ML20133A140
| ML20133A140 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1985 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20133A122 | List: |
| References | |
| FOIA-85-295 NUDOCS 8507200022 | |
| Download: ML20133A140 (51) | |
Text
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! REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NR-198-D-101-E 10F 1 NO: DATE: B 26 W PAGE DEVICE TYPE: Smoke Detector MODEL: 82 Series MANUFACTURER / DISTRIBUTOR: Cable Electric Products, Inc.
234 Dabo11 Street Providence, RI 02940 (401)781-5400 SEALED SOURCE MODEL DESIGNATION: NRD, Inc. Ndel A001 ION Chambers - Nemote Co. (Model N15-09)
Tokyo, Japan ISOTOPE: Americium-241 MAXIMUM ACTIVITY: 0.9 (+ 0.09) microcuries/ unit LEAK TEST FREQUENCY: Not required PRINCIPAL USE: (P) Ion Generator, Smoke Detectors CUSTOM DEVICE: YES X NO ISSUING AGENCY:
U. S. Nuclear Regulatory Comission DATE: Tl- -
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/ ff3' REVIEWER: O L- e Sterling W/ Bell t./h //
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE N_0: NR-271-D-101-E DATE: FEB t 6 95 PAGE10F_1 DEVICE TYPE: Smoke Detector MODEL: 305 -series (Model series sold under various brand names which may have differentplastichousings.)
MANUFACTURER / DISTRIBUTOR: G. S. Edwards Main Street Pittsfield, Maine 04967 (207)487-3104 SEALED SOURCE MODEL DESIGNATION: Amersham Corporation Models AMM-1001 and AMM NRD Model A-001 EAD Model AMX-1100 ISOTOPE: Americium-241 MAXIMUM ACTIVITY: 0.5 i .05 pCi/ unit LEAK TEST FREQUENCY: Not required PRINCIPAL USE: (P) Ion Generators, Smoke Detectors CUSTOM DEVICE: YES X N0
- ISSUING AGENCY
} U.S. Nuclear Regulatory Commission 0 -
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! DATE: February 26, 1985 Reviewer: d ' ,o U Sterling W. Bell
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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
\ SAFETY EVALUATION OF DEVICE
[vs NO: TX293D1018 DATE: November 21,1984 PAGE 1 0F 4 DEVICE TYPE: Neutron Backscatter Level Detector MODEL: LD2220 MANUFACTURER / DISTRIBUTOR: Fisher Controls Highway 380 East P. O. Box 900 McKinney, Texas 75069 SEALED SOURCE MODEL DESIGNATION: Gammatron Inc. Model AN-HP ISOTOPE: Am-241 MAXIMUM ACTIVITY: 200 mci.
LEAK TEST FREQUENCY: 6 months l
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PRINCIPAL USE: General Neutron Source Applications l
CUSTOM DEVICE: YES X N0 i
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C O REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE g: TX213 D1018 DATE: November 21, 1984 PAGE 2 0F 4 DEVICE TYPE:
Neutron Backscatter Level Detector DESCRIPTION:
composedan The Model LD2220 neutron backscatter level detector is ofAm-241 a helium-3 neutron detector mounted beside a source holder containing is mounted on a five foot neutron long aluminum source of tube.
200 millicuries. This assembly A Ludlum Measurements Inc. Model 12 rate meter is mounted at the other end of the tube.
LABELING:
A label containing the standard " Caution - Radioactive Material" assembly. and radiation trefoil is attached to the source-detector This label also contains the source serial number, radionuclide Authorities" on activity and date the outside edge of measurement of the label. with a " Notify Civil company name and serial number of the device isAnother label with the also attached.
DIAGRAM:
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S10E VIEW ..__________n NEUTRON SOURCE FIG.1. Model LD2220 Neutron Backscatter r Level Detecto O
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: TX2T3 D101 S DATE: November 21, 1984 PAGE 3 0F 4 DEVICE TYPE: Neutron Backscatter Level Detector CONDITIONS OF NORMAL USE: The Model LD2220 is intended for use in determining liquid levels inside chemical process equipment. The device is portable and must be used in environments compatable with man. The source-detector assembly is manipulated at the handle end of the device, four and one-half feet from the source-detector assembly.
This device will normally be operated using only a 100 millicurie Am(Be) source. However, 200 millicurie sources may be used. This may occur if vessel walls are thick, thick insulation is present around the vessel or materials inside the vessel are low in hydrogen content.
In general, the device will be removed from storage, taken into the plant, and used by trained operating personnel who have been instructed in the safe use and proper handling of the device by the Radiation Safety Officer. The actual period of use expected is 10 minutes'to one hour per week. After use, the device is returned to storage.
If severe conditions occur (explosion or fire), the device will likely be destroyed. However, the Am(Be) sources should remain intact since these sources are designed to perform under a pressure of 25,000 pounds per square inch and a temperature of 600 centigrade for one hour.
PROTOTYPE TESTING: Several prototypes were tested. Device construction causes the operator to maintain a safe distance from the source in order to operate the device.
EXTERNAL RADIATION LEVELS: Radiation levels at one foot from the source holder with a 200 millicurie source are 1.28 millirem /hr. of gamma radiation and 8 57 millirem /hr. of neutrons.5 Each 200 millicurie source is expected to produce 5 74 x 10 neutrons per second.
QUALITY ASSURANCE AND CONTROL: The device is completely assembled and tested before the sealed source (s) is installed. Each sealed source is certified as to specific activity and neutron output. Each device is then tested for proper operation before release.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE O NO: TX2D D101 S DATE: November 21, 1984 PAGE 4 0F 4 DEVICE TYPE: Neutron Backscatter Level Detector LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- 1. These devices may be distributed to specifically licensed users only.
- 2. Leak testing of the sealed source is required at six month intervals.
3 Repair and maintenance will be provided. Any repair involving the source housing will be handled by N.S.S.I. in Houston, Texas.
4 Source exchanges, if necessary, will be performed by N.S.S.I. in Houston, Texas.
5 The device will be returned to N.S.S.I. for disposal.
- 6. Training to safely use this device is provided to the Radiation Safety Officer. The Radiation Safety Officer may then present a short orientation course to qualify technicians as users.
SAFETY NALYSIS
SUMMARY
- This device can be operated safely by trained personnel. However, the possibility of misuse exists and only trained and competent personnel should be allowed to have access.
REFERENCES:
Application dated November 5,1984 with procedures, accompanying data and drawings.
DATE: A/ae.uf<r 1/ 199 y REVIEWED BY:
DATE: A,,u /,r y a rt/
i REVIEWED BY:
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ISSUING AGENCY: Texas Department of Health O
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO: TX333D115S DATE: September 12, 1984 PAGE 1 0F 2 DEVICE TYPE: Panoramic Radiographic Exposure Device MODEL: 20V, 20VS MANUFACTURER / DISTRIBUTOR: Gulf Nuclear, Inc.
202 Medical Center Blvd.
Webster, Texas 77598 SEALED SOURCE MODEL DESIGNATION: Gulf Nuclear Model RG-13 i
ISOTOPE: Iridium-192 MAXIMUM ACTIVITY: 100 Curies t Depleted Shielding, 13 6 l Uranium kilograms l
LEAK TEST FREQUENCY:
PRINCIPAL USE: Industria'l Radiography l CUSTOM DEVICE: YES X NO
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,' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES pg/ SAFETY EVALUATION OF DEVICE NO: TX333D115S DATE: September 12, 1984 PAGE 2 0F 2 DEVICE TYPE: Panoramic Radiographic Exposure Device ,
DESCRIPTION:
The Model 20V consists of a 30 pound depleted uranium shield mounted in epoxy around a zircaloy "S" tube and enclosed in a rectangular aluminum case with overall dimensions of about 6" x 5" x 10". The device is a crank out type of device which drives the source to and from the shielded position. The drive cable connector, exposure tube i connector, and the crank assembly are made of stainless steel. The exposure tube is plastic with brass fittings and is 22 feet long. The Model 20VS is identical to the 20V, except that the 20VS is enclosed in a rectangular stainless steel case and is certified as a Type B transport container. The Model 20V and 20VS uses the manufacturer's Model RG-13 source and is compatible with either the NEEI RC-6C or NEEI U-110 source changer.
LABELING:
The device bears the manufacturer's name, model, number, serial number, radiation symbol, isotope, number of curies, date, " CAUTION RADI0 ACTIVE MATERIAL", and specifies the device contains 30 pounds of uranium. Source data is contained on a removable label which is provided with each new source.
EXTERNAL RADIATION LEVELS:
The highest radiation level about the device at a distance of six inches from the surface was measured to be 32 millirem per hour for a 100 curie source.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The manufacturer provides an instruction manual of operation for the device and states that all repairs of the device are to be performed by the manufacturer.
DATE: Sa$ ,b /2.f/N REVIEWED BY: o.
DATE: /} h .,/i h O
REVIEWED BY: h d b.! -M 0
ISSUING AGENCY: Texas Department of Health
. s REGISTRY OF RADIOACT!VE 5EALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: TN-391-D-101-G DATE: March 1,1985 PAGE: 1 of 3 DEVICE TYPE: Fill Level Gauge MODEL: Model !$0 MANUFACTURER / DISTRIBUTOR: Industrial Services and Supply Co., Inc. l 2322 Carrollwood Lane -
Cordova, TN 38013 MANUFACTURER / DISTRIBUTOR:
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l SEALED SOURCE MODEL DESIGNATE: Amersham Model AMC.25 ISOTOPE: Americium-241 MAXIMUM ACTIVITY: 50 millicuries LEAK TEST FREQUENCY: 6 inonth intervals af PRINCIPAL USE: Gamma Gauge CUSTOM SOURCE: YES X NO
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' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: TN-391-D-101-G DATE: March 1,1985 PAGE: 2 of 5 DEVICE TYPE: Fill Level Gauge DESCRIPTION:
The gauge is comprised of the shielded beam source and an analyzer target mounted in an inverted "U" shaped housing. The beam source is mounted in one leg with the beam aimed a't the opposite leg. In the opposing leg an analyzer is mounted to receive the incident beam. The unit is designed so that the analyzer target intercepts the entire beam diameter emitted fro:n the source, thus providing shielding in the direction of the beam.
The radiation-source-holder consists of a lead tube of 2 mm wall thickness which immediately surrounds the source capsule. This tube is open on one end which confines the dispersion of the beam and directs it. The opposite end of the tube is closed with a lead cap plug that provides shielding in the opposite direction of the beam and serves as the locking device that holds the source capsule securely in the holder. Surrounding the lead tube is a brass block that serves as the main structure support for the source and the lead shield.
The exit end of the source holder is bolted to a vertical brass plate of 2 mm thickness which serves as the bracket for mounting to the 2 *mm thick stainless steel instrument housing.;
i A 1 mm thick stainless qteel shutter covers the exit hole of the source holder in the "off" or " safe" condition. The shutter mechanism is designed as a fail-safe device.
It is spring loaded in the' closed position and opened by means of a solenoid. The shutter is only open when power is applied to the gauge. When the electrical power is removed, the shutter is automatically closed. On the back side of the instrument housing there is a viewing window that exposes a flag which is connected to the shutter. By this means, the position of the shutter is verified.
I The radiation-source-holder is housed within the inspection head. The inspection head comprises a 2 mm thick stainless steel housing which surrounds the radiation-source-holder. Access to the radiation-source-holder is controlled by fasteners that require tools for removal. Access is accomplished by removing three acorn-type cap nuts from the removeable cover of the inspection head. Inside the inspection head the radiation-source-holder is held in place by another set of lasteners.
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, c REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: TN-391-D-101-G DATE: March 1,1985 PAGE: 3 of 5 DEVICE TYPE: Fill Level Gauge LABELING:
A. Each device shall be provided with a label containing infor: nation as follows:
(1) The receipt, possession, use, and transfer of this device, model number 150, serial number , are subject to a general license or the equivalent and the regulations of the U. S. Nuclear Regulatory Commission or a State with which the N.R.C. has entered into an agreement for the exercise of regulatory authority. (The model and serial number may be omitted from this statement provided they are elsewhere specified in labeling affixed to the device.)
(2) Abandonment or disposal prohibited unless transferred to persons specifically licensed by the U. S. Nuclear Regulatory Commision or an Agreement State.
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(3) Operation prohibited if there is indication of failure of, or damage to, radioactive inaterial contained or ON-OFF mechanism or indicator.
(4) Device shall be tested for leakage of radioactive material and for proper functioning of the ON-OFF mechanism at the ti:ne of installation, replacement of the radioactive material, and thereaf ter at no longer than 6 month intervals.
l , (5) Installation, dismantling, relocation, maintenance, or tests shall be l performed by persons specifically licensed by the U. S. Nuclear l Regulatory Commission or an Agreement State.
- B. Each device shall be provided with a label containing the radiation symbol in I conventional colors, magenta or purple on yellow background, the words
" CAUTION (or DANGER) - RADIOACTIVE MATERIAL", the identity and quantity of radioactive material and its date of measurement, and the name -
l of the distributor of the device.
C. Each label required by items (A) and (B) of above shall contain a statement
" Removal of this label is prohibited".
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, PROTOTYPE TESTING: ,
Gauge - ANSI N538-1979 classification 33-935-935-R-3 Source Capsule - ANSI N5.10-1968 classification C64444 i
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e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: TN-391-D-101-G DATE: March 1,1985 PAGE: 4 of 5 DEVICE TYPE: Fill Level Gauge -
EXTERNAL RADIATION LEVELS: -
With the exception of within the useful beam, the exposure rate around the inspection head is less than 0.075 mrem / hour measured at a 10 cm radius from the surface of the inspection head. At 100 cm radius fro n the surface of the inspection head the exposure rate is less than 0.05 mrem / hour.
The useful beam is shielded completely by the opposite arm of the inspection head.
QUALITY ASSURANCE AND CONTROL:
The device without radioactive source is manufactured by Krones, Inc., of Franklin, WI.
Industrial Services and Supply Cornpany,Inc., will be responsible for:
Determining if the device has been manufactured properly; Loading of the source at the licensce's facility; Performing tests for removable contamination; Verif ying proper operation of the shutter;
- Verifying proper operation of the device as a whole; and Performining an initial radiation survey of the device.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
0 A copy of the Checkmat 150 " Operations and Maintenance Manual," must be supplied by Industrial Services and Supply Company, Inc., prior to use.
(Manual will include: copy of General License, copy of pertinent state regulations, etc.)
l 0
l Loading of the Checkmat 150 with the radioactive source must be performed l
by Industrial Services and Supply Company, Inc.
O This device shall be received, acquired, owned, possessed, used, and transferred in accordance .with the general ~ license provisions of 1200-2 .10 of " State Regulations for Protection Against Radiation" or equivalent U.
S. Nuclear Regulatory Commission or Agreement State regulations.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: TN-391-D-101-G DATE: March 1,1985 PAGE: 5 of 5 DEVICE TYPE: Fill Level Gauge LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont.)
0 The device shall be leak tested at six month intervals using techniques capable of detecting .005 microcurie of removable contamination.
SAFETY ANALYSIS
SUMMARY
Based on our review of thes * ! acts and the information contained in the references cited below, we conclude the device design is acceptable for general licensing purposes. Furthermore, we conclude that the device is likely to retain containment of the radioactive contents under foreseeable conditions of use which might occur during uses specified in this certificate.
REFERENCES:
License application dated December 17, 1984, with attachments, (as amended January 14, 1985).
Letter dated February 4,1985 with attachments.
Letter dated February 1,1985 from Krones, Inc.
Krones Checkmat 150 Operation and Maintenance Manual ISSUING AGENCY: .
l Tennessee Division of Radiological Health DATE: N/[D -
REVIEWED BY: [). q '. t '
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3!I DATE: 8b CONCURRENCE: I
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
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SAFETY EVALUATION OF SOURCE NO: NR-470-S-101-5 DATE: SEP 27 24 PAGE 1 0F 5 SOURCE TYPE: Neutron Reference Source MODEL: C2106-AB00, C2106-AC00 DISTRIBUTOR: U.S. Department of the Navy Naval Electronics Systems Command Washington, DC 20360
- MANUFACTURER
- Monsanto Company
- Dayton Laboratories 1515 Nicholas Road P.O. Box 8, Station B l
ISOTOPE: MAXIMUM ACTIVITY:
i l \ Americium-241: BE 2.5 curies (C2106-AB00) 0.06 curies (C2106-AC00)
LEAK TEST FREQUENCY: 6 months l PRINCIPAL USE: (H) General Neutron Source applications CUSTOM SOURCE: x YES N0 1
U.S. DEPARTMENT OF THE NAVY 9
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE I
NO: NR-470-S-101-S DATE:
ggp g7 gggg PAGE 2 0F 5 DESCRIPTION:
The custom sources are doubly encapsulated and fabricated using 304 stainless steel. Each capsule is sealed by arc welding. The source is designed to allow attachment of a cable assembly. This allows the source to be drawn through a tube that passes by counting equipment on Naval ships. The technicians can determine if the counting equipment and related circurity is operating properly by using this method. The source is normally lockedlin the tube when not in use.
The source models C2106-AB00 and C2106-AC00 are similar in construction, the only difference being that the AB00 has 2.5 curies, the AC00 source has 0.06 curies and is assembled using Monsanto's new welding methodology.
LABELING:
, ,s The outer capsule is electro-etched with the radiation trefoil symbol, the
/ i words, " Caution Radioactive Material", the isotope and activity date, assay
\_,) and unique serial number.
DIAGRAM:
See Attachment I CONDITION OF NORMAL USE:
The source is used by trained personnel to stimulate counting equipment and to test the circurity and. operability of counting equipment aboard Naval ships. The source is normally protected from the severe environs pssociated with open sea travel.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE f NO: NR-470-S-101-S DATE: PAGE 3 0F 5 PROTOTYPE TESTING: '
The Navy reports the sources are very similar in construction as the Monsanto Model 2720 series source. The Monsanto ANSI classification for this source is 68E64525. The Navy source does not have an ANSI classification. However, the Navy reported the source design was subjected to the following conditions.
O Imersion in water 0 Imersion in air 0 Free dropped from a height of 30 feet 0 Impact tested during a 3 pound hammer from a height of 3 feet 0 Heat tested in 1475 F n EXTERNAL RADFRACTION LEVELS:
The Navy reports a total dose rate (gama + neutron) for a 0.06 curies source of:
Centimeter mrem /hr 5 =79 30 = 2.2 100 = 0.2 QUALITY ASSURANCE AND CONTROL:
A quality assurance program is not required for custom sources. They are to be built to the unique engineering specification of the user. However, the source manufacturer was a QA program that has been previously deemed i
acceptable for licensing purposes by the Nuclear Regulatory Comission.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE bp 'L *l b.
NO: NR-470-S-101-5 DATE: PAGE 4 0F 5 LIMITATION AND/0R OTHER CONSIDERATIONS OF USE:
0 The sources shall be distributed only to the specific licensee referred to in this document (US Department of the Navy) 0 The source shall be leak tested at 6 month intervals using techniques capable of detecting 0.005 microcurie of removable contaminations.
O Handling, storage, use, transfer, and disposal to be determine by the licensing authority.
O This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the Nuclear Regulatory Commission.
SAFETY ANALYSIS
SUMMARY
i O B ased on our review of the information and test data cited below, that the source is equivalent to the neutron source previously deemed acceptable for licensing, we conclude that the source design in this document are acceptable for custom licensing purposes.
Furthermore, we conclude that the sources would be expected to maintain their containment integrity for nonnal conditions of uses as specified in this certificate.
REFERENCES:
l The following supporting documents for the source design are hereby incorporated l by reference and are made a part of this registry document.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES ii SAFETY EVALUATION OF SOURCE v'/
NO: NR-470-S-101-S DATE:
g@M PAGE 5 0F 5 REFERENCE (Cont'd):
U.S. Department of the Navy letters dated September 2,1982, October 7,1981 and June 14, 1984 with enclosures thereto ISSUING AGENCY:
U.S. Nuclear Regulatory Comission Da te: Reviewer:
Date: Concurrence:
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE G
NO: NR-476-5-145-S DATE: PAGE 1 0F F 5 OCT 181982 DEVICE TYPE: Beta Source MODEL: NER-8180 MANUFACT'JRER/ DISTRIBUTOR: New England Nuclear Company 601 Treble Cove Road North Billerica, MA 01862 MANUFACTURER / DISTRIBUTOR:
ISOTOPE: Krypton-85 MAXIMUM ACTIVITY: 1150 millicuries MAK TEST FREQUENCY: Not Required PRINCIPAL USE_: (E) Beta Gauging CUSTOM DEVICE: YES X NO S
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I i.. l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
, SAFETY EVALUATION OF SEALED SOURCE f %.
f NO: NR-476-S-145-S DATE: OCT 181982 PAGE 2 0F 5 DEVICE TYPE: Beta Source l
DESCRIPTION The source capsule is made of commercial pure titanium and is 3.4" long x 0.37" wide x 0.27" high ano weighs approximately 20 grams. The active cavity for the Kryoton-85 gas is 1 1/2" long by 1/8" wide with a volume of 0.45 cc. The front of the source is covered by a 2 mil. thick titanium window welded in place. The Krypton-85 gas is
, introduced ir...' '.he source cavity via a copper fill tube which is vacuum brazed to the back of the source. When filled with gas, the fill tube is crimped shut and dip soldered to effect a seal (see diagram).
LABELING:
Each source is engraved with "KR-85." the millicuries, serial number and the month / year.
a addi A f c:.9: source is shipped with a final data package which includes "Certi-ficate nf Se3V4 Soui ce bl.1, '%diation Safety and Instructions Sheet," and a
.... ...ir.;:i eta sheet reporting: (a) capsule content activity value in curies, (b) beta esdssion ia by. M rrypov Z a.a o ichment used and. (d) caosule internal specific w- . : n., w r
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. :. REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE
['T D') N_0: NR-476-5-145-S _DATE: M 3 0F 5 OCT 181982 l
DEVICE TYPE: Beta Source CONDITIONS OF NORMAL USE:
The tiodel NER-8180 Krypton-85 source is intended for use in industrial beta gauging applications wherein it will be secured in a shielded and shuttered holder bearing required identification and warning labels. It is not expected to be subjected to temperatures above 70*C or an external pressure greater than 30 osia.
PROTOTYPE TESTI M:
Two prototyoe sources were tested by New England Nuclear and the reported environ-mental testing results of the NER-8180 line source indicates qualification 6 pursuant to ANSI N542-1977 requirements for performance classification 77C33322.
EXTERNAL RADIATION LEVELS: NER -8100 SOURCE 9 \
CONTACT: 330 R/HR/ MCI.
, 2BQ/HR/ MCI.
+ rl, '
is 0.14R/HR/MCl.
I 30CM.
i S CM.
IC MR/HR/Mcl. L i
(ELCKSCATTEE.Eb DISTANCE FROM SOURCE +
RAblATION) -
BETA RADIATION SURVEY MER-8180 SOURC5 b
CohlTACTs I.9 R/HR/MCl, ri Es
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50 MR/HR/
. n MCI. 0.9MR,/HR/ MCI.
ll Lt 6 CM. 30 cy, D\ TANCE FROM SOURCE ----+-
0.5 MR/RR/ MCI. _ ,
G AMMA RAbtATION SURVEY '
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE I
DATE: g i g 1982 PAGE 4 0F 5 N_0 : NR-476-5-145-S DEVICE TYPE: Beta Source
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EXTERNAL RADIATION LEVELS (Cont'd);
NOTES _
- l. Beta radiation dose rates are measured with a survey meter thru an aluminized mvlar window which is less than 7 mg/cm2 thick.
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- 2. Gamma radiation dose rateg are measured with a survey meter thru a plastic window which is 500 mg/cm thick and filters all the beta radiation.
- 3. The survey meter is calibrated to + 15% and the test sources contain s 5 mci Kr-85.
HUALITY ASSURANCE AND CONTROL:
New England Nuclear has described an acceptable quality assurance program consisting of the following basic components:
Design control Procurement control
- Process quality control including (intent activity measurement, contamination / leakage testing, physical dimensions, and v.'sual inspection.
- Final acceptance and records LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
i A. This source shall be distributed only to specific licensees of the NRC or Agreement l States.
B. Handling, storage, use, transfer, and disposal: To be determined by the licensing authority.
C. This source shall not be subjected to environmental or other conditions of use which exceed the American National Standards Institute (ANSI N542-1977) Classi '
! fication of 77C33322.
D. This source shall be used and/or stored in devices and/or shields which are labeled in accordance with the requirements of Section 20.203,10 CFR 20 or
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q equivalent Agreement State regulations.
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.' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE
>b M: NR-476-5-145-S DATE: OCT 181982 PAGE 5 0F 5 DEVICE TYPE: Beta Source SAFETY
SUMMARY
EVALUATION:
Based on the prototype tests, the claimed ANSI source classification and the stated quality assurance and control program to be carried out by the manufacturer, it is our conclusion that the Model NER-1880 source is acceptable for licensing purposes.
Furthemore, when used in properly designed shielded and shuttered holders by specific licensees who are reouired to train and equip their personnel to safely handle and mount the sources and guard against the high beta radiation exposure, it appears unlikely that persons would be exposed to limits in excess of those specified in 10 CFR 20.
REFERENCES:
The following supporting documents for the Model NER-8180 beta radiation line source are hereby incorporated by reference and are made a part of this registry document:
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- New England Nuclear Corporation letters with attachments dated November 13, 1981 l
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- and October 5, 1982.
Supersede NRC registry document dated January 29, 1982.
ISSUING AGENCY-U.S. Nuclear Regulatory Commission OCT 181982 Date: _ Reviewer: _ 6[f_ _ /d. [ht > ,
OCT 1 81982 .
Date: __
Concurrenc : ,,_ _ _ _ _ [ _ _ _h O
v
O. REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE
/
NO: NR-476-S-150-S DATE:
gg g g PAGE 1 0F 4 SOURCE TYPE: Beta Gas Source MODEL: NER-588 MANUFACTURER / DISTRIBUTOR: New England Nuclear A DuPont Company 331 Trouble Road North Billerica, MA 01862 ISOTOPE: Maximum Activity:
Krypton-85 2500 mil 11 curies
\
LEAK TEST FREQUENCY: Not Required PRINCIPAL USE: (E) Beta Gauges CUSTOM SOURCE: YES X NO e
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF SOURCE N
J NO: NR-476-S-150-S DATE: g PAGE 2 0F 4 SOURCE TYPE: Beta Gas Source DESCRIPTION:
The New England Nuclear Model NER-588 is a krypton-85 source used in industrial beta gauging applications. The krypton gas is introduced into the capsule by way of a copper filled tube. This is crimped and soldered sealed. The capsule has dimensions of 3" X .75" width X 0.77" height and has a 2 mil titanium window.
The capsule is then affixed to a back cover with two drive back screws. This forms the Model NER-588 source.
LABELING:
The source back plate is engraved with the isotope and activity. Space limitation prevents any further labeling. Each source is shipped with a data package which contains other pertinent information.
DIAGRAM:
Q See Attachment 1.
CONDITIONS OF NORMAL USE:
The NER-588 source is employed as a krypton-85 beta gauging source for use in gauging devices that measure the thickness of thin films of paper, plastic or metal.
PROTOTYPE TESTING:
The manufacturer reported that the source has been tested and achieved an ANSI N542 classification of 77C33322.
EXTERNAL RADIATION LEVELS:
The manufacturer reports the following dose rates at various positions and distances:
In Front of Source In Back of Source 5 cm 28050 mR/hr/ mci 5 cm .412 mR/hr/ mci 30 cm 141 mR/hr/mC1 30 cm .0114 mR/hr/ mci 100 cm 70.125 mR/hr/ mci 100 cm .00103 mR/hr/mC1 O
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l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE p ,
NR-476-5-150-S DATE: SEP 24 PAGE 3 0F 4 M: .
SOURCE TYPE: Beta Gas Source QUALITY ASSURANCE AND CONTROL:
The manufacturers quality assurance program provides package verification and test verification for the following critical tests:
- Content activity measurement by beta emission comparison to a reference source.
- Contamination / leakage testing.
- Physical dimensions as specified in the assernbly.
- Visual defects resulting from damage to source capsule during assembly.
Quality assurance shall also provide final item acceptance of each NER-588 source and record deposition and acceptance logs, product data package and v source certificate.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The New England Nuclear Model NER-588 source shall be distributed only to persons specifically licensed by the NRC o. an Agreement State,........
- Han..".ing, storage, use, transfer, and disposal: to be determined by the licensing authority.
- These sources shall not be subjected to environmental or other conditions of use which exceed ANSI N542 Classification 77C33322.
- This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF SOURCE
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NO: NR-476-5-150-S DATE: SEP 4W PAGE 4 0F 4 SOURCE TYPE: Beta Gas Source SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data sited below, the claimed ANSI classification, we conclude that the Model NER-588 source design is acceptable for licensing purposes. Furthermore, we conclude that this source shall be expected to maintain its containment integrity for normal conditions of use'and accidental conditions which might occur during uses specified in i
this certificate.
l
REFERENCES:
The following supporting documents for the New England Nuclear Source l Model NER-588 is hereby incorporated by reference and is made a part of this registry document.
- New England Nuclear Letter of application dated June 12, 1984.
OV ISSUING AGENCY:
U.S. Nuclear Regulatory Commission DATE: REVIEWER:
DATE: CONCURRENCE: <.. , i' <! - '
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
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SAFETY EVALUATION OF SOURCE (ATTACHMENT 1) ,
U' N,0,:NR-476-S-la0-5 DATE: PAGE EP 24 . gg OF T211R-C CAPSt1.E sw :
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'w) REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO. NR-476-S-151-S DATE: JM M y PAGE 1 0F 5 SOURCE TYPE: Beta Ionization Ring Source i
MODEL: NER-004R MANUFACTURER / DISTRIBUTOR: NEN Products 331 Treble Cove Road No. Billerica, MA 01862 ISOTOPE: MAXIMUM ACTIVITY:
Nickel-63 15 mil 11 curies LEAK TEST FREQUENCY: 6 months
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w PRINCIPAL USE: (N) Ionization Generators, Chromatography CUSTOM SOURCE: YES X NO
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t REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES P SAFETY EVALUATION OF SOURCE
< l J NO. NR-476-5-151-S DATE: 8th I b .', PAGE 2 0F 5 SOURCE TYPE: Beta Ionization Ring Source DESCRIPTION:
This source design is similar in methodology of construction to the ,
Model NER-004. The only exception to this is that the NER-004R is I electroplated on both the inner and external surface of the brass ring. That is to say the radioactive Nickel-63 is electroplated onto the entire surfaces I of the brass cylindrical ring. The brass cylinder consists of 70% copper and 30% zinc. The cylinder has a length of 7.70 millimeters, a diameter of 7.0 millimeters, and a wall thickness of 0.15 millimeters. For more information on the Source Model NER-004 consult Registry Sheet '
NR-476-S-131-U.
- LABELING: 4 The manufacturer reports that it is impractical to label the brass ring.
Therefore, information as to the loading, the testing that was done on the
/,') source, and the handling procedures are provided as a separate attachment to
() the shipping papers.
DIAGRAM:
See Attachment 1.
CONDITIONS OF NORMAL USE:
The manufacturer reports that the ring source is intended for use in an air ionization source in a portable chemical agent monitor. The source is secured I
in the instrument probe assembly. The intended operational temperature range of the ring source is -55 C to 70 C. Also the source is to be used at ambient pressures and be exposed to air with varying degrees of humidity. Other applications of a research and development nature are acceptable provided the sources are not subjected to environmental conditions which exceed those listed in the following prototype testing section. .
4
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..h REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES 9 SAFETY EVALUATION OF SOURCE NO. NR-476-S-151-S DATE: g ; , .. ..,,
PAGE 3 0F 5 SOURCE TYPE: Beta Ionization Ring Source PROTOTYPE TESTING:
The manufacturer reports that prototype ring sources were subjected to four environmental tests which meet or exceed the recommended operation and conditions of the source / instrument assembly.
- Methanol leech test--The source rings were individually placed in a 10 mi methanol solution for a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. The amounts of activity found in the solution by a liquid scintillation counting measurement were less than 5 microcuries.
- Water leech test--Source rings were then individually placed in a 10 ml water solution for a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. The amounts of activity found in the solutions by liquid scintillation counting measurements were less than 5 microcuries.
9 Heat test--The source rings were placcd in a Pyrex tube and heated to 250 C for 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> in air. The rings were removed from the oven and allowed to reach ambient temperature. The rings were viewed under 30X magnification and slight oxidization to the ring was observed. The smear test results of the rings each yielded less than 0.1 microcurie. Both pre and post heating conditions were tested. -
- Cold test--The ring sources were individually placed in a dry ice
, bath for a period of 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. The rings were removed from the bath and allowed to reach ambient temperature. The rings were viewed under 30X magnification and no damage to the rings was observed.
The smear test results of the rings each yielded less than 0.5 microcurie after the test.
The above source testing criteria are very similar to the Model NER-004 which has been in use for several years with no reported problems.
EXTERNAL RADIATION LEVELS:
The following are measured dose rates submitted by the manufacturer for the ring source at various distances.
4
s REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO. NR-476-S-151-S DATE: 3EN 3 -
PAGE 4 0F'S SOURCE TYPE: Beta Ionization Ring Source On contact with the source surface--25 R/hr beta.
5 cm from source surface--10 R/hr beta.
30 cm from source surface--Background.
QUALITY ASSURANCE AND CONTROL:
The manufacturer has submitted an acceptable quality control program. This program consists of design controls, procurement controls, process quality controls, and final acceptance inspection and testing.
LIMITATIONS AND OTHER CONSIDERATIONS OF USE:
The source shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
The source shall be leak tested at 6-month intervals using techniques capable of detecting 0.5 microcurie of removable contamination.
Handling, storage, use, transfer and disposal: To be determined by the licensing authority.
This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
e Devices containing this source shall be properly evaluated by the NRC or an Agreement State prior to distribution in i
the comercial market.
e The source shall not be subjected to environmental or other conditions of use which exceed the prototype test criterion specified in this document.
4
.Y REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO. NR-476-S-151-S DATE:
D PAGE 5 0F 5
,, SOURCE TYPE: Beta Ionization Ring Sou :e f .
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, that the testing done on this device is very similar to a previously deemed acceptable model, we can conclude that the Model NER-004R source design is acceptable for licensing purposes.
Furthermore we conclude that this source design will be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model NER-004R are hereby incorporated by reference and are made a part of this registry document.
- NEN Products letter dated October 1, 1984, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear,, Regulatory Commission Date: Reviewer:
Date: J4l U - Concurrence: ik 4 L t
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(3 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE NO. NR-476-5-152-S DATE: gyy g PAGE 1 0F 4 SOURCE TYPE: Photon Disc Source MODEL: NER-474 MANUFACTURER / DISTRIBUTOR: NEN Products 331 Treble Cove Road No. Billerica, MA 01862 ISOTOPE: MAXIMUM ACTIVITY:
Barium-133 50 mil 11 curies LEAK TEST FREQUENCY: 6 months kJ PRINCIPAL USE: (U7 X-RAY FLUORESCENCE CUSTOM SOURCE: YES X N0 i
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~f REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVIC SAFETY EVALUATION OF SOURCE wY i
NO. NR-476-5-152-S DATE:
PAGE 2 0F 4 SOURCE TYPE:
Ju 1119ES Photon Disc Source DESCRIPTION:
The source chloride. matrix consists of Barium-133 as a vitreous ceram insert and fused to the insert to form a ceramic glaze.The mate is uniformly insert deposited on glass fibers in the recess of the stainless steelThe bariu and dried.
fitted into the capsule and T.I.G welded to form the source.The inse 7.9 mm diameter, a 5.1 mm length, and a window thickness of 0.25 mm.The source
. LABELING:
The manufacturer reports the capsule is engraved with the following:
Ba-133.
S/N.
a
- The number of millicuries.
The date, month / year.
DIAGRAM:
See Attachment 1.
l CONDITIONS OF NORMAL USE:
According to the manufacturer, the NER-474 source capsule is designed for applications requiring the emission of gamma photons and X rays. The sources i are intended for use in such applications as fluorescence exciters in non-dispe
! sive X ray fluorescence analyzers of both the fixed station and portable types, gamma sources for thin section and low density thickness gauging systems and densitometers of transmission and backscatter type.
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I R'EGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE
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NO. NR-476-5-152-S DATE: % ] y jggg PAGE 3 0F 4 SOURCE TYPE': Photon Disc Source PROTOTYPE TESTING:
The manufacturer reports that the source uses the same capsule design as the previously approved Models NER-478C and NER-478H. Therefore, the manufacturer reports that the Model NER-474 source design would be expected to meet an ANSI N542-1977 performance classification of C64444.
Additionally, the manufacturer reports that the source was tested to the re,quirements of 10CFR71.77 and has achieved "Special Form" designation.
EXTERNAL RADIATION LEVELS:
See Attachment 2 LJ QUALITY ASSURANCE AND CONTROL: -
According to the manufacturer, capsule configuration control should be maintained by the product design section pursuant to the design control specifications. The design control section maintains control over procurement procedures, capsule component procedures, and incoming inspections on components. The product design section also provides final acceptance of each model source prior to distribution and documentation is sent with each sealed source certifying that it meets acceptable leak test criteria.
l LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The source shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
- - The source shall be leak tested at 6-month intervals using techniques capable of detecting 0.005 microcurie of removable
. contamination.
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- Handling, storage, use, transfer, and disposal: To be determined.by a licensing authority. .
-- -.. - - ~ . - . - - . - . - - -
d REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES lI SAFETY EVALUATION OF SOURCE NO. NR-476-S-152-S DATE:
$2 y yggg PAGE 4 0F 4 SOURCE TYPE: Photon Disk Source
- The source shall not be subjected to environmental or other conditions of use which exceed ANSI classification of 77C64444.
- This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, the claimed ANSI classification, we conclude that the Model NER-474 source design is acceptable for licensing purposes.
Furthermore, we conclude that the source will be expected to maintain its containment integrity for normal conditions of use and accidental conditions which might occur during the uses specified in this certificate.
REFERENCES:
The following supporting documents for the Model NER-474 source design is hereby incorporated by reference and is made a part of this registration document.
- NEN products letter dated July 17, 1984, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: Reviewer: 7 Date: Concurrence: bMb '
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I JAN 111985 ATTACHMENT 1 l
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The manufacturer reports the following dose rates:
_ Dose Rate Report 9
. NER 474 SOURG CONTACT DOSE 1%TE 300 MR/HR/ MCI 75 hfMR/
t MCI 3.5 MR/HR/ MCI
/f 8
5 CM )) -
I 30 CM DISTANCE FROM SOURE +
- 0,5 MR/HR/ MCI -
NOTES
- 1. The observed dose rates are measured with a survey meter thru an aluminized mylar window (sImg/cm2 thigk) and into a 6" long barrel. The meter is calibrated to - 15%. The test source contains 4 mci Ba-133.
- 2. The reported dose rates on contact, at 5 cm., and at 30 cm are calculated from the observed data correcting for distance and geometry of a planar source.
3 The reported dose rates are the maximum for the capsule design. Lower dose rates per mil 11 curie are expected with higher loading due to self-absorption. .
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-S DATE: PAGE 1 of 5 APR 0 41955 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)
MODEL: SPSHAXXX (XXX indicates the unit has been wired for 110 V AC or 220 V AC)
MANUFACTURER / DISTRIBUTOR: Osteon, Inc.
P.O. Box 430 649 California Avenue Wahiawa, HI 96786 SEALED SOURCE MODEL DESIGNATION: AECL Source Model Number C-235, in a Model C-236 source holder ISOTOPE: MAXIMUM ACTIVITY:
Iodine-125 800 millicuries LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use -
CUSTOM DEVICE YES X N0 l
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-S DATE: APR0 41985 PAGE 2 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)
DESCRIPTION:
The Osteo-Analyzer is a three axis scanning bone densitometer, using an AECL Mo. C-235 I-125 source in a C-236 holder. The Osteo-Analyzer is fabricated entirely of machine aluminum and stainless steel, with ball bearings and stain-less steel shafts used for major bearing surfaces.
The C-236 source holder is held in the lockable source compartment of the yolk, a welded aluminum piece that maintains proper orientation with the detector during all motion. The source is screwed to position in the source compartment, then locked in place with a locking cover to present loss or unauthorized .
removal of the source.
The shutter blocks the exit beam during all times that scanning is not being performed. The shutter is designed to close automatically upon loss of power to the scanner.
LABELING:
The C-236 source holder manufacturer by AECL is engraved with the manufacturer,
- isotope, source holder model, and source serial number.
The Osteo-Analyzer will have a warning label on the outside of the case. The source compartment will be marked with the standard warning symbol and the words " Caution-Radioactive Material." The beam direction will also be shown on the yolk. (See Attachment No. 1.)
DIAGRAM:
5ee attachments 2,'t . and 4.
CONDITIONS OF NORMAL USE:
The Osteo-Analyzer will be used by physicians or hospitals under a specific license issued by NRC or Agreement State for the device. The analyzer will be secured in the office or room used for the storage and use of the analyzer.
Under normal conditions, the user will not need to remove the cover to the analyzer, except to change sources. The sources are expected to last 60-90 days before replacement is necessary.
A
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-S DATE: SPh 0 4 ;g3 PAGE 3 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer) -
PROTOTYPE TESTING:
The manufacturer did not test the device, rather, they relied on data submitted on each electronic part and its use to make a determination that the device would operate under the given conditions of use. Additionally, the sources were tested by the source manufacturer to the requirements of ANSI N542 and received the classification of 77C34334. The source holder is constructed of lead-lined stainless steel. This would further protect the source during normal and acci-dental conditions associated with the use of the device.
EXTERNAL RADIATION LEVELS:
The time period necessary for the patient to receive a dose of 10 mR is about 3 seconds at any one location, based on the calculated dose rate to the skin of 3.8 Rem /Sec. Since the beam is tightly collimated to 3 mm and is constantly moving, only a portion of the skin is exposed at any one time.
With the 800 mci source, the scan speed is 4 mm/Sec, resulting in an exposure period to any portion of the skin of 0.75 Sec. Such an exposure period will result in an exposure to the skin of 2.85 mrem. Ostean reports that a dose rate of .001 mR/hr is obtained on any surface of the analyzer with the shutter closed, and reported 1 mR/hr at 3 cm from the device gith the shutter open.
f OUALITY ASSURANCE AND CONTROL:
The following items will be tested for proper operation on every unit:
- Operation of shutter mechanism, including fail-safe provision in i case of power failure. ,
- Fit of source holder (C-236) to source compartment and fit of locking cover over source.
- Source-on indication or computer display when the source is;actually on. i I
The checks shall be part of a final test /QC program developed for testing the l Osteo-Analyzer results on the tests shall be documented for each unit.
l Checks for removable contamination will be made on each unit before shipment l to the user. The check will be capable of detecting 0.005 microcurie of l removable contamination. ,
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-S DATE: 00 4 1983 PAGE 4 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
a The Osteo-Analyzer scanning bone densitometer shall be distributed only to persons specifically licensed by the NRC or an Agreement State.
- The device shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
- The device shall be installed and initially tested for proper operation of the source exposure mechanism, safety warning mechanism, safety warning components, labels, external radiation levels (source exposed, source shielded) and leak tested by Ostean, Inc., or other persons specifically licensed by the NRC or an Agreement State.
- Reviewer Note: Ostean recok. mends the user remove and install the source in the source holder only. However, the user may request authorization to install the source in the source holder.
- This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Basec on our review of the information and test data cited below, the device is equivalent to those previously deemed acceptable for licensing, we conclude that the Model SPSHAXXX Osteon bone mineral analyzer design is acceptable for -
licensing purposes.
Furthermore, we conclude that this device should be accepted to maintain its 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 bone mineral analyzer (Osteo-Analyzer) are hereby incorporated by reference and are made a part of this registry document:
- Osteon, Inc. letters dated on January 19, 1985, and February 20, 1985.
l
REGISTR) 0F RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-5 DATE: .... 'j ig PAGE 5 of 5 DEVICE TYPE: Bone Mineral Analyzer (Osteo-Analyzer)
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
- APR0 4 gggg ,,,-
DATE: REVIEWER: -
DATE:
4 7935 CONCURRENCE: L.,,4. )f/. [ e *
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- $ p "5 of 800 mci of I-125. The maximum skin entrance dose rate in the primary Eg beam path is less than 2.5 mR/second.
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THIS LABEL MUST NOT BE REMOVED.
SE " CAUTION: Federal low restricts this Ei device for use by or on the order of a physician.
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CAPSUL E. ASSEMBLY THIS ASSEMBLY CAN BE USED WITH, CAPSULE HOLDEFC236
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l SECTION SCALE 2:1 C- 236 10' DINE l'25 CAPSULE HOLDER
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8 SERIAL No
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: NR-525-D-101-5 DATE: APR0 4 gg f
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]L .. M _ ]._ p, Collimator v
Beam Direction v .
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, i. N Arm or Heel Tube i
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Lead Detector i;
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Co'limator Detector Preemp
@ steon INCORPORATED Model: SPSHAXXX l
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended in Entirety)
/
NO: NR-616-D-101-E DRE: JAN 2 3 1985 PAGE 10F 1 DEVICE TYPE: . , _
Ionization Smoke Detector 3 MODEL: EGD 4 and 5 Series 7 MANUFACTURER / DISTRIBUTOR: Square D Company Electrical Equipment' P.0 Box 4000 Pinelas Park, FL 33565 MANUFACTURER / DISTRIBUTOR:
SEALED SOURCE MODEL DESIGNATIONi Foil so0rces, NRD M0 del A-001 or Amersham Model AMM-100lH IS0 TOPE: Americium-241 MAXIMUM ACTIVITY: 1 microcurie 4
LEArs TEST FREQUENCY: Not required PRINCIPAL USE: (P) Ion Generators, Smoke Detectors CUSTOM DEVICE: YES X NO DEVICE TYP_E: E Ionization Smoke Detector ISSUING AGENCY: U. S. Nuclear Regulatory Commission Date: l "J3 95 Reviewer: M AV 4 /
Date: ' 5 Concurrence:
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