1、The Institute of Electrical and Electronics Engineers, Inc.3 Park Avenue, New York, NY 10016-5997, USACopyright 1997 by the Institute of Electrical and Electronics Engineers, Inc.All rights reserved. Published 1997. Printed in the United States of America.ISBN 1-55937-884-0No part of this publicatio
2、n may be reproduced in any form, in an electronic retrieval system or otherwise, without the priorwritten permission of the publisher.ANSI N42.23-1986 (R2004)American National StandardMeasurement and AssociatedInstrument Quality Assurance for Radioassay LaboratoriesSponsorNational Committee on Radia
3、tion Instrumentation, N42accrediated by theAmerican National Standards InstituteSecretariatThe Institute of Electrical and Electronics Engineers, Inc.Approved 16 July 1996Reaffirmed 2 December 2004American National Standards InstituteAbstract: A framework that can be used to create a national or an
4、organizational NIST-traceable measure-ment quality assurance (MQA) program that will optimize the quality of radioassays performed by service lab-oratories is presented. This standard serves as a guide for MQA programs developed for specialized sectorsof the radioassay laboratory community, i.e., bi
5、oasssay, routine environmental monitoring, environmental res-toration and waste management, radiopharmaceuticals nuclear power radiochemistry, and other areas in-volved in radioassays.Keywords: Laboratory, measurement quality assurance, quality, quality assurance, quality control, radiationinstrumen
6、tation, radioactivity, radioassay laboratory, radioassays, radiometrologIEEE Standardsdocuments are developed within the IEEE Societies and the Standards Coordinat-ing Committees of the IEEE Standards Board. Members of the committees serve voluntarily andwithout compensation. They are not necessaril
7、y members of the Institute. The standards developedwithin IEEE represent a consensus of the broad expertise on the subject within the Institute as wellas those activities outside of IEEE that have expressed an interest in participating in the develop-ment of the standard.Use of an IEEE Standard is w
8、holly voluntary. The existence of an IEEE Standard does not implythat there are no other ways to produce, test, measure, purchase, market, or provide other goods andservices related to the scope of the IEEE Standard. Furthermore, the viewpoint expressed at thetime a standard is approved and issued i
9、s subject to change brought about through developments inthe state of the art and comments received from users of the standard. Every IEEE Standard is sub-jected to review at least every five years for revision or reaffirmation. When a document is morethan five years old and has not been reaffirmed,
10、 it is reasonable to conclude that its contents,although still of some value, do not wholly reflect the present state of the art. Users are cautioned tocheck to determine that they have the latest edition of any IEEE Standard.Comments for revision of IEEE Standards are welcome from any interested pa
11、rty, regardless ofmembership affiliation with IEEE. Suggestions for changes in documents should be in the form of aproposed change of text, together with appropriate supporting comments.Interpretations: Occasionally questions may arise regarding the meaning of portions of standards asthey relate to
12、specific applications. When the need for interpretations is brought to the attention ofIEEE, the Institute will initiate action to prepare appropriate responses. Since IEEE Standards rep-resent a consensus of all concerned interests, it is important to ensure that any interpretation hasalso received
13、 the concurrence of a balance of interests. For this reason, IEEE and the members of itssocieties and Standards Coordinating Committees are not able to provide an instant response tointerpretation requests except in those cases where the matter has previously received formalconsideration. Comments o
14、n standards and requests for interpretations should be addressed to:Secretary, IEEE Standards Board445 Hoes LaneP.O. Box 1331Piscataway, NJ 08855-1331USAAuthorization to photocopy portions of any individual standard for internal or personal use isgranted by the Institute of Electrical and Electronic
15、s Engineers, Inc., provided that the appropriatefee is paid to Copyright Clearance Center. To arrange for payment of licensing fee, please contactCopyright Clearance Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA;(508) 750-8400. Permission to photocopy portions of any individual
16、 standard for educational class-room use can also be obtained through the Copyright Clearance Center.Note: Attention is called to the possibility that implementation of this standard mayrequire use of subject matter covered by patent rights. By publication of this standard,no position is taken with
17、respect to the existence or validity of any patent rights inconnection therewith. The IEEE shall not be responsible for identifying patents forwhich a license may be required by an IEEE standard or for conducting inquiries intothe legal validity or scope of those patents that are brought to its atte
18、ntion.iiiIntroduction(This introduction is not a part of ANSI N42.23-1996, American National Standard Measurement and Associated Instrument QualityAssurance for Radioassay Laboratories.)This standard is the responsibility of the Accredited Standards Committee on Radiation Instrumentation,N42. Commit
19、tee 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-ter ballot of 2 M
20、arch 1995, closed 15 December 1995.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 Gove
21、rnmental Industrial HygienistsJesse LiebermanBattelle Pacific Northwest Laboratories Kenneth L. SwinthEG the National Institute of Standards and Technology(NIST); and the reference, monitoring, and service laboratoriesc) The protocol for the preparation and distribution of test media by the monitori
22、ng or referencelaboratoriesd) The bases for calculating the required accuracy and precision parameters of radioassaymeasurementse) The protocol for the evaluation and reporting of test resultsf) The protocol for the assessment and evaluation of test results and reporting assessment findings bythe ac
23、crediting organizationg) Guidance for determining the decision limit concentration and the a prioriminimum detectable con-centration for each radionuclide (see annex A)h) The requirements for reporting radioassay results by service laboratories to the customeri) Eleven key elements of a viable QA pr
24、ogram applicable to the service, monitoring, and referencelaboratoriesj) The QA and QC programs for the service, monitoring, and reference laboratoriesSince this is an umbrella MQA standard, no guidance or requirements have been established for the mini-mum performance criteria of precision, accurac
25、y, or detection limits applicable to the routine operation of aradioassay laboratory. However, this standard requires that the service laboratory and its client (either fromwithin the same company or governmental organization, or external) establish precision, bias, detectionlimit, and other quality
26、 performance specifications for each radionuclide within a preprocessing agreementor contract. These quality performance specifications shall be related to the data quality objectives requiringthe radioassays. For radioassays requiring a quality measurement assurance program, this standard requirest
27、he use of a third-party monitoring laboratory to evaluate the ongoing capability of the service laboratory tomeet pre-established, contractual performance specifications. If agreed by the client and service laboratory,the internal QA program of the service laboratory may function as a monitoring lab
28、oratory as long as therequirements for the monitoring laboratory as established in this standard are met.This standard has outlined the minimum requirements necessary to maintain a viable measurement assur-ance program by a radioassay laboratory. As outlined in this standard, the testing of the refe
29、rence, monitor-ing, and service laboratories to assay radionuclides specified in the various testing categories properly is forANSIINSTRUMENTATION QUALITY ASSURANCE FOR RADIOASSAY LABORATORIES N42.23-19963accreditation purposes only. This testing program has been developed to ensure that all radioas
30、say laborato-ries have, at a minimum, radiation measurement instrumentation, representing each radioactive emissiontype, that has been calibrated with radioactive materials traceable to NIST. This testing is considered a mini-mum effort in the accreditation process. As stated previously, it is the r
31、esponsibility of a person or organiza-tion requiring radioassays to incorporate detailed performance specifications for each radionuclide andmatrix within a contract for the service laboratory. A monitoring laboratory shall be utilized to evaluate thecompliance by the service laboratory with the per
32、formance specifications.Several annexes have been developed to provide additional background information, clarifications, and, insome cases, requirements of the standard. Annex A is considered part of this standard and, as such, therequirements specified shall be followed. Annexes B, C, and D provid
33、e information and guidance to supportthe general concepts and recommendations outlined in this standard.2. ReferencesThis standard shall be used in conjunction with the following publications. When the following standards aresuperseded by an approved revision, the revision shall apply.ANSI N13.30-19
34、96, American National Standard for Performance Criteria for Radiobioassay.1ANSI N343-1978 (Reaff 1984), American National Standard Internal Dosimetry for Mixed Fission andActivation Products. ANSI Z34.1-1993, American National Standard for CertificationThird-Party Certification Programs forProducts,
35、 Processes, and Services.ANSI/ASME N45.2.9-1979, Requirements for Collection, Storage and Maintenance of Quality AssuranceRecords for Nuclear Power Plants.2ANSI/ASME NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facilities. ASTM E 29-93a, Standard Recommended Practice For Indicating
36、 Which Places Of Figures Are To Be Con-sidered Significant In Specified Limiting Value.3IEEE Std 1012-1986 (Reaff 1992), IEEE Standard for Software Verification and Validation Plans.4NBS IR 89-4125, Operational And Technical Requirements For Laboratory Accreditation Program For Per-sonnel Dosimetry
37、Processors, July 1989.53. GlossaryThe following terms are of a restricted nature for the purposes of this standard. Terms defined in the Glos-sary of Terms in Nuclear Science and TechnologyB16are not defined in this standard.1ANSI publications are available from the Sales Department, American Nation
38、al Standards Institute, 11 West 42nd Street, 13th Floor,New York, NY 10036, USA.2ASME publications are available from the American Society of Mechanical Engineers, 22 Law Drive, Fairfield, NJ 07007, USA.3ASTM publications are available from the American Society for Testing and Materials, 100 Barr Ha
39、rbor Drive, West Conshohocken,PA 19428-2959, USA.4IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, P.O. Box 1331, Piscataway,NJ 08855-1331, USA.5NBS publications are available from the Superintendent of Documents, US Government Printing Offic
40、e, P.O. Box 37082, Washington,DC 20013-7082, USA.6The numbers in brackets preceded by the letter B correspond to those of the bibliography in clause 6.ANSIN42.23-1996 AMERICAN NATIONAL STANDARD MEASUREMENT AND ASSOCIATED43.1 Special word usageThe word “shall” is used to denote a requirement; the wor
41、d “should” is used to denote a recommendation;and the word “may” is used to denote permission, neither a requirement nor a recommendation. To conformto this standard, all radioassays shall be performed in accordance with its requirements, but not necessarilywith its recommendations; however, justifi
42、cation shall be documented for deviations from recommendations.3.2 Specific terms3.2.1 accreditation: The systematic and objective determination of the competence of a laboratory to per-form its services according to specific test methods/standards, made by a qualified accreditation body, andissuanc
43、e of a certificate attesting to that competence by the body.3.2.2 audit: A planned and documented activity performed to determine by investigation, examination, orevaluation of objective evidence the adequacy of and compliance with established procedures, instructions,drawings, and other applicable
44、documents, and the effectiveness of implementation. An audit should not beconfused with surveillance or inspection activities performed for the sole purpose of process control or prod-uct acceptance. 3.2.3 analyte: The particular radionuclide(s) to be determined in a sample of interest. As a matter
45、of claritywhen interpreting various clauses of this standard, a gamma-ray spectral analysis is considered one analyte.3.2.4 assessment: A planned and documented activity performed to determine whether various elementswithin a quality management system are effective in achieving stated quality object
46、ives.3.2.5 accuracy: A concept employed to describe the dispersion of measurements with respect to a knownvalue. A measurement with small systematic uncertainties is said to have high accuracy.3.2.6 average relative bias (Br): The average relative bias,Br, for a test category is calculated from the
47、indi-vidual relative biases, Bri, and defined aswhereNis the maximum number of test samples measured by an individual service laboratory in a giventest category. The sample size Nshall be at least five.iis the ith sample3.2.7 background: Ambient signal response, recorded by measuring instruments, th
48、at is independent ofradioactivity contributed by the radionuclides being measured in the sample.3.2.8 bias: (a) The deviation of the expected value of a random variable from a corresponding stated (corrector known) value. (b) A fixed deviation from the true value that remains constant over replicate
49、d measure-ments within the statistical precision of the measurement. Syn: deterministic error, fixed error, systematicerror.3.2.9 bias statistic: An estimation of bias calculated from a finite sample of data using a specified formula.BrBrii 1=NN-=ANSIINSTRUMENTATION QUALITY ASSURANCE FOR RADIOASSAY LABORATORIES N42.23-199653.2.10 blind matrix spike: A matrix spike sample sent through normal processing wherein the processorknows that the sample is of quality control origin but does not know the nuclide or nuclide concentration.The terminology “single-blind matrix spike” is al
