ML20155C766
| ML20155C766 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20155C764 | List: |
| References | |
| SSD, NUDOCS 9811030002 | |
| Download: ML20155C766 (30) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE ILQ11 NR-0701-D-104-B DATE: OCr 2 91998 PAGE 1 OF 9 DEVICE TYPE: X-Ray Fluorescence Analyzer f MODEL: SIPS Probe l
DISTRIBUTOR: Metorex Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Center Ewing, NJ 08618 MANUFACTURER: Metorex International Oy l P.O. Box 85 ,
l SF-02201 '
Espoo, Finland l
l SEALED SOURCE MODEL DESIGNATION:
Amersham Corp. Models: IEC.D1, CUC.D1N, CUC.D1, AMC.D2 ISOTOPE: MAXIMUM ACTIVITY:
i Fe-55 (IEC.D1) 40 mci (1.5 GBq)
Cd-109 (CUC.D1N/CUC.D1) 20 mci (0.8 GBq)
Am-241 (AMC.D2) 30 mci (1.1 GBq) i LEAK TEST FREOUENCY: 0 Months PRINCIPAL USE:
(U) X-Ray Fluorescence CUSTOM DEVICE 1 YES X NO 4
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-0701-D-104-B DATE: OCT 2 91988 PAGE 2 OF 9 i
DEVICE TYPE: X-Ray Fluorescence Analyzer
. DESCRIPTION: 1 The SIPS probe is a hand-held x-ray fluorescence probe (see 2 attachment 1), designed for measurement of surface types or '
extended samples, mainly alloys, composites, and other solids such as rocks, minerals, and soils. The probe may house two radioactive sources that are located symmetrically on the l opposite sides of the probe axis, in the tapered snout of the I probe, as well as the necessary electronic equipment to run the device. .The probe has the shape of a pistol with a ribbed I cylindrical body, approximately 250 mm (9.85 in) long and 76 mm l (2.99 in) in diameter. The main body of the probe is aluminum !
alloy consisting of the ribbed cylinder, a base and back cover. '
The cylinder is screwed in to the base and then secured with two locking allen head screws. The end cap is attached to the base with four allen head screws and cannot be easily detached since the screws are-neither visible or assessable from the outside, i The probe handle is attached to the cylinder by tongue-and- l groove, and is also secured with allen head screws.
Sourceu are pointed at an angle of approximately 45 degrees from the opening above the detector (see attachment 2). This opening (window) is covered with 50.8 ym (0.002 in) thick Kapton foil 2, held in place by an aluminum plate. Each source is installed in a densimeta cup which is threaded to a brass holder. This assembly is enclosed in a cup-like shutter made of densimet. The thinnest part of each shutter is 1 mm (0.04 in) thick. The l shutters have an opening, that expose the source when properly oriented. To expose the source, each shutter rotates 180 degrees on its axis, parallel to the axis of the probe. The shutters are controlled individually by electric motors. When the motor drives the shutter open it loads a torsional spring, mounted to the shaft of each motor, that is able to return the shutter back to the closed position in case of power loss. The inner surface of.the end cap is lined with 0.5 mm (0.02 in) of lead sheet, glued in place with loctite. The middle part of the end cap, which provide support for the measuring window and shielding, is made of tungsten.
The measurement is started by placing the probe snout against the sample and pushing the trigger switch located in the probe handle. The measurement is terminated after the preprogrammed 8
Kapton: polyimide film manufactured by Dupont.
2 Densimet alloy 95% tungsten, 3% nickel and 2% iron.
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2 REGISTRY OF-RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-0701-D-104-B DATE: OCT 2 91998 PAGF 3 OF 9
[ DEVICE TYPE: X-Ray Fluorescence Analyzer 11 DESCRIPTION'(Cont.):
time of measurement elapses or by pressing the trigger switch before the~ preset measurement time elapses. The shutters operate in a sequence with only one source exposed at a time.
There are two red light emitting diodes (LED) in the back on the probe. -The left one is111t whenever a measurement is initiated, that is whenever any of the two sources is exposed. The other LED turns on only when either of the shutters is in the j transition between open and closed. In addition, the probe has two mechanical shutter position indicators, one per shutter. A red color " flag" is painted on each shutter. The end cap has on
. one side two small see-through lexan windows which the flag appears in when source is exposed.
Whenever not in use, the probe snout is covered with a special cover (see attachment 3a), which protects the probe window from damage and also served as additional radiation shielding. The end cover is made of aluminum alloy and is lined with 2 mm (0.08 in) covered with a 0.5 mm (0.02 in), 25 mm (0.98 in) copper disk. When small parts have to be measured that do not cover the ~~
end cap during measurements, a small sample cover is used (see attachment 3b), similar in shape to the end cover except taller ;
to allow more room for the sample.
The SIPS probe is used principally with the Metorex Model 960 Portable XRF Analyzer for measurements on-location (in-situ).
LABELING:
Small radioisotope labels, are placed on the measuring head of :
the probe, one for each isotope used in the device containing:
the radiation trefoil, the words " CAUTION RADIOACTIVE MATERIAL" and "REVOMAL OF THIS LABEL IS PROHIBITED", the device model and serial numbers, isotope, isotope serial number, activity, date of assay, and manufacturer's name. When the SIPS probe is distributed to a generally licensed user an additional label, meeting _the requirements of 10 CFR 32.51, is placed on the body of-the probe. Copies of both labels are shown in attachment 4.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES ,
SAFETY EVALUATION OF DEVICE l NO.: NR-0701-D-104-B DATE: OCT 2 91993 PAGE 4 OF 9 QEVICE TYPE: X-Ray Fluorescence Analyzer l
LABELING (Cont.):
An additional label intended to inhibit disassembly of the probe will be affixed to the base of the probe covering access screws.
This label states that only authorized personnel should open or service the device.
l DIAGRAM:
See attachments 1-4.
CONDITIONS OF NORMAL USE:
The probe is intended for measurements of extended surfaces such as metal plates, bars, rods, shaped, etc. The measured object must cover the window of the probe end cap. For small parts measurements the probe is mounted vertically on a stand, which is attached to the probe back cover with a thumb screw. Listed below are the normal operating conditions, as stated by Metorex, for the SIPS probe:
Ambient temperature:
Operation 0 to 50 C (32 to 122 F)
Storage -20 to 85 C (-4 to 185 F)
Humidity:
Continuous operation at 20 to 95% RH, no condensation Air pressure during transport:
30 to 200 kPa (1/3 to 2 atm)
Shock resistance:
Vibration: 2 g, 10 to 150 Hz Bump: 25 g Metorex estimates the expected life cycle of the SIPS probes to be at least 5 years.
. i
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r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
NO.: NR-0701-D-104-B DATE: OCT 2 9 BM PAGE 5 OF 9 DEVICE TYPE .X-Ray Fluorescence Analyzer PROTOTYPE TESTING:
A prototype SIPS probe r;3 subjected to a drop test. It comprised of dropping the probe from various heights (300, 400, 550, 750, and 1000 mm) onto a concrete floor with industrial carpet (no foam under) , glued to the concrete. It was noticed that each time the probe was dropped the probe measuring head (snout) exhibited the tendency to hit-the floor first because the
- probe' snout is the heaviest part of the probe. The integrity of the source mechanism, shutters and shielding were not compromised
~
by dropping the probe up to 1 m (39.4 in) in height. No increase in dose rate was observed around the probe after the test.
l Another SIPS proPe was subjected to a 2 m (68.8 in) drop test onto a concrete floor. The probe was dropped four times. After the first drop, a functional test was performed. It was discovered that the shutter did not open on impact, but after the functional test it remained open and did not close automatically.
The shutter was manually closed and the same probe was tested'for drops 2-4. The radiation measurements after the drop test indicated no increase in radiation levels.
A vibration test was performed on a SIPS probe. The vibration l was performed in the direction of the three principal axis for !
30 minutes over a frequency range of 10 to 500 Hz with I acceleration of 2 g. The probe did not sustain any damage and functioned normally after testing. l In addition, a SIPS probe was subjected to a reliability test. l The probe executed 300,000 test cycles exercising shutter mechanisms. No noticeable signs of wear were observed in the probe mechanics after the test. Metorex stated that the number of cycles executed by the probe during the test was equivalent to
- more than 6 years of continuous operations, 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> / day.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l
NO.: N R-0'7 01-D- 10 4 -B DATE: PAGE 6 OF 9 OCT 2 91998 l
DEVICE TYPE: X-Ray Fluorescence Analyzer l EXTERNAL RADIATION LEVELS:
l The following dose rates were reported by the manufacturer for the SIPS probe containing the following isotope combinations:
I 20 mci Cd*" and 40 mci Fe55, 30 mci Am241 and 20 mci Cd2", and 30 mci Am242 and 40 mci Fe55 :
l l
Measured Dose Rates for SIPS Probe ;
i [ mrem /hr (pSv/hr) ]
Isotopes Cd-109/Fe-55 Am-241/Cd-109 Am-241/Fe-55 Fe-55 Shutter Cd closed Cd open Am closed Am open Am closed Am closed Am open open Position Fe closed Fe closed Cd closed Cd closed Cd open Fe cbsed Fe closed or closed 5cm <0.05 3.0 0.1 0.65 3.0 <0.1 0.6 <0.05 (1.97 in) (<0.5) (30.0) (1.0) (6.5) (30.0) (<l.0) (6.0) (<0.5) i 30cm <0.05 0.2 0.05 0.1 0.2 0.05 0.1 <0.05 (11.81 in) (<0.5) (2.0) (0.5) (1.0) (2.0) (0.5) (l.0) (<0.5) 100 cm <0.05 <0.05 <0.05 0.05 <0.05 <0.05 0.05 <0.05 (39.37 in) (<0.5) (<0.5) (<0.5) (0.5) (<0.5) (<0.5) (0.5) (<0.5)
The maximum dose rates at the back of the probe and at the trigger never exceeded 0.05 mrem /hr (0.5 pSv/hr). When either the probe cover or small sample cover were placed over the probe snout, no dose rate measurement reading was reported higher than 0.05 mrem /hr, regardless of whether the shutter was open or closed.
All measurements with shutter open c're made with a 2 mm thick stainless steel standard placed over the probe measuring window (Lypical of normal use conditions).
During measurement, the operator presses the probe against the measured object, pointing the probe snout away from himself, holding the probe by the handle. It is reasonable to assume that during normal operation of the probe, no part of the worker's body would be closer than 30 cm to the radiation area in front of the probe snout. Based on these zealistic assumptions, Metorex's concluded that the maximum radiation dose to an operator per calendar year quarter is not likely to exceed 24 mrem (24 0pSv) l (8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> / day, 50% duty cycle at 0.1 mrem /hr).
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-0701-D-104-B DATE: OCT 2 91998 pgog 7 og 9 DEVICE TYPE: X-Ray Fluorescence Analyzer OUALITY ASSURANCE AND CONTROL:
Metorex is an ISO 9001 certified company. Production of Metorex devices is performed under Q/A, O/C procedures as required by the ISO 9001. The analyzers and probes delivered to Metorex, Inc.
from Finland for distribution are tested for operation, integrity of construction and assembly, accuracy of paper documentation, and analytical performance. All SIPS probes will be wiped tested and surveyed for radiation levels prior to distribution.
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, for general licensees, in accordance with 10 CFR 31.5 or Agreement State eauivalent.
l
- 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
- This registration sheet and the information contained within l the references shall not be changed without the written l consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Netorex has provided sufficient information to provide reasonable assurance that:
- The device can be safely operated by persons not having training in radiological protection.
l
- 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 l
l l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-0701-D-104-8 DATE: OCT 2 91998 PAGE 8 OF 9 DEVICE TYPE: .X-Ray Fluorescence Analyzer SAFETY ANALYSIS
SUMMARY
(Cont.):
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),
- 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:
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)
Based on review of the SIPS probe, and the information and test data cited below,, we conclude that this device is acceptable for licensing purposes.
Furthermore, we conclude that this device would be expected to maintain it's containment integrity for normal conditions of use
- and likely accidental conditions which might occur during uses specified in this certificate.
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REGISTRY OF' RADIOACTIVE' SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NQ,: NR-0701-D-104-B DATE: OCT 2 91998 pngg 9 op 9 DEVICE TYPE: X-Ray Fluorescence Analyzer
REFERENCES:
The following supporting documents for the SIPS probe are hereby incorporated by reference and are made a part of this registry
. document.
- ~ .Metorex's application dated October 16, 1997. l
- Metorex's letters dated April 19, 1998, June 17, 1998, July 6, 1998, and October 12, 1998, with enclosures thereto.
-l
- Metorex's facsimile dated October 20, 1998. .
ISSUING AGENCY:
1
. U.S. Nuclear Regulatory Commission
/s l OCT 2 91998
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c Date: Reviewer:
o n W..Lubinski Date:
OCT 2 91998 Concurrence:
y
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steven L. Baggett i
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE h NR-0701-D-104-B DATE: OCT 2 91998 ATTACHMENT 1 l
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4 I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
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l NO.: NR-0701-D-104-B DATE: OCT 2 91998 ATTACHMENT 2 i
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l NO.- NR-0701-D-104-B DATE: ATTACHMENT 4 OCT 2 91998 i
i 1
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. Isotope I.sotope..S/N mAramat Date REMOVAL OF THl$ LABELIS PROHielTED METOREX INC.
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W GENERAL LICENSE LABEL (IN ACCORDANCE WITH 10 CFR 32.51)
PAGE1 NRC FORM 567 U. 8. NUCLEAR REGULAlORY COMMISSION
- ')
d l REQUEST FOR A SEALED SOURCE OR L
DEVICE EVALUATION INSTRUCTIONS: Send tNo request AND a copy of au related letters /appNcetions and drawings to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the License Tracidg System milestone to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the appGestion and background flies.
REQUESTER REGION / LOCATION:
N I 11 Ill U IV V U HQ LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANTS NAME C s SOURCE REVIEW AMENDMENT OF
[h/7 f) / c:. ()n ) drf '
REGISTRATION SHEET ;
MAL CONTROL NUMBER (S) DEVICE REVIEW NUMBER (S) I FQ . 8[- 7d/-No/ f ww LETIRIAPPUCA"i)DATE m Mem UCENSE NUMBER (S) CUSTOM REVIEW
~v pga fan CrosstoadS OrP rafe Cen+er-0- 80x 3540 n'we Icn, ur n Rst r ss4n FOR 8888 USE ONLY REVIEWER MODEL NUMBERS
- s/P5 b ro v nn>/v DATE AS$GNED / /
NUMBER
< DAM TO FEES 7 ASSGy8 - N 3 DATE 4 RECENED /a 7/U<
TYPE OF ACTION (Indicate the number of each type) 4lm/9Ff l COMMERCIAL DISTRIOUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98)
NEW AMENDMENT
)EW g AMENDMENT
]NEW AMENDMENT
] AMENDMENT NEW j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN -
NO FEES REQUIRED NO j OTHER (Spec #y)
TOTAL NUMBER OF NOTES REVIEW HOURS 7, j[.od "/[c/
NUMBER OF l DEFICIENCY LETTERS h b- ~~~k~N' h 4% u l
7 NUMBER OF ,
DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NAME CHANGE j NEW REGISTRATION - J PRODUCT INACTIVE -
ADDRESS CHANGE ,
ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY AMOUNT RECENED n 8h. " f ,(4 3
]9A CHECK NUMBER U 9B 9C 9D h _
MATANN PDATED DATE OF CHECK N' LOG LqwD j MATSYS UPDATED 4,g ,Y % AS REQUIRED
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I li Appendix C: Review Checklist REGISTRATION #:
MANUFACTURER / DISTRIBUTOR: MdEX MODEL #:
sip 5 y -. MY h-vouac.m c M ra-tre Ts cc T
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RE' IRENCES:
DESCRIPTION OK/DEF COUMENTS
=
FIRST PAGE Registrant's name and address / -
5Mf,
~
Manufacturers and distributor's name and address / ' ;
si vt Custom users name and address d/A Model number Type (from Reg. Guide 10.10 or 10.11) / () X -Em Fove Oc t vcc M I Users authority to possess g h (specific, general, both, exempt) k Radionuclides, activity (Max w/% error), form, manufacturer, model, NRC registered (note on registration certificate if source is registered as part of the device)
Leak test frequency no periodic leak test for: krypton-85, tritium, radioactive gas, h isotopes with half-lives of 30 days or less, beta- or gamma-emitting material of no more than 3.7 MBq (100 microcuries), or ,/
alpha emitting material of no'more than 370 kBq (10 y microcuries).
Greater than 6 month frequency:
use criteria in 10 CFR 32.51(b) or 32.74(b)(1)
DESCRIPTION / CONSTRUCTION If registrant is requesting to register more than one source / device on a certificate, are designs similar enough to do so?
Device / source design with complete engineering drawings (dimensions, tolerances, list of materials)
Assembly methods (screw, welds, etc.); [
verify integrity Source mounting (size and integrity) and security V r
45 NUREG-1550 ,
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l DESCRIPTION OK/DEF COMMENTS ( l Is source ANSI classification sufficient:
Radiography - Unprotected - 43515 Radiography - In Device -43313 j Medical - Radiography - 32312 ~ '
Medical - y Teletherapy - 53524 y Gauges - Unprotected - 43333 y Gauges - In Device - 43232 .
p Gauges, Low Energy y Gauges, V
/ I or X-ray fluorescence - 33222 Oil Well Logging I56522 Portath Moist / Density -43333 Neutron Applications - 43323 y irradiators (11, lit, IV) - 43424 y Irradiators (I) - 43323 Static Eliminators - 22222 Smoke Detectors - 32222 (from ANSI N542-1977)
Definition of shutter operation (locked in Off position, not locked /
in On position), Fail safe, spacing and tolerances
~
OrwOff indicators (description, qty., location) g Safety interlocks, guards, etc. to prevent access to beam or high radiation levels l
Corrosion between unlike materials (aluminum & steel, depleted uranium & steel, etc.) see " Corrosion" information f '
g4 m pg,u q Shielding efficiency and integrity For medical devices - was a FDA 510k provide? (provide written notification to FDA)
Welllogging sources must be nondispersible and nonsoluble.
(see Appendix H for a list of approved well logging sources)
See " ANSI and Other Standards" list for references for particular y source / device designs (e g. radiography, Brachytherapy, etc.)
LABELING Copy of label /
Materials, dimensions, colors (note on registration certificate if ^ # "' ' # " "
labeling is exempt from the color requirements of 10 CFR Part [ff 20)
DCF M 4 n cev' Permanent attachment and location (s) visible to users?
Contents: Model#, Serial #, Isotope, Activity, Manufacturer, Date ,j v
of Assay, Trefoil, " CAUTION RADIOACTIVE MATERIAL" (Depleted Uranium information must be included) a 46
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NUREG-1550 Q"i l: ,
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m l' . .
pa$
b au DESCRIPTION OK/DEF COMMENTS CONDITIONS OF USE l
Expected working life of the source / device (years, operations)
Mions to be taken when product reaches end of its working
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Maximum allowable temperature, vibration, shock, corrosion, /
etc. (during use, handling, storage, and transport)
How the device wi!! be used [ l Meets dose hmits of Part 32 fohnd E distribution /
PROTOTYPE TESTING / HISTORICAL USE Tests methods and conditions (for source and device)
Tests results g((
Years of use (incidents, failures, etc.) h Similarities to other sources / devices if they are used as basis gf RADIATION PROFILES Survey instrument used (type, window, sensittvity, etc.) /
i Conditions g Distance from source / surface (per ANSI 538-1979) f Shutter On and Off/ source shielded Scatter (product in beam)
Guards and shields in place l
! Verify radiation surveys for y radiation meet inv' law.
Verify radiation surveys for non y radiation have not been calculated using inv2 law.
a 47 . NUREG-1550 l
l I
y DESCRIPTION OK/DEF COMMENTS QUALITY ASSURANCE t
i Materials, subassemblies, services ~
/ i Assembly methods (screws, welding, etc.) ./
Dimensions and tolerances
/
Activity, radiation levels, leak tests 1 y
OA Manual
/
INSTALLATION Fixed, portable, rnovable fixed installation but portable source m
housing inherent shielding, inaccessibility pk-Interlocks, locks, barriers
\
Beam access: size of air gap / opening to beam (verdy ct w1Ui nownu W [jhf /
Mounting integrity SAFETY INSTRUCTIONS Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation surveys ACCOMPANYING DOCUMENTATION Leak tests results and radiation surveys 7 ha \
Transportation documents
/
Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation survey instructions if '
r applicable , O l For GL dist. Verify NRC Regions and Agreement State ! I listing is up-to-date and copies of all pedinent 1
e regulations /
NUREG-1550 48 i
l .
n DESCRIPTION OK/DEF COMMENTS SERVICING
~
Manufacturer provides or user performs:
'if +' ' b b "
4###
U Calibration (O 'e
- W O i d N Installation Relocation t) n Leak Test ,~
A Maintenance 2 Radiation Survey
' _fi Repair & Training - gf 64cch*4ib
_fi Source Changelinstallation FOREIGN MANUFACTURERS Drop ship Who and where is source installed Leak test and radiation surveys OA in the U.S.
I r
l 49 (4UREG-1550
' ' CHECKUST FOR ADDITIONAL REQUIREMdNiS IN TH EVALU ilON Mj' 3 2f M OF DEVICES USED UNDER A GENERAL LICENSE DISTRIBUTOR:
MODEL #: REGISTRATION #:
REVIEWER: DATE:
Description OK/Def Comments Design is the device designed for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative V
/
chsmu:alcomposition, or for producing light or an ionized atmosphere?
Operation Can the device be safely operated by persons not having training in radiological protection? .h Can the radicactive material contained in the devi e be releved or inadverter Jy removed from the oevice unde . Jinary conditions of handling, storage, and use? [ g If periodic tests (leak, shutter, etc.) are allowed for periods greater than 6 months, use and attach the Periodic Test y Checklist.
Maximum Dose Commitments is it unlikely that any person will receive in one year a dose in excess of 10 percent of the annuallimits specified in 10 CFR 20.1201(a)? (Provide an estimate of the dose to a worker for jv each activity to be performed)
Under accident conditions (such as fire and explosion) associated with the handling, storage and use of the device,is it unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as follows:
Part of Body Dose (rem)
Whole body; head and trunk; active blood forming organs; gonads; or lens of eye 15 Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 l Other organs 50 i Labeling Does each device bear a durable, legible, clearly visible label or /
labels?
Does the label (s) contain in a clearly identified and separate statement, instructions and precautions necessary to assure safe j installation, operation, and servicing of the device (documents /
such as operating and service manuals may be identified in the !
label and used to provide this information)?
l l
l Rev 0; 4/23/97 Page 1of 3 I
l l
l
CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION l OF DEVICES USED UNDER A GENERAL LICENSE i
Description l OK/Def Comments l Does the label (s) contain in a clearly identified and separate statement, the requirements, or lack of requirement, for leak
- i testing, " for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity?
Does the label (s) contain in a clearly identified and separate statement the information called for in the following statement in the same or substantially similar form?:
The receipt, possession, use, and transfer of this device 'Model l
', Serial No. 8, are subject to a generallicense or the i equivalent and the regulations of the U.S. NRC or of a State with which the NRC has entered into an agreement for the exercise of regulatory authority. This 1.oel shall be maintained on the device in a legible condition. Removal of this labelis prohibited.
l CAUTION-RADIOACTIVE MATERIAL (Name of manufuturer. or initial transferor):
' Devices designed for general licensure prior to January 19, 1975 may bear labels authorized by the regulations in effect on l January 1,1975.
{
- The model, serial number, and the name of the manufacturer, I or initial transferor may be omitted from this label provided the l information is elsewhere specified in labeling affixed to the I device.
Periodic Testing If the device is to be tested at intervals longer than 6 months for proper operation of the on off mechanism and indicator, if any, or for leakage of radioactive material, or for both; has the applicant provided sufficient information to demonstrate that such longer interval is justified by performance characteristics of I the device or simi!ar devices, and by design features which have a significant bearing on the probability or consequences of g j leakage of radioactive material from the device or failure of the (( 4 N ri L9 on-off mechanism or indicator?
g[7 The following information was used to justify an increased interval:
Primary containment (source capsule)
Protection of primary containment Method of sealing cor.tainment Containment construction materials Form of contained radioactive material Maximum temperature withstood during prototype tests Maximum pressure withstood during prototype tests '
Maximum quantity of contained radioactive material Radiotoxicity of contained radioactive material l
Operating experience with identical devices or similarly I designed and constructed devices.
Other (specify)
Rev 0: 4/23/97 Page 2of 3
i .o CHECKLIST FOR ADDITIONAL REQUIREMENTS IN THE EVALUATION OF DEVICES USED UNDER A GENERAL LICENSE Description l OK/DM Comments Accompanying Documentation Z '
Verify NRC Regions and Agreement State listing is up to-date (/
and copies of all pertinent regulations \
i Servicing A -- /
If the generallicensee will be authorized to perform any of the fo!!owing activities, did the applicant provide written instructions to be followed by the generallicensee, estimated calendar doses associated with such activity or activities, and the bases for
(
these estimates? (Maximum allowed doses apply to these i
activities in combination with any other doses received from handling, storage or use) '
install the device g Collect the sample to be analyzid by a specific licensee l
for leakage of radioactive material
, Service the device
/ Test the on-off mechanism and indicator Remove the device from installation I
1 l
L 1.
1 Rev 0: 4/23/97-Page 3of 3
,r, ,--
! d
- I p RCl?u l p &- UNITED STATES g j t
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20666-0001 I
l i
! 4 9 + . * * * ,o FAX N0'S 301 - 415-5369 )
i l PLEASE CHECK ONE - LOCAL ( ) LONG DISTANCE (XX) I PLEASE TYPE OR USE A BOLD FELT TIP PEN.
i
( TELECOPIES WILL NOT BE RETURNED )
TO LOCATION
- 1. Stanislaw Piorek METOREX FAX # 609-530-0842 VERIFICATION Letter requesting additional information as per our conversation on Tuesday June 2. 1998.
. i l
NUMBER OF PAGES 2 AND COVER SHEET
. FROM Eric Comoton PHONE EXT. 301-415-5799 0FFICE NMSS MAIL STOP T-8F5
TRANSMISSION l
R PORT '
g; 9e /0 s 3 -7
-84' L.-2040 00'99-301 415 5369 DATE TIME DURATION REMOTE ID MODE PAGES RESULT l 01.01 00:00 01'00" 609 530 0342 ECM 3 0.K. l l
1 1
I l
1
___ ._ __m . . _ _ _ . . . . - _ -__ _ _ .. -_ .
ApG-31-199813t40 . USHRC R1 LAS 61o 337 5393 P.02
. . . o=ro w n p
August 25,1998 Mr. Eric H. Reber Nuclear Materials SafetyBranch U.S. Nuclear Regulatory Commision Region 1 475 AllendaleRoad King ofPrussia, PA 19406
Subject:
SIPS probe 1
- Metorex International Oy, Espoo Finland have received from Mr. Joseph Loftus of Metorex Inc. copies offour sets ofdocuments pertaining to the SIPS probe. Dr.
Stanislaw Piorek has submitted the documents to NRC on the following days:
October 16,1997 April 19,1998 June 17,1998 July 6,1998 I have inspected these documents especially to find out whether the given design radiation safety structures and features is excactly the same as in the probes that hav been delivered from Metorex International Oy to Metorex Inc during 1997 and 1998 for further delivery in the USA. I found actually only one thing that may be different in
- the earliest deliveries and one further point that is actually a mistake in the documentationitself.
The aforementioned difference is not in the probe itself but in the "end cap cover a radiation shield" shown in Figure C of the April 19,1998 documents. The screw 5 in the drawing) was not originally included but was added in autumn 1997 and thus the oldest caps in the USA may be without this.
The mistake mentioned above is in the drawing that is called Figure 3 in the October 16,1997 set and Figure Ia in the April 19,1998 set. There the material of the " source holder" is said to be aluminum but in reality it is densimet (tungsten alloy) as is s already in Figure 2 of the latter set. This change to a better shielding material was made already in the beginning of 1996 meaning that all the US probes have this
'made ofdensimet.
It should be noted that all the labels pertaining to radiation safety are made and fixed the probe by Metorex Inc.
Metorex Intemational qy h .e J uko Koskinen Y YD $
. . _ , _ ._ .,_ , , a - -
PfE-31-1998 13:39 UStRC R1 LAS 610 337 5393 P.01
,{
} NUCLEAR REGULATORY COMMISSION f REGION I 475 ALLENDALE ROAD
- .u* / KING OF PRUS$1A, PENNSYLVAN(A 194061415 1
1 DATE: _
3/ 98 MESSAGE TO: 84eVc htcrwW vv l
TELECOPY NUMBER: l~ ~d bi NUMBER OF PAGES: k (INCLUDING THIS REQUEST FORM)
MESSAGE FROM: d6kw N5 (U.S.N.R.C., REGION 1, KING OF PRUSSIA, PA)
TRANSMITTED BY:
DATE & TIME:
VERIFIED BY:
b
- l. ..
l.
i
)
i August 21,1998 i
l CAL No.1-98-007 E
Joseph P. Loftus, President Metorex, Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, New Jersey 08618 a
SUBJECT:
CONFIRMATORY ACTION LETTER i
Dear Mr. Loftus:
l On August 19,1998, you informed the NRC Region I that Metorex had distributed 25 to l
30 SIPS probes prior to being authorized by NRC to do so. Metorex has submitted an application to the NRC to add the SIPS probe to its distribution license. During an inspection on August 20,1998, you provided documentation indicating that 26 SIPS devices had been distributed without authorization. Records indicated that several different models (i.e., 960, 960EA,2000, and 2000EA) of SIPS devices had been
. distributed. Also, one SIPS device at your facility did not have required labeling applied to the' probe that housed the radioactive material.
Pursuant to a telephone conversation between you and John R. McGrath on August 21, 1998, it is our understanding that you have taken (or will take) the following actions t
which will be completed by the dates specified:
- 1. Immediately cease distribution and demonstration of the SIPS devices.
- 2. Contact each of your customers by August 28,1998, and request that they discontinue use of the devices, place the devices in storage and inform Metorex i
when they have completed these actions.
- 3. - Perform an analysis to determine that the distributed devices are the same design as the device described in letters to the NRC dated October 16,1997, April 19,1998, L . June 17,1998 and July 6,1998, and inform the' NRC of the results of this analysis by August 28,1998.
- 4. By August 28,1998, perform a complete inventory of the sealed sources at your facility to determine'the accuracy of the July 20,1998 inventory. You will also
'- ruiew receipt records to confirm that the list of distributed devices provided to NRC inspectors on August 20,1998 is accurate.
- 5. By August 28,1998, replace or provide new labels and instruct customers to place the label on the probe of the device (as required by 10 CFR 32.51(a)(3)).
7
~, i s
}
Pursuant to Section 182 of the Atomic Energy Act,42 U.S.C. 2232, you are required to:
- 1) Notify me immediately if your understanding differs from that set forth
! above; ,
- 2) Notify me if for any reason you cannot complete the actions within the specified schedule and advise me in writing of your modified schedule in advance of the change; and
- 3) Notify me in writing when you have completed the actions addressed in this Confirmatory Action Letter.
Issuance of this Confirmatory Action Letter does not preclude issuance of an order formalizing the above commitments or requiring other actions on the part of the licensee; nor does it preclude the NRC from taking enforcement action for violations of NRC requirements that may have prompted the issuance of this letter. In addition, failure to take the actions addressed in this Confirmatory Action Letter may result in enforcement action.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Sincerely, Original Signed By:
A. Randolph Blough, Director Division of Nuclear Materials Safety Docket No. 030-34246 License No. 29-30342-01 cc:
State of New Jersey Distribution:
PUBLIC
. . - . - - . - . . . . ~ .
.j=
- Nuclear Safety Information Center (NSIC)
- l. .. Region I Docket Room (w/ concurrences) l -H. Thompson, DEDR
' H. Miller, RI W. Axelson, RI D.' Cool, NMSS ;
J. Lieberman, OE '
A. Nicosia, OGC L. Davis, OGC T. Walker, RI D. White, RI R. Bores, RI ,
M. Campion, Ri l l
1 I
, i l'
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i DOCUMENT NAME: s:\PENDING\METOREX.WPD OFFICE DNMS -/ DNMS / ORA / DRA NAME REBER/MCGRATH BLOUGH HOLODY Axelson DATE s08/21/98 s08/21/98 s/08/21/98 s/08/21/98 l- Wiggins for:
OFFICIAL RECORD COPY i-a
, . ,~- . _ , . _ . . -
- - , - . . _ . _ , .-....,....,.-,.4.__ - . , . - . . _ . . . . . - .
- =
,1 /* * * %e y* . UNITED STATES j, d jf NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C 2055MN1 3
4 9 ,o* '
- "* NUCLEAR REGULATORY COMMISSION DIVISION OF INDUSTRIAL AND MEDICAL NUCLEAR SAFETY -
(FAX 301-415-5369)
DATE:
/
28[Y
/
FROM: 64'c co,+vF rt> N 1
PHONE NUMBER: [w) '/' f- G '/'/
TO: cf " # <" " *'
- c"E TO:
FAX NUMBER:[Bv ) 35 7 -Q6'P FAX NUMBER: .
l TO: TO: i 1
FAX NUMBER: FAX NUMBER:
MESSAGE:
Xct,rx Wwwu G- rv icuty , cA t. wo. /- (?pr- oo P NUMBER OF PAGES (INCLUDING COVER SHEET) /+3
l h g( )f August 21,1998 V #~
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CAL No.1-98-007 Joseph P. Loftus, President Ib Metorex, Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Ewing, New Jersey 08618
SUBJECT:
CONFIRMATORY ACTION LETTER
Dear Mr. Loftus:
On August 19,1998, you informed the NRC Region I that Metorex had distributed 25 to 30 SIPS probes prior to being authorized by NRC to do so. Metorex has submitted an application to the NRC to add the SIPS probe to its distribution license. During an inspection on August .20,1998, you provided documentation indicating that 26 SIPS devices had been distributed without authorization. Records indicated that several different models (i.e., 960,960EA, 2000, and 2000EA) of SIPS devices had been distributed. Also, one SIPS device at your facility did not have required labeling applied to the probe that housed the radioactive material.
Pursuant to a telephone conversation between you and John R. McGrath on August 21, 1998, it is our understanding that you have taken (or will take) the following actions i which will be completed by the dates specified: I l
- 1. Immediately cease distribution and demonstration of the SIPS devices. l l
- 2. Contact each of your customers by August 28,1998, and request that they discontinue use of the devices, place the devices in storage and inform Metorex l when they have completed these actions.
- 3. Perform an analysis to determine that the distributed devices are the same design as the device described in letters to the NRC dated October 16,1997, April 19,1998, June 17,1998 and July 6,1998, and inform the NRC of the results of this analysis l by August 28,1998. )
- 4. By August 28,1998, perform a complete inventory of the sealed sources at your i facility to determine the accuracy of the July 20,1998 inventory. You will also l
review receipt records to confirm that the list of distributed devices provided to NRC inspectors on August 20,1998 is accurate. l
- 5. By August 28,1998, r? place or provide new labels and instruct customers to place the label on the probe of the device (as required by 10 CFR 32.51(a)(3)).
[}f .
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l l
.._ . . . _ _ ._ . ._-.m_ _ . = . . . . _ . . _ . _ . _ . _ . _ . . _ . _ _ _ _ _ . _ _ _ . . . - . _ . . -
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l 3:
l l
lV Nuclear Safety Information Center (NSIC)
Region l Docket Room (w/ concurrences) i H. Thompson, DEDR
- j. H. Miller, RI W. Axelson, RI L
L D.' Cool, . NM SS l J. Lieberman, OE l A. Nicosia, OGC-l~ ' L. Davis, OGC
- j. - T. Walker, RI L
D. White, RI I- . R. Bores, RI M. Campion, RI l
t l-l DOCUMENT NAME: s:\PENDING\METOREX.WPD OFFICE DNMS / DNMS / ORA / DRA NAME REBER/MCGRATH BLOUGH HOLODY Axelson DATE s08/21/98 508/21/98 s/08/21/98 s/08/21/98 Wiggins for:
0FFICIAL RECORD COPY l
L
c.-._.. .. . . _ . - . _ _ _ _ _ . _ _ _ _ _ . _ _ __ . __.- _ _ _ __ _ _.._..__.._. __
l..
9 Pursuant to Section 182 of the Atomic Energy Act,42 U.S.C. 2232, you are required to:
- 1) Notify me immediately if your understanding differs from that set forth above;
- 2) Notify me if for any reason you cannot complete the actions within the
( specified schedule and advise me in writing of your modified schedule in -
l advance of the change; and l
- 3) Notify me in writing when you have completed the actions addressed in this Confirmatory Action Letter.
Issuance of this Confirmatory Action Letter does not preclude issuance of an order j formalizing the above commitmen's or requiring other actions on the part of the licensee; i nor does it preclude the NRC from taking enforcement action for violations of NRC requirements that may have nrorcipted the issuance of this letter. In addition, failure to take the actions addressed in this Confirmatory Action Letter may result in enforcement action.
In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards l information so that it can be placed in the PDR without redaction. If personal privacy or
! proprietary information is necessary to provide an acceptable response, then please provide l a bracketed copy of your response that identifies the information that should be protected 4 l and a redacted copy of your response that deletes such information. If you request j withholding of such material, you must specifically identify the portions of your response !
that you seek to have withheld and provide in detail the bases for your claim of withholding )
(e.g., explain why the disclosure of information will create an unwarranted invasion of I personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financialinformation). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
i Sincerely,
! Original Signed By:
A. Randolph Blough, Director l Division of Nuclear Materials Safety i
Docket Wo. 030-34246 Lie:ense No. 29-30342-01 t ec:
State of New Jersey Distribution:
PUBLIC
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l Additional Concerns based on Metorex's letter dated June 17,1998
- 1. Concerning the drop test results, please providejustification of the statement
" radioactive sources were not damaged during testing." Was a leak test performed and/or external radiation levels measured after drop test? Lastly, please verify that the critical and vulnerable points of the device were subject to impact.
- 2. !n Order fer u: to evclecte that 'hc generc! ucer w"! net be expeced to more than the annuc! decc ! -!!c 00 ctated in 10 CFR 32.51, p!cccc indiccte the typicc! number of meccurement (ccenc) which w"! be expected during c typicc! day. .^! 0, p!cccc ecti Otc the max! mum number Of meccurement: w"Ich could be made during heavy uce in One day. Lect!y, cena -- that a meccureme^t (ucing both courses) 7"" not exceed a maximuni cf 30 cecende Oc indiccted in the Opp.cction.-
- 3. Ok
- 4. Ok
- 5. Prior to distribution, is the wipe test performed on the device after source installation, or is it provided by the source manufacturer? Furthermore, are the final quality control tests, indicated in item 5 of you letter, performed at Metorex USA or Finland? l l
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