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1、The Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue, New York, NY 10016-5997, USA Copyright 1997 by the Institute of Electrical and Electronics Engineers, Inc. All rights reserved. Published 1997. Printed in the United States of America. ISBN 1-55937-884-0 No part of this publi
2、cation may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission of the publisher. ANSI N42.23-1986 (R2004) American National Standard Measurement and Associated Instrument Quality Assurance for Radioassay Laboratories Sponsor National Commit
3、tee on Radiation Instrumentation, N42 accrediated by the American National Standards Institute Secretariat The Institute of Electrical and Electronics Engineers, Inc. Approved 16 July 1996 Reaffirmed 2 December 2004 American National Standards Institute Abstract: A framework that can be used to crea
4、te a national or an 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 sectors of the radioassay laborat
5、ory community, i.e., bioasssay, 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 c
6、ontrol, radiation instrumentation, radioactivity, radioassay laboratory, radioassays, radiometrolog Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 12:14:25 MDTNo re
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19、f those patents that are brought to its attention. Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 12:14:25 MDTNo reproduction or networking permitted without licens
20、e from IHS -,-,- iii Introduction (This introduction is not a part of ANSI N42.23-1996, American National Standard Measurement and Associated Instrument Quality Assurance for Radioassay Laboratories.) This standard is the responsibility of the Accredited Standards Committee on Radiation Instrumentat
21、ion, N42. Committee N42 delegated development of this standard to Subcommittee N42.RM. Drafts were reviewed by Committee N42, Subcommittee N42.RM, and other interested parties, and the comments received were utilized in producing the standard as fi nally approved. The standard was approved by N42 le
22、t- ter ballot of 2 March 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, Chair Luigi Napoli, Administrative Secretary Organization RepresentedName of Representative
23、American Conference of Governmental Industrial HygienistsJesse Lieberman Battelle Pacifi c Northwest Laboratories Kenneth L. Swinth EG the National Institute of Standards and Technology (NIST); and the reference, monitoring, and service laboratories c)The protocol for the preparation and distributio
24、n of test media by the monitoring or reference laboratories d)The bases for calculating the required accuracy and precision parameters of radioassay measurements e)The protocol for the evaluation and reporting of test results f) The protocol for the assessment and evaluation of test results and repo
25、rting assessment fi ndings by the accrediting organization g)Guidance for determining the decision limit concentration and the a priori minimum detectable con- centration for each radionuclide (see annex A) h)The requirements for reporting radioassay results by service laboratories to the customer i
26、)Eleven key elements of a viable QA program applicable to the service, monitoring, and reference laboratories j)The QA and QC programs for the service, monitoring, and reference laboratories Since this is an umbrella MQA standard, no guidance or requirements have been established for the mini- mum p
27、erformance criteria of precision, accuracy, or detection limits applicable to the routine operation of a radioassay laboratory. However, this standard requires that the service laboratory and its client (either from within the same company or governmental organization, or external) establish precisi
28、on, bias, detection limit, and other quality performance specifi cations for each radionuclide within a preprocessing agreement or contract. These quality performance specifi cations shall be related to the data quality objectives requiring the radioassays. For radioassays requiring a quality measur
29、ement assurance program, this standard requires the use of a third-party monitoring laboratory to evaluate the ongoing capability of the service laboratory to meet pre-established, contractual performance specifi cations. If agreed by the client and service laboratory, the internal QA program of the
30、 service laboratory may function as a monitoring laboratory as long as the requirements 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
31、. As outlined in this standard, the testing of the reference, monitor- ing, and service laboratories to assay radionuclides specifi ed in the various testing categories properly is for Copyright The Institute of Electrical and Electronics Engineers, Inc. Provided by IHS under license with IEEELicens
32、ee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 12:14:25 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI INSTRUMENTATION QUALITY ASSURANCE FOR RADIOASSAY LABORATORIESN42.23-1996 3 accreditation purposes only. This testing program has been developed
33、to ensure that all radioassay laborato- ries have, at a minimum, radiation measurement instrumentation, representing each radioactive emission type, that has been calibrated with radioactive materials traceable to NIST. This testing is considered a mini- mum effort in the accreditation process. As s
34、tated previously, it is the responsibility of a person or organiza- tion requiring radioassays to incorporate detailed performance specifi cations for each radionuclide and matrix within a contract for the service laboratory. A monitoring laboratory shall be utilized to evaluate the compliance by th
35、e service laboratory with the performance specifi cations. Several annexes have been developed to provide additional background information, clarifi cations, and, in some cases, requirements of the standard. Annex A is considered part of this standard and, as such, the requirements specifi ed shall
36、be followed. Annexes B, C, and D provide information and guidance to support the general concepts and recommendations outlined in this standard. 2. References This standard shall be used in conjunction with the following publications. When the following standards are superseded by an approved revisi
37、on, the revision shall apply. ANSI N13.30-1996, American National Standard for Performance Criteria for Radiobioassay. 1 ANSI N343-1978 (Reaff 1984), American National Standard Internal Dosimetry for Mixed Fission and Activation Products. ANSI Z34.1-1993, American National Standard for Certifi catio
38、nThird-Party Certifi cation Programs for Products, Processes, and Services. ANSI/ASME N45.2.9-1979, Requirements for Collection, Storage and Maintenance of Quality Assurance Records for Nuclear Power Plants. 2 ANSI/ASME NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facilities. ASTM
39、E 29-93a, Standard Recommended Practice For Indicating Which Places Of Figures Are To Be Con- sidered Signifi cant In Specifi ed Limiting Value. 3 IEEE Std 1012-1986 (Reaff 1992), IEEE Standard for Software Verifi cation and Validation Plans. 4 NBS IR 89-4125, Operational And Technical Requirements
40、For Laboratory Accreditation Program For Per- sonnel Dosimetry Processors, July 1989. 5 3. Glossary The following terms are of a restricted nature for the purposes of this standard. Terms defi ned in the Glos- sary of Terms in Nuclear Science and Technology B1 6 are not defi ned in this standard. 1
41、ANSI publications are available from the Sales Department, American National Standards Institute, 11 West 42nd Street, 13th Floor, New York, NY 10036, USA. 2 ASME publications are available from the American Society of Mechanical Engineers, 22 Law Drive, Fairfi eld, NJ 07007, USA. 3 ASTM publication
42、s are available from the American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, USA. 4 IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, P.O. Box 1331, Piscataway, NJ 08855-1331, USA. 5 NBS publica
43、tions are available from the Superintendent of Documents, US Government Printing Offi ce, P.O. Box 37082, Washington, DC 20013-7082, USA. 6 The numbers in brackets preceded by the letter B correspond to those of the bibliography in clause 6. Copyright The Institute of Electrical and Electronics Engi
44、neers, Inc. Provided by IHS under license with IEEELicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 12:14:25 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI N42.23-1996AMERICAN NATIONAL STANDARD MEASUREMENT AND ASSOCIATED 4 3.1 Special word usa
45、ge The word “shall” is used to denote a requirement; the word “should” is used to denote a recommendation; and the word “may” is used to denote permission, neither a requirement nor a recommendation. To conform to this standard, all radioassays shall be performed in accordance with its requirements,
46、 but not necessarily with its recommendations; however, justifi cation shall be documented for deviations from recommendations. 3.2 Specifi c terms 3.2.1 accreditation: The systematic and objective determination of the competence of a laboratory to per- form its services according to specifi c test
47、methods/standards, made by a qualifi ed accreditation body, and issuance of a certifi cate attesting to that competence by the body. 3.2.2 audit: A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance
48、 with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or prod- uct acceptance. 3.2.3 analyte: The part
49、icular radionuclide(s) to be determined in a sample of interest. As a matter of clarity when 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 elements within a quality management system are effective in achieving stated quality objectives. 3.2.5 accuracy: A concept employe