ML20097J596
| ML20097J596 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/1996 |
| From: | NRC |
| To: | |
| References | |
| NUREG-BR-0177, NUREG-BR-0177-N96-1, NUREG-BR-177, NUREG-BR-177-N96-1, NUDOCS 9602050039 | |
| Download: ML20097J596 (7) | |
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Sealed Source & Device Newsletter
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U.S. Nuclear Courtesy of the NUREGlUR-0177 i
I Regulatory Scaled Source No.96-1
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Commission Safety Section January 1996 With technology constantly changing and the need to protect public health and safety, it is imperative that communications between the U.S. Nuclear Regulatory Commission (NRC) and Agreement State programs and also between these regulatory authorities and users of radioactive sealed sources and devices be open and cooperative. The NRC Scaled Source Safety Section (SSSS) is providing this newsletter to promote such communications.
TECIINICAL ISSUES the requirements for radiography associated equipment. The questions concerned generic issues APGEE CORPORATION 10 CFR PART usersIf r dio y equip cN. " h[51 21 REPORT OF DEFECT IN SOME LB 7400 SERIES DEVICES response was based on current requirements d
contained in 10 CFR Part 32 and Part 34, and those that become effective on January 10,1996. Ilelow Apgee Corporation, Ilerthold Systems..
is a summary of the questions asked and the Incorporated, and the manufacturer contmue t investigate the defect in the shutter mechanisms of answers NRC provided:
some 13erthold model Lil 7440 and Lil 7442 Q: Is associated equipment, shown to meet 10 devices. Ilerthold indicates that alllicensees who CFR 34.20 requirements with one camera received the initial bulletin have responded and model, automatically approved for use witti that all shutter mechanisms have been tested for other camera models with which it has not the potential defect. Of the 400 devices tested,50 been tested?
(12.5 percent) showed signs of the defect. Positive results of the defect were distributed over a variety A: Associated equipment that meets 10 CFR of industrial applications, with rates of occurrence 34.20 equipment requirements when tested ranging from 9 to 25 percent and with no particular with one camera is not allowed to be used industry seeing a significantly higher frequency, with another camera unless it has either:
Apgee expects to complete the analysis and issue a passed all appropriate tests; been shown report of findings to the NRC soon.
through engineering analysis that it would likely meet the test requirements; or been Possessors of Ilerthold model LII 7400 series granted a license exemption. In all cases, devices received between 1991 and 1992, who have before the equipment may be used, NRC or not been contacted by Apgee/Ilerthold, should an Agreement State must have deemed it contact Mr. Ilud Smith of Apgec/Ilerthold directly acceptable, for licensing purposes.
at (412) 378-1900.
Q: What are the requirements for approval of CLARIFICATION OF THE NE\\V equipment with an anothers approved camera, RADIOGRAPHY EOUIPMENT RULE and who is responsible for meeting these REQUIREMENTS FOR ASSOCIATED requirements?
EQUIPMENT A: All associated equipment must either be listed Recently, a radiography equipment manufacturer on a registration certificate as specifically requested clarification on several issues concerning approved for use with the radiography camera i
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component, built to the same specifications.
For the associated equipment to be approved, subjected to, and pass the appropriate a safety evaluation must be performed, and a equipment tests, or by providing an determination made that the equipment meets engineering analysis that demonstrates the the requirements in 10 CFR Part 34.
component would be expected to pass the tests.
The regulations in 10 CFR Ibrt 34 are t'serbased.
Therefore, the licensee / user is ultimately The manufacturer and/or licensee determines the responsible for ensuring that its radiography label content (i.e., company logo, model number, equipment (regardless of manufacturer or supplicy etc.) using size, durability, uniqueness, and case of has met the appropriate requirements or has been identification as criteria. Information on labeling granted a license exemption. In addition,10 CFR of components is typically found in the labeling 30.32, Application for specific licenses, states under section of the associated cameras registration paragraph (g), that the applicant (licensee) must certificate, and includes only those associated either Identify the source or device... as registered equipment items that have been approved for use with the Commission.. or an Agreement State, or with the camera. The location of the label shall be provide the information identified in 10 CFR such that modification of the component could be 32.210(c). In most cases, for efficiency and easily recognized. For example; guide tubes and convenience, the manufacturer submits the guide tube connectors are important for the safe information and request to register the equipment.
operation of the system and are required to pass certam performance tests in ANSI N432-1980.
Manufacturers or suppliers of associated One way these components have been labeled so equipment seeking approval of their components that modifications are recognizable is that the for use with other cameras must provide, to the connectors themselves have been labeled. 'Ib appropriate licensing authority, the information shorten a guide tube, the guide tube must be cut necessary to perform a safety evaluation, as (thereby remcving a connector), and another T
outlined in 10 CFR 32.210, and demonstrate that connector reattached. If the new connector is not the component meets 10 CFR 34.20 requirements.
labeled appropriately (i.e., not supplied by the If the associated equipment is deemed acceptable manufacturer for an approved modification or for licensing purposes, a registration certificate or labeled in accordance with the licensees approval similar document, stating that this component is of the modification) or contains no labeling, this approved for use with the radiography camera, will would be an indication to an inspector that the be generated. This document will be forwarded to guide tube has been modified and may not be the applicant, to the appropriate person (s)in NRC authorized for use.
regional offices and Agreement States, and to any This policy has been implemented for all other concerned parties, as appropnate.
radiography equipment manufacturers that have Q: What are the regulatory requirements for s aled sources and/or devices registered with NRC.
labeling associated equipment to indicate it Q: What are the quality control requirements for meets 10 CFR Ibrt 34.20 requirements?
manufacturers and suppliers of associated equipment?
A: 'Ib identify associated equipment - used with a radiography camera or changer and that has A: Manufacturers and suppliers of associated an effect on the overall safety and/or integrity equipment must have adequate quality of the camera, changer, or source - that has assurance and control programs, approved in been shown to meet 10 CFR 34.20 accordance with 10 CFR 32.210 requirements, requirements, our policy is that the equipment to ensure the equipment meets 10 CFR 34.20 be labeled, and in such a manner that the requirements, and any additional labeling cannot usily be removed. The requirements listed in a certificate of associated equipment includes guide tubes registration or approval document issued by an (including J or similar-type guide tubes),
appropnate hcensmg authority, control tubes, control / drive cables, and Q: How are various manufacturers source models collimators that could come in contact with determined to be compatible for use with a the scaled source. Ily labeling the equipment, specific source changer? Who is resp (msible the manufacturer and/or licensee is indicatmg for providing the information necessary to that the component is expected to meet the make this determination?
requirements in 10 CFR 34.20. 'lhe abihty of a component to meet these requirements may A: 'Ihe process to verify that one manufacturers be demonstrated by having either a prototype source model is compatible for use in another 2
I manufacturers source changer is similar to the DOE /NRC ACCEPTANCE PROGRAM process used to verify that one manufacturers UPDATE source is compatible for use in another manufacturers camera.
The following are the current actions with the U.S.
Department of Energy (DOE), under this program:
The manufacturer / distributor of the source model or source changer, or a licensce/ user may request a e
DOE is reviewing a proposed Memorandum particular combination be approved for use. The of Understanding (MOU) intended to codify request, regardless of who makes it, must include and formalize the program. The MOU was an application for safety evaluation of the proposed drafted as a joint venture between NRC and combination. The safety evaluation will consist of a DOE staff and has been signed by the review and analysis of the information as required Director, Office of Nuclear Materials Safety by 10 CFR 32.210 and 10 CFR 34.20 to ensure that and Safeguards, the radiation safety properties of the source and device, when used together as intended, are DOE is working to resolve a State of Illinois adequate to protect health and minimize danger to request for assistance with the retrieval of life and property.
several Am/Be welllogging sources.
The basic procedure for verifying that one o
DOE assisted the State of Texas with the manufacturers source is compatible for use in retrieval and control of a damaged Am/Be another manufacturers source changer is well logging source.
summarized below:
In addition, NRC has published the procedures 1.
Get drawings, including tolerances, of the NRC staff should follow when considering changer and scaled source.
requesting DOE assistance under this program.
2.
Compare dimensions to ensure the The procedures are contained in Inspection Manual Chapter 1303, and Policy and Guidance components are compatible when manufactured within tolerance.
Directive 9-12. Agreement State personnel may use these procedures as a guide when considering 3.
Verify that the combination has been shown, cither through prototype testing or engineering analysis, to meet the eqt'ipment h1ECHANICAL FORENSICS requirements in 10 CFR Part 34.
The following is an overview of salient points taken 4.
Verify the external radiation levels are within from an article in the October 1995, edition of the limits specified in 10 CFR 34.21.
Equipment Today. The article is entitled Mechanical Forensics: Dead Machinesiell No 5.
Verify the source changer locking mecham.
Lies. The author notes that Mechanical Forensics sm will work properly with the proposed scaled is the proper term for the process of failure source. This may be demonstrated through a analysis and is quick to note that Murphys law review of the design drawings, a visual usually dictates when a failure occurs. Several check / demonstration of the actual products, po nts in the article may interest readers and are presented below; the manufacturers statements / descriptions, and prototype testing results.
Failures occur for many reasons, including normal wear and tear, abuse, manufacturing and/or LICENSING OF THE AMERSHAM material defects, insufficient design, and improper
'MODEL 650L RADIOGRAPHY or insufficient maintenance. Every failure has a SOURCE CHANGER cause, and every cause has a reason...it is these reasons that mechanical forensicologists seek. The NRC plans to use licensing discretion to allow tricky part is that equipment is made of a system of licensecs, authorized for possession and use of interacting components, and problems have a way Amersham Model 650 source changers, to possess of chainreacting through the system, obscuring the and use Model 650L source changers without a cause and results.
license amendment. This action is based on the similarity of the construction and use of these Determining the cause of a failure has benefits:
devices, and is needed to enable thcsc licensecs to you can changc the factors responsible and avoid obtain ap' proved source changers for use after future failures.1b do this, an investigation should, January 10,1996.
at a minimum, creompass the following steps:
3
1.
Clearly state the exact problem / failure.
load can cause both brittle and ductile fractures if in excess of the metals yield 2.
Organize your fact gathering. 3. Carefully strength.
observe and precisely record the facts.
o Overloads: a sudden internal load, often 4.
Incorporate all facts in a logical manner.
related to the same causes and exhibiting the 5.
Identify the root cause. 6. Communicate with the party responsible for the failure (i.e.
e Cyclic loads: Repetitive loads, typically less manufacturer, servicing agent, user).
than theyield strength of the metal, created by the normal operation of the machine. This 7.
Make recommended repairs.
type of load may lead to fatigue fractures.
8.
'!hke steps to avoid similar problems in the THE SSSS CONDUCTS A SEALED futme.
SOURCE AND DEVICE (SS&D)
Start the investigation by a visual inspection of the
\\VORKSHOP failed equipment. This usually requires some basic During the week of September 12-15,1995,the tools to separate machine parts; a magnet to SSSS conducted a SS&D workshop intended to determine ferrous and non. ferrous metals, a provide training and background information on magnifying glass, and a good flashlight. A camera performing SS&D safety evaluations. Participants is also useful to record the findmgs.
included representatives from each Agreement State, several non-Agreement States who have When investigating the cause(s) of a fractured applied for Agreement State status, and the NRC metal part, it is important to keep m, mmd that Office of State Programs. Feedback from parts typically break at their weakest poi'it, and participants has been mostly positive and with metals, higher temperatures mean a decrease supportive. A number of participants indicated m strength. In addition, the type of fracture is an that they felt the workshop was helpful and important consideration and may provide clues t worthwhile, and several suggestions for the cause of the failure. The three types of metal improvements were provided for future workshops.
fractures follow:
1.
Ilrittle fractures are linked more to results ONGOING PROJECTS than root causes, happen quickly, produce fragments, and the parts are not usually bent SS&D TESTING CONTRACT or deformed.
As reported in the last issue of the newsletter, 2.
Ductile fractures are also related more to Southwest Research Institute was issued Thsk results than root causes, typically occur Order One for the testing of industrial radiographic quickly (although not as fast as brittle equipment. However, because of SwRIs estimate fractures), and some twisting and stretching of of substantial additional costs and delays for the part is typically evident.
completion of the Thsk, and the lack of deliverables received from SwRI, it was decided to stop work on 3.
Fatigue fractures result from a combination of this Thsk. In accordance with the contract, SwRI cyclical loads and physical irregularities will deliver all test data and equipment to NRC.
(known as stress raisers)in the part. The fracture surface is typically flat, smooth, and SwRI has been working to complete four final light in color, and is characterized by reports for publication. The report on the Roxler semicircular benchmarks radiating from the source cap investigation was submitted in final form fracture origin.
by SwRI and published as NUREG/CR-6074, 04-4448-010, Vol. 5. In addition, reports on the Metal part fractures are caused by an applied load failed brachytherapy source wire investigation, the to the part, sufficient to exceed the parts limit of brachytherapy needle applicator investigation, and strength. Loads may be applied suddenly or the General Radioisotope Products scaled source cyclically over time. lypical load types include:
investigation have also been submitted in final form by SwRI for publication by NRC. These renorts e
impact loads: a sudden external load caused will be published as NUREG/CR-6074, Vols. 2,3.
by improper equipment operation, or the and 4, respectively. Published repods are available failure of another component. This type of from the NRC Pu'olic Document Room or the 4
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Government Printing Office. The SSSS will also information dealing with SS&Ds. For information have a limited number of extra copies that may be on connecting to and using FedWorld, please requested. Questions concerning this contract contact the FedWorld help desk at (703) 487-4608.
should be directed to Doug Broaddus, the contract For questions regarding the SSD HHS, please technical monitor, at (301) 415-5847. In addition, if contact Michele Hurgess at (301) 415-5868 or Steve you believe that a particular device or scaled Hapgett at (301) 415-7273.
source may be a candidate for testing under this contract (e.g., product design is questionable for its intended or actual conditions of use, or the product RADIOGRAPIIY CROSS-REFERENCE has potential inherent problems), please inform the PROGRAM (RADXREF)
SSSS so that the product may be considered for future testing.
Copics of the latest version of the RADXREF database program, Version 2.0a, dated October 1995, have been mailed to all registered users.
TIIE SS&D BULLETIN BOARD This program is intended as a licensing guide for SYSTEM compatibic models in industrial radiography, as indicated by current registration certificates or A new Hulletin Hoard System has been created on appropriate letters from the licensing authority.
FedWorld entitled, The Scaled Sources and The program provides an efficient means for Devices Hulletin Board System (SS&D HHS). The cross-referencing the compatibility of industrial SS&D HHS was created by the SSSS and may be radiography sources, changers, and cameras. Every accessed, free of charge, on the FedWorld effort has been made to ensure the accuracy of the Information Service Network. The SS&D HHS information contained in the database. However, provides users access to electronic copies of the program should not be viewed as the ultimate materials and information dealing with the authority for determining compatibility of registration of sealed sources and devices and other equipment, but, rather, applicable registration information commonly requested from the SSSS.
certificates should be reviewed for additional Much of the information contained on the HHS details or restrictions and for information about may be viewed on screen and/or downloaded to models that may not be listed in the program. In your computer. Examples of materials and addition, please be aware that the database may not information contained on the SS&D HHS include reflect information contained in certificates issued downloadabic copics of the RADXREF and SS&D or amended after October 1995.
REGISTRY programs in compressed format, past issues of the SS&D Newsletter, and copics of applicable regulatory guides.
Updates to the RADXREF database and program w 11 be made periodically, as necessary, and will be made available on the SSD HHS via FedWorld. In The SS&D HHS has been set up to facilitate easy addition, updates may also be disseminated either access to these materials, and cach screen provides via distribution of replacement data / programs on either on-screen directions or an "About.. " file to floppy diskettes or by the issuance of addendum l
give you further information on how to use the hardcopy lists containing the changes made in the l
features of the SS&D HHS. For best results, users data. If you have problems downloading the I
should carefully read all on-screen directions and RADXREF program f.om the SSD HHS, need a I
"About.." sections. Please be aware that as copy mailed to you, do not have access to changes to the system occur, these sections may FedWorld and wish to remain on the maiUng list also change. In addition, it is recommended that for future updates, or have any questions about the users view the "SSD Late Hrcaking News and program, please call either'Michele Burgess at Informatian" section each time they log onto the (301) 415-5868, or Thomas Rich at (301) 415-7893, system. This section serves as a means to alert or write to them at the US Nuclear Regulatory users to new options, changes, and updates on the Commission, Washington, D.C. 20555, Mail Stop SS&D HHS, and to highlight other important T-8F5.
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. 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, requests for back issues, or articles to Kim Randall or Doug Broaddus of the SSSS at: SS&D Newsletter, US Nuclear Regulatory Commission, Mail Stop T-8 F5, Washington, DC 20555, or FAX (301) 415-5369.
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