IA-86-351, Package of Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Sealed Source
| ML20203G194 | |
| Person / Time | |
|---|---|
| Issue date: | 10/09/1981 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20203G192 | List: |
| References | |
| FOIA-86-351 NUDOCS 8608010021 | |
| Download: ML20203G194 (19) | |
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' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR1365206S DATE: October 09, 1981 PAGE 1 0F 5 SEALED SOURCE TYPE: Low Energy Photon Source 110 DEL: GDC.CY1
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MANUFACTURER / DISTRIBUTOR: Amersham Corporation 2636 S.' Clearbrook Drive Arlington Heights, IL 60005 MANUFACTURER / DISTRIBUTOR:
ISOTOPE: Gadolinium-153 MAXIMUM ACTIVITY: 3 curies k
LEAK TEST FRE00ENCY: 6 months PRINCIPAL USE: Gamma Gauges LUSTOM SOURCE: YES X NO k
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( REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR1365206S DATE: October 09, 1981 PAGE 2 0F 5 SEALED SOURCE TYPE: Low Energy Photon Source DESCRIPTION:
The Amersham Corporation Model GbC.CY1 sealed source consists of gadolinium-153 as gadolinium oxide pressed into a cylindrical pellet. This pellet is then encapsulated in a titanium capsule and sealed by autcgenous tungsten inert gas welding as per the following diagram. The activity of the finished source is measured using a Si(Li) detector calibrated against a calibrated secondary americium-241 standard. The chemical purity (Ci/ gram) will be supplied by Oak Ridge National Laboratory.
LABELING:
The sources are engraved as follows:
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- 1. Serial number
- 2. Chemical symbol and mass number of the radionuclide, i.e. , Gd-153
- 3. Nominal activity 4 Manufacturer's name (Ali
- 5. The word " Radioactive
- 6. Year of manufacture All sources are accompanied by a test report giving leak and measurement test data and dates and by unpacking and handling instructions.
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(' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE l
i fiO.: NR136S206S DATE: October 09, 1981 PAGE 3 0F 5 SEALED SOURCE TYPE: Low Energy Photon Source DIAGRAft:
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The model GDC.CY1 sealed source is designed primarily for use iii bone mineral analysis. The source in normal use is not expected to be subjected to excessive extremes of temperature, physical shock or to corrosive environments.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE !
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NO.: HR136520SS DATE[: October 09, 1981 PAGE 4 0F 5 SEALED SOURCE TYPE: Low Energy Photon Source PROTOTYPE TESTIN,G:
Two simulated prototype sources having a pressed pellet of aluminum powder with 10 uCi of soluble cesium chloride on the surface were tested in accordance with recommendations cf the American National Standard Institute (ANSI) N542-1977 by the immersion and vacuum bubble leak test method. Based on these prototype tests, the claimed ANSI rating of the source design is C.44333. l EXTERNAL RADIATION LEVELS:
Dose rate values for the source loaded with two curies of gadolinium-153 assuming a specific activity of 100 curie /gm were calculated by the manufacturer as follows:
({. 25 cm 1 meter Front 1.65 R/ hour 103 mR/ hour Back 100 mR/ hour 6 mR/ hour Side 365'mR/ hour 23 mR/ hour QUALITY ASSURANCE AND CONTROL:
All components are inspected to ensure compliance with drawings. l Gadolinium-153 purity (curies / gram) is certified by Oak Ridge National Laboratory.
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The finished source is bubble, wipe, and immersion tested to ensure leakage is less than 0.005 uCi.
The activity of the finished source is measured using a Si(L1) detector calibrated against a secondary americium-241 standard.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
A. This source shall be distributed to specific licensees of the NRC or Agreement States other than licensees specifically licensed pursuant to 635.14, 10 CFR 35 or equivalent Agreement State regulations. Distribution of the source to persons licensed pursuant to 935.14,10 CFR 35 and 935.100-(f) Group VI is prohibited, k
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REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR13652065 DATE: October 09, 1981 PAGE 5 0F 5 SEALED SOURCE TYPE: Low Energy Photon Source LIMITATIONS AND/0R 0THER CONSIDERATIONS OF USE (CONT'D): !
B. T.his source shall not be subjected to environmental or other conditions of use which exceed ANSI Classification,77C44333 (ANSI N542-1977).
C. Leak Testing: To be performed at six month intervals using techniques approved by the licensing authority and capable of detecting the presence of 0.005 microcurie of activity. -
D. Handling, Use, Storage, Transfer _and Disposal: To be determined by the licensing authority.
SAFETY ANALYSIS
SUMMARY
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Based on the information and test data contained in the references listed below, we conclude that the Amersham Corporation Model GDC.CY1 sealed source design is acceptable for licensing purposes in accordance with the provisions of this registration document. Furthermore we conclude that this source would be expected to maintain its containment integrity for the specified conditions of normal use, including such accident conditions that might be applicable to these conditions.
REFERENCES:
The following supporting documents for the Model GDC.CY1 sealed source design are ;
hereby incorporated by reference and are made a part of this registry document. '
Application dated August 17, 1981 and attachments thereto.
Letter dated October 2,1981.
Date October 9, 1981 Reviewed By /s/
Joseph M. Brown, Jr.
Date October 9, 1981 Concurrence /s/
Bernard Singer ISSUING AGENCY:
k' U.S. Nuclear Regulatory Commission
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE i (AMENDED IN ITS ENTIRETY)
NO: NR-476-S-153-S DATE: FES S6 g PAGE: 2 of 4 SOURCE TYPE: B. A. Photon Source s
DESCRIPTION:
The New England Nuclear Models NER-430 a'nd NER-431 bone mineral analyzer photon sources consist cf gadolinium-153 as a gadolinium trioxide compound (GD2 0 3 ) in the form of a compressed pellet placed in the bottom of the single capsule body. With spacer and cap inserted into the capsule body, the top is sealed with T. I. G. weld. The assembled size, of both the NER-430 and NER-431, is
.225 inches in diameter and .885 inches in length. The NER-430 was constructed of 1100 aluminum and weighs 1.5 gm and as for the NER-431, it is constructed of 316 or 316L stainless steel and weighs 4.5 gm. Starting with Serial Number
[. G-250 the NER-430 will be constructed of titanium and weighs 2.4 grans all
( other capsule specifications remain the same. Source Serial Number G-227 is also constructed of titanium.
LABELING:
Models NER-430 and NER-431 sources are engraved with the isotope, activity, assay date and a unique serial number. The manufacturer reports that the source storage and shipping container is labeled to meet all regulatory requirements.
DIAGRAM:
(See Attachment 1)
CONDITIONS OF NORMAL USE:
The models NER-430 and NER-431 gadolinium-153 radiation sources are components of bone mineral content analyzer wherein it will be secured in a shielded and shuttered holder bearing appropriate identification and warning labels.
Other applications of a research and development nature are acceptable provided I the sources are not subjected to environmental conditions which exceed its ANSI
[\ N542-1977 performance c't.ssification C32312. The manufacturer reports the useful life of the source to be 3 years.
4 REGI5TRYOFRADI0ACTIVESEALEDSOURCESANDDEVICkS '
SAFETY EVALUATION OF SOURCE '
(AMENDED IN ITS ENTIRETY)
N0: NR-476-5-153-S DATE: PAGE: 3 of 4 ._
SOURCE TYPE: B. A. Photon Source PROTOTYPE TESTING:
The manufacturer administered two alumium capsules and two stainless steel capsules and two titanium capsules to test as prescribed by ANSI N542-1977.
The testing report of the NER-430 and NER-431 GD-153 bone mineral analyzer photon source indicate qualification of the capsule design pursuant to ANSI N542-1977 requirements for Performance Classification 77C32312.
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EXTERNAL RADIATION LEVELS:
External radiation dose rate was calculated to be:
Titanium or Aluminum Capsule NER-430 Stainless Steel Capsule NER-431 3.0 mR/hr/ mci at 5 cm 2.0 mR/hr/ mci at 5 cm 0.1 mR/hr/ mci at 30 cm 0.07 mR/hr/ mci at 30 cm QUALITY ASSURANCE AND CONTROL:
The manufacturer has previously provided an acceptable quality control program.
This program has been deemed acceptable for licensing purposes by the NRC.
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE:
The New England Nuclear i4odels NER-430 and NER-431 sources shall be
- distributer', only to persons specifically licensed by the NRC or an l
Agreement State.
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- Sources shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 microcurie of removable contamination.
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t' l REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE (AMENDED IN ITS ENTIRETY)
N0: NR-476-5-153-S DATE: PAGE: 4 of 4 SOURCE TYPE: B. A. Photon Source
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LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE: (Continued)
These sources shall not be subjected to environmental or other .
conditions af use which exceed ANSI Classification 77C32312.
This registration sheet and the information contained with the references shall not be changed or transferred without the written consent of the NRC.
- e. SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, that this amendment changes the construction material of the NER-430 from aluminum to titanium, and the claimed ANSI classification, we continue to conclude that the Models NER-430 and NER-431 sealed source designs are acceptable for licensing purposes. Furthermore, we conclude that these sources would be expected 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 New England Nuclear Models NER-430 and NER-431 are hereby incorporated by reference and are made a part of this registry document. .
Dupont, Inc. letters dated February 13, 1985, April 5, 1985 and December 11, 1985 enclosure thereto.
Supersedes registration sheet NR-476-S-153-S dated May 7, 1984.
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U.S. Nuclear Regulatory Comission , f yfA DATE: // ' NT , REVIEWER:_J - i' f NE
(_ DATE: CONCURRENCE:
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l' REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SOURCE i l
(AMENDED IN ITS ENTIRETY)
NO: NR-476-S-153-5 DATE: ATTACHMENT:
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eiLLanicA. MASSACMUSETTS Gd 153 'FtOTOl4 SOURCE NCN 84XEL CAPSAE E pet. 430 uoo AWMNUM nut O 36 OR 36. W SL ILG. wCD.
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NO: NR-476-S-153-S DATE: PAGE: 1 of 4 FD 8 0 m SOURCE TYPE: B. A. Photon Source A
MODEL: NER-430, NER-431 MANUFACTURER / DISTRIBUTOR: New England Nuclear 331 Trebble Cove Road No. Billerica, MA 01862 ISOTOPE: MAXIMUM ACTIVITY:
Gadolinium-153 2.0 curies LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: (V) General Medical Use CUSTOM SOURCE: YES X_NO
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES 1
SAFETY EVALUATION OF SEALED SOURCES (CORRECTEDPAGE-3/24/86)
N_0: NH185S10lS DATE: March [ 1986 PAGE 1 0F 3 SEALED SOURCE h/PE: Medical Radiography Source MODEL: OS-213A MANUFACTURER: Gammatron, Inc.
P.O. Box 34042 Houston, Texas 77034 .
DISTRIBUTOR: Biosources, LTD.
Four Bud Way, Suite Four Nashua, New Hampshire 03063
.'- ISOTOPE: Gd-153 MAXIMUM ACTIVITY: 2.0 Ci.
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: Medical Radiography (B)
CUSTOM SOURCE: YES X No CUSTOM USER:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES s
jp: NH185S10lS DATE: March 3, 1986 PAGE 2 of 3 SEALED SOURCE TYPE: Medical Radiography Source DESCRIPTION: The Model OS-213A is a sealed source containing a pressed pellet of the oxide of Gd-153. The sealed source capsule is made of Class 1100 pure alurrinum. Th'e Gd-153 pellet is positioned on one end of -
the capsule by a hardened aluminum alloy spacer. W e source " window" is about 0.025 inches thick and the side wall is 0.05 inches thick. We Diameter of the source capsule is 0.225 inches and the length is 0.88 inches.
Source pellets contain Eu-152 and Eu-154 as an impurity at 50-100 parts per million (0.5-1.0 mci /Ci Gd-153) s-LABELING: Each sealed source capsule is engraved with the isotope, the quantity, the model number and the serial number.
DIAGRAM:
Source 1100 A1 Pellet Shells 2024-T6 1100 A1 (Gd23 0) Al Spacer Plu9 , Engraved ,
Ident. Data 035 9 4 f/////////////////////' s
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t 5- REGISTRY OF RADIQACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE 5 s
DATE: March 3, 1986 PAGE 3 0F 3 3: NH185S10lS SEALED SOURCE TYPE: Medical Radiography Source CONDITIONS OF NORMAL USE: The Model OS-213A is designed for use in medical devices. It, therefore, is designed to operate at normal temperatures and l pressures found in medical facilities or research laboratories. .
l PROTOTYPE TESTING: Non-radioactive prototype capsules containing lithium chloride mono-hydride, were constructed and tested in accordance with ANSI Standards. The source design was demonstrated to meet ANSI Standard N5t42-1977 classification 77C32312.
EXTERNAL RADIATION LEVELS: Exposure rates of l' Ci of Gd-153 at a distance
' of 30 cm are 0.35 R/hr, for the pellet end and 0.30R/hr for the weld end of
- an aluminum encapsulation. A stainless steel encapsulation will reduce exposure rates to 16 percent of these values.
I OUALITY ASSURANCE AND CONTROL: Quality control procedures include:
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- 1. Material Control and traceability for conformance to specification.
1 2. Calibration and maintenance of measurement equipment.
l 3. Fabrication inspections and testing, and
!, 4. Final assembly inspection and test.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- 1. These sources are designed to be used in bone mineral analyzers.
1 2. These sources aremanufactured for Biosources, LTD. may be distributed to authorized recipients only.
l SAFETY ANALYSIS
SUMMARY
- This source, if used in a bone mineral analyzer according to the users manual, may be used with minimal exposure.
REFERENCES:
Letter and associated material dated May 31, 1985 et seq.
from Biosources, LTD.
t DATE: wd 7. /9 Pd REVIEWED BY: Mcaeda b l DATE: M 1 /98 REVIEWED BY: b 1
i ISSUING AGENCY: New Hampshire Radiological Health Program i
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
- l. SAFETY EVALUATION OF SEALED SOURCES i
i NO: TX333S129S- DATE: PAGE 1 0F 5 FEB O 61986 SEALED SOURCE TYPE: Medical Radiography Source MODEL: GD-1X Series I
MANUFACTURER / DISTRIBUTOR: A Gulf Nuclear, Inc.
202 Medical Center Blvd.
Webster _, Texas 77598 MANUFACTURER / DISTRIBUTOR:
,e- ISOTOPE: Gadolinium-153 MAXIMUM ACTIVITY: 1.5 Curies L.-
LEAK TEST FREQUENCY: 6 months PRINCIPAL USE: Medical Radiography l CUSTOM SOURCE: YES X NO I
CUSTOM USER:
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s REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES r; SAFETY EVALUATION OF SEALED SOURCES s
NO: TX333S129S' DATE: FEB. O S 1966 .PAGE 2 0F 5 SEALED SOURCE TYPE: Medical Raolography Secree DESCRIPTION:
The GD-1X Series contains the oxide of gadolinium-153 encapsulated in various metals. The "X" designator describes the metal encapsulation.
The table below provides physical information on each type of source.
Encapsulation '
Diameter Length Designator Material - (in.) (in.)
T titanium 0.225 0.885 titanium 0.225 0.500 17-4PH S stainless steel 0.185 0 310 S 17-4 stainless steel 0.225 0.885
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.. aluminum 0.225 .0885 B 17-4 PH S.S.
W/Be window 0.240 .0885 The gadolinium-153 oxide contains Eu-152 and Eu-154 as an impurity at l 50-100 parts per million (0.5- 1.0 mci. Eu-152 and Eu-154/C1. Gd-153).
LABELING: Each source is engraved with the model number, the isotope and the serial number.
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BEGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES TX333S129S' DATE: PAGE 3 0F 5
}{0: FEB. O 61986 SEALED SOURCE TYPE: Medical Radiography Source DIAGRAM:
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCES (3
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NO: TX333S129S' DATE: FEB.O m*ons , PAGE 4 0F 5 SEALED SOURCE TYPE: Medical Radiography Source CONDITIONS OF NORMAL USE:
This source is designed primarily for medical diagnostic research and cedical diagnostic use. The source is installed into medical equipment to be used under 1,aboratory conditio.ns. Because the half life of Gd-153 is only about 240 days, the expected useful life of the cource is 3 years. ..
I PROTOTYPE TESTING:
This source was tested and found to meet ANSI classification 77C32312 using all encapsulations.
EXTERNAL RADIATION LEVELS:
. Exposure rates of 1 Ci of Gd-153 at a distance of 30 cm are 0.35 R/hr, for the pellet end and 0.30 R/hr for the weld end of an aluminum encapsulation. A stainless steel encapsulation will reduce exposure rates to 16, percent of these values.
QUALITY ASSURANCE AND CONTROL: ,
1 Each capsule is tested using the vacuum-ethylene glycol leak test method and is tested to meet prototype specifications.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
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- 1. This sealed source shall be distributed to authorized users for ,
the purpose of medical research and/or use. This includes Group !
VI licensees pursuant to 10CFR35. !
- 2. This sealed source shall be leak tested at six month intervals. I
- 3. Specifics of handling, storage, use, transfer and disposal should l be determined by the licensing authority. l
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- l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
- SAFETY EVALUATION OF SEALED SOURCES 0F M: TX333S129S' DATE: FES. O 61986 PAGE 5 5 SEALED SOURCE TYPE: Medical Radiography Source SAFETY ANALYSIS
SUMMARY
Based upon the information submitted and the fact that this source i will be used by persons trained in the medical professions, this )
sealed source can be used within acceptable limits. ,
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REFERENCES:
This summary was prepared with the aid of Gulf Nuclear, Inc. letters dated April 5, 1979, March 25, 1980, April 23, 1980, July 25, 1983, c October 15, 1985, and November 14, 1985, and all associated drawings, documents and procedures.
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DATE: ~) - [- TS REVIF.WED BY DATE: 1 - b " hd REVIEWED BY: [m d b m (j f
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ISSUING AGENCY: Texas Department of Health
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