ML20217F812
| ML20217F812 | |
| Person / Time | |
|---|---|
| Issue date: | 04/27/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20217F790 | List: |
| References | |
| SSD, NUDOCS 9804280274 | |
| Download: ML20217F812 (8) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY FNALUATION OF DEVICE NO,: NR-8096-D-801-G DATE:
APR 2 71998 PAGE 1 OF 5 DEVICE TYPFg Electron Capture Detector MODEIll D42 D_LSIRIBUTORi ES Industries 701 South Route 73 West Berlin, NJ 08091 MANuPACTURER:
Siemens AG Ostliche Rheinbruckenstr.50 D-7500 Karlsruhne 21 Germany SEALED SOURCE MODEL DESIGNATION:
Amersham Corp:
Model NBC Foil Source ISOTOPE:
If,AXIMUM ACTIVITY:
Nickel-63 10 millicuries (0.37 GBq)
LEAK TEST FREOUENCY:
6 months PRINCIPAL USE:
(N) Ion Generators, Chromatography CUSTOM DEyJLQR1 YES X
__ NO 9804280274 980427 PDR RC SSD pgy
r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO,: NR-8096-D-801-G DATE: AMI 2 71998 PAGE 2 OF 5 DEVICE TYPE:
Electron Capture Detector DESCRIPTION:
The electron capture detector (ECD) consists of a stainless steel detector cell within which the sample gas to be analyzed is passed over and irradiated by the nickel-63 foil source.
The source has a length of 1.38 inches (35 mm), a width of 0.45 inches (11.5 mm) and a thickness of 0.002 inch (0.05 mm).
l The maximum source activity is 10 millicurie (0.37 GBq).
Electronic circuitry measures the decrease in current due to capture of electrons by the sample gas.
The detector can be operated at a maximum temperature of 610 F (340oC).
To help maintain a constant temperature the cell and heating element are placed inside an insulated aluminum protective hood The protective hood measures about 9.6 inches (24.4 cm) in diameter i
and 9 inches (22.9 cm) in height.
Tamper resistant bolts deny user access to the foil and the use of a thermostat shuts down all heating elements if the j
temperature exceeds 662 F (350 C).
This includes the shut down of the oven heaters, j
i LABELING:
1 A metal label is affixed to the ECD by use of a metal tether which contains the wording requirements of 10 CFR 20.1901, 10 CFR 20.1904 and 10 CFR 32.51.
A waver of the color requirements of 10 CFR 20.1901 had been granted by the NRC.
I DIAGRAM:
See attachment 1.
CONDITIONS OF NORMAL USE:
The ECD is used as one type of detector in the Siemens Sichromat Gas Chromatograph units.
Such instruments are located in 3
analytical laboratories.
They may be operated by technicians who de not have training in radiation protection.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
NO.: NR-8096-D-801-G DATE:
APR 2 71998 PAGE 3 OF 5 l
l DEVICE TYPE:
Electron Capture Detector EROTOTYPE TESTING:
The ECD manufacturer used a source design that had been registered with the NRC.
In lieu of actual test data for the ECD, the manufacturer had indicated that the ECD had been in use in Europe for a period of seven years.
During that time frame no problems or incidents associated with the release of byproduct material were reported.
The unit was considered to be field tested prior to distribution of the ECD, since a function test and swipe test were performed.
EXTERNAL RADIATION LEVELS:
The manufacturer reported that there is no detectable dose rate on any accessible surface of the cell or protective cover.
Information provided by the source manufacturer indicated that the calculated dose rate from a 10 millicurie source is about 3 mrem / hour (30 Sv/hr) at 3.9 inches (10 cm).
t OUALITY ASSURANCE AND CONTROL:
The USA distributor of the devi>ce maintained records of all tests performed on the device by the manufacturer.
Furthermore, the distributor was kept informed of any changes that were made in the ECD.
The distributor made sure that the proper labels were affixed to the ECD, that the tamper resistant bolts were used, and periodically reviewed incoming ECDs to determine if any changes had been made.
A swipe test was performed by the distributor prior to distribution to a customer.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
l
- The device may be used by general licensees as defined by 10 CFR 31.5 of the NRC's rules and regulations or equivalent provisions of an Agreement State.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-8096-D-801-G TATE.
APR 2 71998 PAGE 4 OF 5 DEVICE TYPE:
Electron Capture Detector LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont.)
- The device shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
l 1
- This registration sheet and the information contained within the references shall not be changed without the written l
consent of the NRC.
SAFETY ANALYSIS
SUMMARY
l As of the effective date of this registration certificate, ES Industries no longer imports or sells the Model D42 ECD.
In addition, the company will no longer provide servicing but has indicated that they will work with users for contacting the manufacturer about providing necessary servicing.
ES Industries estimates that approximately 30 ECDs had been sold in the United States.
Based on our review of the information cited below, that the electron capture detector cell is equivalent to detectors i
previously deemed acceptable for licensing purposes, the unlikely event of a fire or accidental condition associated with j
its use, and even if the source was to become exposed it would be next to impossible for an individual to exceed the 15 rem j
(150 pSv) dose associated with accidental conditions based on 3 mrem per hour (30 pSv/hr) from a source we continue to conclude that the electron capture detector design is acceptable for use l
by general licensees as defined by 10 CFR 31.5.
Furthermore, we continue to conclude that the device would be expected to maintain containment integrity for normal conditions of use and accident conditions which might occur during uses j
specified in this certificate, i
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lL----
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,: NR-8096-D-801-G DATE: ARR 2 71998 PAGE 5 OF 5 DEVICE TYPE:
Electron Capture Detector
REFERENCE:
i The following supporting documents for the Model D42 ECD are hereby incorporated by reference and are made a part of this terminating registry document.
- ES Industries letters dated December 4, 1984, April 25, 1985, June 11, 1985, June 21, 1985, May 29, 1997, and June 24, 1997, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
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ARI 2 71998 Date:
Reviewer:
}fjW.' Eubinski
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l APR 2 71998 A
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Date:
Concurrence:
Sfeven L,'5aggett f
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PAGEi NRC FORM 567 U. S. NUCLEAR REGULATORY COMMIS$10N REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION I NOTE: Retain a copy of this request with the application and backgro INSTRUCTIONS: Send this request AND a copy of all related letters /appilcatene and drawings to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the Ucense Tracking System milestone to 19 and assign to reviewer code I-5.
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