ML20207L164

Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Device Amended in Entirety Re Models N610-0063,N610-0134 & Voyager.Certificate:NR-536-D-110-B

ML20207L164
Person / Time
Issue date:	03/11/1999
From:	Michele Burgess, John Lubinski NRC
To:
Shared Package
ML20137A721	List: ML20207L156 ML20207L164 ML20207L272 ML20207L277 ML20207L302
References
SSD, NUDOCS 9903180011
Download: ML20207L164 (12)

Text

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES

! SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

EQ1 NR-536-D-110-B DATE: MAR I I 1999 PAGE: 1 of 8 DEVICE TYPE: Detector Cell Assembly MODEL: N610-0063,.N610-0134, Voyager DISTRIBUTOR: Perkin-Elmer Corporation 761 Main Avenue Norwalk, Connecticut 06859-0098 MANUFACTURER: PE Photovac 330 Cochran Drive Markham, Ontario Canada L3R 8E5 PE Instruslents Asia PTE 13-01 Peninsula Plaza 111 North Bridge Road Singapore 0617 l Republic of Singapore l

SEALED SOURCE MODEL DESIGNATION: Nuclear Radiation Development Model N1001 New England Nuclear Corp.

Model NER-004 Amersham /Searle Corp.

Model NBC l l

ISOTOPE: MAXIMUM ACTIVITY:

Nickel-63 15 mci (0.56 GBq)

LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (N) Ion Generators, Chromatography l

CUSTOM SOURCE: YES X NO l

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I l REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY) l HQ1 NR-536-D-110-B DATE: MAR I l iggg PAGE: 2 of 8 DEVICE TYPE: Detector Cell Assembly }

DESCRIPTION:

Models N610-0063 and N610-0134 Perkin-Elmer Autosystem Gas Chromatographs may contain an electron capture detector (ECD) of either Model N610-0063 or N610-0134. These ECDs consist of a heater, a temperature controlling mechanism, and a Nickel-63 foil situated in a cylindrical cavity (approximately 6 inches (15.2 cm) long) of a two piece 304 stainlese steel detector ,

body (approximately 3 x 1.5 inches (7.6 x 3.8 cm)). The sealed source l foil for use in the cell assembly consists of a corrosion resistant metal foil substrate wh!ch has Nickel-63 electrolytically deposited on one side. The sources used in these models are manufactured by i Nuclear Radiation Development, Inc. (Model N1001), Amersham /Searle Corporation (Model NBC), and New England Nuclear Corporation (Model NER-004). The two body parts are fixed together using four tamper resistant screws. Power to the heaters is interrupted when the temperature of the foil exceeds 470*C (878"F) by a microprocessor control in the circuitry.

An effluent transfer tube (anode) is located in line with the l horizontally arranged source. At the cell (cathode) the carrier gas (methane / argon or nitrogen) contacts the cylindrically formed foil and exits through a small tube at the other end of the detector.

These cell assemblies are very similar to previously evaluated and registered Models L413-0128, L413-0127, N600-0030, and N600-0113.

Models N610-0063 and N610-0134 are somewhat different mechanically to  ;

meet the needs of the new Autosystem gas chromatograph. The l difference between Models N610-0063 and N610-0134 is the use of a l 240 volt heater in Model N610-0134 instead of a 120 volt heater in Model N610-0063. The difference is required due to the 240 volt line i found in the overseas market.

Model Voyager 1

The Model Voyager is a complete gas chromatograph system which contains an ECD. The Voyager is portable and is expected to be used in all environs and has dimensions of 5.73 x 10.5 x 15.4 inches (14.6 x 26.7 x 39.1 cm). The ECD is a Model 200155 cell assembly and is identical to the two models discussed above, except that it has .

been modified to allow for a different mounting in the Model Voyager.  !

The sources used in the Voyager are manufactured by Nuclear Radiation Development, Inc. (Model1N1001) or Amersham /Searle Corporation (Model NBC). The Model 200155 ECD is mounted in an aluminum box I

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1 REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE i

(AMENDED IN ITS ENTIRETY)

HQ1 NR-536-D-110-B DATE: gg l j lggg PAGE: 3 of 8 DEVICE TYPE: Detector Cell Assembly DESCRIPTION: (Cont'd) within the Voyager and is insulated with foam. The aluminum box has a lid which is held in place with 4 tamper resistant screws. The ECD can be accessed through a small port for leak testing.

LABELING:

Models N610-0063 and N610-0134 Each ECD is stamped'with an individual serial number. An aluminum plate containing the radiation symbol, the statement " DANGER RADIOACTIVE MATERIAL," the isc. ope, activity, date of assay, and maximum operating temperatur- is affixed to the cell body. The cell area of each gas _ chromatogra ,h bears a label marked with the standard radioactive symbol and the words " CAUTION - Radioactive Material."

The device is labeled in accordance with the requirements of 10 CFR 32.51, if generally licensed. The label is attached to the ECD cell assembly by a wire tether similar to the one used for previously evaluated and registered models. This type of label will only be applied to those devices that are generally licensed.

The device will be labeled in accordance with 10 CFR 20.1901 when distributed to persons specifically licensed. This label is also attached to the ECD cell assembly by a wire tether similar to that used on the generally licensed devices.

Model Voyager The ECD in the Voyager is stamped with an individual serial number.

An aluminum plate containing the radiation symbol, the statement

" DANGER RADIOACTIVE MATERIAL," the isotope, activity, date of assay, and maximum operating temperature is affixed to the cell body. The access port to the aluminum box containing the ECD of each gas chromatograph bears a label marked with.the standard radiation trefoil and the words " Electron Capture Detector, CAUTION - Detector contains radioactive material, Read. user's manual before accessing." In addition, the lid of the aluminum' box bears a' label marked with the l i

standard radiation trefoil'and the words " CAUTION - Radioactive Material."

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[ REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES f ./

J SAFETY EVALUATION OF DEVICE

./- (AMENDED IN ITS ENTIRETY) 8 6- NQ1 NR-536-D-110-B' DATE: M M I I l999 PAGE: 4 of 8

.DEyICE TYPE: Detector Cell Assembly J'

LABELING

(Cont'd)

The Voyager device is labeled in accordance with the requirements of 10 CFR 32.51,. if generally licensed. The label is attached to the outside bottom cover of the device. This label will only be applied to'those devices that are generally licensed.

.The device will be labeled in accordance.with 10 CFR 20.1901 when distributed to persons specifically licensed. This label is also attached to the outside bottom cover of the device.

DIAGRAM:

See Attachments 1, 2, and;3.

CONDITIONS OF NORMAL USE:

ECD assemblies N610-0063.and NG10-0134 are designed.to produce ionized atmospheres for quantitative or qualitative measurement of elements in gas streams. They are components of the Perkin-Elmer Corporation's Gas Chromatographs Systems. The ECD will' be used in laboratory environs by persons trained in the use of. gas-chromatograph oquipment.

The ECD will normally, be, operated -at temperatures up to 460*C (860'F).

The Model Voyager device contains an ECD that is designed to produce an ionized atmosphere for. quantitative or qualitative measurement of elements in. gas streams. The Voyager is portable and will be used in field environs-by persons. trained in the use of gas' chromatography

-equipment. The devi< will~normally be operated at~ temperatures up to 80*C (176*F), but haL rated maximum temperature of 460*C (860*F).

The ECD is equipped with safety features which prevent it from exceeding 135'c (275'F) .

The expected working life of the Model Voyager is anticipated to be 10

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.or more years. The Ni-63 source nor radiological safety aspects are a limitationLwith respect to the working life.

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l REGISTRY Of RADIGACTIVE RWsLED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY) 2 HQ1 'NR-536-D-110-B DATE: MQ l 1193) PAGE: 5 of 8 DEVICE TYPE: Detector Cell Assembly I PROTOTYPE TESTING:

l Model N610-0063 and N610-0134 ECDs with sealed sources installed were tested to and met the minimum classification of C42211 for chromatography sources per ANSI N542-1977 In addition, the following tests were conducted:

o Pressure test to 30 psig e Drop test from 1.5 meters-e Temperature tests to 600'C The Model 200155 ECD used in the Model Voyager, with sealed sources installed, was tested to and met the minimum classification of 77C32211 for chromatography sources per ANSI N542-1977.

)

EXTERNAL RADIATION LEVELS:

Since the walls of the ECD cell are far in excess of the range of the maximum energy beta particles emitted from the contained source, surface readings on the ECD are not expected to exceed ambient background levels.

OUALITY ASSURANCE AND CONTROL:

The manufacturer has demonstrated an acceptable QA/QC program consisting of a 100 percent inspection of the ECD's as follows:

1. Cell closure seals are inspected for leakage by pressurizing blocked off cells with dry nitrogen at 30 psi.

2. Cell saturation current is measured to specified levels.

3. Each cell is baked out for two hours in a vacuum furnace 200"C (392*F) temperature and at air pressure of less than 0.07 mm (0.003 in) of mercury.

4. 100 percent wipe tested.

5. Functional test made on each cell.

Perkin-Elmer will manufacture all units in accordance with quality assurance and control programs as accepted by the NRC.

I f REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY)

, HQ1 NR-536-D-110-B DATE: MAR 111399 PAGE: 6 of 8 l

DEVICE TYPE: Detector Cell Assembly OUALITY ASSURANCE AND CONTROL: (Cont'd)

With respect to the Model Voyagers, Perkin-Elmer Corporation has )

committed to auditing the quality assurance and control program of PE I Photovac and PE Instruments Asia PTE on a frequency of once every 12 months. This audit will encompass a review of all the systems specified in the detailed flowcharts included with the application for amendment of this registration certificate. A copy of the audit reports will be kept on file at Perkin-Elmer for review by the NRC.

Perkin-Elmer commits that they will manufacture and distribute all units in accordance with a current Iso-9001 program, and that PE Instruments Asia PTE will manufacture all units in accordance with a current ISO-9001 or Iso-9002 program. Certificates verifying current Iso certification will be kept on file at Perkin-Elmer for review by NRC.

l LIMITATIONS AND/OR CONSIDERATION OF USE:

• These devices may be distributed to persons specifically licensed or generally licensed by the NRC or an Agreement State, e Labeling of the device shall be in accordance with the requirements of 10 CFR 20.1901, whan distributed to persons specifically licensed and in accordance with the requirements of 10 CFR 32.51, when distributed to persons generally licensed.  !

e These devices shall be leak tested at six month intervals either by:

a. Persons specifically licensed by the NRC or an Agreement State; or

b. The general licensee using a leak test kit and following the instructions supplied with the device.

e For Models N610-0063 and N610-0134, in lieu of using the conventional radiation caution colors (magenta or purple on yellow background) as specified in 10 CFR Part 20.1901, black anodized background with silver lettering and radiation symbol is authorized for use with the ECD labels. l

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AHENDED IN'ITS ENTIRETY)

EQ1 NR-536-D-110-B DATE: M N I I OOI PAGE: 7'of 8 DEVICE TYPE: ' Detector Cell Assembly LIMITATIONS AND/OR CONSIDERATION OF USE: (Cont'd) l-l e- Reviewer Note: The Ni-631 sources that may be used in the model l . Voyager are the-Nuclear, Radiation Development, Inc. model N1001 l and Amershtm/Searle Corporation model NBC. The New England L

Nuclear Corporation model NER-004 Ni-63 source is not approved for use in the model Voyager.

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

l SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data submitted by the references cited below, we continue to conclude that the N610-0063, N610-0134, and Voyager models are acceptable for distribution to persons who are either specifically or generally licensed. The manufacturer'has submitted sufficient information to demonstrate that the safety criteria of Secti.on 32.51 of 10 CFR Part 32 are met:

o Under ordinary conditions of handling, storage, and use of the j device, the byproduct material contained in the device wi.ll not I be release or inadvertently removed from the source housing, and I l it is unlikely that any person will receive in any period of one i

year'a dose in excess of 10 percent of the limits specified in

! 'Section 20.1201(a) of.10 CFR Part 20.

• Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the source housing, it is l unlikely that any person would receive an external radiation dose of dose commitment in excess of the' dose to the appropriate organ as specified in the following table:

'Part of Body DOSE Whole body; head and trunk; active 15 rem (0.15 Sv)-

blood-forming organs; gonads; or lens'of' eye Hands and forearms; feet and ankles; 200 rem (2.0 Sv) l ~ localized areas of skin average over areas no larger than i cm 8{ 0.15 in 8)

Other organs 150 rem (0.50 Sv) l i

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES I l

SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ1 'NR-536-D-110-B DATE: MAR l 11399 PAGE: 8 of 8 DEVICE TYPE: Detector Cell Assembly SAFETY ANALYSIS

SUMMARY

(Cont'd)

Furthermore, we continue to conclude the Models Voyager, N610-0063 and N610-0134, would be expected to maintain their integrity for normal conditions of use and ac0idental conditions which might occur during uses specified in this registration certificate.

I In this registration certificate, two ECDs are combined with a i complete gas chromatograph device. The ECD in the model Voyager (200155) is sufficiently similar to models N610-0063 and N610-0134 to combine them in one registration certificate. The radiation safety evaluation results for the three ECDs are the same. In addition, all three model ECDs are manufactured by Perkin-Elmer Corporation'under the-same quality assurance and control program. The model 200155 ECD is incorporated into the model Voyager gas chromatograph by PE Photovac of Canada.

REFERENCES:

The following supporting documents for'the detector cells are hereby I incorporated by reference and are~made a part of this, registry document:

o Perkin-Elmer Corporation. letters and facsimiles dated January 17, 1990, July 6, 1990, August'2,-1996, Merch'18, 1997, september 22, j 1997, November 10, 1997, December 29, 1997, February 4, 1998, and February 19, 1999,'with enclosures thereto.

e PE Photovac letters dated February 25, 1997, February 26, 1997, i and March 18, 1997, with enclosures thereto, and facsimiles dated l

' March 20, 1997, and April 2, 1997. ,

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ISSUING AGENCY

U.S. NUCLEAR REGULATORY COMMISSION 1 Date: Reviewer: m Miche e L. Burgess a

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MAR 111339 i L Date: Reviewer: i

[J"ohnW. Lubinsk3N--

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

IEL_;. NR-53 6-D-110-B DATE: if80 1 1 1339 ATTACHMENT 1 Electron Capture Detector

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I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

! E: NR-536-D-110-B DATE: MAR I I 1393 ATTACHMENT 2 Model Voyager ECD Module Assembly

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&: NR-536-D-110-B DATE: MAR l 11933 ATTACHMENT 3 Model Voyager Gas Chromatograph Nas sas

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March 11, 1999 Mr. John Widomski The Perkin-Elmer Corporation 761 Main Avenue Norwalk, CT 06859-0098

Dear Mr. Widomski:

Based on the information submitted in your application dated September 22,1997, and subsequent letters, with enclosures thereto, we continue to conclude the Models N610-0063,

' N610-0134, and Voyager are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-0536-D-110-B). j Please be advised that you must manufacture and distribute the product in accordance with the l statements and representations contained in your application, with enclosures thereto, and the I information set out in your registration certificate. As a general rule, you must request and 1 obtain an amendment to the certificate before you make changes or modifications to the i information submitted to obtain the certificate, j

Please read over the registration certificate in its entirety and notify us immediately if there are i any errors or omissions.  !

i Please be aware that, as a holder of an NRC registration certificate, you may be subject to the l NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.

Please note that due to the fact that Perkin-Elmer has pursued the option of committing to maintain and operate under valid ISO-9000 certifications, some documents submitted in the ,

early parts of the device review are now unnecessary. Therefore, we are returning the following j communications from Perkin-Elmer: facsimiles dated April 17,1998 (2), May 20,1998, and i October 15,1998, and letters dated June 8,1998, and June 18,1998., with attachments thereto.

If you have any questions, please contact me at (301) 415-5868 or Mr. Larry W. Camper at (301) 415 7855.

1 Sincerely, i A

Mic ele L. Burgess, Mechanical Engineer Material Safety Branch Division of Industrial and i Medical Nuclear Safety  ;

Office of Nuclear Materid Safety and Safeguards

Enclosure:

Asstated  !

cc w/ encl: SKimberley, LFDCB  ;

DiEktl2Rtion; - ,. ..

AV I IMNS r/f  : SSD-97-63 NE017  !

DOCUMENT NAME: A:\DONE\NR536110. CMP T

• receive a capo of this document, indicate in the box: *C' = Copy without attachment enclosure *E* = Copv with ettachmenteclosure "N* = No copy l

OFFICE - MSB E l l j NAME MBurgess/mb7F///S  ;

DATE 0:ll/d 9 /99 l

l OFFICIAL RECORD COPY 03l(000W f

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

N HQ1 NR-536-D-110-B DATE: MAI PAGE: 1 of 8 l

l DEVICE TYPE: Detector Cell Assembly I

l MODEL: N610-0063, N610-0134, Voyager DISTRIBUTOR: Perkin-Elmer Corporation 761 Main Avenue Norwalk, Connecticut 06859-0098 MANUFACTURER: PE Photovac 330 Cochran Drive Markham, Ontario Canada L3R 8E5 PE Instruments Asia PTE 13-01 Peninsula Plaza 111 North Bridge Road singapore 0617 Republic of Singapore SEALED SOURCE MODEL DESIGNATION: Nuclear Radiation Development Model N1001 New England' Nuclear Corp.

Model NER-004 Amersham /Searle Corp.

Model NBC ISOTOPE: MAXIMUM ACTIVITY:

Nickel-63 15 mci (0.56 GBq)

LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (N) Ion Generators, Chromatography CUSTOM SOURCE: YES X NO

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F REGISTRY Of P.ADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ1 NR-536-D-110-B DATE: VE 139 PAGE. 2 of 8 DEVICE TYPE: Detector Cell Assembly DESCRIPTION:

Models N610-0063 and N610-0134 Perkin-Elmer Autosystem Gas Chromatographs may contain an electron capture detector (ECD) of either Model N610-0063 or N610-0134. These I ECDs consist of a heater, a temperature controlling mechanism, and a Nickel-63 foil situated in a cylindrical cavity (approximately 6 inches (15.2 cm) long) of a two piece 304 stainless steel detector body (approximately 3 x 1.5 inches (7.6 x 3.8 cm)). The sealed source foil for use in the cell assembly consists of a corrosion resistant metal foil substrate which has Nickel-63 electrolytically deposited on

.one side. The sources used in these models are manufactured by Nuclear Radiation Development, Inc. (Model N1001), Amersham /Searle Corporation (Model NBC), and New England Nuclear Corporation (Model NER-004). The two body parts are fixed together using four tamper resistant screws. Power to the heaters is interrupted when the temperature of the foil exceeds 470*C (878'F) by a microprocessor control in the circuitry.

An effluent transfer tube (anode) is located in line with the horizontally arranged source. At the cell (cathode) the carrier gas (methane / argon or nitrogen) contacts the cylindrically fcrmed foil and ,

exits through a small tube at the other end of the detector.

These cell assemblies are very similar to previously evaluated and registered Models L413-0128, L413-0127, N600-0030, and N600-0113.

Models N610-0063 and N610-0134 are somewhat different mechanically to meet the needs of the new Autosystem gas chromatograph. The difference between Models N610-0063 and N610-0134 is the use of a 240 volt heater in Model N610-0134 instead of a 120 volt heater in Model N610-0063. The difference is required due to the 240 volt line found in the overseas market.

Model Voyager The Model Voyager is a complete gas chromatograph system which contains an ECD. The Voyager is portable and is expected to be used

in all environs and has dimensions of 5.73 x 10.S x 15.4 inches

! (14.6 x 26.7 x 39.1 cm). The ECD is a Model 200155 cell assembly and is identical to the two models discussed above, except that it has been modified to allow for a different mounting in the Model Voyager.

The sources used in the Voyager are manufactured by Nuclear Radiation Development, Inc. (Model N1001) or Amersham /searle Corporation (Model NBC). The Model 200155 ECD is mounted in an aluminum box i

9 l

i REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NQ1 NR-536-D-110-B DATE: yg ' 33 PAGE: 3 of 8 '

DEVICE TYPE: Detector Cell Assembly DESCRIPTION: (Cont'd) within the Voyager and is insulated with foam. The aluminum box has a lid which is held in place with 4 tamper resistant screws. The ECD can be accessed through a small port for leak testing.

LABELING:

Models N610-0063 and N610-0134 Each ECD is stamped with an individual serial number. An aluminum plate containing the radiation symbol, the statement " DANGER RADIOACTIVE MATERIAL," the isotope, activity, date of assay, and I maximum operating temperature is affixed to the cell body. The cell

' area of each gas chromatograph bears a label marked with the standard radioactive symbol and the words " CAUTION - Radioactive Material."

The device is labeled in accordance with the requirements of 10 CFR 32.51, if generally licensed. The label is attached to the ECD cell assembly by a wire tether similar to the one used for previously evaluated and registered models. This type of label will only be applied to those devices that are generally licensed.

The device will be labeled in accordance with 10 CFR 20.1901 when distributed to persons specifically licensed. This label is also attached to the ECD cell assembly by a wire tether similar to that used on the generally licensed devices.

Model Voyager The ECD in the Voyager is stamped with an individual serial number.

An aluminum plate containing the radiation symbol, the statement

" DANGER RADIOACTIVE MATERIAL," the isotope, activity, date of assay, and maximum operating temperature is affixed to the cell body. The access port to the aluminum box containing the ECD of each gas chromatograph bears a label marked with the standard radiation trefoil and the words " Electron Capture Detector, CAUTION - Detector contains radioactive material, Read user's manual before accessing " In addition, the lid of the aluminum box bears a label marked with the standard radiation trefoil and the words " CAUTION - Radioactive l Material."

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I REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i

(AMENDED IN ITS ENTIRETY) l NQ1 NR-536-D-110-B DATE: MAE '1H PAGE: 4 of 8 DEVICE TYPE: Detector Cell Assembly LABELING: (Cont'd)

The Voyager device is labeled in accordance with the requirements of 10 CFR 32.51, if generally licensed. The label is attached to the outside bottom cover of the device. This label will only be applied to those devices that are generally licensed.

1 The device will be labeled in accordance with 10 CFR 20.1901 when distributed to persons specifically licensed. This label is also

• ttached to the outside bottom cover of the device.

DIAGRAM:

ll See Attachments 1, 2, and 3.

CONDITIONS OF NORMAL USE:

ECD assemblies N610-0063 and N610-0134 are designed to produce ionized atmospheres for quantitative or qualitative measurement of elements in I gas streams. They are components of the Perkin-Elmer Corporation's l

Gas Chromatographs Systems. The ECD will be used in laboratory 1 environs by persons trained in the use of gas chromatograph equipment.

The ECD will normally be operated at temperatures up to 460*C (860*F).

The Model Voyager device contains an ECD that is designed to produce an ionized atmosphere for quantitative or qualitative measurement of elements in gas streams. The Voyager is portable and will be used in field environs by persons trained in the use of gas chromatography equipment. The device will normally be operated at temperatures up to 80*C (17 6

• F') , but has a rated maximum temperature of 460*C (860*F).

The ECD is equipped with safety features which prevent it from exceeding 135'C (275'F).

The expected working life of the Model Voyager is anticipated to be 10 l or more years. The Ni-63 source nor radiological safety aspects are a limitation with respect to the working life.

i

REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ1 NR-536-D-110-B DATE: IME : ?H PAGE: 5 of 8 DEVICE TYPE: Detector Cell Assembly l

PROTOTYPE TESTING:

Model N610-0063 and N610-0134 ECDs with sealed sources installed were tested to and met the minimum classification of C42211 for chromatography sources per ANSI N542-1977 In addition, the following tests were conducted:

• Pressure test to 30 psig

• Drop test from 1.5 meters

• Temperature tests to 600"C The Model 200155 ECD used in the Model Voyager, with sealed sources installed, was tested to and met the minimum classification of 77C32211 for chromatography sources per ANSI N542-1977.

EXTERNAL RADIATION LEVELS:

Since the walls of the ECD cell are far in excess of the range of the

maximum energy beta particles emitted from the contained source, l surface readings on the ECD are not expected to exceed ambient L background levels.

OUALITY ASSURANCE AND CONTROL:  ;

The manufacturer has demonstrated an acceptable QA/QC program consisting of a 100 percent inspection of the ECD's as follows:

l l 1. Cell closure seals are inspected for leakage by pressurizing blocked off cells with dry nitrogen at 30 psi.

i

2. Cell saturation current is measured to specified levels.

3. Each cell is baked out for two hours in a vacuum furnace 200'C (392*F) temperature and at air pressure of less than 0.07 mm (0.003 in) of mercury.

4. 100. percent wipe tested.

l 1

5. Functional test made on each cell.

i Perkin-Elmer will manufacture all units in accordance with quality assurance and control programs as accepted by the NRC.

I l.

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

NQ1' NR-536-D-110-B DATE: M- }33 PAGE: 6 of 8 DEVICE TYPE: Detector Cell Assembly OUALITY ASSURANCE AND CONTROL: (Cont'd)

With respect to the Model Voyagers,.Perkin-Elmer Corporation has committed to auditing the quality assurance and control program of PE Photovac and PE Instruments Asia PTE on a frequency of once every 12 months. This audit will encompass a review of all the systems specified in the detailed flowcharts included with the application for amendment of this registration certificate. A copy of the audit reports will be kept on file at Perkin-Elmer for review by the NRC.

Perkin-Elmer commits that they will manufacture land distribute all units in accordance with a current Iso-9001 program, and that PE Instruments Asia PTE will manufacture all units in accordance with a current ISO-9001 or ISO-9002 program. Certificates verifying current Iso certification will be kept on file at Perkin-Elmer for review by NRC.

LIMITATIONS AND/OR CONSIDERATION OF USE:

• These devices may be distributed to persons specifically licensed or generally licensed by the NRC or an Agreement State, e Labeling of the device shall be in accordance with the requirements of 10 CFR 20.1901, when distributed to persons specifically licensed and in accordance with the requirements of 10 CFR 32.51, when distributed to persons generally licensed.

e These devices shall be leak tested at six month intervals either by:

a. Persons specifically licensed by the NRC or an Agreement State; or

b. The general licensee using a leak test kit and following the instructions supplied with the device, o For Models N610-0063 and N610-0134, in lieu of using the conventional radiation caution colors (magenta or purple on yellow background) as specified in 10 CFR Part 20.1901, black t

anodized background with silver lettering and radiation symbol is authorized for use with the ECD labels.

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REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

1. NO HQ1 NR-536-D-110-B DATE. PAGE. 7 of 8 DEVICE TYPE: Detector Cell Assembly LIMITATIONS AND/OR CONSIDERATION OF USE: (Cont'd)

• Egyiewer Note: The Ni-63 sources that may be used in the model Voyager are the Nuclear Radiation Development, Inc. model N1001 and Amersham /Searle Corporation model NBC. The New England Nuclear Corporation model NER-004 Ni-63 source is not approved for use in the model Voyager.

• This registration sheet and the informa, ion contained within the references shall not be changed withow+mthe written consent of the NRC. ,

1 SAFETY ANALYSIS

SUMMARY

Based on our review of the information and test data submitted by the references cited below, we continue to conclude that the N610-0063, i N610-0134, and Voyager models are acceptable for distribution to persons who are either specifically or generally licensed. The manufacturer has submitted sufficient information to demonstrate that the safety criteria of Section 32.51 of 10 CFR Part 32 are met:

• Under ordinary conditions of handling, storage, and use of the I

device, the byproduct material contained in the device will not be release or inadvertently removed from the source housing, and it is unlikely that any person will receive in any period of one year a dose in excess of 10 percent of the limits specified in Section 20.1201(a) of 10 CFR Part 20.

• Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the source housing, it is unlikely that any person would receive an external radiation dose of dose commitment in excess of the dose to the appropriate organ as specified in the following table: l Part of Body DOSE Whole body; head and trunk; active 15 rem (0.15 Sv) l blood-forming organs; gonads; or lens of eye 1

l Hands and forearms; feet and ankles; 200 rem (2.0 Sv) I l localized areas of skin average over j l areas no larger than 1 cm2 (0.15 in) 2 Other organs 50 rem (0.50 Sv) i I

1 1

REGISTRY Of RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

E21 NR-536-D-110-B DATE: 3G  :

.3) PAGE: 8 of 8

. DEVICE TYPE: Detector Cell Assembly SAFETY ANALYSIS

SUMMARY

(Cont'd)

Furthermore, we continue to conclude the Models Voyager, N610-0063 and N610-0134, would be expected to maintain their integrity for normal conditions of use and accidental conditions which might occur during uses specified in this registration certificate.

In this registration certificate, two ECDs are combined with a complete gas chromatograph device, The ECD in the model Voyager (200155) is sufficiently similar to models N610-0063 and N610-0134 to combine them in one registration certificate. The radiation safety evaluation results for the three ECDs are the same. In addition, all three model ECDs are manufactured by Perkin-Elmer Corporation under the same quality assurance and control program. The model 200155 ECD is incorporated into the model Voyager gas chromatograph by PE Photovac of Canada.

REFERENCES:

The following supporting documents for the detector cells are hereby incorporated by reference and are made a part of this registry document:

o Perkin-Elmer Corporation letters and facsimiles dated January 17, 1990, July 6, 1990, August 2, 1996, March 18, 1997, September 22, 1997, November 10, 1997, December 29, 1997, February 4, 1998, and February 19, 1999, with enclosures thereto.

e PE Photovac letters dated February 25, 1997, February 26, 1997, and March 18, 1997, with enclosures thereto, and facsimiles dated March 20, 1997, and April 2, 1997.

ISSUING AGENCY:

U.S. NUCLEAR REGULATORY COMMISSION Date:

MAE 4 i!533 Reviewer: N- M M M e- XN Miche e L. Burges$

ME I 11539 '

Date: Reviewer: .. v

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, , APR 17 '98 09:18 FR PE-OUALITY ASSURANCE 203 762 6599 TO 813014155369 P.01,'09 Date: n)b l f) , k Nuzuber of pages including Ecr sheet:

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