1、 American National Standard ANSI/HPS N13.30-2011 (R2017) Performance Criteria for Radiobioassay Approved 16 December 2011 Reaffirmed 14 June 2017 American National Standards Institute, Inc. ii Published by Health Physics Society 1313 Dolley Madison Blvd. Suite 402 McLean, VA 22101 Copyright 2017 by
2、the Health Physics Society. All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the United States of America ANSI/HPS N13.30-2011 (R2017) iii This standard was co
3、nsensus-balloted and approved by the ANSI/HPS N13 Committee on 9 December 2011. At the time of balloting, the N13 Committee had the following membership: Chairperson Tracy A. Ikenberry Vice Chairperson Michelle L. Johnson American Association of Physicians in Medicine (AAPM) Robert A. Phillips Ameri
4、can College of Occupational and Environmental Medicine Bryce Breitenstein American Industrial Hygiene Association (AIHA) Ray Johnson American Iron and Steel Institute Anthony La Mastra American Mining Congress Scott C. Munson American Nuclear Insurers Bob Oliveira American Nuclear Society (ANS) Nola
5、n E. Hertel Conference of Radiation Control Program Directors (CRCPD) Earl Fordham Council on Ionizing Radiation Measurements and Standards (CIRMS) Chris Soares Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) Leonard Smith Health Physics Society (HPS) Sandy Perle Institute of Electri
6、cal and Electronic Engineers (IEEE) Mike Unterweger Institute of Nuclear Materials Management (INMM) Vacant National Council on Radiation Protection and Measurements (NCRP) David Schauer National Registry of Radiation Protection Technologists (NRRPT) Dwaine Brown Nuclear Energy Institute (NEI) Ralph
7、 L. Andersen U.S. Department of Commerce Thomas J. McGiff U.S. Department of Energy Joel Rabovsky U.S. Department of Defense Timothy Mikulski U.S. Department of Homeland Security Don Potter U.S. Environmental Protection Agency Mike Boyd U.S. Nuclear Regulatory Commission Donald A. Cool U.S. Navy Lui
8、s A. Benevides Individual members Joseph P. Ring L. Max Scott Toshihide Ushino A. N. Tschaeche iv The ANSI/HPS N13.30 Working Group responsible for the development of this standard had the following members: Jay MacLellan, Chair Pacific Northwest National Laboratory Steven Baker Pacific Northwest Na
9、tional Laboratory Anita Bhatt U.S. DOE Radiological and Environmental Sciences Laboratory David McCurdy Technical Consultant Dawn Lewis Los Alamos National Laboratory Frazier Bronson Canberra Kenneth Inn National Institute of Standards and Technology Matt Lardy TestAmerica Laboratories, Inc. J. Stan
10、 Morton GEL Laboratories, LLC Myint Thein Oak Ridge National Laboratory, retired Thomas LaBone MJW Corporation The current working group gratefully acknowledges the valuable contributions from past working group member Allen Brodsky (Georgetown University). This standard was interactively reviewed b
11、y members of the U.S. DOE Radiological and Environmental Sciences Laboratory. Individuals who reviewed and commented on the standard included Guy Marlette and Guy Backstrom. v Oversight for development of this standard was provided by the N13 Administrative Committee, which had the following members
12、: Chair: Tracy A. Ikenberry Vice-Chair: Michelle L. Johnson Secretary/Standards Coordinator: Nancy Johnson Internal Dosimetry Section Manager: Timothy Lynch Environmental Section Manager: Tracy A. Ikenberry (acting) External Dosimetry Section Manager: Charles A. (Gus) Potter Instrumentation Section
13、Manager: Michelle Johnson (acting) Medical and Operational Health Physics Section Manager: Robert Forrest vi Contents 1.0 Purpose and Scope 1 1.1 Introduction 1 1.2 Purpose . 1 1.3 Scope 1 2.0 Normative References 2 3.0 Definitions . 2 3.1 Special Word Usage 2 3.2 Specific Terms . 3 4.0 Quality Assu
14、rance and Quality Control for Radiobioassay Service Laboratories 6 4.1 Quality Assurance 6 4.1.1 Quality Assurance Plan . 7 4.1.2 Responsible Quality Assurance Person or Organization 7 4.1.3 Records Retention 7 4.2 Quality Control . 8 4.2.1 Quality Control Procedures . 8 4.2.2 Performance Checks of
15、Instrumentation for Direct and Indirect Radiobioassay . 8 4.2.2.1 Performance Checks on Direct (In Vivo) Radiobioassay Procedures . 8 4.2.2.2 Performance Checks on Indirect (Biological Sample) Radiobioassay Procedures 8 4.2.3 Use of Reference Radioactive Materials . 8 4.3 Performance Criteria for Ra
16、diobioassay 9 4.3.1 Relative Bias . 9 4.3.2 Relative Precision . 9 4.3.3 Relative Bias and Relative Precision Performance Criterion 10 4.3.4 Decision Level (LCor DC) and Minimum Detectable Amount (MDA) . 10 4.3.4.1 Radiobioassay Decision Level (LCor DC) . 10 4.3.4.2 Calculation of Minimum Detectable
17、 Amount (MDA) or Minimum Detectable Concentration (MDC). 11 4.4 Periodic Quality Control Evaluation by the Service Laboratory 11 4.4.1 Periodic Quality Control Evaluation of Bias and Measurement Uncertainty 11 4.4.2 Periodic Quality Control Evaluation of the Decision Level 11 4.4.3 Periodic Quality
18、Control Evaluation of the Minimum Detectable Amount 11 5.0 Direct Radiobioassay (In Vivo Counting) Measurements . 12 5.1 Facility Criteria . 12 5.1.1 Equipment . 12 5.1.2 Services 12 5.1.3 Location 12 5.2 Personnel Preparation . 13 5.3 Interpretation of Measurements . 13 5.3.1 Identification of Radi
19、onuclides 13 5.3.2 Quantification 13 5.4 Reporting Results 14 6.0 Indirect Radiobioassay (In Vitro) Measurements . 14 6.1 Customer Responsibilities 14 6.2 Analytical Methodology 15 6.2.1 Types of Analyses. 15 6.2.2 Analytical Equipment and Facilities. 15 6.2.3 Operating Procedures and Instructions .
20、 15 6.2.3.1 Sample Preparation 15 6.2.3.2 Chemical Procedures . 15 6.2.4 Interpretation of Results 15 vii 6.2.4.1 Identification of Radionuclide(s) 15 6.2.4.2 Quantification 16 6.3 Periodic Quality Control Evaluation by the Service Laboratory 16 6.4 Reporting Results 16 7.0 Performance Testing Progr
21、am 16 7.1 Testing Laboratory . 16 7.2 Testing Protocols . 17 7.3 Test Selection 17 7.4 Evaluation of Laboratory Performance . 17 7.5 Frequency of Testing . 17 7.6 Specification for Test Radionuclide 17 7.7 Selection of Activity 17 7.8 Certification of Activity 17 7.9 Radiobioassay Measurements . 18
22、7.9.1 Direct Radiobioassay Measurements . 18 7.9.1.1 Direct Radiobioassay Test Phantom Distribution and Instructions 18 7.9.1.2 Direct Radiobioassay Measurement Protocol . 18 7.9.1.3 Direct Radiobioassay Reporting Protocol . 18 7.9.1.4 Direct Radiobioassay Test Categories 18 7.9.1.5 Direct Radiobioa
23、ssay Test Radionuclides and Activity Ranges 18 7.9.1.6 Test Phantom: Lung Measurement. 18 7.9.1.7 Test Phantom: Total Body Measurements 19 7.9.1.8 Test Phantom: Thyroid . 19 7.9.2 Indirect Radiobioassay Measurements . 19 7.9.2.1 Indirect Radiobioassay Test Sample Distribution and Instructions . 19 7
24、.9.2.2 Indirect Radiobioassay Measurement Protocol. 19 7.9.2.3 Indirect Radiobioassay Reporting Protocol . 20 7.9.2.4 Indirect Radiobioassay Test Radionuclides and Activity Ranges . 20 Annex A: Selection of Minimum Testing Levels and Performance Sample Matrix Recipes 23 Annex B: Radiobioassay Proced
25、ures . 25 Annex C: Bibliography 31 Tables Table 1. Maximum acceptable number of incorrect detection decisions out of N measurements. 12 Table 2. Minimum testing level (MTL) for direct radiobioassay performance testing 21 Table 3. Minimum testing level (MTL) for indirect radiobioassay performance tes
26、ting . 22 Table B1. Radiobioassay uncertainty estimates . 29 Table B2. Synthetic urine matrix recipe . 30 Table B3. Synthetic fecal matrix recipe . 30 AMERICAN NATIONAL STANDARD ANSI/HPS N13.30-2011 1 Performance Criteria for Radiobioassay 1.0 Purpose and Scope 1.1 Introduction In the course of empl
27、oyment, individuals may work with radioactive materials that, under certain circumstances, could be taken into the body. Radiation protection programs may include means for direct or indirect measurements, or both, of radioactive ma-terial that has entered the body. The perfor-mance criteria require
28、d for such measurements usually depend upon the purpose for the radiobioassay measure-ment. Radiobioassay measurements are made for the purpose of determining the internal human burden of radioactive ma-terial, estimating doses and dose commit-ments for risk estimates, radiation protection managemen
29、t, medical management where appropriate, and providing the necessary data for legal and record-keeping require-ments. Measurements that are made as part of a routine monitoring program are usually at a lower minimum detectable amount (MDA) or minimum detectable concentration (MDC) than those to be u
30、sed for diagnostic purposes. Routine examination measure-ments may be made less frequently, and diagnostic measurements may sometimes require more rapid turnaround times. Much of the information in this standard is contained in other internal dosimetry stan-dards for individual radionuclides. This d
31、oc-ument collects, expands, and standardizes the performance criteria contained in the other standards. It also provides a consen-sus on the statistical definitions of the quan-titative performance criteria of bias, precision, and MDA. Section 2.0 provides normative references with direct impact on
32、compliance with this standard. Definitions for certain words used in the text are included in Section 3.0. These definitions are included to give the precise meaning intended. Furthermore, the standard created unique terms; definitions for these terms are given in Section 3.0 as well as in the text.
33、 Sections 4.0 through 6.0 were written primarily to provide guidance for radiobioassay service laboratories, whe-reas Section 7.0 relates to testing laborato-ries and provides criteria for performance testing. The information in these sections provides beneficial insight for service labora-tories, f
34、or users of the laboratorys services, and for testing laboratories, and it provides a possible basis for an interlaboratory quality assurance program. 1.2 Purpose The purpose of this standard is to provide criteria for quality assurance, evaluation of performance, and the accreditation of radiobioas
35、say service laboratories. These criteria include bias, precision, and determination of the MDA or MDC. 1.3 Scope Criteria and guidance for direct radiobioassay (in vivo) and indirect radiobioassay (in vitro) are given in separate sections of this standard. In addition, examples to clarify concepts a
36、nd methods that are described in this standard, and information that may be useful in implementing this standard, are presented in annexes to the standard. The annexes are illustrative and are not a part of the standard. This standard addresses the following: 1. the accuracy (bias and precision) of
37、direct (in vivo) measurements of activity and quantities of selected important ra-dionuclides in test phantoms and indi-rect (in vitro) measurements of activity and quantities of selected important ra-dionuclides in test samples; 2. methods for determining the minimum detectable amount; 3. minimum t
38、esting levels and testing ranges; 4. requirements for reporting radiobioassay results by service laboratories; 5. quality assurance in service laborato-ries; 6. quality control in service laboratories; 7. protocol for reporting test evaluations by ANSI/HPS N13.30-2011 2 service laboratories to the t
39、esting labor-atory; 8. default procedures when the service laboratory customer does not specify the performance criteria. The scope of this standard does not include the following: 1. detailed radiochemical methods for se-parating radionuclides from biological samples; 2. detailed procedures for in
40、vivo and in vitro radioactivity measurements; 3. metabolic data and mathematical mod-els for converting radiobioassay results into absorbed dose and equivalent dose; 4. any aspects of a service laboratory cus-tomers radiation protection program; 5. procedures for the preparation and dis-tribution of
41、 test samples and phantoms by the testing laboratories. Analytical methods for radiobioassay are not currently standardized but are available in the literature. Some analytical methods are provided in references appended to this standard and in other American National Standards Institute (ANSI) stan
42、dards for specific radionuclides. Guidance for con-verting radiobioassay results into dose are provided in publications of federal and state regulations and guides, the International Commission on Radiological Protection (ICRP), the National Council on Radiation Protection and Measurements (NCRP), a
43、nd the International Commission on Radio-logical Units and Measurements (ICRU). Recommendations of the ICRP, NCRP, and ICRU, and experience with the practical application of these recommendations to the conduct of radiobioassay services and the interpretation and use of bioassay results in radiation
44、 protection programs, have been considered in the development of this standard. 2.0 Normative References Application of this standard is contingent upon adherence to the following references: ANSI N44.3-1973. Thyroid radioiodine up-take measurements using a neck phantom. ANSI N42.23-1996. Measuremen
45、t and as-sociated instrument quality assurance for radioassay laboratories. ANSI N13.35-2009. Specifications for the bottle manikin absorption phantom. ANSI/NCSL Z540.2 R2002. American national standard for expressing uncertainty U.S. guide to the expression of uncertainty in measurement. ICRP Publi
46、cation 89; 2001. Basic anato-mical and physiological data for use in radiological protections: reference values. ISO 17025; 2005. General requirements for the competence of testing and calibration laboratories. ISO/IEC Guide 99; 2007. International vo-cabulary of metrologyBasic and general concepts
47、and associated terms (VIM). ISO 43; 1997. Proficiency testing by inter-laboratory comparisons. NCRP Report No. 58; 1985. A handbook of radioactivity measurement procedures. 3.0 Definitions Terms defined in ISO/IEC Guide 99, International Vocabulary of MetrologyBasic and General Concepts and Associat
48、ed Terms (VIM) (ISO/IEC 2007) or the National Institute of Standards and Technology (NIST) Technical Note 1297 (Taylor and Kuyatt 1994), titled Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results, are not defined in this standard. A word or term requiring a more prec
49、ise definition is redefined in this section even though it was included in one of the aforementioned references. The following terms are of a restricted nature for the purposes of this standard. 3.1 Special Word Usage The word “shall“ is used to denote a requirement; the word “should“ is used to ANSI/HPS N13.30-2011 3 denote a recommendation; and the word “may“ is used to denote permission, neither a requirement nor a recommendation. To conform to this standard, all radiobioassays shall be performed in accordance with its requi
