ML20198K125

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Sealed Source for NER-8430.Certificate: NR-476-S-839-S

ML20198K125
Person / Time
Issue date:	09/02/1994
From:	Steven Baggett, John Lubinski NRC
To:
Shared Package
ML20198K039	List: ML20198K035 ML20198K050 ML20198K090 ML20198K110 ML20198K125
References
SSD, NUDOCS 9801140325
Download: ML20198K125 (7)

Text

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

%,L NR-476-S-839-S DATEt September 2, 1994 PAGE 1 OF 4 SEALED SOURCE TYPEt X-ray Fluoresconce Scaled Sodrce MODELt ilER-8430 BANUPACTURER/ DISTRIBUTOR:

DuPont Merck Pharitaceutical Co.

Radiopharmaceutical Divicion 331 Trsble Covo Road H. Bilterica, MA 01862 1

gg MAXIMUM ACTIVITY:-

Gadolinium-153 500 millicuries (18.5 GBq)

LEAK TEST FREOUENCY:

6 montha PRINCIPAL USE:.

(V) General Medical Use CUSTOM SOURCE:

YES X

NO 9001140325 900112 l

PDR RC SSD PDR

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HO.1 NR-476-S-839-S DATEt September 2, 1994 PAGE 2 OP 4 SEALED SOURCE TYPEt_

X-ray Fluorescence Scaled Source DESCRIPTION 1 The Model HER-8430 was designed for use as a component of a radical X-ray fluotescence analysis device.

The source is cylindrically shaped and contains gadolinium-153 as a compressed 0.020" (0.051 cm) tnick by 0.100" (0.254 cm) in oxide pellet, diameter.

It is constructed from 316L stainicas steel, has overall dimensions of 0.310" (0.787 cm) in length by 0.185" (0.470 cm) it. diameter, and is singly encapsulated.

The nource is sealed by a TIG weld at one end a-d '1as a 0.020" (0 051 cm) thick window at the other end.

LABELINGt Each source is engraved with the isotope, activity, serial d

number, and month and year of manufacture.

DIAGRAM:

See attachment 1.

CONDITIONS OF NOPMAL_USEt The Model NER-8430 scaled source will be a component of a medical device for in-vivo lead analysis by X-ray fluorescence.

Therefore, during normal use the source will be subjected only to controlled laboratory conditions suitable for human occupancy.

No extremes in environmental or operating conditions are expected.

PROTOTYPE TESTINGt.

A prototype of the source design was tested in accordance with the specifications of ANSI H542-1977 and the design achieved an ANSI classification of 77C63232.

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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.1. NR-476-5-839-S DATEt September 2, 1994 PAGE 3 OF 4 SEALED SOURCE TYPEt X-ray Fluorescence Scaled Source EXTERNAL RADIATION LEVELSJ, The characteristic radiation doses from the window of a source are listed belowt Radiation Dose Level Distance (cmi/ fin.)

(mR/hr/ mci)/fusv/hr/MBal_

2540/687 contact 5/1 97 8/2 3 0 / :.1. 8 2/0.5 The radiation levels at the back surface and sides of the source were measured to be 4 mR/hr/ mci (1 pSv/hr/MBq) and 7 mR/hr/ mci (2 pSv/hr/MBq), respectively.

OUALITY ASSURANCE AND CONTROL:

The source was manufactured and distributed under the guidelines of DuPont Merck Pharmaceutical Company's quality assurance and control program.

The program has been deemed acceptable for licensing purposes by NRC.

A copy of the program is on file with the Source containment and Devices Branch.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

. The source was distributed to persons specifically licensed by the NRC or an Agreement State.

• The source shall not be subjected to environments which exceed its ANSI classification.

The source shall be leak test at intervals not to exceed 6 months using techniques capable of detecting the presence of 0.005 microcurie (185 Bq) of removable contamination.

• Handling, storage, use, transfer, and disposal:

To be determined by the licensing authority.

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.t NR-476-S-839-S DATE: September 2, 1994 PAGE 4 OF 4 SEALED SOURCE TYPE:

X-ray Fluoresconco Scaled Source LIMITATIQNS AND/OR OTHER CONSIDERATIONS OF USE (Cont.):

This registration cortificate and the information contained within tl.e references shall not be changed without the written consent of the NRC.

SAFETY ANALYEIS

SUMMARY

DuPont never manufactured or distribited the Model HER-8430 scaled sourco.

Based on review of the Model HER-8430 sealed sourco, and the information and test data cited below, we continue to conclude that the sealed source is acceptable for specific licensing purposes.

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

REFERENCES:

The following supportAng documents for the Model NER-8430 sealed source are hereby incorporated by reference and are made a part of this registry document.

• DuPont Merck letters dated August 19, 1994, July 1,

1991, and March 7, 1989, with onclosures thoroto.

ISSUING AGENCY:

a a U.S. Nuclear Regulatory Commission j

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Datet Sentember 2.

1994_

Reviewer:

3 Lubinski

/ohnW Date Sentember 2.

1994 Concurrence

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/ 'S'teven Z. Baggett

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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES-SAFETY EVALUAfION OF SEALED SOURCE 11 M NR-476-S-839-S DATE: f,cptember 2, 1994 ATTAc1tMENT 1 x

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R TjgN A-A MODEL NER-8430

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?,E 3 : 5 T F.~. : F FX :: A.T '/E J EA'.I: 5:'JE :Z3 Td;; CE'!: IS SAFETY E'lA'.'JAT:::: :7 CE'll:E NO,:. NR-8021-D-801-S DATE: January 16, 19')5 PAGE 1 OF 5 DEVICE TYPE 1 Sample Irradiator b

MODEL:

-801 MANi>FACTURER/ DISTRIBUTOR:

Daybreak Nuclear and Medical Systems, Inc.

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50 Denison Drive 3u ' '. f o r d, CT 26437 EJALED SOURCE MQHEL DESIGNATICN:

Isotope Products Laborator...

Model BF90 Ti ISOTOPE:

MAXIMUM ACTIVITY _;.

Strontium-90 100 millicuries (3.7 GBq)

LEAK TEST FREOUENCY:

C Months l

PRINCIPAL USE1 (T) Other (Thermoluminescence Authentication)

CUSTOM D8VICE:

X YES NO

.c CUSTOM USER:

Detroit Institute of Arts Conservation Services Laboratory 5200 Woodward Avenue Detroit, MI 48202 ru ns,a o, c -

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E*/:!I NO,: NR-8021-D-801-S DATE: January 16, 1995 PAGE 2 OF 5 DEVICE TYPE:

Sample Irradiator pESCRIPTION:

The Model 801 was a coc..bination thert. luminescence reader and multiple sample irradiator which could expose up to 230 samples exposure time intervals ranging from 0 (cero) to sequentially atThe source houcing was constructed of formed lead 9999 seconds.

The units were which is mounted onto an aluminum source holder.

equipped with a shutter methanis-whtch were automatically closed cy a retur-spr:r.g wher a v:r fa;'_ure :ccured.

_:: a: tat.r., sample t_'ay A::ess to sam,_es were placcd the front of the The the tray was gained by a leading door ' cated athis body into the beam path when device.

The user could not put loading or uploading the samples.

LABELING:

The devices were labeled in accordance with the requirements of Section 20.201, 10 CFR Part 20, 4

DIAGRAM:

See attachments 1 and 2.

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k CONDITIONS OF NORMAL USE:

The device was used in a laboratory that is climatically The controlled and was used by trained laboratory technicians.

device was in a controlled access room which contained smoke detectors and fire suppression cquipment.

According to a letter 3

Institute of Arts dated February 8, 1993, the from the Detrorr.

device had not been used since 1984 &nd the Detroir Institute ot 1988, to read "for -*orage Arts amended its license on March 16, including the one contaiaed in only" for all its sealed sources, the Model 801.

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3 ATE 7i EVA*.', A~ ~ ; ; F :EV 2E NO,: NR-8021-D-801-S DATfa January 16, 1995 PAGE 3 OF S 4

DEVICE TYPFa Sample Irradiator PROTOTYPE TESTIN_q1

-Since this was a-custom device, the manufacturer did not perform actual testing on the unit.

However, they did submit an ANSI x-N538 classification of 12-785-785-121.

Additicnally, the manufacturer censidered the event.s that would cccur during a fire and had :leter :.ed ti:at :he

'ted es i wcu' d flew ar 'und the scurce

• hus aint aining shie.hrg _ntegrity.

EXTERNAL RADIATION LEVELS:

The following dose rates in millirem per hour were reported by the manufacturer:

Ton Front Left Side Riaht Side SyLk Bottom Surface 1.1 0.45 0.70 0.70 1.2 2.0 30 cm 0.2 0.]'

O.17 0.20 0.15 0.25 1m 0.04 0.02 Q.03 0.04 0.04 0.05 The following dose rates in microsieverts per hour were reported by the manufacturer:

Tqn Front Left Side Riaht Side pa_qh Bottom Surface 11.0 4.5 7.0 7.0 12 20 11.81 in.

2.0-1.0 1.7 2.0 1.5 2.5 39.37 in.

0.4 0.2 0.3 0.4 0.4 0.5 OUALITY ASSURANCE AND CONTROL:

This device-was built to meet Daybreak specifications under the direct. supervision of Mr. V.

J.

Bortolot, President of Daybreak Nuclear and Medical Systems, Inc.

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?5 A'C ;E*. : :E3 SAFETY EVAL"A!!!N OF 'EV :E NO,t NR-8t_1-D-801-S DATEt January 16, 1995 PAGE 4 OF 5 DEVICE TYPE:

Sample Irradiator LIMITATIONS AND/OR OTHER CONSIDER \\TIONS OF USEt

• This custom device was distributed to and used by the Detroit Institute of Arts.

• Handling, Storage, Use, Transfer, anc Disposal: To be determined by the licensing authority.

• ~hese ievices shall be leak te.-ter at intervals ot to excaed 6 Tenths using ta ".nig as apable of detecting 0.005 Tac.: curia.135 ?"

- tr/at antamination.

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

SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data cited below, the fact that the device will be used by persons trained in radiation protect'on and that a similar device manufactured by Daybreak was previcusly deemed' acceptable for licensing nurposes by the NRC and the Agreement States, we concluded that the Model 801 multiple sample irradiator was acceptable for custom licensing purposes.

Furthermore, wn concluded that this device would be expected to maintain its containntent integrity for normal conditions of use and accidental conditions which might occur during used specified in-this certificate.

As of the effective date of this certificate, the Detroit Institute of Arts has the device in storage pending disposal.

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NO,: -NR-8021-D-801-S DATE: January 16, 1995 PAGE S OF 5-w DEVICE TYPE;. -Sample Irradiator

REFERENCES:

The following supporting documents for the Model 801 multiple sample irradiater are hereby incorporated by reference'and are of this. registry document.

made a part

1993,

'nstitute Of Arts '.etters dated February 14, May.:.,

".383.

February 2, 1993 and September 29, :993, with

• Detrcit en:10 ures theroto.

ISSUING AGENCYt U.S. Nuclear Regulatory Commission.

W N Date:

January 16. 1995 Reviewer:

o W. Rich a

b Date.:

January 16, 1995_

Concurrcnce:

_ _ Steven L. 4aggett m

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REGISTRY OF FA:!:aCT!7E SEALE: 5:UR E5 A.0 CE7::E5 SAFETY EVALUAT:CN OF DEVICE ILQ1 NR-860-D-801-E DATE:

January 10, 1995 PAGE 1 OF 2 QEif]CE TYPE:

Computer Systems Containing a Smoke Detector Unit

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MODEL:

Part # 52524694--

-MANUFACTURER / DISTRIBUTOR:

Control Data Corporation 3101 East 80th Street Min.ea clis. Minnesota 55440 SEALED SOURCE MODEL DESIGNATION:

Honeywell TC 100C Smoke Detector Unit ISOTQ2E1 MAXIMUM ACTIVITY:

Americium-241 1 microcurie (37 kEq)

LEAK TEST FREOUENCY:

Not Required PRINCIPAL USE:

(P) Ion Generators, Smoke Detectors CUSTOM DEVICE: _

YES X

NO

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F.E3:3TF.Y OF FA' :A:!:'JE JEALi; 2 ;*.F.;E3 ;J.T ;E'l :E3 SAFETY E'lALUAT ;N OF CE' LICE HQ1-NR-860-D-801-E DATE:

. anua ry 10, 1995 PAGE 2 OF 2 PEVICE TYPE:

Computer Systems Containing a Smoke Detector Unit DESCRIPTION:

The Honeywell Model TC 100C smoke detector electronics are removed from its plastic case and are then attached to a Control Data Corporation printed circuit board.

This assembly is then mounted into a metal box and covered with a expanded metal cage.

The box is then mounted into the computer cabinet near the exhaust fan, The access panels :- the : mputer cabinet are held in place cy screws that ru,ait e a spec.4 toci to rem. ce them.

Thus, fu: ther res*ri ting accd s :: tha source assembly.

Con rol Data Corporation has not mace the ModeA Part 4 52524694 since 1988.

They have terminated their license and do not intend to use or distribute this model.

REFERENCES:

The following supporting documents for the Model #52524694 are hereby incorporated by reference and are made a part of this registry document.

Control Data Corporation's letter dated February 11, 1983, August 5, 1991 and May 11, 1993, and license application dated November 12, 1982, with enilosures thereto.

ISSUING AGENCY.

U.S. Nuclear Regulatory Commission g?'

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S Date:

_ January 10. 1995 Reviewer:

A fC' StevenjL. Baggett Date:

' January 10. 1995 Concurrence:

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John W.

Lubinski

-w REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE N O.. :.

NR-0291-S-801-S DE May 25, 1995 PAGE 1 OF 4

_OURCE TYPE:

Measuring Device Source S

liODEld.

TCB-1, Fischer Dwg. 89.0000-9402.00/4 Fischer Technology, Inc.

MANUFACTURER /DISTRIBUTORL 750 Marshall Phelps Road Windsor, CT 06095 Isotope Products, Inc.

19EUI,4TUR12s; 1800 N. Keystone St.

Bu: bank, CA 91506 SEALED.SOURCX_liQDEL DESIGNATIOlli Isotope Products TC -1 PR I} jim ACTIVITY:

ISOTOPE:

600 microcuries (22 MBq)

Promethium-147 50 microcurics (1.9 MBq)

Thallium-204 5 microcuries (0.19 MBq)

Strontium-90 20 microcuries (0.74 MBq)

Ruthenium-106 50 microcuries (1.9 MBq)

Bismuth-210 LEAK TEST FREOUENCY:

6 months ERINCIPAL USE:

(E)

Beta Gauges YES X

NO CUSTOM SOURCE;_

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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURC8 H2.1 NR-0291-S-801-S DATE.

May 25, 1995 EAGE ? OF 4 SQL!RCE TYPE:

Measuring Device Source DESCRIPTION:

in the forra of a bead of ceramic or ceramic-Radioactive materiallike materials made by the fabricator is placed inside the h (0.076 cm) in end of a stainless steel cylinder which is 0.03"is held in place with opoxy.

diameter and 0.G" (1.5 cm) long.

It These sources were distributed as a set of scaled sources by for in their beta backscatter unit Fischer Technology for use meastring coating thickness.

LMELIE.;

The sources are too small for labeling to be considered practicable.

DIAGRAht See Attachment 1.

Col;DITIONS OF NORMAL USE;_

An in measurement equipment.

These sources are designed for usein a holder within the device, and individual source is mounted may be exchanged for another source by the user to meet the specific measuring needs.

include: temperature rangina from Typical operating conditions normal atmospheric pressure, approximately 68-113*F (20-45'C),

and non-corrosive atmospheres.

EROTOTYPE_ TESTING 1 states that tests of these Isotope Products, the manufacturer, using the sources indicate they have a classification of C22232, standards in ANSI NS 10-1968.

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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE HQ 1-NR-0291-S-801-3 DATE:

May 25, 1995 PAGE 3 OF 4 SOURCE TYPE:

Measuring Device Source EXTERNAL RADIATION LEVELS:

Fischer Technologies states that the following dose levels would be found at a distance of 3.9" (10 cm) from the sources below.

Radionuclide Source, Size Dose Ratn Promethium-147 400 pCi (15 MBq) 14.1 mr/hr (0.14 mSv/hr)

Thallium-204 30 pCi (1.1 MBq) 16.2 mr/hr (G.16 mSv/hr)

Strontium-90 5 pCi (0.05 MBq) 45 mr/hr (0.45 mSv/hr)

QUALITY iSSURAMCE AND CONTROL:

Isotope Products, the manufacturer of the sources, had a quality assurance and control program which had been deemed acceptable for licensing purposes by the California Department of public health.

LIMITATIONS AUD/OR OTHER CONSIDERATIONS OF USE:

The sources may only be transferred to persons specifically licensed by the NRC or an Agreement State.

transfer and disposal are to be Handling, storage, use,

. determined by the licensing authority.

a Scaled sources exceeding 100 pCi (3.7 MBq) are required to be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination-This registration sheet and the information contained within

. the references shall not be changed without the written

-consent of che NRC.

SAFETY ANALYSIS

SUMMARY

These sources are not current products distributed by Fischer Technology, Inc.

These models were discontinued and the company no longer provides service or support to these sources.

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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.:

NR-0291-S-801-S DATE:

May 25, 1995 PAGE 4 OF.4 SOURCE TYPE:

Measuring Device Source

REFERENCES:

The following supporting documents for the Model TCB-1 device are hereby incorporated by reference and ar e made a part of this registry document.

Fischer Technology, Inc. letter of August 8,

1991,

. requesting termination of this registry 1980, for Fischer NRC Registration dated January 10, Tect, ology, Inc.

1972, for 1

California Registry Sheet dated November 24,

. Isotope Products Laboratories ISSUING AGENCY l',S. Nuclear Regulatory Commission Date:

May 25. 19M Reviewer:

Thomas W.

Rich I

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t

,e Date:

May 25. 1995 Concurrence:

Steven L.

Baggett I

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-REGISTRY OF RADIOACTIVE SEALED Sv0RCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.:

NR-0291-S-801-S DATE:

May 25, 1995 ATTACHMENT 1

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