ML20046D008
| ML20046D008 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1993 |
| From: | NRC |
| To: | |
| References | |
| NUREG-BR-0177, NUREG-BR-0177-N93-2, NUREG-BR-177, NUREG-BR-177-N93-2, NUDOCS 9308160029 | |
| Download: ML20046D008 (4) | |
Text
Sealed Source & Device Newsletter 4
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U.S. Nuclear Courtesy of the NUREGIBR-0177 ii 1
Regulatory Sealed Source No. 93-2
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Commission Safety Section July 1993 l
With technology constantly changing and the need to protect public health and safety, it is imperative that communications between the US Nuclear Regulatory Commission (NRC) and Agreement State programs and also between these regulatory authorities and users of i
radioactive sealed sources and devices be open and cooperative. The Sealed Source Safety i
Section (SSSS) of the NRC is providing this newsletter to promote such communications.
ADMINISTRATIVEISSUES on several Model 702 source assemblies had cracked l
or broken.
During the month of June the first registration cer-he cause of the failures was attributed by RTS to the tificate with a vendor number greater than 0999 was hardness specifation on the source connector issued. De number was 8001; an " Inactive" certifi-sleeve specifally, the connector sleeves were too i
l cate. All" Inactive" vendor numbers issued, from that hard. RTS determined that the lot of connector r
date on, will be in the range of 8001 to 9999.
sleeves used in sources manufactured between No-vember 12,1992, and the time the repon was filed
" Active" vendor numbers will cxmtinue to be issued exhibited hardness in the high end of the range speci-l in the range of 0101 to 0799, until all these numbers fied on the assembly drawings. It was determined that are used up as well. At that time, new vendor num-lots manufactured before the date the report was bers will be issued in the range of 1001 to 7999. All filed were in the mxidle to low end of the specified previously issued vendor numbers will continue to be hardness range. Since the failures were attributed to valid.
the connectors being too hard, the only sources af-fected by the Orders were those manufactured from In summary, all "Inacuve" certificates will have ven-November 12,1992, up to the time the report was dor numbers in the range of 0801 to 0999 or 8001 to filed.
9999; all " Active" certirates will have vendor num-bers in the range of 0101 to 0799 or, in the future, RTS determined that only nine NRC licensees and i
2001 to 7999.
eight Agreement State licensees (two of the licensees held both NRC and Agreement State licenses) had recerved Model 702 source assemblics that were TECHNICAL ISSUES manufactured between these dates and, included the i
names and addresses of these Imaeat m the report to NRC. Additionally, RTS initially sent a bulletin to RTS TECHNOLOGY'S MODEL 702 cach of these &=aer making them aware of the RADIOGRAPHY SOURCE possible defect. Once RTS was made aware that NRC was issuing Orders to the nine NRC licensees, it On May 20,1993, NRC issued Orders to nine rachog-contacted all affected licensees to arrange for dis-raphy licensees who had received R*IS Technology, posal of the source assemblies. He licensees have Inc. (RTS) Mode! 702 source assemblies within the since removed the affected source assemblics from previous 6 months. The Orders modified their li-service. None of the affected source assemblics re-censes to prohibit use of these source assemblies, mams in service.
specifically those sources with serial numbers lower than 1867. The reason for the acuan was that on May To ensure that sundar failures do not occur, RTS has 13,1993, RTS, in amud. ace with 10 CFR Part 21, modified the hardness specifation by lowering the reported to the Cnm=W that connector sleeves high end of the range.ncrefore, source assemblics 9308160029 930731 PDR NUREG BR-0177 R PDR
manufactured efter May 12,1993 (serial numbers One exception to this b if the source isopproved for 1867 and higher), will meet this new specification, to the higher activity for crclusive use in the desice.De minmuze the potential for this type of failure.
" Limitations and/or Other Considerations of Use" section of the certificate would indicate if this is the SERVICE BULLETIN ISSUED BY
'"S*~
NORDION INTERNATIONAL, INCORPORATED Question De registration certificate for the device lists the leak test frequency as "36 months." he In May 1993, Nordion sent out a senice bulletin to registration certificate for the source used in the de-users of its Gammacc11-40E, -1000E, and -3000E vice lists the leak test frequency as "6 months." Since Category I irradiators, to inform them of a potential the souwe leak test frequency is only 6 months, does problem with the sample exposure control system.
inis mean the device is subject to the 6 month leak During testing, there were a few cases (four m 21,000 test frequency as well?
cycles) of control system problems affecting the Answr De leak test frequency of the soume would timer. De problem also could provide incorrect dis-be 6 months when it is not installed in the device.
play or printout information. As a result, Nordion When installed in the device, the leak test frequency informed the above users that they would be supplied of the doice takes precedence over that of the with backup timers, to verify the exposure time for source. Herefore, the device would only need to be the irradiated sample, in case of a control system leak tested at an at interval ofless than 36 months, as error. An amendment was also provided for their long as the source remains in the device.
Operator Manuals. Dere is no potential radiation hazard to users of these systems, as a result of this Questiore Are general licensees required to have cer-problem.
tification on file that packages they ship l'ack to the manufacturer meet the Type A shipping require-ments?
QUESTIONS Answr Yes. All persons are subject to this require-ment. For further information contact Mr. Wendel his section of the newsletter is provided to answer frequently asked questions:
Carricker, of the U.S. Department of Transportation at (202) 366-4501.
Question: If the registration certificate for the Model Questiort I've searched the national registry listing of ABC device has the following information on the first scaled sources and devices and cannot find a registra-page; tion certifiste for the Model 123 sealed sourte.
However, the registration certificate for the Model SEALED SOURCE MODEL DESIGNATION:
ABC device lists the Model 123 as the sealed source Acme Models 123 and 456 model used in the device. Why isn't the sealed source registered?
IS E:
NW ANS Answr Registration information for the sealed Cesium-137 50 millicuries sourre may be included as part of the device registra-and the registration certificate for the Model 123 tion certificate. Typically the source and device would source lists the marunum activity as 30 millicuries:
have the same manufacturer and the scaled source What is the maxunum activity of a Model 123 source would be intended for exclusive use in the des ice with that may be used in the Model ABC device?
which it was registered (i.e. not for distnbution as an ndividual source).herefore, a separate registration certificate would not be issued for the sealed source.
Anser The manmum activity for a Model 123 ne "Lamitations and/or Other Considerations of source that may be used in the device is 30 milheuries.
Use" section of the certificate should state that the However, the maximum activity for the Model ABC source is registered as part of the device for exclusive device is listed as 50 millicuries.This may be due to use in the doice.
the Model 456 source being approved for up to 50 millicuries, or the Model ABC device may contain An exception to this is if a manufacturer has several two sources that, together total an activity of 50 mil-devices that contain the same source, and the source licuries. His would typically be indiated on the first is manufactured by the same manufacturer's. If the page of the registration certificate.He description source is intended for use onlyin the manufacturer's section of the Model ABC device registration certifi-devices, then the source has been allowed to be regis-cate should list the manmum activity for each source tered with several devices. However, this practice is model and/or combination of sourte models.
no longer recommended.
2
Questiorr If the prircipal use code denotes the source If you know of any devices or sealed sources that for use in X-ray Fluorescence, can it be used for appear to have inherent problems, or do not appear general medical applications?
to be adequately designed for their intended condi-tions of use, please inform the SSSS, so that we may Answer in many cases, yes. The principal use code include examples of these products for testing, denotes the use that most accurately descnbes the manufacturer's intended predommant use for the sealed source. This does not mean that it cannot be SSD ComputerProgmm: he first version of the SSD used for other purposes. He licensing reviewer registry program uss available in July 1992. Develop-should compare the conditions of use proposed by ment of Version 2.0 continues. Persons located in the user with the conditions of use and performance Agreement States who did not receive a wpy of the classification provided by the vendor and listed in the first version and would like a copy should contact certificate of registration. Generally,industrialappij.
Lloyd Bolling (OSP) at (301) 504-2327; all others cations meet or exceed the ANSI performance classi.
should contact Tom Rich or Doug Broaddus at (301) fication for medical uses. Additionally, some per.
504-2511.
formance tests, such as the tensile stress test on the eyelet of a needle, are not applicable for a particular Radio 8mP y Cmss-Refaence Pmsmm (RADXREF):
h use.
Version 2.0 of RADXREF has been distributed. If you received a copy of the previous version, you ONGOING PROJECTS should have received the 2.0 update. If you believe you should have received a copy of Version 2.0 but Scaled Source and Device (SSD) Testuqr he first did not, please contact Iloyd Bolling at (301) phase of the SSD testing contract has been com.
504-2327 (for persons located in an Agreement pleted. Work on the second phase will be underway State) or contact Tom Rich or Doug Broaddus at soon.
(301) 504-2511 (all other requests).
If readers of this newsletter need answers to specific questions, or have information that they believe will be valuable to other users and regulators of scaled sources and devices, we encourage them to provide this information to the SSSS by the 15th of each month. We will review the submitted information;if we find it to be within the scope of this newsletter, the information will be covered in a future issue. Send all questions, comments or articles to Kim Jones or Doug Broaddus of the SSSS at: SS&D Newsletter, US Nuclear Regulatory Commission, Mail Stop 6-H-3, Washington DC,20555, or FAX (301) 504-2260.
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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. $300 I?055513n"32 I 130 US Noc_oggy Pk-o f$ghehPLICATIONSSVCS P~211 WLSHINGTON DC p 555 PFUhTf.D Oh MECYC11D PAPER
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