ML20206U212
| ML20206U212 | |
| Person / Time | |
|---|---|
| Issue date: | 02/10/1999 |
| From: | Compton E NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Patterson J External (Affiliation Not Assigned) |
| Shared Package | |
| ML20206U187 | List: |
| References | |
| SSD, NUDOCS 9905250107 | |
| Download: ML20206U212 (24) | |
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NUCLEAR REGULATORY COMMISSION g
UNITED STATES E
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February 10, 1999 John 1. H. Patterson, Ph.D.
Metorex, Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618
Dear Dr. Patterson:
This letter is in response to your application dated December 4,1998, to Ms. Judith Joustra, requesting amendments to the registration certificate of the Model SSPS and HEPS probes (NR-701-D-101-B). We are in the process of evaluating your request. However, in order to continue our evaluation, the following information is necessary:
The model numbers (types) that you had provided for the radiation sources you wish to use in the Courier 8 configuration (using the HEPS 2412 probe) are Amersham product codes, that the NRC does not recognize. Please provide NRC or Agreement state registration numbers for these sources. For more information contact Amersham. Note, we believe that the product code CLCK3699 is registered as model CLCL; however, we are uncertain of the registration number for the product code CLCK3403.
2.
Please provide a more detailed description of the reference source assembly for the modified SSPS probe. Specifically, please include dimensions and indicate materials of construction of the push rods and joints as shown on SSPS Figure 1. The SSPS Figure 2 needs to be resubmitted with dimensions.
The radiation measurement data for the HEPS 2412 probe, in Table 1 (shutter closed) and Table 2 (shutter open) of Section 1.5 shows that the radiation measurements are greater with the shutter closed than with the shutter open. Please explain the reasons for these readings.
/ Also, these radiation levels are higher than the maximum external radiation levels currently indicated in the registration certificate (NR-701-D-101 B) for an essentially similar type probe. Therefore, please demonstrate that use of this probe with the new configuration by an individual untrained in radiological protection, in addition to other handling and storage conditions under a general license is unlikely to receive an excess of 10 percent of the annual dose limits specified in 10 CFR 20.1201(a) as required by 10 CFR 32.51(c). Please indicate all assumptions made and the basis for each, l
4.
The construction description and drawings of shutter mechanisms of the HEPS 2412 probe are confusing. Figure 11.1, shows cut-away views of the HEPS device, however these views do not clearly show how the parts are interconnected. Please provide a more concite description of the shutter and latch assembly and/or more complete technical drawing (s), clearly showing how the parts fit together.
9905250107 990521 PDR RC SSD PDR
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- e NRC requires a commitment from, Metorex Inc. to distribute these probes (both the modified SSPS and HEPS 2412) to persons generally licensed pursuant to 10 CFR 31.5, in accordance with the requirements of 10 CFR 32.51.
- Presently, your application dated December 4,1998, presents the information necessary for a technical review of the devices, in a disjointed fashion. Some of the pages are not numbered, source drawings were copied incompletely, and references to drawings as figures are confusing.
l l
Therefore, we request that you resubmit the complete amendment application addressing all the issues above. Please note all pages in an application must be numbered consecutively.
Additionally, all drawings should have a drawing number, revision number, company name, title, scale, and date. You may find information on the content and format of the application in Section 6,"How to File" of NUREG-1556, Vol. 3, " Application for Sealed Source and Device Evaluation and Registration."
Please provide the requested information within thirty (30) days. If we do not receive the requested information within thirty (30) days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application. If you have any questions, or you wish to meet us, please contact me at (301) 415-5799 or John Jankovich at (301) 415-7904.
Sincerely,
,. D w
a.
Eric B. Compton, Engineering Aide Materials Safety Branch Division of Industrial and l
Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards
4 february 10, 1999 e
5.
NRC requires a commitment from, Metorex Inc. to distribute these probes (both the modified SSPS and HEPS 2412) to persons generally bcensed pursuant to 10 CFR 31.5, in accordance with the requirements of 10 CFR 32.51.
Presently, your application dated December 4,1998, presents the information necessary for a technical review of the devices, in a disjointed fashion. Some of the pages are not numbered, source drawings were copied incompletely, and references to drawings as figures are confusing.
Therefore, we request that you resubmit the complete amendment application addressing all the issues above. Please note all pages in an application must be numbered consecutively.
Additionally, all drawings should have a drawing number, revision number, company name, title, scale, and date. You may find information on the content and format of the application in Section 6, "How to File" of NUREG-1556, Vol. 3, " Application for Scaled Source and Device Evaluation and Registration."
Please provide the requested information within thir1y (30) days. If we do not receive the requested information within thirty (30) days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application. If you have any questions, or you wish to meet us, please contact me at (301) 415-5799 or John Jankovich at (301) 415-7904.
Sincerely, original signed by Eric Compton Eric B. Compton, Engineering Aide Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards Distribution:
NE01h IMNS r/f SSD-99-01 SSD File # NR-701-D-101-B DOCUMENT NAME: H:\\ERIC\\COMPLTR\\METOREX1.DEF To receive 3 copy of this document. Indicate in the boa: *C' = Copy without attachment / enclosure "E' - Copy w,th attachment / enclosure
- N* = No copy OFFICE MSB
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l NAME ECompton ft JJankovich Tf UBhachu &L.-,-
DATE 02/ W /99 02/ K /99 i
02/ $ /99
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L OFFICIAL RECORD COPY j
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE:
PAGE 1 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe MODELS:
HEPS, LEPS, DOPS, SAPS, SSPS, SLPS (Formerly 820, 840, 880) Probes and Courier 8 Analyzer DISTRIBUTOR:
Motorex Incorporated (formerly Outokumpu Electronics, Inc.)
860 Town Center Drive Langhorne, PA 19047 MANUFACTURER:
rex International, Oy
'rmerly Outokumpu Instruments)
SF b2 0 Espoo, Finland SEALED SOURCE MODEL DESIGNATION:
Various; See Table in Description Section ISOTOPE:
MAXIMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq)
Cadmium-109 20 mci (0.74 GBq)
Curium-244 100 mci (3.70 GBq)
Iron-55 80 mci (2.96 GBq)
LEAK TEST FREOUENCY:
6 months PRINCIPAL USE:
(U)
X-Ray Fluorescence CUSTOM DEVICE:
YES X
NO
I l
l l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE:
PAGE 2 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe 1
DESCRIPTION:
The Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS X-ray Fluorescence Probes and Courier 8 analyzer are devices designed to perform element analysis of various materials in different environments.
The probes are designed for use in laboratory or 4
industrial plant environs or under field conditions.
The Models HEPS, LEPS, SAPS, and SLPS probes are the same probes which were i
previously registered by Princeton Gamma Tech with the 820, 840, and 880 X-ray Fluorescence Analyzers.
The Model DOPS has been previously registered for Columbia Scientific by the State of Texas with the Model 880 X-ray Fluorescence Analyzer.
The Model SSPS operates similar to the SAPS probe,-but using two sources.
The previously registered Models 820, 840, and 880 X-ray Fluorescence Analyzers included the probes as well as an external analyzer.
The Models 820, 840, and 880 analyzers contain a power supply and controlling electronics and perform an analysis of data received from the probes.
These analyzers contain no radioactive material.
The probes may be used with the models 820, 840, or 880 analyzers or attached to a personal computer (PC) containing software developed by the manufacturer.
The manufacturers PC based software operates the probes in the same manner as the analyzers.
The probes will be plugged directly into the PC via an expansion card installed in the PC.
No modification to the probes is necessary for use with the PC based system.
Each of the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes contain one or two radioactive sources.
There are two general categories of probes; the laboratory sample type probe and the surface analysis type probe.
A laboratory sample type probe contains a sample chamber into which discrete samples are placed in order to perform elemental analysis.
This type of probe may be either a Light Elements Probe System (LEPS) or a Heavy Elements Probe System (HEPS).
A surface analysis type probe is physically placed on the surface of an object in order to perform elemental analysis of the object or materials within the object.
This type of probe may be either a Surface Analysis Probe System l
(SAPS), a Surface Analysis Probe System for Light Elements l
(SLPS), a Solid State Probe System (SSPS), or a Dual Source Surface Probe (DOPS).
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)'
NO.: NR-701-D-101-B DATE:
PAGE 3 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Laboratory sample type probes contain a radioactive source (Am-241, Cd-109, or Cm-244 for the HEPS or Fe-55 for the LEPS), a
)
sample chamber, a chamber cover, a slide or shutter mechanism, shielding and associated electronics.
The probes measure approximately 3.25" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high.
Older laboratory sample type probes employ an automatic shutter mechanism to shield the source when not in use.
Whenever a sample is placed in the sample chamber and the sample lid is closed, the shutter is automatically withdrawn to allow for irradiation of the sample.
Characteristic X-rays given off by the sample are detected by the probes and analyzed either by a Model 820, _840, or 880 analyzer.or by the PC software.
The shutter is automatically moved to the shielded position by a return spring whenever the sample lid is opened.
Newer. laboratory sample type probes employ a slide mechanism in order to shield the source during sample change.
Operation of the probe consists of opening the sample cover, inserting a sample, closing the sample cover and sliding the sample into the measurement position.
Sliding the sample into the measurement position exposes the source which irradiates the sample.
Once the analysis is complete, the sample chamber is drawn back to the sample change position and the cover can be lifted and the sample withdrawn.
This action automatically shields the source.
The design of the probe ensures the cover cannot be lifted unless the sample is in the change position.
Surface analysis type probes are used only with the Models 840 and 880 analyzers or the PC based system.
These probes vary in shape, shutter mechanism and number of sources used, but operate using similar principles.
The basic operation of these probes is to place the sample window of the probe on the object to be analyzed, expose the source, detect characteristic x-rays given off by the object and analyze these x-rays to determine the elemental makeup of the object.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (ANENDED IN ITS ENTIRETY)
FO.: NR-701-D-101-B DATE:
PAGE 4 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
The SAPS probe contains a single source (either Am-241, Cd-109 or Cm-244), a shutter mechanism, and associated electronics.
The
^
probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6" (15.2 cm) deep and is contained within a Zinc (88%)
and Aluminum (12%) shell.
A trigger and lever system mechanically operates the shutter mechanism.
Source position is indicated by a flag in a window on the side of the probe (green for secured, red for~ exposed).
The SLPS contains a single source (Fe-55), an automatic mechanical shutter mechanism, and associated electronics.
Operation of the_ probe consists of placing the probe on the surface of the object to be analyzed.
This action depresses a microswitch plunger located on the bottom of the probe which, in turn, rotates the shutter to the irradiate position.
The shutter is automatically' moved to the shielded position by a return i
spring whenever the probe is removed from the sample surface.
This shutter assembly is the same as the one used with the older laboratory sample type probes.
The probe measures approximately 3.3" (8.3 cm)' wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high and is contained within a Zinc (88%) and Aluminum (12%) shell.
The SSPS contains two sources (Am-241, Cd-109, or Fe-55), dual shutter mechanisms operated by dual liquid nitrogen pneumatic systems, a liquid nitrogen dewar, and associated electronics.
The probe measures approximately 9.25" (23.5 cm) long by 4" (10.3 cm) wide by 9.75" (24.8 cm) high.
Operation of the probe consists of the operator selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger.
An electro-mechanical valve for source number one allows compressed nitrogen gas to enter a pneumatic cylinder which pushes the source into the measurement position.
Once the surface has been irradiated for the appropriate time interval the pneumatic cylinder is vented and a return spring pushes the source back into the shielded position.
Once source number one is secured, source number two is moved to the measurement position in the same manner using an independent, identical pneumatic system. If desired, the operator may elect to irradiate the surface using only one source.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE:
PAGE 5 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Newer SSPS models incorporate a reference source assembly to provide a reference spectrum when both shutters are closed.
The reference source assembly contains a recessed hole for a reference source covered by a silver cover and an aluminum cover glued and swaged (4 points) into placed.
Each shutter mechanism is connected, by an aluminum rod, to the reference source assembly. When either shutter is open, the reference source holder is positioned off the axis of the x-ray detector.
Sources may be moved to the measurement position only if there is sufficient liquid nitrogen in the dewar and only if external power is applied.
Source position is indicated by two windows (one for each source on either side of the probe).
Green indicates source secured while red indicates source exposed.
Source position is additionally indicated by an LED indicator on the probe handle.
This LED lights whenever either source is exposed.
The SSPS probe may be used with an optional sample chamber which can be attached to the bottom of the device.
This sample chamber is used by inverting the probe, connecting the sample cover, placing the sample on the radiation window, closing the sample cover, and pressing the start button.
Operation of the probe is not affected in this configuration.
The DOPS contains two sources (Am-241/Cm-244, Cd-109/Am-241, or Cd-109/Fe-55), an automatic shutter mechanism which sequentially exposes each source for a specific time period, and associated electronics.
The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6.5" (16.5 cm) long.
Operation of the probe consists of selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger.
The probe shutter mechanism consists of a two-piece shutter (one piece fixed and one piece movable) and a movable source holder.
Pulling the trigger causes a mechanical linkage to slide the movable shutter and source holder in unison into a configuration which exposes source number one.
i l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO : NR-701-D-101-B DATE:
PAGE 6 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Once the surface has been irradiated for the appropriate time interval, a microswitch releases the source holder which slides back to its original position.
This action shields source number one and exposes source number two.
Once the surface has been irradiated for the appropriate time interval, a microswitch releases the movable shutter which slides back into its original position, shielding source number two.
When used with a Model 820 analyzer, a LEPS and/or HEPS probe is built into the analyzer body.
The construction of each probe is not modified for this type of application.
i The courier 8 analyzer is designed for continuos measurement of liquid samples.
This analyzer contains a MEPS probe mounted in a sample cell.
When the probe is mounted, a lower support arm in the cell releases a safety catch in the probe allowing the shutter to open while' locking the probe into the cell.
This action exposes a radiation hazard label, indicating the probe is properly mounted and the sh stor.is open.
With the shutter open, the probe cannot be removed com the cell.
Disconnecting the probe automatically closes the probe. The sample cell is constructed with a 50 pm (1.97E-4 in) Mylar foil window.
Should this window leak, it would results in a short circuit between two metal concentric metal rings located around the window, sounding an alarm and stopping the sample flow.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE:
PAGE 7 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
I Sources and maximum activities are authorized for use in the i
probes as listed in the tables below:
l MODEL BY MANUFACTURER MAXIMUM ISOTOPE i
ISOTOPE ACTIVITY AMERSHAM Ih1Pont Mereck PRODUCTS I
Iron-55 80 mci /3.0 GBq IEC.Al NER-460 A XFB IEC.D1 Curium-244 100 mci /3.7 GBq CLCL XFB h,_._f Cadmium-109 20 mci /0.7 GBq CUC.D1 NER-465 XFB CUC.D1N Americium-241 30 mci /1.1 GBq AMC.D2 NER-478 GFS & XFB 50 mci /1.9 GBq for Model XFB.
MAXIMUM ACTIVITY BY PROBE TYPE (mci /GBq)
ISOTOPE SLPS LSP
_JAPS DOPS SSPS Iron-55(annular) 40/1.5 80/3.0 Iron-55(disc) 40/1.5 40/1.5 40/1.5 40/1.5 Curium-244 100/3.7 100/3.7 100/3.7 Cadmium-109 20/0.7 20/0.7 20/0.7 20/0.7 Americium-241 30/1.1 30/1.1 30/1.1 30/1.1
- Laboratory Semple Probe; includes LEPS, HEPS and Courier 8.
pW The SSPS probe [contains a V.G. Khlopin Radium Institute (Russia)
Low Energy Photon Source that is registered as part of this registry sheet and is not registered separately.
This source contains 1.3 pCi (50 kBq) of cadmium-109, and is 1 mm (0.04") in diameter by 0.2 mm (0.008") thick.
l L
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE:
PAGE 8 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe LABELING:
Each probe will contain an identification label that meets 10 CFR 20 requirements and which includes the probe type and serial number, source serial number, isotope, activity and date of assay.
Additionally the probes intended for distribution to persons generally licensed will contain a general license label in accordance with the requirements of 10 CFR 32.51.
DIAGRAM:
See Attachments 1 - 4.
CONDITIONS OF NORMAL USE:
The probes are designed for use in various environments including laboratories, industrial plants, and outdoor field uses (e.g.,
agricultural and mineral' exploration).
The probes may be used in portable and fixed applications.
The probes are not expected to be subjected to corrosive atmospheres, excessive vibration, or extreme temperatures due to the fact that the devices require the operator to be present for_ operation.
The manufacturer states that the expected useful lifetime of each probe is 10 to 15 years.
PROTOTYPE TESTING:
l The sealed sources used in the probes have achieved the minimum ANSI classifications as shown below:
MODEL NO.
ANSI RATING IEC.Al 77C33232 IEC.D1 77C54344 CLCL 77C54444 CUC.D1 68C44344 CUC.D1N 68C44344 AMC.D2 77C64545 NER-460 A 68C32212 NER-465 68C33232 NER-478
- 68CA3333, XFB 68C3 2232.
GFS 77C64545
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVATUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B paTE:
PAGE 9 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe PROTOTYPE TESTING: (Cont'd)
The DOPS and SSPS probes were subjected to shutter reliability tests which continuously operated the shutter mechanism for more than 100,000 cycles for the DOPS probe and 250,000 cycles for the SSPS probe.
The manufacturer reported no appreciable wear or problems associated with the operation of the shutter mechanisms following the tests.
These probes (excluding the SSPS, and Courier 8) have been approved by the state of Texas for Columbia Scientific, Inc.,
since 1988 with no reported equipment failures.
J EXTERNAL RADIATION LEVELS:
Metorex reports that the highest dose rates exhibited by the HEPS, LEPS, DOPS, SAPS, SSPS, and SLPS probes are 0.2 mR/hr (2 pSv/hr) at 1.97" (5 cm) and less than 0.05 mR/hr (0.5 pSv/hr) at 11.8"(30 cm).
Similarly, Motorex reports that the highest dose rates exhibited by the Courier 8 analyzer are 1.3 mR/hr (13.0 pSv/hr) at 1.97" (5 cm) and 0.09 mR/hr (0.9 pSv/hr) at 11.8" (30 cm).
OUALITY ASSURANCE AND CONTROL:
Metorex has agreed to abide by the quality assurance and control standards previously submitted by Princeton Gamma-Tech, and found to be adequate by the Source Containment and Devices Branch of the NRC.
These Quality Assurance standards cover the following areas:
1)
Quality Assurance Organization; 2)
General Quality Assurance Policy; 3)
Incoming Inspections and Vendor Qualifications; 4)
Test Procedures; 5)
Personnel Training; 6)
Non-Conforming Items Policy (Rejects);
7)
Document Control; 8)
Final Testing; 9)
Quality Audits and Reports.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE:
PAGE 10 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE :
Probes intended for distribution to persons generally licensed pursuant to Section 31.5, 10 CFR Part 31, must be initially transferred in accordance with the requirements of Section 32.51, 10 CFR Part 32 or equivalent provisions of an Agreement State.
The probes shall be tested for leakage at intervals not to exceed 6 months using techniques capable of detecting 0.005 microcurie (185 Bq) of removable I
contamination.
Probes intended for use by persons generally licensed shall be initially tested for proper operation ~of the source exposure mechanism, safety warning components, i
labels, external radiation levels and leak tested by Outokumpo Electronics, Inc., or other persons specifically licensed by the NRC or an Agreement State.
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 submitted and test data cited below, we continue to conclude that Metorex, Inc., has provided reasonable assurance that:
The probes can be safely operated by persons not having 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 device, and it is unlikely that any person will receive in any period of one calendar quarter a dose in excess of 10 percent of the limits specified in the table in Section 20.201(a), 10 CFR 20.
e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (ABENDED IN ITS ENTIRETY)
NO, NR-701-D-101-B DATE:
PAGE 11 OF 12 DEVICE TYPE:
X-Ray Fluorescence Probe SAFETY ANALYSIS
SUMMARY
- (Cont'd)
{
Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any persons would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified below.
PART OF BODY POJE O
Whole body; head and trunk active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv) l 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 (0.5 Sv)
Furthermore, continue to conclude that these devices would be expected to maintain their 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 Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS, X-Ray Fluorescence Probes and the Courier 8 analyzer, are hereby incorporated by reference and are made a part of this registry document.
Princeton Gamma-Tech, Inc. letters dated December 30,1985, January 15, 1987, May 18, 1987, June 12, 1987, and May 5, 1988.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
'(AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE:
PAGE 12 OF 12 DEVICE TYPE 1 X-Ray Fluorescence Probe
REFERENCES:
(Cont'd)
Outokumpu Electronics, Inc. letters dated February 8,
- 1991, September 12, 1991, February 3, 1992, October 9,
- 1992, December 18, 1992, December 30, 1992, February 22, 1993, March 29, 1993, and April 29, 1993, with enclosures thereto.
Metorex Incorporated's letters dated March 5,1999, July 24, 1995, and July 5, 1994, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
Reviewer:
Ujagar S.
Bhachu Date:
Concurrence:
John P.
Jankovich
7.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
F161 NR-701-101-B DATE:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.; NR-701-101-B DATE:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) l NO,; NR-701-101-B DATE:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES i
SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,; NR-701-101-B DATE:
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(VsSrJO HVr!TS To fl() ~ b l -b ~/0 ) - 0 5.03 Elements of Acolications to be Reviewed.
The reviewer should verify that the technical information in the application is adequate or subject to rejection and should document, through the use of a standardized checklist, the basis for the action. The following subject areas should be reviewed:
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m e s: nere designadon of model number, sealed source or device type, and principal use code; 7 a
designation of manufacturer, distributor, or U.S. representative for foreign vendors; /
designation of suppliers; /
certification and signature of a management representative; i
specificatien of proprietary information, adequacy of attidavit; d/A
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registration 4 medical devices (i.e. Food and Drug Administration Form 510k); N/d r
commercial distribution,or custom user; I
radi6niTcKdis Dsed in~the product;
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leak test frequency; W u 3" "
conditions of use:
p s A S.sa r t ~
likely environn ents, use, handling, storage, and transportation, extreme conditions (corrosion, vibration, impact, compressive loads, explosion, flooding, poor air quality, excessive low or high temperatures, thermal cycling),
operational cycling, estimated working life;
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design features, construction of the p)o uct:
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description of the operation, design and construction data, /
a integrity in accident and unlikely use conditions; x
labeling: 7
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text construction, /
location; /
prototype testing (one or combination of): /
test results, engineering analysis, operational history, radiation profiles; /o similar or equivalent products; comparison t gg jpgugg g,g e
quality control and quality assurance; installation, servicing, and instructions to users.
To perform an acceptance review, the reviewer may use the list above as a guide for the subjects which should be addressed. Acceptance and rejection criteria are identical to those that are used for registration reviews in the applicable review documents.
The reviewer may use the " Application and Review Checklist," Appendix C, in " Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration,"NUREG-1556, Volume 3, for documenting the acceptance review. It must be noted that this checklist has been designed for use in registration reviews. Therefore, when used for acceptance reviews, the reviewer should note that the checkmarks and remarks are related to an acceptance review, JCc CPrfn&;C pgy n vs a
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SUMMARY
DATA Name and Complete Mailing Address of the Applicant:
Name, Title, and Telephone Number of the Individual to lie M F'Tr#r/< /NC Contacted If AdditionalInformation or Clarification is Needed Pra strCSTwV cDo:a s w catf a rt e fN rrL.
by the NRC:
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7tt i r c u y N, p it. O 30 f!!!'s ' I'}
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/ / ) f d 9'~ +f(> f - foc>o 609 5f'If ~6),$d The Applkant is(check one):
1 If the Applicant is Not the Manufacturer, Provide the Name and Custom User
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Manufacturer
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YO / d Distributor Manufacturer and Distributor if the Applicant is a Custom User, Provide the Name and Provide the Name, Complete Mailing Address, and Function of Complete Mailing Address of the Distributor:
Other Companies Invoked:
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Model Number: j'j p$
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Principal Use Code (see Appendix F): (Q)
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Name Used by the Industry 'to Identify the Product (e.g.,
For Use by:
Radiography Exposure Device, Teletherap*v Source.
Calibration Source, etc.):
Specific Licensees Only gy g g fg 5 6 W c-5
General Licensees Only i
7tlQ nth Specific and General Licensees y
Persons Exempt from Licensing Leak-Test Frequency:
Principal Sectian of the 10 CFR that Applies to the User (e.g.,
Periodic Leak-Testing is Not Required General Licensees under 10 CFR 31.5): '
// 7 e# -
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/6 Months
__ g Radionuclides and Maximum Activities (including loading Attached isjustification for a leak test frequency of tolerance): #0'O greater than 6 months b, /0 7
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CERTIFICATION:
THE APPt ICANT UNDLRsTANDs TilAT ALL STATLMENTs AND REPRESENTATIONS MADE IN THis A TIE APPtICANT AND ANY OF FICIAL EXECUTING Tills CERTillCATION ON BF HALF OF TIIL APPLICANT. NAMED IN ITIM 2 PREPARED IN CONTORM11Y %TDI TITLE 10. CODE OF fTDERAL REGULATIONS. PARTS 30 AND AND CORRECT 10 '.TE BE si OF THEIR ANO41LDGE AND BELIEF.
WARNING 18 U s C. s0CTION 1001 ACT OF JUNE 25.1948 62 STAT. 749 MAKEs IT A CRIMINAL OITEN REPRESENTATION TO ANY DLPARTMENT OR AGENCY OF THE UNITED siAlls As TO ANY MATTER WITHIN ITs C:rtifying Officer-Ty ped Name and Title
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Signature:
Date:
NUREG - 1556, Vol 3 C-2
lr el APPENDIX C CllECKLIST Registration Certificate lloider:
Medel:
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DESCRIPTION OK/DEF COMMENTS DESCRIPilON, CONSTRUCTION If registration certificate holder is requesting to register more than one
_ source / device on a certificate, are designs similar enough to do so?
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M M9MOE Desice/ source design uith complete engineering drawings (dimensions.[
tolerances, list of materials)
Assembly methods (screw. welds. etc.):
serify integrity A/cs/)
4 h p r r @ // L / W PO 7 Kf" Source mounting (site and integrity ) and security
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is source ANSI classificatmn suf6aent (frorn ANSI N542-1977):
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Radiography - Unprotected 43515 Rad.ography - In Deuce 43313 Medical-Radmgraphy 32312 Medical-y Teletherapy 53524 y Gauges Unprotected 43333 y Gauges - In Device 43232
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p Gauges. Low EnerF) y Gauges, or Lray fluorescence.
33222 Oil Well Loggmg.
56522 Portable Moist / Density fM/4 5+1# A G4'k NP[/C(CA jfy 43333 Neutron Applications.
[66f341 43323
[6 V3 #/ #/
y irradiators (II, III, IV) 43424 y irradiators (1).
43323 i
Smoke Detectors.
22222 32222 Definition of shutter operation (locked in Off position, not locked in On position), fail safe, spacing and tolerances
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On-O1T indicators (description. qty., location)
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S: ety interlocks guards, etc. to present access to beam or high radiation -
3,, g p,y,r g g f rfc C Corrosion between unlike materials (e g., aluminum & steel, depleted uranium & steel, etc )
i Shielding efficiency and integrity i
For medical devices: Was a $10(L) prosided? (provide written notification to FDA)
An Well logging sources must be nondispersible and nonsoluble. (see Appendis B for a list of approved well logging sources as of Nos ember 1991)
N See "AN$1 and Other Standards" list for references for particular source /desice designs ic g. radiography, Ilrachytherapy, etc )
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l C3 NUREG - 1556, Vol. 3 L
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CllECKLIST Registration Certificate lloider:
Niodel:
j DESCRIPTION OK/DEF COMMENTS 1.AllLLING L,*PY *II*bCI poac s nr
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A WMMW pa xx w?Y Materials, dimensions, colors (note on registration certificate iflabeling is esempt from the color requirements of 10 CFR Part 20)
Permanent attachment anJ locatwn(s)- usible to users?
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Contents: Modela. Serials, isotope. Actiuty Manufacturer, Date of Assay, Trefoil. " CAUTION. RADIOACTIVE MA fERIAL"(Depleted Uranium information must be included)
CONDITIONS OF l'SI:
1.spected uorking life of the source deuce () ears, operations)
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g-TJ(t.Os)) g (f)
Actions to be taken uhen product reaches end ofits uorking hfe.
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f Maumum allowable temperature. ubratmn, shock corrosion, etc. (during
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l use. handling, storage, and transport)
N ilow the desice will be used h
i Meets dose limits of Part 32 for distribution Feneral licensees or persons esempt from licensing PROTOTYPE TESTINCr111STORICAL USE
\\s Tests methods and conditions (for source and des ice) gr Tests results nob Years of use (incidents, failures, etc. )
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,o,q v e5 r et/ cf c
>A y-4 (?.e v #g Similarities to other sourcevdevices if the) are used as basis.
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- up95, RADIATION PROFILES Suncy instrument used (type. uindow thickness, sensitisity, etc.)
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Conditions: including ensironments, scatter (product m beam), and use of Nm) h Pfi' i
,o guards and shields OFF y
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Distance from source / surface (per ANSI $38-1979)
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D^'>$ ] k /[ h{M' M Shutter Open and Closed / Source Shielded
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Verif) radiation surveys for y radiation meet inv law.
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Cn. 74 q 2
Verify radiatian suncy s for non-y radiation have not been calculated using 2
inv 1aw.
f/ /k en NUREG 1556, Vol. 3 C-4
APPENDIX t CllECKLIST Registration Certificate IIolder:
Model:
DESCRIPTION OK/DE F COMMENTS QUALITY ASSURANCE Materials, subassemblies, services
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Assembly methods (screw s, w elding, etc.)
Dimensions and tolerances Actis ity, radiation les els, leak tests QA Manual and comparison of manual to Regulatory Guide 6 9 INS f ALLA IION 7'
Fised portable, mosable, thed installation but portable source housing Inherent shielding, inaccessibility Beam access: sire of air gap opemng to beam and use of interlocks, locks, additional shielding or barriers Mounting integrity SAFETY INSTRUCTIONS Operation, maintenance, cahbration, damage failure, specific warnings leak test, and radiation surveys ACCOMPANYING DOCUMENTATION
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Leak tests results and radiation suncy s
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Transportation documents Operation, maintenance, cabbration, damage / failure, specific warnings, leak test, and radiation suncy instructions if applicable For Distribution to General Licensees:
Verify NRC Regions and Agreement State listing is up-to-date and copies of all pertinent regulations
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C-5 NUREG - 1556, Vol. 3
i i
P APPENDIN t CllECKLIST Registration Certificate lloider:
Model:
DESCRIPTION OK/DEF COMMENTS QUALITY ASSURANCE Materials, subassemblies, services
/
Assembly methods (screw s, w elding. etc.)
Dimensions and tolerances Actisity, radiation les els, leak tests QA Manual and comparison of manual to Regulatory Guide 6 9 INSTALLAI!ON
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Fixed. portable. mos able, thed installation but portable source housing Inherent shielding, inaccessibility Beam access: size of air gap / opening to beam and use ofinterlocks, locks, additional shielding or barriers
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Mountmg integrity SAFETY INSTRUCTIONS Operation, maintenance, calibration, damage, failure, specific w arnings, leak test, and radiation surveys ACCOMPANYING DOCUMENTATION
,/
Leak tests results and radiation surs eys
/
Transportation documents Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation survey instructions if applicable For Distribution to General Licensees:
Verify NRC Regions and Agreement State listing is up-to-date and copies of all pertinent regulations
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C-5 NUREG - 1556, Vol 3 a