1、 ANSI N42.22-1995(R2002)American National StandardTraceability of Radioactive Sources to the National Institute of Standards and Technology (NIST) and Associated Instrument Quality ControlSponsorNational Committee on Radiation Instrumentation, N42Accredited by theAmerican National Standards Institut
2、eSecretariatThe Institute of Electrical and Electronics Engineers, Inc.Reaffirmed September 30, 2002Approved August 24, 1995American National Standards InstituteAbstract: A mechanism for manufacturers to estabilish traceability of radionuclide sources that arecertified for radionuclide activity; con
3、centration; or alpha, beta, x-, or gamma-ray emission rate to theNational Institute of Standards and Technology (NIST) is described.Keywords: instrument quality control, NIST, quality, quality assurance, quality control, radiationinstrumentation, radioactivity, radionuclide sources, traceabilityThe
4、Institute of Electrical and Electronics Engineers, Inc.345 East 47th Street, New York, NY 10017-2394, USACopyright 1995 by the Institute of Electrical and Electronics Engineers, Inc.All rights reserved. Published 1995. Printed in the United States of America.ISBN 1-55937-559-0No part of this publica
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13、the matter has previously received formal consideration. Comments on standards and requests for interpretations should be addressed to:Secretary, IEEE Standards Board445 Hoes LaneP.O. Box 1331Piscataway, NJ 08855-1331USAIEEE Standards documents may involve the use of patented technology. Theirapprov
14、al by the Institute of Electrical and Electronics Engineers does not mean thatusing such technology for the purpose of conforming to such standards is authorizedby the patent owner. It is the obligation of the user of such technology to obtain allnecessary permissions.iiiIntroduction(This introducti
15、on is not a part of ANSI N42.22-1995, American National StandardTraceability of Radioactive Sources to theNational Institute of Standards and Technology (NIST) and Associated Instrument Quality Control.)This standard is the responsibility of the Accredited Standards Committee on Radiation Instrument
16、ation,N42. Committee N42 delegated development of this standard to Subcommittee N42.RM. Drafts werereviewed by Committee N42, Subcommittee N42.RM, and other interested parties, and the commentsreceived were utilized in producing the standard as finally approved. The standard was approved by N42 let-
17、ter ballot of 18 November 1994.At the time it approved this standard, the Accredited Standards Committee on Radiation Instrumentation,N42, had the following members:Louis Costrell,ChairLuigi Napoli,Administrative SecretaryOrganization Represented Name of RepresentativeAmerican Conference of Governme
18、ntal Industrial Hygienists.Jesse LiebermanBattelle Pacific Northwest Laboratories .Kenneth L. SwinthHealth Physics SocietyGeorge Campbell Joseph R. Stencel (Alt.)Institute of Electrical and Electronics EngineersLouis Costrell Julian Forster (Alt.)Anthony J. Spurgin (Alt.)Lawrence Berkeley Laboratory
19、.Edward J. LampoLawrence Livermore National LaboratoryPaul L. PhelpsOak Ridge National LaboratoryHugh R. BrashearUS Army Center for EW/RSTAEdward GroeberUS Department of Commerce,National Institute of Standards and TechnologyLouis Costrell Michael Unterweger (Alt.)US Department of Energy.Gerald Gold
20、steinUS Federal Emergency Management Agency Carl R. SiebentrittUS Nuclear Regulatory CommissionEdward C. Wenzinger, Sr.Members-at-Large.Joseph C. Bellian Al N. TschaecheErnesto A. Corte Edward J. VallarioMorgan Cox Lee J. WagnerJohn M. Gallagher Sanford Wagner Jack M. SelbyAt the time this standard
21、was approved, Subcommittee N42.RM had the following members: Frank X. Masse,ChairJ. M. R. Hutchinson,SecretaryRobert Ayres Bert M. Coursey Y. Kobyashi D. M. MontgomeryJoseph G. Bellian Michael Devine Markku Koskelo Carl W. SeidelJohn D. Buchanan Roger Ferris J. L. Lazewatsky John SonewaldR. F. Coley
22、 Robert J. Gehrke David E. McCurdy M. P. UnterwegerThe working group for this standard had the following members:Daniel M. Montgomery,Project LeaderMichael Devine Roger Ferris Dale D. Hoppes J. M. R. HutchinsonThe following persons were on the balloting committee that approved this document for subm
23、ission to theAmerican National Standards Institute:Joseph G. Bellian Julian Forster Paul L. Phelps Al N. TschaecheHugh R. Brashear John M. Gallagher Jack M. Selby Michael UnterwegerGeorge Campbell Gerald Goldstein Carl L. Siebentritt Edward J. VallarioErnesto A. Corte Edward Groeber Anthony J. Spurg
24、in Lee J. WagnerLouis Costrell Edward J. Lampo Joseph R. Stencel Sanford WagnerMorgan Cox Jesse Lieberman Kenneth L. Swinth Edward C. Wenzinger, Sr.Mary Lynne NielsenIEEE Standards Project EditorMylar is a registered trademark of E.I. du Pont de Nemours and Company.ivContentsCLAUSE PAGE1. Overview 1
25、1.1 Scope 11.2 Purpose. 12. References 13. Definitions 23.1 Special word usage 23.2 Glossary . 24. Quality assurance program 34.1 Organizational structure. 44.2 Quality assurance manual 44.3 Design control 54.4 Control of purchased material, equipment, and services . 54.5 Procedures and instructions
26、 . 54.6 Document control. 64.7 Records 64.8 Personnel qualifications. 64.9 Quality control of instruments . 64.10 Product quality control. 74.11 Audits. 75. Facilities and equipment 75.1 Facilities. 75.2 Equipment 86. Participation in NIST MAP . 86.1 Verification tests 86.2 Acceptance criteria. 96.3
27、 Traceability of derived sources 97. Traceability by participation in a national standardizing laboratory (NSL) MAP 108. Certificates . 108.1 Physical description of the source 108.2 Calibration method. 108.3 Impurities . 118.4 Uncertainty estimates. 118.5 Decay data and user notes 119. Bibliography
28、 111American National Standard Traceability of Radioactive Sources to the National Institute of Standards and Technology (NIST) and Associated Instrument Quality Control1. Overview1.1 ScopeThe standard provides a description of the criteria necessary for manufacturers to maintain and assure mea-sure
29、ment traceability of radionuclides to the National Institute of Standards and Technology (NIST). Thesecriteria are provided in the following areas:a) Quality assurance program b) Facilities and equipmentc) Participation in a NIST Measurements Assurance Program (MAP)d) Certificates1.2 PurposeThe purp
30、ose of this standard is to describe a mechanism for manufacturers to establish traceability of radio-nuclide sources that are certified for radionuclide activity (Bq); concentration (Bq/g); or alpha, beta, x-, orgamma-ray-emission rate (s1) to NIST. Traceability requires the implementation of a qual
31、ity assurance pro-gram and participation in a MAP as described in this standard.2. ReferencesThis standard shall be used in conjunction with the following publications. If the following publications aresuperseded by an approved revision, the revision shall apply.ANSIN42.22-1995 AMERICAN NATIONAL STA
32、NDARD TRACEABILITY OF RADIOACTIVE2ANSI N42.14-1991, American National Standard Calibration and Use of Germanium Spectrometers for theMeasurement of Gamma-Ray Emission Rates of Radionuclides.1ANSI N42.15-1990, American National Standard Performance Verification of Liquid-Scintillation Systems.ANSI PN
33、42.23/D2, Draft Measurement and Associated Instrumentation Quality Assurance for RadioassayLaboratories, Aug. 1994.2ASME NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facilities.3ISO/IEC Guide 25: 1990, General requirements for the competence of calibration and testing laboratories.
34、43. Definitions3.1 Special word usageThe word “shall” denotes a requirement and the word “should” denotes a recommendation. To conform tothis standard, sources shall be manufactured in accordance with the requirements of this standard, but notnecessarily with its recommendations. However, justificat
35、ion should be documented for deviations from rec-ommendations.3.2 Glossary3.1 certified sources.Sources that have been certified for radionuclide activity (Bq); concentration (Bq/g);or alpha, beta, x-, or gamma-ray emission rate (s1).3.2 derived traceable sources. Sources prepared or derived from ce
36、rtified sources that have been calibratedin accordance with this standard. Examples are dilutions of a liquid standard and special geometries such ascharcoal cartridges, marinelli (reentrant) beakers, and filters.3.3 manufacturer.Any organization that produces and distributes sources that are certif
37、ied with respect toradionuclide activity or a radiation emission rate.3.4 Measurements Assurance Program (MAP).A program that allows manufacturers to verify the accu-racy of their measurements through exchange and measurement of samples with NIST. This involves theanalysis of blind test samples sent
38、 to the manufacturers by NIST, and NIST measurement of sources certifiedand provided by the manufacturers.3.5 NIST. The National Institute of Standards and Technology, the US federal agency with legally mandatedauthority to maintain national physical standards for the activity of radionuclides.3.6 N
39、IST source verification.The process of verification of the capability of a manufacturer to calibrate aradionuclide source that is traceable to NIST. This is achieved through calibration by the manufacturer of a1N42 publications are available from the Institute of Electrical and Electronics Engineers
40、, 445 Hoes Lane, P.O. Box 1331, Piscataway,NJ 08855-1331, USA.2This authorized standards project was not approved at the time this went to press. It is available from the IEEE. 3ASME publications are available from the American Society of Mechanical Engineers, 22 Law Drive, Fairfield, NJ 07007, USA.
41、4ISO publications are available from the ISO Central Secretariat, Case Postale 56, 1 rue de Varemb, CH-1211, Genve 20, Switzer-land/Suisse. ISO publications are also available in the United States from the Sales Department, American National Standards Institute,11 West 42nd Street, 13th Floor, New Y
42、ork, NY 10036, USA.ANSISOURCES TO NIST AND ASSOCIATED INSTRUMENT QUALITY CONTROL N42.22-19953source distributed by NIST without disclosure of the known value. The reported value is compared to theNIST value and, if appropriate, a report of traceability is issued.3.7 product verification.The process
43、of verification of the traceability of a calibration standard of a manu-facturer by NIST. This is achieved by the submission of a source from a manufacturer to NIST for verifica-tion of the value certified by the manufacturer. The reported value is compared to the NIST value, and ifappropriate, a re
44、port of traceability is issued.3.8 NIST traceability. The process of relating the measurement accuracy of radionuclide sources to nationalphysical standards. Traceability is achieved by demonstrating the capability to produce accurate standard-ized sources by participation in a MAP with linkage to N
45、IST and production of certified materials in accor-dance with a quality assurance program that meets the guidance provided in this standard. Traceability ofsources requires demonstrated measurement traceability as described in clause 6 and applies only to prod-ucts produced in accordance with this s
46、tandard.3.9 reference material.A material or substance one or more properties that are sufficiently well establishedto be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning val-ues to materials.3.10 total propagated uncertainty.An estimate or approxima
47、tion of the accuracy of a measured value bypropagation of individual uncertainties in accordance with NIST recommendations B4.3.11 verification. Confirmation by examination (testing) with evidence that specified requirements havebeen met.4. Quality assurance programTo establish and maintain traceabi
48、lity, manufacturers shall implement a quality assurance program. Qualityassurance consists of all planned and systematic actions that provide confidence in the manufacturing andcalibration of sources. The quality assurance program shall be documented in a quality assurance manual,which is controlled
49、 to ensure that responsible individuals are utilizing the current version.Guidance for establishing quality assurance programs can be found in a number of documents, includingASME NQA-1-1994,5ISO Guide 25, ANSI PN42.23, and B6. ASME NQA-1-1994 addresses NuclearRegulatory Commission (NRC) quality assurance requirements contained in 10 CFR 50 Appendix B fornuclear facilities (nuclear power reactors and fuel facilities) B5. While there are no regulatory require-ments for suppliers of certified radionuclide sources to meet this standard, appropriate sections of ASMENQA-1-1994 have
