ML20217R151
| ML20217R151 | |
| Person / Time | |
|---|---|
| Issue date: | 10/27/1995 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20216B030 | List: |
| References | |
| SSD, NUDOCS 9805140162 | |
| Download: ML20217R151 (6) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-213-D-101-B DATE: October 27, 1995 PAGE 1 OF 6 DEVICE TYPE:
Electron Capture Detector MODEL:
902, 902A, 902B 30 H g way 2b2 S uth Raritan, NJ 08869 MANUFACTURER:
Chrompack BV P.O. Box 519 2600 AM DELFT The Netherlands 1
I SEALED SOURCE MODEL DESIGNATION:
DuPont Merck Model NER-004 l
1 ISOTOPE:
MAXIMUM ACTIVITY:
i Nickel-63 10 millicuries (370 MBq)
LEAK TEST FREOUENCY:
36 Months i
PRINCIPAL USE:
(N) Ion Generator, Cnromatography 1
CUSTOM DEVICE:
YES X
NO 9905140162 951025 PDR RC ssp PDR
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i
SAFETY EVALUATION OF DEVICE NO.: NR-213-D-101-B DATE: October 27, 1995 PAGE 2 OF 6 l
DEVICE TYPE:
Electron Capture Detector l
i DESCRIPTION:
I l
The Models 902, 902A, and 902B electron capture detectors (ECDs) are constructed of 304 stainless steel and consists of an outer main body into which the source holder is screw fixed.
The ECD head and end cap is affixed to the end of the main body.
The coaxial cable protrudes from this end cap.
j Once the cell is assembled, the nickel-63 source cannot be accessed or removed from the cell without extraordinary means or i
the use of special tool.
Chrompack gas chromatographs are designed to allow similar use of any two detectors.
The nickel-63 source is used for its emission of beta radiation to j
ionize the column effluent.
?
The device is designed such that it will operate at temperatures up to 400*C (752*F).
However, use is limited to temperatures up to 350*C (662 F).
The Models 902, 902A, and 902B differ only in electronics and electrical details; differences have no effect on the radiological safety.
LABELING:
The ECDs are labeled as follows:
1.
A metal tag is affixed, with a pop rivet, to the neck of the detector.
The label includes the radiation trefoil symbol, the words " Caution Radioactive Material," the name of the distributor, isotope, activity, model number, and the following wording:
THIS LABEL SHALL BE MAINTAINED ON THE DEVICE IN A LEGIBLE CONDITION.
REMOVAL OF THIS LABEL IS PROHIBITED.
See Chrompack's Users Manual for further instructions.
Wipe Test - Once Every 36 Months
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO.: NR-213-D-101-B PATE: October 27, 1995 PAGE 3 OF 6 DEVICE TYPE:
E2.ectron Capture Detector 1
LABELING (Cont.)-
U2 receipt, possession, use, and transfer of this device are subject to a general licenset or the equivalent and the regulations of the i
U.S. NRC or and Agreement State.
Abandonment or disposal prohibited unless transferred to persons specifically licensed i
by the U.S. Nuclear Regulatory Commission or i
an Agreement State.
'l 2.
The serial number of the detector is stamped / engraved on the base of the detector.
1 3.
The trefoil symbol and the words " CAUTION RADIOACTIVE MATERIAL" are included on the protective cover that shields the electronic controller.
4.
The trefoil symbol and the words " CAUTION RADIOACTIVE l
MATERIAL" are included (black on a yellow background) on a sticker on the outside of the chromatograph.
I i
CONDITIONS OF NORMAL USE:
1 The ECDs are to be used in gas chromatographs under controlled, analytical laboratory conditions.
They are not a field devices.
Therefore, they will not be subject to significant vibration, impact, puncture, compressive loads, or extreme cold under normal operating conditions.
However, they may be subject to l
temperatures up to (350 C) 662aF.
The ECDs are specifically designed for use with Chrompack gas chromatographs and cannot be used as a component on any other product.
PROTOTYPE TESTING:
i The model NER-004 source has been tested by the manufacturer and has achieved an ANSI N542-1977 classification of 77C32211.
'The wording is adjusted in accordance with the panicular license held by the user.
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-213-D-101-B DATR1 October 27, 1995 PAGE 4 OF 6 DEVICE TYPE:
Electron Capture Detector PROTOTYPE TESTING (Cont.)-
Chrompack reports that prototype testing of the source included subjecting it to a temperature of 400*C (752*F) with no damage to the source.
In addition, Chrompack reports that there have been over 50 ECDs transferred from their current location and there have been no reported failures related to the radiological safety of the device.
EXTERNAL RADIATION LEVELS:
Chrompack reports an exposure rate of less than or equal to 0.01 mR/hr (0.1 pSv/hr) on any accessible surface of the detector unit.
OUALITY ASSURANCE AND CONTROL:
Chrompack was issued a license, by NRC Region I, that authorizes distribution of the ECDs.
Any information concerning Chrompack's quality assurance and control program was submitted to Region I as part of the license application.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The device may be distributed to specific or general licensees of NRC or an Agreement State.
Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority or as required by Section 31.5, 10 CFR Part 31 or Agreement State equivalent.
The device may only be used in Chrompack gas chromatographs which incorporate equipment which ensures that the ECD will not be subjected to temperatures which exceed 350*C (662 *F).
- 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.
1 i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO,1 NR-213-D-101-B DATE: October 27, 1995 PAGE 5 OF 6 DE" ICE TYPE:
Electron Capture Detector LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont.)-
- The user may mount the device into gas chromatographs.
However, the device may not be dismantled in any way by the user unless he obtains a specific license from NRC or an Agreement State to perform such activities.
t
- This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
The ECDs have been registered based on the following:
1.
The designs were previously approved for distribution by the Illinois Department of Nuclear Safety.
2.
Upon relocation of the point of distribution of the devices to New Jersey, NRC Region I evaluated Chrompack's application to distribute the ECDs and issued Chrompack a distribution license.
3.
Sufficient information has been provided to reasonable assurance that:
i The device can be safely operated by persons not having e
training in radiological protection.
- Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be released or inadvertently removed from the i
source housing, and it is unlikely that any person will
{
receive in any period of one calendar quarter a dose in i
excess of 10 percent of the limits specified in the table in Section 20.101(a), 10 CFR Part 20.
,k Under accident conditions associated with handling, storage, and use of the source housing, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the following chart:
i
)
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-213-D-101-B DATE: October 27, 1995 EAGE 6 OF 6 DEVICE TYPE:
Electron Capture Detector SAFETY ANALYSIS
SUMMARY
(Cont.)-
PART OF BODY DOSE Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv)
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rem (2.0 SV)
Other organs 50 rem (0.50 Sv)
REFERENCES:
The following supporting documents for the electron capture detectors are hereby incorporated by reference and are made a part of this registry document.
- Chrompack's application dated August 19, 1992.
- Chrompack's letters dated April 10, 1995, January 6,
- 1995, and October 26, 1994, (2 letters) with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
,/
/
Date:
October 27, 1995 Reviewer:
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pOohnW.
binski 4f7"'
/
29 Date:
October 27, 1995 Concurrence:
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Steven L. Baggett