Amended in Entirety)

NO.: NR-169-S-157-S PAGE 5 0F 6 DATE:

gy SOURCE-TYPE: Gamma / Photon Source

~

. LIMITATIONS AND/0R CONSIDERATION OF USE:

I o This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information contained in the reference cited L,.'.ow, we conclude that the model C-324 source design continues to be acceptable for licensing purposes. The basic source design has been approved for the use of 500 mci of iodine-125 since 1977. The increased maximum activity of 3 curies of iodine-125 and the use of the additional radionuclides and their respective maximum activities listed in this certificate are not expected to have a deleterious effect on source containment. Therefore, we conclude that the model C-324 sealed sources would be expected _to mairtain_their containment integrity for normal conditions of use and accident conditions which might occur during uses specified in this certificate.

REFERENCES:

The following supporting documents for the model C-324 sources are hereby incorporated by reference and are made a part of this registry document:

i L~'_~_-_-.- - - ,

-. . . . . . . .. . . . . . - - - - . .~ . - . . . _ .

3

( s i '

i i

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l t

SAFETY EVALUATION OF SOURCE (Amended in Entirety) i i

i

, NO.: NR-169-S-157-S. DATE: JUN 12 g PAGE 6 0F 6

~

SOURCE TYPE: Gamma / Photon Source '

h

REFERENCES:

r i

o Atomic Energy of Canada, Limited letters dated' February 2, 1984, and ,

enclosures thereto.

1 -

! o Superseded Registration Certificate No. NR-169-S-157-S, dated i November 20, 1979. '

l i

i Date Reviewed 1, 2//, bp

$' I l Date Concurrence

~ - -/

E/ M -

I_

ISSUING AGENCY U.S. Nuclear Regulatory Commission I

l _ .

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q' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE. ,

(Corrected Copy)

NO.: NR-169-S-156-S DATE: JUN 12 Eg4 PAGE 1 0F 4 i

SEALED SOURCE TYPE: Gamma / Photon Source MODEL: C-225/C-236 MANUFACTURER / DISTRIBUTOR: Atomic Energy of Canada, Ltd.

Commercial Products P.O. Box 13500 Kanata, Ontario Canada K2K 1X8 ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 500 mil 11 curies LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (T) Other

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CUSTOM DEVICE: YES X N0 5

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. i REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Corrected Copy)

NO.: NR-169-S-156-S DATE: M I2 % PAGE 2 0F 4 i

SEALED SOURCE TYPE: Gamma / Photon Source DESCRIPTION:

! The C-225 inner capsule may be placed in a C-236 cylindrical brass holder 1.343 inches long and 5/8 inch 0.D. The walls of this holder are approximately 0.025 inch thick. The inner capsule is held in the C-236 holder by brazing a 2-mil thick tin filter over the source holder opening-and pressing a 0.2-inch i diameter by 0.187 inch long brass bush into place. The holder is equipped j with a brass end cap which provides approximately 1/4 inch of brass shielding.

1 a Model C-225 inner capsule: Iodine-125 electroplated on the end of a

, silver wire is encapsulated in a 1 inch long 316L stainless steel cylindrical capsule with a 0.124-inch 0.D. and 30-mil walls. The wire is <

held in place by means of a glass spacer and stainless steel plug is welded in place to seal the capsule. The active portion of the source is positioned at the end of the capsule.

1 i

LABELING:

The inner capsules are engraved with "AECL, I-125, C-225" and the source serial number. .The outer source holder is engraved with "AECL, I-125, C-236,"

and the source serial number.

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. - . .. . - - . . .~.-.. _-.- _ . . . - ..

i-3 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

! SAFETY EVALUATION OF SOURCE (CorrectedCopy) j NO.: NR-169-S-156-5 DATE:

JUN 121984 PAGE 3 0F 4 l

! SEALED SOURCE TYPE: Gamma / Photon Source

QUALITY ASSURANCE AND CONTROL

)

i i

The manufacturer performs both destructive and nondestructive tests on the source. Veld quality is checked by destructive means. Each source is checked ,

ch ou ce h cke fo c n t on bo h nra o er u es by

]- dry smearing the source. Activity limits for the-smears are 0.005 microcurie

, on the inner capsule and 0.0005 micrucurie on the outer capsule. The smear test is repeated after seven days or more and within seven days of shipment.

i j

REFERENCES:

I o

l Date: November 20, 1979 Reviewed: Earl G. Wright j Date: November 20, 1979- Concurrence: Joseph M. Brown Jr.

l ISSUING AGENCY:

, U.S. Nuclear Regulatory Commission !

i i

! C .- __ . . . . , . - - _ _ _ - _ _ . . _ _ . . _ . . _ . . _ _ _ . . _ _ _ . . - _ . . . . , _ . . . - - . _ . - _ , - . . _ _ . . , . , . . _ . , . . . _ . _ . . - - - -

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (Corrected Copy)

NO.: NR-169-5-156-S DATE: M I2 % PAGE 4 0F 4 SEALED SOURCE TYPE: Gamma / Photon Source NOTE:

This corrected copy deletes the Model C-235/C-236 source from this Registration Certificate effective upon the. issuance of Certificate No.

NR-169-S-161-S.

2 i

Date Reviewed bul, ffI bksi #.

{/ ' I Date Concurrence -

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.fr REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l NO.: CA406S1195 DATE: June 09, 1975 PAGE 10F 2 ,

SEALED SOURCE TYPE: Industrial Gauge And X-Ray Fluorescence e

MODEL: 254 t1ANUFACTURER/ DISTRIBUTOR: Isotope Products, Inc.

1800 N. Keystone Street Burbank, CA 91506

l MANUFACTURER / DISTRIBUTOR:

ISOTOPE: Any radionuclide MAXIMUM' ACTIVITY: 200 millicuries

,_ from atomic numbers

( 3-83 .

Americium-241 LEAK TEST FRE00ENCY: 6 Months PRINCIPAL USE: X-Ray Fluorescence CUSTOM SOURCE: YES X NO i

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

i NO.: CA406S119S DATE: June 09, 1975 PAGE 2 0F 2 l SEALED SOURCE TYPE: Industrial Gauge And X-Ray Fluorescence :

DESCRIPTION: 1 The radionuclides are in the form of cermet, electrodeposited wire, or ceramic beads. These sources are annular and are doubly encapsulated. The inner capsule is a stainless steel (304) tubing with welded ends. The diameter of the tubing is 0.065" and the thickness of the wall of the tubing is 0.0065". The outer capsule (annulus) is also constructed of stainless steel (304). The dimensions for the annular outer capsule are 1-1/16" inner diameter,1-7/16" outer diameter and 5/32": '

high. The minimum thickness of the side-walls is 0.02" and the minimum thickness of the annular window is 0.005". The outer capsule is sealed by a 1/16" thick annular plug by fusion welding all around.

LABELING:

C The following is engraved on the source capsule: Isotope, amount, Serial number and date.

PROTOTYPE TESTING:

f The manufacturer states that tests of these sources indicate a 32232 classification and can be cualified as special form material. They have undergone prototype tests as described in USASI NS-10-1968.

LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE: ;

A 6 month leak test interval is recommended. A specific license is required for possession of the sources.

ISSUING AGENCY:

California Department of Health l

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

-NO.: NR13651875 DATE: .May 23, 1980 PAGE 10F 3 SEALED SOURCE TYPE: Industrial Gauge Source MODEL: --

i MANUFACTURER / DISTRIBUTOR: Amersham Corporation 2636 S. Clearbrook Drive Arlington Heights, IL 60005 I

I MANUFACTURER / DISTRIBUTOR:

I i ,

i IS0 TOPE: Iodine-125 MAXIMUM ACTIVITY: 625 mil 11 curies 1

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l LEAK TEST FREQUENCY: 6 months i

PRINCIPAL USE: Ganna Gauges 4

CUSTOM SOURCE: YES X N0 e

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

I 1

NO.: NR136S187S DATE: May'23, 1980 PAGE 2 0F 3 !

I SEALED SOURCE TYPE: Industrial Gauge Source !

i

?

j DESCRIPTION:

t

} The iodine-125 is extracted from sodium iodide solution and absorbed into an ion i :

exchange bead. The bead is dried and mounted into the capsule constructed of

{ aluminun which is sealed using epoxy resin. The source capsule dimensions are 9.75 i inches long by 2.90 inches in diameter.

LABELING: .

, All sources are permanently engraved with serial number and details of the nuclide and activity.

4 CONDITIONS OF NOPyAL USE:

l The Model IMC.P3 is designed for use in industrial gauging devices at ambient j temperature and atmospheric pressure.

PROTOTYPE TESTING: '

1 Prototype sources were tested per ANSI N542-1977 and designated ANSI 77C34345. -

EXTERNAL RADIATION LEVELS: I The external radiation level from the source is as follows: -

P 1

At 5 cm 30 rads / hour !

l At 30 cm 0.85 rads / hour i . :

OUALITY ASSURANCE AND CONTROL:

e

} Capsule components and materials are visually and dimensionally checked for !

compliance with Model IMC.P3 drawing.

Finished shources are checked for freedom from leakage and contamination by wipe and innersion test methods (ANSI N542,1977 AppendixA).

j LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:

, A. This source shall be distributed only to specific licensees of NRC or Agreement States.

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( i REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE 1

N0.: NR1365187S DATE: May 23, 1980 PAGE 3 0F 3

. SEALED SOURCE TYPE: Industrial Gauge Source LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE (CONT'D):

B. Handling, Storage, Use, Transfer, and Disposal: To be determined by the licensing authority.

C. The Model IliC.P3 shall not be subjected to environmental or other conditions of use which exceed ANSI Classification 77C34345.

D. Leak Testing: The Model IMC.P3 shall be leak tested at 6 month intervals using techniques approved by the licensing authority and capable of detecting

] 0.005 microcuries of removable contamination.

REFERENCES:

The safety review and registration of Model IMC.P3 sealed source design is based on infornation in Amersham Corporation letters dated March 28, 1980, April 21, 1980 and May 6, 1980, and enclosures thereto.

Date May 23, 1980 Reviewed By /s/

Earl G. Wright Date May 23, 1980 Concurrence /s/

Jacob Kastner i

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

( ( t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED COPY) i i

NO: NR-136-S-175-S DATE: g 07 W PAGE: 1 of 6 1

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SOURCE TYPE: Low Energy Camma Point Source I

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MODEL: IMC.P2 ,

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! MANUFACTURER / DISTRIBUTOR: Amersham Corporation 1

4 2636 S. Clearbrook Drive i

j Arlington Heights, Illinois 60005 l

i MANUFACTURER / DISTRIBUTOR:

i I l

! l 4 ISOTOPE: Iodine-125 MAXIMUM ACTIVITYi 635 millicuries I 1

1 i

t j LEAK TEST FREQUENCY: 12 months i

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i PRINCIPAL USE: (V) General Medical Use i

i f

CUSTOM SOURCE: YES X NO j .

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o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED COPY) 1 i

NO: NR-136-S-175-S DATE: gay 07 355 PAGE: 2 of 6 i i 4 SOURCE TYPE: . Low Energy Gamma Point Source-DESCRIPTION: '

i The Model IMCP2 point source consists of iodine-125 which is extracted from sodium iodide solution and absorbed onto a 1 mm ion exchange bead. The bead is then dried and mounted into one end of an inner beryllium or aluminum capsule.

~

The bead is held against the end of the capsule by a beryllium or aluminum plug i which is sealed with epoxy resin. The beryllium or aluminum capsule is sealed

< by epoxy resin in a stainless steel outer capsule with as a 45' collimated i opening at the bead end which is covered by a 0.005 mm titanium vindow. The

! overall dimensions of.the source are.10 mm in length and 3 mm in diameter.

Each finished source is visually inspected and bubble, wipe, and immersion tested. i I 4 LABELING:

4 l Each source is engraved with details of:

4

. 1. The nuclide j 2. The activity 1 3. A serial number -

i' The source is supplied to customers in plastic tubes labeled to show the model number, manufacturer radiation symbol, activity and date. These tubes are contained in small lead pots labeled with the nuclide and model number.

1 1

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. ( O REGISTRY OF RADI0 ACTIVE SEALED' SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (AMENDED COPY)

NO: NR-136-S-175-S DATE: NAy 07 E PAGE: 3 of 6 SOURCE TYPE: Low Energy Gamma Point Source DIAGRAM:

ITEM DRG NO. . TITLE-1 4RC10847/S Capsule X105/1 Inner Cell 2 4RC10848/S Capsule x105 Inner Plug 3 4RC10849/S - Capsule x105 Outer Holder & Plug 4 - 3,0px0,005 thk. Titanium Window 5 - I-125 on 1,09 Resin Bead

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L' 10.0 (Ref. Only) > PLtlGS .

PROTOTYPE TESTING:

The manufacturer has submitted information on prototype testing showing the source have a classification of C34343 based on ANSI Standard N5.10-1968.

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- REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

. SAFETY EVALUATION OF SOURCE

'(AMENDED C01-Y)

NO: NR-136-S-175-S DATE: any 07 W PACE: 4 of 6 -

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SOURCE TYPE: Low Energy Garma Point Source EXTERNAL RADIATION LEVEL:

Based on measurements using LiF thermoluminescent dosimetere dose

] rates at Sem and 25cm have been calculated as follows:

Activity 625 MCI I-125 at Sem: - 30 rads /hr 25cm: - 1.2 rads /hr These values are fer measurements in beam. The radiation from this source type is collimated and reduces rapidly at angles greater than

! 60* to the source axis.

1 QUALITY ASSURANCE AND CONTROL:

During manufacture capsule components and materials are checked visually and dimensionally to ensure that they comply with enginea. ring specifications.

The following table summarizes the quality control procedures that

ensure that production sources meet the standards of the design and prototype tests.

! Comnonent Object of Insnection Type of Test Iodine-125 Purity add Activity Gamma counting and

.- snectrometry.

b

Capsule ~.Y.aterial specification . Purchased against supplier evaluated material specifi-

. cations.

Dimensional tolerances Checked by

< ceasurement.

i

! Finished Source Seal qualit;.- Visual inspection bubble, wipe and

. immersion tests (APPENDIX 2)

Radiat, ion output Gamma counting and spectrometry.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED COPY)

NO: NR-136-S-175-S DATE: EUN II'\UIb PAGE: 5 of 6 SOURCE TYPE: Low Energy Gamma Point Source LI?i1TATIONS AND/OR OTHER CONSIDERATIONS OF USE:

o The IMCP2 source shall be distribute only to persons

specifically licensed by the NRC or an Agreement State.

o The IMCP2 source shall be leak test at twelve (12) month I

intervals using techniques capable of detecting 0.005 microcuries of removable contamination.

i o Handling, storage, use, transfer, and disposal: To be ;

} determined by the licensing authority.

o This registration sheet and the information contained within the references shall not be changed or transferred 4

without.the written consent of the NRC.

SAFETY ANALYSIS SL'MMARY:

1 l Based on our review of the information and test data cited below, we conclude

that the model IMCP2 low energy gamma point source designs area acceptable for licensing purposes.

l Furthermore, we conclude that this source would be expected to maintain its e containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.

This amendment increases the leak test interval from 6 months to 12 months.

Amersham has provided sufficient data to demonstrate the acceptability of the extend leak test frequency.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED COPY)

NY UI M NO: NR-136-S-175-S DATE: PAGE: 6 of 6 SOURCE TYPE: Low Energy Gamma Point Source 1

REFERENCES:

The following supporting documents for the Model IMCP2 source are hereby incorporated by reference and are made a part of this registry document.

o Amersham Corporation letters dated October 30, 1979, -

January 21, 1985 and March'll, 1985 with enclosures thereto.

J

! o Supersede Document Number NR-136-S-175-U dated November 20, 1979.

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l

ISSUING AGENCY

U. S. NUCLEAR REGULATORY COMMISSION j DATE REVIEWER. <W DATE prf 07 1M6 CONCURRENCE 0- - A Nl h . .

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR136S1620 DATE: December 1978 PAGE 1 0F 2 A

SEALED SOURCE TYPE: Low Energy Garra Point Source MODEL: IMCPI MANUFACTURER / DISTRIBUTOR: Amersham Corporation 1 2636 S. Clearbrook Drive Arlington Heights, IL 60005 MANUFACTURER / DISTRIBUTOR:

'I ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 200 millicuries l

LEAK TEST FREQUENCY: ,

I l PRINCIPAL USE: General Medical Use CUSTOM SOURCE: YES X NO I.

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE N0.: NR136S162U DATE: December 1978 PAGE 2 0F 2 SEALED SOURCE TYPE: Low Energy Garna Point Source DESCRIPTION:

The Model IMCPI point source consists of iodine-125 which is extracted from sodium iodide solution and absorbed onto an ion exchange bead. The bead is then dried and mounted into a 1 mm recess in- the end of a Dural aluminum capsule. The capsule 4

dimensions are 6.2 mm diameter and 6.25 mm in height with a wall thickness of 2 mm. The bead is held in place by a 1 mm thick aluminum cup insert which is 5 mm high and 5.1 mm in diameter and is sealed at' the opposite end from the source by epoxy resin forming a single encapsulation of the bead. Each source is visually inspected and bubble, wipe, and immersion tested.

LABELING:

Each source is engraved with details of

1. The nuclide -

2. The activity

3. A serial number 4 The radiation symbol.

PROTOTYPE TESTING:

The manufacturer has submitted information on prototype testing showing the sources

~

have a classification of C34343 based on the ANSI standard N5.10-1968.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission i

a

(~; REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: CA406S136U DATE: December 10, 1981 PAGE 10F 4 SEALED SOURCE TYPE: X-Ray Fluorescence Sources MODEL: All 55, AN 57, AN 109, AN 125, AN 241 MANUFACTURER / DISTRIBUTOR: Isotope Products, Inc.

1800 N. Keystone Street Burbank, CA 91506 t1ANUFACTURER/ DISTRIBUTOR:

f ISOTOPE: Iron-55 MAXIMUM ACTIVITY: 100 mil 11 curies Cobalt-57 100 mil 11 curies

(- Cadmium-109 100 mil 11 curies Iodine-125 200 mil 11 curies Americium-241 100 millicuries.

LEAK TEST FREQUENCY: 6 Months PRINCIPAL USE: X-Ray Fluorescence i

CUSTOM SOURCE: YES X NO i

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{u .-' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE 4

N0.: CA4065136U DATE: December 10, 1981 PAGE 2 0F 4 SEALED SOURCE TYPE: X-Ray Fluorescence Sources DESCRIPTION:

These sources are annular and are of various sizes. Construction of the sources is as follows:

AN 55: Elemental iron is electro-deposited and diffusion bonded on a nickel disc. A beryllium sheet about 0.005" is then placed over the nickel disc and sealed in position by epoxy resin.

AN 55: Ccbalt-57 distributed within aluminum cermet wire received from Radiochemical Centre is placed in a 304L stainless steel tube, with a wall thickness of about 0.009", which is sealed at the ends by fusion welding.

(I AN 109: Elemental Cadmium is electro-deposited on a silver wire, which is then placed in aluminum tubing, with a wall thickness of about 0.005", which is sealed at the ends by cold welding.

AN 125: Iodine is electro-deposited on copper wire, which is then placed in aluminum tubing, with a wall thickness of about 0.005", which is sealed at the ends by cold welding.

i AN 241:

Americium-241 distributed within aluminum cermet wire received from 3 Radiochemical Centre is placed in a 304L stainless steel tube, with a wall thickness of about 0.009", which is sealed at the ends by fusion welding.

l Isotope Sealed Source Model

' Maximum Activity (mci)

Designation: Norwelly Used:

Iron-55 AN 55 Series

100 Cobalt-57 AN 57 Series 100 Cadmium-109 AN 109 Series 100 Iodine-125 AN 125 Series 200 Americium-241 AN 241 Series 100 i t

Following digits indicate nominal activity in millicuries. Thus "AN 55-100" would indicate 100 millicuries of Iron 55.

CONDITIONS OF NORMAL USE:

! g These sealed sources are usually furnished to customers in holders of various m designs. They are used as X-ray fluorescence sources.

i

l l

' f': REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE i

NO.: CA4065136U DATE: December 10, 1981 PAGE 3 0F 4 SEALED SOURCE TYPE: X-Ray Fluorescence Sources PROTOTYPE TESTING:

The manufacturer and distributor performs prototype tests of the various models to detemine adequacy of the sources to withstand nomal environments to which x-ray fluorescence sources are exposed. He certifies that sources encapsulated in stainless steel meet the requirements for "special form material" as defined by 49 CFR 173.398. Prototype tests have shown that the AN-55, AN-109 and AN-125 are classified as USANSI 68C 32232, but only when these sources are in their respective holders.

.These sealed sources should withstand loss of containment when subjected to forces and heat encountered in "special form" tests described on 49 CFR 173.398. They are not designed for use other than as X-ray filmrescence sources held in appropriate holders. The AN-55, AN-109, and AN-125 Series may withstand some heat and pressure

(

as described in the prototype testing, but only when retained in a holder specifically designed for the source.

EXTERNAL RADI'A TION LEVELS:

A radiation profile in mr/hr for a 200 mci Am-241 source was provided by the manufacturer. The values below have been normalized to 100 mci activity as authorized:

Top Bottom Sides Surface: Shielded: 0.04-0.1 0.4 less than 0.08 Unshielded: 1.0-7.0 0.4 0.08 At 6": Shielded: less than 0.1 0.025 less than 0.08 Unshielded: 0.25-1.0 0.025 less than 0.08 OUALITY ASSURANCE AND CONTROL:

I Each source is bubble and wipe tested prior to mounting in holder and subsequent distribution lo the specifically licensed user.

LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:

All sources above shall be leak tested at intervals not to exceed six (6) months.

These sources are inherently relatively delicate. Before licensing one of these l

l L - -

(7j; REGISTRY OF RADI0 ACTIVE. SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: CA406S136U DATE: December 10, 1981 PAGE 4 0F 4 SEALED SOURCE TYPE: X-Ray Fluorescence Sources lit 11TATIONS AND/0R OTHER CONSIDERATIONS OF USE (CONT'D):

sources for any purpose other than as an X-ray fluorescence source, an evaluation should be made to determine adequacy of the source for environmental conditions which might be encountered by it.

REFERENCES:

1. Previous sheet authorization (72-7).

2. Letter dated August 14, 1981, signed by Kenneth Heln, requesting authorization for 100 mci activity in the AN-241 Series.

3. Letter with attachments dated September 24, 1974, signed by Karl Amlaur and (7 , f4nufacturer's Information Sheets . dated January 5,1972, signed by Karl Amlaur. These documents used for classifications, external radiation levels, and quality assurance are on file at the State of California Department of Health Services, Radiologic Health Branch.

Date December 10, 1981 -Reviewed By Date December 10, 1981 Concurrence ISSUING AGENCY:

California Department of Health Services

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d D REGISTR'I 0F RADI0 ACTIVE SEALED SOURCES'AND DEVICES 4

, i SAFETY EVALUATION OF SOURCE ,

) (Amended in its entirety) ,

I

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- NO. NR-460-S-167-S DATE: PAGE: 1 of 6 s

SOURCE TYPE: Therapeutic Seed Source MODEL: 6711 ,

1 MANUFACTURER / DISTRIBUTOR:

i Minnesota Mining and, Manufacturing a

3M Center ,

St. Paul, MN 55101 3

4 .

4 ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 100 mil 11 curies i

LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES I NO i

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A REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

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SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

NO: NR-460-S-167-S DATE: M 25 Mr PAGE: 2 of 6 SOURCE TYPE: Therapeutic Seed Source EESCRIPTION:

The 3M Company Model 6711 seed contains iodine-125 absorbed on a solid silver bar and encapsulated in a cylindrical titanium capsule which is sealed by tungsten-inert-gas weld at each end of the capsule.

LABELING:

Because of the small size of I-125 Seeds, it is not possible to label each source as to its radioactive content. I-125 Seeds supplied as a group of seeds with an assay within a stated range on the assay date, are packaged in a 1 dran, screw cap glass vial, onto which is affixed a label stating radioactive content, a sample of which is attached below. This label displays the caution symbol and is printed in colors to comply with the provisions of 10 CFR 32.72 and 10 CFR 20.203.

i 1-125 Seeds 3M GNI Therapeutic Wa'l#.!:::'.".:::f:. :r'-~ ,

1-125 Seedi F0r interstitial _ ,. ..

~ codine 12s) --.

-Cautim aaf.udive NMal . Brachytherapy ,_ _ ..., .:

' be- -e L,a No. 6711 -- me .

e *","' " gO ob; [d]IE_E,s. :::'::; .

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"5- c ".".,'4 % s"21 L'L"1TA 0 00 aa.ui.on

,8 ;a*':a l'.'::",I:,tri,,, ::.7l =:.::."

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27.'=1. : ! = t.::,....,

Label for Lead Storage / Shipping Container - Model 6711

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4 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

I NO: NR-460-S-167-S DATE: )N25 W PAGE: 3 of 6 SOURCE TYPE: Therapeutic Seed Source DIACRAM:

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. f a 4 --

o - - 3.0mm

, 4.s == r CONDITIONS OF NORMAL USE:

The 3M Company 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 temperture and pressure variations from 121*C at PSI to 138'C at 35 PSI.

k- i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

NO: hR-460-S-167-S DATE: 0b ) PACE: 4 of 6 SOURCE TYPE: Therapeutic Seed Source PROTOTYPE TESTING:

Prototype 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 paragraphs 4.2.2 and 4.2.3. 3M Company reports that the prototype passed the ANSI tests for impact and percussion. High temperature test results show that the Model 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 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 2 15%). Results are:

1-125 Seed Average Dose Rates (mr/hr)

~

Activity at 5 cm At 30 cm Model 6711 0.1 mci (comp) 2.5 0.053 Model 6711 40.0 mci (comp) 1000 21.2

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

NO: NR-460-S-167-S DATE: E PAGE: 5 of 6 SOURCE TYPE: Therapeutic Seed Source 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, and autoclave, x-ray inspection, and assay for radioactivity.

Complete details of the quality control program are included in the February 8,1980 application. -

4 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 Licensees should observe the 3M Company instructions for handling and using the I-125 seeds.

REGISTRY OF RADI0ACTHWL4 RL EL@ ROURCES AND DEVICES

/] ,/

(.,FETY EVALUATION OF SOURCE (.,/

, (Amsnd:d in its sntir:ty)

NO: NR-460-S-167-S DATE: eEjN25 g PAGE: 6 of 6 SOURCE TYPE: Therapeutic Seed Source SAFETY ANALYSIS Sl'M!ARY:

Based on our review of the information and test data referenced below, we conclude that the Series 6711 Therapeutic Seed 3M Sources with new design changes 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 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 concludes that the integrity of the new design surpasses the old design.

REFERENCES:

The following supporting documents for the Model 6711 therapeutic seed: source, 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- 16rS dated June 23, 1980.

ISSUING AGENCY:

U. S. Nuclear Regulatory Commission 4W 2 5 1985 Date: Reviewers gf b $

M 2 5 198r Date: Concurrence: 41 M , bw-0'

f-n h d ,

l

() REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amendt.d in its entirety)

) NO.: NR46051665 DATE': ' June 23, 1980 .PAGE 1 0F 4~

4 SEALED SOURCE TYPE: Therapeutic Seed Source -

l MODEL: 6702 MANUFACTURER / DISTRIBUTOR: Minnesota Mining and Manufacturing 3M Center c St. Paul, MN 55101 i i

3 MANUFACTURER / DISTRIBUTOR:

ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 50 mil 11 curies

-( )

i 1 !

i G

1 LEAK TEST FREQUENCY: 6 months j PRINCIPAL USE: General Medical Use i

! l l CUSTOM SOURCE: YES X NO l

e

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4 6

_ _ . , , , _ . . . . . - . , . . . . - . , , _ , _ _ _ , -. - , - . . . , . . -.-__.___--.-.,,.,,_.__,,m,, -

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its entirety)

NO.: NR4605166S DATE: June 23, 1980 PAGE 2 0F 4 SEALED SOURCE TYPE: Therapeutic Seed Source DESCRIPTION:

The 3M Nodel 6702 seed contains iodine-125 absorbed on anion exchange resin spheres and encapsulated in a cylindrical titanium capsule which is sealed by tungsten-inert-gas weld at each end of the capsule. The resin beads are separated by a 0.6 mm diameter gold sphere.

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 1

date, are packaged in a 1 dram vial, onto which is affixed a label stating,

" Caution-Radiation Material " isotope date, manufacturer logo, and the trefo,il symbol. activity range, total activity, assay DIAGRAM:

O.?e.*e*

Ii.n'E*"

nn mena N /

e'l-0 @ @ @f) <

4.s mm = .

n --- -_ .- -. =-

~_ . . a .,

w w m u m n.: . - - a~

CONDITIONS OF NORMAL USE: ,

The Model 6702 sealed source (therapeutic seed) is designed for use in the interstitial treatment of cancerous tumors. The seeds are designed to withstand normal autoclave temperature and pressure variations from 121*C at 15 psi to 138'C at 35 psi.

PROTOTYPE TESTING:

Prototypes of the Model 6702 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 O aSr'""' '.2.2 and 4.2.3. as reports that the prototype passed the ANSI tests

a m7.: . '..Ib J

Q..L l ,

REGISTRY OF RADIOACTIVE SEALED SOURCES AND 'DEVILES SAFETY EVALUATION OF SEALED SOURCE (Corrected Page) 1 M: NR460S1665 DATE: June 23,1980 PAGE 3 Of, 4 SEALED SOURCE TYPE: Therapeutic Seed Source PROTOTYPE TESTING (Cont'd):

for impact and percussion. H,tgh temperature test results show that the Model 6702 sealed source retains its integrity up to temperatures of 250*C. At'that temperature, the anion exchange resin breaks down arid releases the iodine.

However, the capsule does lose its integrity and leaks iodine at temperatures of ,

about 600'C. 3M Cc!pany states that the sources should not be subjected to temperatures in excess 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 6702 was determined by the 3M Company t using film badges (specified accuracy +_15%). Results are:

1-125 Seed Activity Average Dose Rates (mr/hr)

At 5 cm At 30 cm

- 0.1 mci 2.5 0.053 40.0 mci 1000 21 .2 QUALITY ASSURANCE AND CONTROL:

The 3M Company conducts the following quality control tests and inspection df 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.

LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE: .

A. Licensees shouTd observe the 3M Company instructions for handling and using the I-125 seeds; specifich11y 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, glhss, nylon and teflon should be used), t

3. Seeds should not be exposed to temperatures in excess of 138'C and pressures in excess of 35 psi.

1 O O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION 0F SEALED SOURCE (Amended in its entirety).

DATE: June 23, 1980 PAGE 4 0F 4 NO.: NR4605166S SEALED SOURCE TYPE: Therapeutic Seed Source LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE (CONT'D):

B. Dose rates of about 1000 mr/hr at 5 cm from these sources are possible.

Personnel monitoring is reouired by persons using the sources (extremity eenitoring, i.e., ring dosimeter are suggested) and the source shall be handled only with appropriate handling equipment.

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 therpeutic sealed sources are hereby incorporated by reference and are made a part of this registry document:

o 3M Company application receieved 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, and enclosures thereto.

o Reference also 3M Company License No. 22-00657-59MD o Supersedes registration 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 O

. . , , . d

j ..

!O I

aEstStav 0F a>0104CTtvE Se^ LEO S0uaCES ANo OEv!CES (A Wn N b"i k h b hth 4

f NO.: NR460S165S DATE: June 23, 1980 PAGE 10F 4 ' ,

i SEALED SOURCE TYPE: Therapeutic Seed Source J

} I40 DEL: 6701 I ftANUFACTURER/ DISTRIBUTOR: itinnesota Mining and Manufacturing 3M Center i St. Paul, fitt 55101 1 ,

, MANUFACTURER / DISTRIBUTOR:

i

ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 50 mil 11 curies

!O i'

i.

i !

i

?

l LEAK TEST FRE00ENCY: 6 months i

PRINCIPAL USE: General Medical Use l

l CUSTOM SOURCE: YES X N0 t

i I

.~

e 4

O I

_ _ . . . __ . -_ _ - _ _ ._ m _ ._ _

l

- O .

C s

O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE >

(Amended in its entirety) i NO.: NR460S165S DATE: June 23, 1980 PAGE 2 0F 4 '

SEALED SOURCE TYPE: Therapeutic Seed Source- .

i t i DESCRIPTION:

1 The 3M Model 6701 seed contains iodine-125 absorbed on anion exchange resin spheres 1 and encapsulated in a cylindrical titanium capsule which is sealed by turgsten- t

inert-gas weld at each end of the capsule. The resin beads are separated by a.

0.6 m diarreter gold sphere.

1 LABELING:

l 4

Because of their small size, individuals seeds are not labeled. The seeds are supplied as a group of seeds with an activity within a stated range on the assay 3 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:

$5Sa??ar I

n\ \ / -

o$m(?@ @ @(.)..

! [ 4.s mm 1 l

CONDITIONS OF NORMAL USE: I 1

) The Model 6701 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 pressure variations from 121*C at 15 psi to 138'C i at 35 psi. This design may contain up to 50 mil 11 curies for use as a calibration

. source. .

! PROTOTYPE TESTING:

I '

i Prototypes of the Model 6701 sealed source (seeds) were subjected to tests to demonstrate that the sources will maintain their integrity under stresses of use

O

)

aad accid at- th t sts a rfar'# d r ia accord ac ith ^ast a44 t-2973 paragraphs 4.2.2 and 4.2.3. 3M reports that the prototype passed the ANSI tests t i

l

i

1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES '

SAFETY EVALUATION OF SEALED SOURCE (Corrected Page)

M: NR4605165S DATE: June 23,1980 PAGE 3 01 4 SEALED SOURCE TYPE: Therapeutic Seed Source PROTOTYPE TESTING (Cont'd):

for impact and percussion. High temperature test results show that the Model 6701 sealed source retains its integrity up to temperatures of 250*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 shot'id not be subjected to temperatures in excess 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 6701 was determined by the 3M Company using film badges (specified accuracy +_15%). Results are:

1-125 Seed Activity Average Dose Rates (mr/hr)

At 5 cm At 30 cm 0.1 mci 2.5 0.053 40.0 mC1 1000 21.2 QUALITY 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 ins;,ection, and assay for radioactivity. Complete details of the quality control program are included in the May 1,1980 application.

LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:

A. Licensees should obsr.rve the 3M Company instructions for handling and using the I-125 seeds; spacifically 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).

3. Seeds should not be exposed to temperatures in excess of 138'C and pressures in excess of 35 psi.

B. Personnel monitoring is required by persons using the sources and the should be handled only w)th appropriate handling equipment.

l

b) v gl REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES C'i SAFETY EVALUATION OF SEALED SOURCE (Amended in ~its entirety) f.0.: NR46051655 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 ne presence of 0.005 microcurie of iodine-125 on the test samples.

D. Handlir:g, 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 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, and enclosures thereto, o Reference also 3M Company License No. 22-00657-59MD o Supersedes registration document dated June 23, 1980.

Date June 23, 1980 Reviewed By /s/

Earl G. Wright Date June 23, 1980 Concurrence /s/

Barnard Singer ISSUING AGENCY:

U.S. Nuclear Regulatory Commission PJ

]j

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy) 0 N_0_: NR-482-D-102-S DATE: AUG 111983 ,

PAGE 1 0F,5 (Corrected Page)*

(5/14/85)

DEVICE TYPE: Medical Diagnostic Bone Scanner -

MODEL: N2740 (scanner unit), N2780 (computer unit) - Formerly 278 and 278A MANUFACTURER / DISTRIBUTOR:. Norland Corporation Norland Instrument /Ino-Tech. Inc.

Norland Drive Fort Atkinston, WI 53538 MANUFACTURER / DISTRIBUTOR:

Fi-j'QMgi" I. ,

f( SEALED SOURCE MODEL DESIGNATION: AECL-CP Models C-235 C-236*

Amersham Models J 9~,~4052'4C40PAMC.25.

_ ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: Up to 400 mill'icuries (see descri Americium-241 45 mi111 curies tion)

LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM DEVICE: YES X NO l

l

\ .

t

REGi .RY OF RADI0 ACTIVE SEALED SOURCEa i.ND DEVICES

,' SAFETY EVALUATION OF DEVICE

.. (Amended Copy)

? .

~ '

, M: NR-482-D-102-S DATE: AUG11I303 PAGE 2 g 5 (Corrected Page)*

DEVICE TYPE: Medical Diagnostic Bone Scanner (5/14/85)

_ DESCRIPTION:

The former Model 278 and 278A consisted of a computer module and a scanner module designed for the medical diagnosis of bone maladies. The manufacturer has assigned a model number to each separate module and made some minor changes in the units.

These changes do not alter the radiation safety of the device. The computer module will be the Model N2780. The module will have a different physical appearance than the Model 278 unit but it will have the same computer program. The scanner unit will be the Model N2740. The unit module will have the same physical appearance as the Model 278. .But outside the unit will be a made of some different materials.

The source and holders shielding are Models are identical to 178A588A the Model for I-125 and 189A020A for Am-241.* Shutter 278.

This device is designed to emit a well-collimated beam 4 millimeters in diameter at the panel surface, diverging to about 4 centimeters in diameter at the point of interception by the detector and its collimator. The source is located in the base of the scanner unit, which is about 12 inches by 14 inches by 4 inches and weighs about 40 pounds. The detector and source are at opposite ends (upper and lower) of a "C" frame. The C" frame is moved back and fortheby an electric motor to scan a

( patient's arm or leg which is positioned horizontally on top of the scanner panel normal to the scan direction and is controlled by the computer module. The radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 inches filled with 60 mil thick tissue equivalent plastic.

A lack secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel.

The shutter is controlled by the computer to energize (open) a solenoid. Power failure results in closing the shutter by a spring.

Sealed Source Model Designation Isotope and Activity AECL-CP Models:

C-235 I-125 400 mci C-236* I-125 400 mC1 Amersham Corp. Models:

IMC-129 I-125 200 mci IMC-4052 I-125 100 mci IMC-4040 1-125 400 mci AMC3 25 , AMC.P1 Am-241 45 mC1

LABELING:

The Mcdel N2740 scanner is labeled in accordance with the provisions of Section 20.203, 10' CFR Part 20 and Section 32.74 of 10 CFR Part 32.

l ., .'.

. REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVfCES SAFETY EVALUATION OF DEVICE (Amended Copy)

\',

NO: NR-482-D-102-S DATE: APR 2 619g4 PAGE 1 E 5 DEVICE TYPE: Medical Diagnostic Bone Scanner OUALITY ASSURANCE AND CONTROL:

The manufacturer performs the following quality assurance and control programs:

o Source holder assembly parts are checked 100% for critical dimensions and tolerances, as well as for good mating surfaces, o Incoming sealed source capsules are accompanied by a leak test report by the source manufacturer. Leak test results are checked and filed by Norland, o Source capsules are loaded into source holders and individually checked for Am-241 and I-125 content. Details of measurement equipment and procedures are provided. After measurements, sot.rce assemblies are labeled.

o The device is tested for proper operation of the shutter mechanism for at least 80 full automatic ccans of a phantom.

DIAGRAM:

l :

Co111 mated Detector _Q.T T-R n U Tissue Equivalent A :

'J (Water) i Soft -

g Tissue Bone

.- O I QT -

\-wx- /

i

(~~~.

CONDITIONS OF NORMAL USE:

The Model N2740 will be used for medical diagnostic bone scanning. Operating conditions are typical of those found in medical diagnostic facilities. The device will be used by trained personnel.

I i

k REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES '

SAFETY EVALUATION OF DEVICE '

j m (Amended Copy)

[1

'n' s.

NO: NR-482-D-102-S DATE: APR 2 61984 PAGE 4 0F_ 5 l t DEVICE TYPE: Medical Diagnostic Bone Scanner l t

. F EXTERNAL RADIATION LEVELS:

) The maximum radiation level associated with the scanner is found at the panel's i surface in the primary beam of radiation (passing through~ 0 mils of tissue- .

]

equivalent plastic in the panel). These levels are: !

i For 200 millicuries of Iodine-125 i 32.4 R/Hr l for 45 millicuries of Americium-241 0.72 R/Hr The radiation. level at the panel with the shutter closed is 0.21 mR/hr for lodine-125 i j and 0.12 mr/hr for Americium-241. !

1 !

I The distance between the source and the panel surface at which the above radiation j levels exist is about 2.5 centimeters. The beam distance is 4 millimeters at the

panel surface.

j ;

i The dose rate at the deck surface with a new 200 mci source of I-125 is approximately '

{ 9 mR/ sect with a 45 mci Am-241 it is approximately 0.2 mR/hr. Dose rates for l i 400 mil 11 curies of I-125 would be proportional to the I-125 dose rates listed ;

I above.

l Norland reports that the dose rates on the surface of the N1076 holder is 0.2 mr/hr. !

LIMITATIONS AND/0R OTHER CONSIDERATIONS OT USE:

i f o The device shall be distributed only to persons specifically licensed by the NRC l t pursuant to Sections 35.13 or 35.14 and 35.100 of 10 CFR 35, or equivalent l l provisions of an Agreement State regulations, i

o The source used in this device shall be leak tested at least at 6 month intervals

. using techniques capable of detecting the presence of 0.005 microcurie of j removable contamination. i o Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. .

o Reviewers Note: The user is required to remove and replace the source holder.

! You should check to determine if they have adequate controls to perform this task.

! o Tie Norland Corporation provides written instructions covering: radiation !

j safe,ty, source exchange, patient dose, device operations, maintenance, and !

j repair. :

1

! n Thit ragistration sheet and the information contained within the references 6 i shall not be changed or transferred without the written consent of the NRC. .

I l l

__-~ _ ___ _ __._._ _ _ _ . _ _ . . - -_ _.- - _ ..-. _ _ _ __. _ '

~

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)

?!0: NR-482-D-102-S DATE: APR 2 61984 PAGE 5 0F,5 DEVICE TYPE: Medical Diagnostic Bone Scanner 1

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below that the Norland Bone Scanner was deemed acceptable for Itcensing purposes in July 1980 and that the changes made do not alter the radiation safety of the device, we continue to find the bone scanner design as acceptable for licensing purposes. Furthermore,

! we conclude that the device would be expected to maintain source containment integrity for normal conditions of use and accidental conditions which might occur during the specified uses in this certificate.

i

REFERENCES:

The following supporting documents for the bone scanner design are hereby incorporated by reference and are made a part of this registry document <

o Norland Corporation letters dated August 20,1979, April 12,1980, June 16,1980,

' June 25,1980, June 30,1983, and November 1,1983, with enclosures thereto.

o Supersedes registration sheet dated July 1,1980, ISSU!NG AGENCY:

U.S. Nuclear Regulatory Commission Date:

APR 2 01984 Reviewer; [e M Date: Concurrence: f,2,,. /, Mt . dm~ u.

h' ll

~

,, REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

' SAFETY EVALUATION OF DEVICE

! IU UATU January 5,1984 PAGE 1 Of_ 5

_NO: NR- 430-0-1 U2-5 DEVICE TYPE: Forearm Scanner

.j t

i MODEL: SP2 ,

s Lunar Radiation Corporation l MANUFACTURER / DISTRIBUTOR:

i 10 North Charter Street ,

- Madison. WI 53715 ;

1 r i

MANUFACTURER / DISTRIBUTOR:

s e

1 i

1 SEALED SOURCE MODEL DESIGNATION: Atomic Energy of Canada limited Model Nos.

' C235. C324, or Amersham Corporation Model i IMC.P2 j .

l I

l ISOTOPEi Iodine-125 MAXIMUM ACTIVITY _: 300 millicuries l ,

t LEAK TEST FREQUENCY _: 6 months t PRINCIPAL USE_: (V) General Medical Use (bone mineral analyzer)

CUSTOM DEVICE: YES X NO I

- . _ _ . . _ _ _ _ _- ,_ - _._ .-. . _ . . . _ _ _ _ _ _ _ _ . . _ _ . _ . _ _ , , , _ _ _ _ , _ _ . . . _ . . . . , , . . . . _ _ . , _ , . _ = _ . _ _ . , _ _ _ . . _ -

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE N0: NR-430-0-102-S DATE: January 5,1984 PAGE 2 0F 5 DEVICE TYPE: Forearm Scanner DESCRIPTION:

The SP2 scanner consists of a rectilinear drive mechanism (stepper motors) that covers a 6 x 11 cm area. The drive is housed in an aluminum pan that sits on top of a table. The beam can exit through the 1/8" lucite sheet that covers the top of the scanner. This lucite sheet is fixed to an aluminum top that covers the scanner mechanism except .in the area where the scan is done. The source is located in a brass source holder that in turn is secured in an aluminum plate (6 mm thick);

this plate is moved in a rectilinear pattern under the lucite by the drive mechanism.

The source is located 3.3 cm below the table top. A scintillation detector is located opposite the source (on a C-arm attached to the plate) at a distance of about 16 cm (13 cm above the table top). The chuck ring that holds the scintillation detector effectively occludes the beam from the source when the shutter above the source is opened.

The shutter above the source is opened by a rotary solenoid; the shutter is normally closed. The shutter is a steel blade with 3 mm of lead that occludes the beam.

( Beam divergence is 3 mm at table top and 2 cm at the detector chuck. When the shutter is opened, a red light on the scanner enclosure box is activated. At the same time an indicator (upper right hand corner of computer screen) shows that the source is open. In several of the programs used with the scanner the counts are shown in the upper right hand corner. The shutter is opened only when the scanner is actively in use. Interruption of a program, crash of the computer or power failure causing mechnical closing of the shutter.

The critical shielding components of the device include the source holder. The usual source holder provides 6 mm brass casing about the sealed source in all directions but the exit beam. The source is placed in the holder by the source manufacturer prior to distribution to the users so that handling involves only a minimal risk provided caution is taken with the emergent beam. The source holder is provided with a screw-on brass cap. Collimation is provided by the source holder which effectively confines the beam and reduced unwanted scattered radiation.

The source (in holder) needs to be changed only once every six months for use on adults or once a year for use in children. This involves only a few moments of handling with negligible exposure of the hands.

The source holder is inserted by the operator into an arbor and screwed into place.

This is explained in the Operators Manual, t.ABELING:

( The source holder is engraved with the wording, " Caution-Radioactive . ' ,

Notify Civil Authorization If Found." the isotope, activity, and date of assay, ,

Additionally, the scanner is labeled with the manufacturers name and address, the radiation trefoil symbol and the words, " Caution Radioactive Material,"

. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

.y

(?.'

N0_: NR-430-D-102-5 DATE: January 5,1984 PAGE 3 ,0J 5 DEVICE TYPE: Forearm Scanner DIAGRAM:

l See Attachments 1 and 2.

CONDITIONS OF NORMAL USE:

Nomal use of the SP2 will be in hospitals and larger general clinics. They will also be used in specialized clinics fer radiology nuclear medicine, for endocrine disorders or for orthopedic surgery. The typical hands sn user will be a radiologic ,

j technician or laboratory technician with nuclear medicine training operating under medical supervision. Some users will be physicians with training in radiological !

, bastes and specific training in use of the instrument. The useful life of the I source is one year in transmission sr.anning applications.

PROTOTYPE TESTING:

The AECL sources have achieved an ANSI N542 classification of 68C34334. The Amersham Corporation source achieved an ANSI N542 classification of 68C34343. ,

i The SP2 was put through functional testing at the University of Wisconsin Bone

] Mineral Lab. The SP2 is equivalent in function to be previously approved DP3

unit with the exception of the size of the unit. The DP3 has been in use for the past year without any incidents. Additionally, the FDA has granted a ,

510 k for the device. .

i EXTERNAL RADIATION LEVELS _:

Lunar Radiation Corporation reports that a 43 millicurie Iodine-125 source in the '

source holder arbor with shytter closed yields dose rates undetectable using conventional low dose TLD.or Gm detectors. Lunar Radiation used a specific gamma-ray constant of unattenuated Iodine-125 sources of 0.156 mr/hr/mC1 at i 1 meter. Through calculations (based on 200 mC1) the expected dose rate on i the table top, which is 3.3 cm from the source is 8 mrem /sec. The maximum dose !

3 rate of source holder was reported to be 0.2 mrem / hour. The maximum dose to.the !

operator at I meter was calculated to be 0.002 mrem / hour.

During the scanning of a perticular area, the area is exposed for about three :

seconds given a dose to patients' of about 15 mrem. Since sources normally are !

used for three half lives, the actual dose would be less than the above during l 1 the period of use. In addition, the limb is usually enclosed in a bolus of l tissue equivalent material which provides 0.5 to 1.5 cm of beam attenuation.. .

QUALI,T_Y,ASSURAf 3 AND CONTROL:

Lunar Radiation Corporation has documented a quality control program that: l l

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 1:.

NO: NR-430-D-102-S DATE: January 5,1984 PAGE 4 0F 5 DEVICE TYPE: Forearm Scanner QUALITY ASSURANCE AND CONTROL (Cont'd):

o Tests shutter function and alignment o Tests radiation detection equipment o Tests all electronics o Tests software package o Checks mechnical construction of the unit Lunar indicates that the program, in general, conforms to FDA standards. for good m'anufacturtng practices; All devices must pass all tests and checks before it is released to the user.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

o The device shall be distributed only to persons speciff.cally licensed by the

'iRC or an Agreement State, pursuant to Section 30.33,10 CfR .10 and 1.0 CFR 35' or equivalent regulations of an Agreement State.

o The device shall be leak tested at six month intervals using techniques capable of detecting 0.005 microcuries of removable contamination.

o Handling, storage, use, transfer, and disposal: TobedeterminedbyIhe licensing authority.

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 Reviewers Note: Lunar Radiation Corporation does not install the source. The installation of the source is the responsibility of the user.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information cited below, that the device is to be used by trained and specifically licensed personnel, that a similar unit, Model DP3, has been in use for the past year without incident, we conclude that the Model SP2 bone mineral analyzer design is acceptable for licensing purposes, The' .

device is used in clinical diagnostic laboratories and the most probable hazard the source would encounter is fire. The source itself has been tested in accordance with American National Standard Institute (ANSI) requirement for medical use.

Furthermore, the source is enclosed within a brass holder, which could be expected to maintain containment integrity for normal and accidental conditions applicable

( to the uses specified in this document.,

REFERENCES:

The following supporting documents for the Model SP2 bone mineral analyzer is hereby incorporated by reference and is made a part of this registry document:

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE 1'

'2' M: NR-430-D-102-S DATE: January 5,1984 PAGE 5 E 5 DEVICE TYPE: Forearm S::anner REFERENCES (Cont'd):

o Lunar Radiation Corporation letter dated October 20, 1983, with enclosures

thereto.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission ,

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M anuary 5, 84 Concurrence: _ b,J, Am .,b, Date: in.

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NO.: NR-525-D-101-S DATE: -

PAGE 1 of-5' \

APR 0 4 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)

MODEL: SPSHAXXX (XXX indicates the unit has been wired for 110 V AC or 220 V AC) .

MANUFACTURER / DISTRIBUTOR: Osteon, Inc. '

P.O. Box 430 649 California Avenue Wahiawa, HI 96786 SEALED SOURCE MODEL DESIGNATION: AECL Source Model Number C-235, in a Model C-236 source holder .

' ISOTOPE: MAXIMUM ACTIVITY:

Iodine-125 800 millicuries ;*

LEAK TEST FREQUENCY: 6 months ,

PRINCIPAL USE: (V) General Medical Use CUSTOM DEVICE YES X NO l

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NO.: NR-525-0-101-S DATE: APR0 41985 PAGE 2 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)

DESCRIPTION:

The Ostec-Analyzer is a three axis scanning bone densitoineter, using an AECL Mo. C-235 I-125 source in a C-236 holder. The Osteo-Analyzer is fabricated entirely of machine aluminum and stainless steel, with ball bearings and stain-1,ess steel shafts used for major bearing surfaces.

The C-236 source holder is held in the lockable source compartment of the yolk, a welded aluminum piece that maintains proper orientation with the detector during all motion. The source is screwed to position in the source compartment, then locked in place with a locking cover to present loss or unauthort.ed removal of the source.

The shutter blocks the exit beam during all times that scanning is not being performed. The shutter is designed to close automatically upon loss of power to the scanner.

LADELING:

The C-236 source holder manufacturer by AECL is engraved with the manufacturer, isotope, source holder model, and source serial number.

The Osteo-Analyzer will have a warning label on the outside of the case. The source compartment will be marked with the standird warning symbol and the words " Caution-Radioactive Material." The beam direction will also be shown on the yolk. (See Attachment No. 1.)

DIAGRAM:

5eeattachments2,3,and4.

CONDITIONS OF NORMAL USE:

The Osteo-Analyzer will be used by physicians or hospitals under a specific license issued by NRC or Agreement State for the device The analyzer will be secured in the office or room used for the storage and use of the analyzer.

Under normal conditions, the user will not need to remove the cover to the analyzer, except to change sources. The sources are' expected to last 60-90 days before replacement is necessary.

O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

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NO.: NR-525-D-101-S DATE: [sPh 0 4g pAGE 3 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer) -

PROTOTYPE TESTING:

The manufacturer did not test the device, rather, they relied on data submitted on each electronic part and its use to make a determination that the device would operate under the~given conditions of use. Additionally, the sources were tested by the source manufacturer to the requirements of ANSI N542 and received the classification of 77C34334. The source holder is constructed of lead-lined stainless steel. This would further protect the source during normal and acci-dental conditions associated with the use of the device.

EXTERNAL RADIATION LEVELS:

Tne time period necessary for the patient to receive a dose of 10 mR is about 3 seconds at any one location, based on the calculated dose rate to the skin of 3.8 Rem /Sec. Since the beam is tightly collimated to 3 mm and is constantly moving, only a portion of the skin is exposed at any one time.

With the 800 mci source, the scan speed is 4 mm/Sec, resulting in.an exposure period to any portion of the skin of 0.75 Sec. Such an exposure period will result in an exposure to the skin of 2.85 mrem. Ostea'n reports that a dose .

rate of .001 mR/hr is obtained on any surface of the analyzer with the shutter closed, and reported 1 mR/hr at 3 cm from the device gith the shutter open.

I i l QUALITY ASSURANCE AND CONTROL:

ihe following items will be tested for proper operation on every unit:

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Operation of shutter mechanism, including fail-safe provision in case of power failure. ,

Fit of source holder (C-236) to source ccmpartment and fit of locking cover over source. .

l Source-on indication or computer display when the source is;actually

, on. l l l The checks shall be part of a final test /QC program developed for testing the Osteo-Analyzer results on the tests shall be documented for each unit..

Checks for r:emovable contamination will be made on each unit before shipment to the user. The check will be capable of detecting 0.005 microcurie of l removable contamination. ;

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NO.: NR-525-D-101-5 DATE: IC 4 ZSgg PAGE 4 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

The Osteo-Analyzer scanning bone densitometer shall be distributed only to persons specifically licensed by the NRC or an Agreement State.

The device shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.

The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning mechanism, safety warning components, labels, external radiation levels (source exposed, source shielded) and leak tested by Ostean, Inc...or other persons specifically licensed by the NRC or an Agreement State.

Reviewer Note: Ostean recommends the user remove and install the source in the source holder only. However, the user may request authorization to install the source in the source holder.

This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below, the device is equivalent to those previously deemed acceptable for licensing, we conclude .

that the Model SPSHAXXX Osteon bone mineral analyzer design is acceptable for ,

licensing purposes. '

Furthermore, we conclude that this device should be accepted to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this' certificate. !

REFERENCES:

The following supporting documents for the bone mineral analyzer (Osteo-Analyzer) are hereby incorporated by reference and are made a part of this registry document:

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Osteon, Inc. letters dated on January 15, 1985, and February 20,

!( 1985.

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. SAFETY EVALUATION OF DEVICE D

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NO.: NR-525-D-101-S . DATE: . .. a ' 4 ;33e PAGE 5 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission ,

MR0 4;g ,fr-DATE: REVIEWER: --

DATE: <EM CONCURRENCE: L ,4 M. IM * *

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25 of 800 mci of I-125. The maximum yg skin entrance dose rate in the primary t;w beam path is less than 2.5 mR/second.

THIS LABEL MUST NOT BE REMOVED.

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' NO.: NR-525-0-101-5 DATE: AP 1 : 4 995 4

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IdDINE 12:5 CAPSULE HOLDER 7:-::S HOLDER WILL ACCOMM00 ATE CtPSULE ASSEMBLY-C235 4.ENCRIVED BOTTOM OF HOLDER- AECL (s.

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p t+a c h m e n f Y REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

('. NO.: NR-525-D-101-S DATE: SPR 0 4 7ggg Source Key Lock

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SAFETY EVALUATION OF DEVICE.

(Amended Copy)

I NO.: NR-422-D-101-5 DATE: ggg g PAGE 1 0F 7 DEVICE' TYPE: Portable Fluoroscope

'MODEL: LS-80X, LS-82X, LSM-80X, or LSM-82X X = 1, 2, 3, etc.

-Models may be either hand held or bench mount units.

LS-Units are for Industrial Applictions '

LSM-Units are for Medical Applications MANUFACTURER / DISTRIBUTOR: Lixi, Inc.

. 1438 Brooks Drive l Downers Grove, IL 60515 SEALED SOURCE MODEL DESIGNATION: Amersham Corporation, Model IMC.P2 9 Atomic Energy of Canada, Ltd., Model C-324 Amersham Corporation, Model AMC.17 (For Am-241 only)

ISOTOPE: MAXIMUM ACTIVITY Iodine-125 500 mil 11 curies Americium-241 375 millicuries;j LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (A)~ Industrial Radiography i

CUSTOM DEVICE: YES _X_ NO

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N0_: NR-422-D-101-S DATE: g g g PAGE 2 0F 7 ,

DEVICE TYPE: Portable Fluoroscope DESCRIPTION:

d The Lixiscope is a hand held or bench top mountable, fully portable

! - fluoroscope for real time X-ray imaging. It is based on a modular approach

~

where the three major components are physically independent but held together by a housing and, therefore, components are easily replaceable. The three

! major components are the X-ray source in the stainless steel housing, the i converter phosphor or scintillator and the microchannel visible light image 1

intensifier. The latter two components are contained within the scope body 4

which may be constructed of stainless steel or aluminum. The sealed source is contained'inside a collimated source housing. The co111mation of the source varies depending on the distance b? tween the source and the image intensifier

, and the diameter of the image intensifier. The source housing is constructed l ([ in such a fashion as to permit its attachment to the Lixiscope body only if it U '

has been designed for the particular combination of distance bar length and detector diameter (see Figure 1). During operation, the sealed source may be l unshielded by depressing the trigger mechanism. A red flag appears from the

! source housing, indicating the source is unshielded. When the trigger is released, the source is automatically returned to the shielded position. The

. Lixiscope is supplied in four different models. The LS-80X series has a 3

stainless steel scope body and source housing. The LS-82X series has an -

i aluminum scope body and a stainless steel housing. The LSM-80X series has a i stainless steel scope body and source housing. An electronic audible time l'

alarm that sounds every 10 seconds when the source is in the unshielded position has been added. The LSM-82X series has an aluminum scope body in the

stainless steel source housing. The electronic audible time has also been i added to.this unit. The FDA has approved the use of the LSM series Lixiscope l by medical licensees.

FIGURE 1 I (ForIodine-125 i OLD SOURCE NEW T-SERIES BAR DETECTOR l DIAMETER HEAD MODEL SOURCE HEAD MODEL DISTANCE No. 21 TI 21 2 inches 1 inches No. 31 TI 31 3 inches 'l inches No. 32 TI 32 3 inches 2 inches l No. 42 TI 42 4 inches 2 inches i

No. 62 TI 62 6 inches 2 inches k% No. 82 TI 82 8 inches 2 inches Americium-241 is only provided in a TA31 source housing and will only interchange with source heads on Lixi Imaging Scopes that have been modified for Americium-241 by Lixi.

l ,

l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

(, SAFETY EVALUATION OF DEVICE i

(AmendedCopy)

NO.: NR-422-D-101-S DATE IM PAGE 3 0F 7 DEVICE TYPE: Portable Fluoroscope The bench mount units are scopes that are attached to the base of a case that has a removable top. This case is like a slide projector case. Once unlocked, the top of the case can be removed. The user then adjusts the height of the unit to suit his or her need. The source is put into the unshielded position by the use of a key. The key replaces only the hydraulic trigger mechanism and cannot be removed from the lock while it is in the "on" position. Therefore, the top of the case cannot be securely closed while the source is in the unshielded position. The manufacturer reports that the model is constructed to allow the user to view large and awkward objects that could not normally be viewed by one person.

The Lixiscope is powered by dry cell batteries in the handle. A lock is provided to prevent the source from being inadvertently put in the unshielded

( position and the scope is stored in the locked transportation case.

In addition, a new series of sourceholder heads will also be used. They are manually controlled isotope exposure devices for distribution with Iodine-125 and Americium-241. This new design is designated by the model no. Tx X where T represents a type of head (manual), 1 X isanalphabicletterlh$t represents the isotope (such as I = Iodine-125 and A = Americium-241), and X is a number which represents a different mounting in collimation designs. 2 The manufacturer reports that Tx3x2series exposure devices were designed to eliminate the need for a hydraulte system to activate the devices on Lixiscopes. The devices are operated by a 90* rotation of the exposure control handle. The devices incorporate a steel pin which travels in a slot over the 90* rotation and at both ends of the slot are holes that capture the S

- -- _ _ _ ~ - - - - . . . - . -. . - - _. -

! / 'M REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i

4

\: SAFETY EVALUATION OF DEVICE (Amended Copy) ;

! I 4 :

NO.: NR-422-D-101-S DATE $ ll PAGE 4 0F 7 i !

! ' DEVICE TYPEI: Portable Fluoroscope .

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! pin and then turn it 90' to change the device from the "off" to the "on" i position (or vice versa). The new sourceholder has the same padlock security i as the current devices.

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[ On hydraulically controlled units the manufacturer indicates that remote or j secondary control mechanism for.Lixiscopes can be added without any increase

, in radiation exposure danger. Lixi, Inc., has evaluated four basic methods ,

i of remotely controlling a Lixi source holder head on a Lixiscope.

i These include hydraulic actuated pistons, air actuated solenoids, i electromechanical solenoids, and manual cable controls. >

LABELING:

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! The Lixiscope is labeled to meet the requirements of Section 20.203, 10 CFR 20. It is also labeled to warn the user to keep his hands out of the i beam. As for the newer models, the labels will be similar to that now used on l Lixiscopes with the proper radionuclide included.-

DIAGRAM:

i See Attachment 1.

1 I

i CONDITIONS OF NORMAL USE:

i The Lixiscope is intended for use as a portable fluoroscope. The device has both industrial and medical users and is designed to withstand the rigors of i normal handling associated with those environments.

i The Lixiscope.is functional from -20*C ot +65'C. However, the normal j temperature operating range is O'C to 40*C because this is the range the average human user would normally tolerate.

I PROTOTYPE TESTING:

k According to the device manufacturer, the Lixiscope has been subjected to and l' passed a series of tests based on the draft ANSI Standard N432. The type of tests done included shielding efficiency test, horizontal shock test, vertical shock test, accidental drop test and endurance test. All tests were t as specified by ANSI except for the accidental drop test. Lixi, Inc., drop l l

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(','i' SAFETY EVALUATION OF DEVICE (Amended Copy)

NO.: NR-422-D-101-S DATE:

Mi6 W PAGE 5 0F 7 DEVICE TYPE: Portable Fluoroscope tested from 5.5 meters instead of 9 meters. We consider the Lixi, Inc., drop test to be adequate since the exposure rate is specified in Section 8.4.1 of ANSI N432 cannot be exceeded regardless of the condition of the device shielding. The new source holder designs have also been tested to the same tests prescribed above and maintained containment integrity.

EXTERNAL RADIATION LEVELS:

See attachment 2 and 3 for a listing of dose rates at various distances from the source housing.

, QUALITY ASSURANCE AND CONTROL: ,

We have reviewed Lixi, Inc., quality assurance and control program and have found it acceptable. A copy of the program is on file with the Material Certifications and Procedures Branch.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE_:

o Distribution - The Lixiscope shall be distributed only to persons ,

specifically licensed under 10CFR30 or 10CFR35 of the NRC rules and regulations or equivalent provisions of an Agreement State.

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\ "i REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES 4

' SAFETY EVALUATION OF DEVICE i l (Amended Copy)

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NO: NR-422-D-101-S DATE: W$5 g PAGE 6 0F 7 DEVICE TYPE: Portable Fluoroscope o Training Requirements - The Lixiscope should be used by or under the 4

direct supervision of persons who, as a minimum, have successfully

+

completed the Lixi, Inc., training program or an equivalent NRC or Agreement accepted training program.

l o Leak Testing - The Lixiscope shall be leak tested at intervals not ;

i 'to exceed 6 months using techniques capable of detecting the i presence of 0.005 microcurie of removable contamination.

! o Sealed Source Installation Removal, or Maintenance - These i operations shall be perfomed only by the sealed source manufacturer j or other persons specifically licensed to do so.

o Inventory Control Program - The licensee shall develop an inventory control program to maintain the accountability of the licensee's i Lixiscopes and document by record, the receipt, transfer, use, and

(, disposal of all Lixiscopes of the license. The physical inventory j ( ~

shall be made at 6 month intervals and records should be retained l for inspection by NRC.

i o Source Housing Assembly, Installation, and Removal - Since the i sealed source is secured in the assembly and is fully shielded, the

! licensee may perform installation and removal of the integral

! assembly in accordance with instructions in the Lixi, Inc.,

instruction manual.

! o . Disposal - Unserviceable or unwanted source housing assemblies

containing radioactive sources shall be returned to Lixi, Inc., the

i sealed source manufacturer, or other persons specifically licensed .

' to receive the unit. I i o Licenses for Industrial Uses of the Lixiscope - Should specifically j prohibit its use on humans or animals. Only licensed physicians or veterinarians will be pemitted to use a Lixiscope for these '

purposes. 7

o Am-241 - For industrial use distribution only.

I

! SAFETY ANALYSIS SUP#tARY:

j j Based on our review of the information and tes't data contained in the references stated below and that this amendment only adds a new series of l sourceholder heads and Americium-241 with a maximum activity of 375 millicuries j to a sealed source Amersham Corporation Model AMC. 17, we conclude that the

! Lixi, Inc., Lixiscope is acceptable for licensing purposes in accordance with '

l k. the-terms and conditions of this certificate of registration. '

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

(,.. (Amended Copy) l NO.: NR-422-D-101-S DATE PAGE 7 0F 7 DEVICE TYPE: Portable Fluoroscope .

When used by trained personnel in accordance with the manufacturer's instructions it is unlikely that any person will be exposed to dose or dose I commitments in excess of those specified in Part 20. Furthennore, the sealed source cannot be removed from its shielded housing without special tools and based on prototype test results the device is expected to withstand accident conditions likely to occur during transportation, storage or use.

If the device should fall into the hands of untrained personnel, either through theft or loss, it is unlikely to result in personal dose or dose ~

comitment levels in excess of the limits specified in Part 20. Factors which limit potential exposure are: The device and carrying case are provided with locks which prevent unshielding of the source, the device and carrying case are clearly labeled as to their radioactive content, the sealed source cannot be placed in its unshielded position without a key to unlock the device and special tools to remove the pin securing the source, r

i

REFERENCES:

The following supporting documents for the Lixiscope models are hereby incorporated by references and made a part of this registry document:

o Lixi, Inc., letters dated September 19, 1980, October 30, 1980 February 2,1981. February 9,1981, March 3,1981. January 28, 1983, March 25, 1983, November 16, 1984, November 20, 1984, December 14,1984 and June 6, 1985 with enclosures thereto.

l o Supersedes NRC Registry Document No. NR-422-D-101-S dated April 8, 1983.

ISSUING AGENCY:

l U.S. Nuclear Regulatory Comission Date: Jo n e_ c25. /9fT Reviewer:

Date: 10na 5 /9M Concurrence:

fL #f/3 e f.

I

(

l e

NR-422-D-101-S DAT M I I ATTACHMENT 1 i'

Scaled Source Isotope Holder . Red "on indicator" Ambient Light Shield Collimator Porthole RADIATION BEAM

__ r m I L I I

/ [3 ^

Distance Bar Arm Trigger

( 13ess u>rse.ge Battery Access Cap laet. ..... k'an -

m o

?O

..., ~.

% ,890 O}

NI.ldl_ .

lASTl3 TO Af M/N/ W/7H Dsd2Avrb acA1/ DF rsd*

,\\,.\

o-

..._2 ... T-scaks same I,1 N *3'*3 e 1 9

NR-422-D-101-S DATE: Ogg g ATTACHMENT 1 (3

Exposure Boles (mR/sec.) at the Confer of the Boom For 500 MCI Dwough 50 mCl of on 1125 Loaded LDO Source HooJ in the Operating Mode Distance from Source Hood 500 MCI 400 mCl 300 mCl 200 mCl 100 MCI 50 MCI 1cm 7&O 622 467 31.1 156 7.8 2cm 200 156 11.7 7.8 19 1.9 3cm 8.3 69 E2 35 1.7 09 4cm A8 3.9 29 1.9 1.0 05 5cm 12 25 1.9 1.2 06 Q3 6cm 22 1.7 1.3 09 04 02 7cm 1.6 1.3 1.0 06 Q3 Q2 8cm 1.2 1.0 07 QS 02 Q1 9cm 1.0 08 06 Q4 Q2 Q1 10 cm 08 06 QS Q3 Q2 0 06 11 cm 06 QS Q4 03 Q1 006

(, 12 cm 13 cm 05 Q5 04 Q4 Q3 Q3 Q2 Q2 Q1 01 0 05 0.05 14 cm 04 Q3 Q2 Q2 Q1 0 04 15 cm Q3 Q3 Q2 Q1 0 07 0 03 NOTES c) The otne figures con be murhpisod by 60 to gW mR per rrunute vcWues for the dWorient 6-125 i actMbes listed b) Refer to sechon 10 "Scr.4cc.cLca of Table A Ocse Rates" for further 6 4,...stM c) f rodchon output values are needed at drfferent distances er loveds. they may be calculated by the irwerse square low.

d) This Table was derNed from moost.soments mode using o 153 mCl 1-125 source in a UXI holder head and o Ebertine R0 58 meter.

I e) Vo!ves are rounded.

I l

1 1

m- .

,t-NR-422-0-101-S DATE:, y 1lyf ATTACHMENT 3

->c. Exposure Rates (mR/sec.) at the Center of the Beam for 300 mci of an Am-241 Loaded LIXI Source Head in the Operating Mode.

Distance from Am-241 Source Head 300 mci Surface 2 .9 1 cm 1 .00 2 cm 0 .53 3 cm 0 .32 4 cm 0 .22 5 cm 0 .15 6 cm 0 .12 7 cm 0 .09 8 cm 0 .07 9 cm 0 .06 10 cm 0.05 NOTES:

A) The above figures can be multiplied by sixty (60) to give mR per minute values.

B) Am.241 is not recommended as an imaging source for medical use.

C) This table was derived from measurements made using a 300 mC1 Am-241 source in a T-Series LIXl Source Holder Head and a Victoreen 541R Dosimeter.

D) After ten years, the exposure rates will reduce by 1.7 percent.

-- e

I .

f .

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES (7.i.( SAFETY EVALUATION OF DEVICE (AMENDED COPY)

NO: NR-495-D-101-S DATE: PAGE: 1 of 5 DEVICE TYPE: Bone Density Scanner MODEL: ND1100 DISTRIBUTOR: Nuclear Data, Inc.

Instrumentation Division

i Golf & Meacham Roads Schaumburg, IL 60196 l -

MANUFACTURER:

Molesgaard Medical f Rungsteduej 13 Dk-2970 Horsholm Denmark i

SEALED SOURCE MODEL DESIGNATION: Atomic Energy of Canada Limited Model C-324 4 Amersham Corp Model IMC.P2 ISOTOPE: Iodine-125 MAXIMUM ACTIVITY: 200 millicuries LEAK TEST FREQUENCY: 6 months l

PRINCIPAL USE: (V) General Medical use of Bone Mineral Analyzer i

CUSTON DEVICE: YES X NO l

l

s)

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES

( N SAFETY EVALUATION OF DEVICE (AMENDEDCOPY)

NO: NR-495-D-101-S DATE: SEP 2 5 EM6 PAGE: 2 of 5 DEVICE TYPE: Bone Density Scanner DESCRIPTION:

The ND1100 bone mineral scanner is an instrument for determination of bone mineral content. The patient grasps the handle in the water-filled acrylic container whereby the forearm is automatically positioned. A collimated photon beam source is scanned across the forearm in a rectilinear format by stepping motors. The photons passing through the forearm are detected by a scintillation detector placed opposite the source. This data is transferred to a computer for data processing and presentation. ,

The device is constructed of aluminum and lexan panels. The water reservoir is made of an acrylic plastic. The source holder is attached to an aluminum arm

(' by a set screw which inturn is attached to the stepping motors. The source

\

holder is a lead-lined stainless cylinder with a manual rotary shutter mechanism. There are two lamps on the panel of the device that tells the user if the source shutter is opened or closed. Additionally, the computer software will not allow the operator to process data until the shutter is placed in the closed position.

LABELING:

The device and source holder are labeled in accordance with Section 20.203, 10 CFR 20.

DIAGRAM:

See Attachments 1 and 2.

CONDITIONS OF NORMAL USE:

The bone density scanner is used by trained personnel to determine the bone mineral content in the forearm. The scanner was designed for use in medical clinics and hospitals having environmentally controlled environs. The device has an expected useful life of 12.5 years. The source is usually changed at five month intervals.

I 1

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES (t SAFETY EVALUATION OF DEVICE (AMENDED COPY)

NO: NR-495-D-101-S DATE: PAGE: 3 of 5 3

i DEVICE TYPE: Bone Density Scanner thEP 2 5 5B05 PROTOTYPE TESTING:

The manufacturer did not test the device, rather, they relied on data submitted on each electronic part and its use in Europe to make a determination the :

device would operate under the given conditions of use. Additionally, the sources were tested by the source manufacturer to the requirements of ANSI N542 and received a classification of 77C34334. The source holder is constructed of lead-lined stainless steel; this woulc further protect the source during normal

and accidental conditions associated with the use of the device.

I EXTERNAL RADIATION LEVELS:

(

I Nuclear Data reports that, after one year of dosimetery recordkeeping, the dose to the operator failed to register upon any of the dosimeters used. Therefore, there is minimal hazard associated with the use of the device. Additionally, i they reported the following dose rates around the source holder containing a 200 mci source:

5 cm 30 cm 100 cm 0.25 mR/hr .007 mR/hr 6.3x10-4 mR/hr i Furthermore, they reported that the radiation dose to the patient's forearm at j the completion of a scan is on the order of 3-4 mrad.

I QUALITY ASSURANCE AND CONTROL:

1 Nuclear Data reports their quality assurance program is designed on the approach set forth in military specification Mil-Q-9858A and FDA Section 21 820 Subpart J. The following is topic list of the inspection procedures used:

Exterior inspection j

Interior inspection ,

i Operational inspection l Current leakage inspection i

i

-- _ _ . - = _. . = - - - -.

REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES (tr.

SAFETY EVALUATION OF DEVICE (AMENDED COPY)

NO: NR-495-D-101-S DATE: FAGE: 4 of 5 DEVICE TYPE: Bone Density Scanner !

LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE

The device shall be distributed only to persons specifically licensed by the NRC pursuant to Section 10 CFR 35.13 or 35.14 and 35.100 or equivalent provisions of an Agreement State.

The device, when containing a source, shall be leak tested at six l

month intervals using techiques capable of detecting 0.005 microcurie

of removable contamination.

This registration sheet and the limitations contained within the references shall not be changed or transferred without the written consent of the NRC.

Review Note: Nuclear Data, Inc. does not install the source into the ,

holder or into the bone scanner. The sources are usually sent directly from the source manufacturer in the source holder to the user. The installation of the source and source holder is the responsibility of the user. Furthermore, any service done on a

source holder or a device containing a source will have to be performed by persons specifically licensed by the NRC or an Agreement State.

I SAFETY ANALYSIS

SUMMARY

r Based on our review of the information and test data cited below, that the FDA has granted the device a 510k and that the sources are previously approved for use, and that the amendment only adds a new source manufacturer, we conclude that the Model ND1100 bone scanner design is acceptable for licensing purposes.

Futhermore, we conclude that the device would be expected to maintain its ccntainment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate. ;

I l !

[P

\>c; REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDEDCOPY)

NO: NR-495-D-101-S DATE: % PAGE: 5 of 5 DEVICE TYPE: Bone Density Scanner

REFERENCES:

The following supporting documents for the ND1100 bone scanner are hereby

. incorporated by reference and are made a part of this registry document Nuclear Data Inc. letters dated November 4,1983, January 24, 1984 and June 17, 1985 with enclosures thereto.

ISSUING AGENCY:

U. S. Nuclear Regulatory Comission SEP 2 5 W iA 17 DATE: REVIEWER: /) Cli-~i

! '. c eX 0-

/.,

DATE: SEP 25 W CONCURRENCE: L gu M. d e 'f-l

-NO: NR-495-D-l'01 -5 DATE: .

ATTACHMENT 1 SEP 2 51985 e

- .i

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ND1100 Source Holder 1 e m

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4) Mjustment screw

5) Lid '

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6) Cable from inductive switch '~

7) Amle J 7 fl Inductive switch

9) Hole in rotatable front 7 101 Lead collimator

11) Nut an$ washer

12) Screw for lid -

13) Pole for cable M

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16) Fcam x .N - .di i d*'*r I'? 5

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Top View of N01100 Bone Scanner

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ML20140H420

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ML20140H420

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