ML020930476
| ML020930476 | |
| Person / Time | |
|---|---|
| Issue date: | 04/03/2002 |
| From: | Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | MDS Nordion |
| References | |
| SSD 02-07 | |
| Download: ML020930476 (7) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 1 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source MODEL:
C-164 MANUFACTURER/DISTRIBUTOR:
MDS Nordion, a Division of MDS (Canada) Inc.
(formerly Nordion International Inc. and Atomic Energy of Canada Ltd.)
447 March Road Ottawa, ON Canada K2K 1X8 ISOTOPE:
MAXIMUM ACTIVITY:
Antimony-124 80 mCi (2.96 GBq)
Cobalt-60 50 ci (1.85 TBq)
Iridium-192 500 Ci (18.5 TBq)
LEAK TEST FREQUENCY:
6 Months PRINCIPAL USE:
(A) Industrial Radiography (D) Gamma Gauge CUSTOM DEVICE:
YES X NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 2 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source DESCRIPTION:
The sealed source model C-164 is a single encapsulated fusion welded source that is used in self-contained, portable detectors such as a Beryllium Analyzer. The C-164 source may also be used for industrial radiography where the source remains in the device. The C-164 source may contain up to 80 mCi (2.96 GBq) of antimony-124, or up to 50 Ci (1.85 TBq) of cobalt-60, or up to 500 Ci (18.5 TBq) of iridium-192, in pellet form.
The model C-164 capsule is constructed of stainless steel (Type 304L). It consists of two parts: a hexagonal shaped receptacle having a maximum outside dimension of 0.250" (6.35 mm) across the flats, a maximum overall length of 0.325" (8.25 mm) and a nominal wall thickness 0.015" (0.38 mm); and a plug having a maximum outside diameter of 0.238" (6.05 mm) and 0.270" (6.86 mm) in height. After the source is loaded, the two parts are threaded together via #8-36 UNF thread and fusion welded.
The isotope material is in pellet form, either 1 mm, 2 mm, or 3 mm (0.04", 0.08", or 0.12") in diameter. Nominal thickness may range between 1 and 2 mm. With 1 mm and 2 mm diameter pellets, a cylindrical spacer made of aluminum is used to hold the isotope in position.
LABELING:
The C-164 source is engraved on its outer surface in the following manner:
MDSN (an abbreviation for MDS Nordion)
DA (D is MDS Nordion's identification for antimony-124, and A is the identification for C-164 sources) or CA (C is MDS Nordion's identification for cobalt-60, and A is the identification for C-164 sources) or BL (B is MDS Nordion's identification for iridium-192, and L is the identification for C-164 sources) xxx (a unique serial number)
Trefoil Symbol
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 3 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source DIAGRAMS:
See Attachment 1.
CONDITIONS OF NORMAL USE:
The C-164 source is designed primarily for use in portable detectors with the source secured in the device. The Detector is hand carried by trained technical personnel. Typical environmental conditions are:
Temperature: -40C to 80C (-40F to 176F)
Pressure: Atmospheric Vibration: None Corrosion: Range from none to mildly corrosive vapor The manufacturer estimates that typical life of the source loaded to maximum activity is approximately 2 months, 6 months, and 25 years with antimony-124, iridium-192, and cobalt-60, respectively.
PROTOTYPE TESTING:
The C-164 prototypes have been tested and classified to E64334 as prescribed in ANSI/HPS N43.6-1997 and ISO 2919:1999(E). This classification exceeds the requirements for gamma gauge of E43232 and industrial radiography of E43313.
The C-164 sealed source is certified as Special Form Radioactive Material by the Canadian Nuclear Safety Commission (CNSC) under the certificate number CDN/0001/S.
MDS Nordion has manufactured well over 400 C-164 sealed sources since 1969. There have been no known written or verbal reports indicating leakage or other defects pertaining to the C-164 sources.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 4 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source EXTERNAL RADIATION LEVELS:
The manufacturer provided the following dose rates for antimony-124 with 80 mCi (2.96 GBq), cobalt-60 with 50 Ci (1.85 TBq), and iridium-192 with 500 Ci (18.5 TBq).
Distance from Source Isotope Radiation Level mR/hr mSv/hr 100 cm (39.37")
antimony-124 78.40 0.78 cobalt-60 66.00 0.66 iridium-192 240.00 2.40 30 cm (11.81")
antimony-124 871.00 8.71 cobalt-60 733.00 7.33 iridium-192 2,667.00 26.67 10 cm (3.94")
antimony-124 7,840.00 78.40 Cobalt-60 6,600.00 66.00 Iridium-192 24,000.00 240.00 QUALITY ASSURANCE AND CONTROL:
MDS Nordion maintains an ISO 9001 compliant quality assurance and control program, which has been deemed acceptable for licensing purposes by the NRC under Quality Assurance Program No.0703 which expires July 31, 2005.
All MDS Nordion C-164 sealed source(s) quality requirements for design, manufacturing, inspection and testing are carried out in accordance with the ISO 9001 Quality System. To assure these requirements, Technical Specifications have been prepared and are available for inspection purposes. IN/TS 0010 C000 is used for Technical Specification for Radioisotopes and Sources and IS/OP 0040 C000 for Engraving Procedure.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 5 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source QUALITY ASSURANCE AND CONTROL (Contd):
Documented policies and procedures are maintained to ensure that all purchased components, materials, and services conform to specified requirements.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
The source shall be distributed to persons specifically licensed by the NRC or an Agreement State.
Handling, storage, use, transfer, and disposal: To be determined by the licensing authority. In view that these sources exhibit high dose rates, the sources should be handled by experienced licensed personnel using adequate handling equipment and procedures.
The source shall be leak tested at intervals not to exceed 6 months using techniques capable of detecting 0.005 µCi (185 Bq) of removable contamination.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on review of the Model C-164 sealed source, its ANSI and ISO classifications, and the information and test data cited below, we conclude that the source is acceptable for licensing purposes.
Furthermore, we conclude that the source 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.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO.: NR-0220-S-127-S DATE:
PAGE 6 OF 6 SOURCE TYPE:
Gamma Gauge or Industrial Radiography Source
REFERENCES:
The following supporting documents for the Model C-164 sealed source are hereby incorporated by reference and are made part of this registry document.
MDS Nordion, Inc. application dated February 12, 2002, with enclosures thereto.
MDS Nordion, Inc. letter dated March 25, 2002, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
Reviewer:
Seung J. Lee Date:
Concurrence:
John P. Jankovich
REGISTRATION OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE NO:
NR-0220-S-127-S DATE:
ATTACHMENT 1 Model C-164 Sealed Source