1、ANSI/HPS N13.39-2001 Health Physics Society An American National Standard Design of Internal Dosimety Programs Supplement 5 HEALTH PHYSICS 2001 i ANSI/HPS N13.39-2001 American National Standard Design of Internal Dosimetry Programs Approved: May 24, 2001 Reaffirmed: July 19, 2011 American National S
2、tandards Institute, Inc. ii Published by Health Physics Society 1313 Dolley Madison Blvd. Suite 402 McLean, VA 22101 Copyright 2001 by 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 pr
3、ior written permission of the publisher. Printed in the United States of America ANSI/HPS N13.39-2001 iii Contents 1. Introduction 1 2. Scope, Purpose, and Application 1 2.1 Normative References 2 3. Definitions for this Standard 2 3.1 Bioassay . 2 3.2 Detection Levels . 3 3.3 Dose 3 3.4 Intake, Lim
4、its. 3 3.5 Quality. 4 3.6 Reference Levels 5 3.7 Types of Monitoring Program . 5 3.8 Uncategorized Definitions. 5 4. Essential Elements of Internal Dosimetry Programs 6 4.1 Program Organization. 6 4.1.1 Management . 6 4.1.2 Staffing 6 4.1.3 Qualifications, Training, and Resources . 6 4.2 Program Doc
5、umentation. 7 4.2.1 Program Description . 7 4.2.2 Procedures Documentation 7 4.2.3 Technical Basis Documentation 7 4.3 Monitoring for Intakes . 7 4.3.1 Criteria for Selecting Workers and Others for Monitoring of Intakes 8 4.3.2 Minimum Detection Levels for Bioassay Measurements 8 4.4 Investigating P
6、otential Intakes 8 4.5 Assessing Internal Dose. 8 4.6 Recording and Reporting 9 4.7 Quality Assurance and Quality Control. 9 4.8 Evaluating Compliance . 9 5. Reference Levels 9 5.1 Applicability. 9 5.2 Derived Reference Levels 10 5.3 Screening Level 11 iv 5.4 Verification Level. 11 5.5 Investigation
7、 Level 12 5.6 Medical Referral Level 12 5.7 Flowchart 12 6. Organization 13 6.1 Organizational Requirements . 13 6.2 Staffing Requirements 13 6.3 Staff Qualifications 13 6.4 Training . 15 6.4.1 Radiation Workers. 15 6.4.2 Internal Dosimetry Technicians, Counting Equipment Operators, and Radiochemist
8、ry Technicians . 15 6.4.3 Internal Dosimetrists . 15 6.5 Retraining and Continuing Education . 15 7. Program Documentation . 16 7.1 Program Description . 16 7.2 Technical Basis Document . 16 7.3 Procedures 17 7.4 Control and Revision of Documents . 17 8. Quality Assurance . 17 8.1 Objectives . 17 8.
9、2 Activities Affected by Quality 17 8.3 Achieving Quality Assurance Objectives 18 8.3.1 Organizational Structure . 18 8.3.2 Resources and Personnel. 18 8.3.3 Operations. 18 8.3.4 Records. 19 8.3.5 Auditing the Quality System 19 8.3.6 Use of Computer Hardware and Software 19 8.3.7 Acquisition of Data
10、 19 8.3.8 Peer Review 19 9. Monitoring for Intakes of Radionuclides 20 9.1 Types of Monitoring Programs 20 9.2 Selection of Monitoring Methods 20 9.3 Interferences in Monitoring Methods 21 9.4 Frequency of Monitoring . 21 v 9.5 Derived Reference Levels for Routine Monitoring 22 9.6 Bioassay Sampling
11、 and Measurements . 22 9.7 Confirmation of Intake. 23 10. Participation in Intake Monitoring Programs . 24 10.1 Confirmatory Monitoring . 24 10.2 Routine Monitoring Participation Level . 25 10.3 Special Monitoring 26 11. Internal Dose Assessment 26 11.1 Biokinetic Models 27 11.2 Exceptions to Standa
12、rd Models 27 11.2.1 Radionuclides Used in Medical and Biological Research. 27 11.2.2 Site-Specific Models 27 11.2.3 Significant Personal Variations . 27 11.2.4 Exposures Above the Investigation Level. 28 11.2.5 Decorporation Therapy . 28 11.3 Calculation of Dose. 28 11.3.1 Direct Determination of th
13、e Number of Transformations in the Body or an Organ. 28 11.3.2 Two-Step Method 28 11.4 Factors that Influence Accuracy of Internal Dose. 29 11.4.1 Accuracy of Bioassay Measurements. 29 11.4.2 Time of Intake 29 11.4.3 Lung Solubility Class. 29 11.4.4 Particle Size Distribution . 29 11.4.5 Metabolic M
14、odel 30 11.4.6 Interference from Prior Intakes or Non-Occupational Exposures. 30 11.4.7 Uncertainties in Internal Dose Estimates 30 11.5 Work Restriction . 30 11.6 Action Levels Implying Increasing Complexity of Dose Assessment . 30 11.6.1 Less than 1 Investigation Level. 30 11.6.2 Greater than 1 In
15、vestigation Level 30 11.7 Reevaluation of a Dose 30 12. Incident Response 31 12.1 Response Plans 31 12.2 Medical Intervention 31 12.3 Collection and Analysis of Samples . 32 vi 12.4 Effect of Medical Intervention on Intake and Dose Assessment 32 12.5 Workplace Samples 32 13. Record and Report Requir
16、ements 33 13.1 Recordkeeping Requirements 33 13.2 Types of Records 33 13.2.1 Records Related to the Individual Worker 33 13.2.2 Records Related to Procedures and Methods 33 13.3 Reporting of Internal Doses to Workers . 33 13.4 Reporting Data and Results 34 13.4.1 Air Sampling and Bioassay Measuremen
17、ts 34 13.4.2 Committed Effective Dose. 34 13.4.3 Organ Committed Equivalent Dose 34 13.5 Dose Assessment Documentation . 34 13.5.1 Assessment of Current Doses 34 13.5.2 Dose to the Embryo/Fetus 34 13.5.3 Dose Reassessments . 34 13.6 Privacy, Security and Retention of Records. 35 13.6.1 Privacy of Re
18、cords 35 13.6.2 Identification of the Individual 35 13.6.3 Security and Back-up of Records . 35 13.6.4 Retention of Records 35 14. References 35 15. Bibliography. 37 APPENDIX A - GUIDANCE FOR BIOASSAY IMPLEMENTATION LEVELS BASED ON MATERIAL IN PROCESSA-1 APPENDIX B - RATIONALE FOR REFERENCE LEVELSB-
19、1 APPENDIX C - UNCERTAINTIES IN INTERNAL DOSE ESTIMATES. C-1 APPENDIX D - ACRONYMS . D-1 vii The Health Physics Society Standards Committee Working Group responsible for generating this standard was composed of the following members: Donald E. Bihl, Chair Pacific Northwest National Laboratory, U.S.A
20、. Carol D. Berger Integrated Environmental Management, Inc., U.S.A. Elizabeth M. Brackett MJW Corporation, U.S.A. Darrell R. Fisher Pacific Northwest National Laboratory, U.S.A. Frank E. Gallagher III University of California, Irvine, U.S.A. James P. Griffin MJW Corporation, U.S.A. Richard B. Holtzm
21、an Emeritus from Argonne National Laboratory, U.S.A. Walter S. Loring U.S. Army, U.S.A. Karam S. Thind Ontario Hydro, Canada Consultants: William Inkret Los Alamos National Laboratory, U.S.A Brian Methe Albany Medical Center, U.S.A. Michael Stabin Oak Ridge Institute for Science and Education, U.S.A
22、. Daniel J. Strom Pacific Northwest National Laboratory, U.S.A. Robert Wilson University of North Carolina at Chapel Hill, U.S.A Maria Limson Zamora Health Canada, Canada viii This standard was consensus balloted and approved by the ANSI-Accredited HPS N13 Committee on July 24, 2001. At the time of
23、balloting, the HPS N13 Committee had the following membership: Chairperson Joseph Ring Vice Chairperson Toshihide Ushino American Chemical Society Al Zirkes American College of Occupational and Environmental Medicine Bryce Breitenstein American Industrial Hygiene Association Bruce Zaczynski American
24、 Iron and Steel Institute Anthony LaMastra Peter Hernandez (alt.) American Mining Congress Scott Munson American Nuclear Insurers Jerre Forbes American Nuclear Society Nolan Hertel Conference of Radiation Control Program Directors Roland Fletcher Council on Ionizing Radiation Measurements and Standa
25、rds Jileen Shobe Chris Soares (alt.) Health Physics Society Jack Fix Institute of Electrical and Electronic Engineers Lou Costrell Institute of Nuclear Materials Management Kenneth Okolowitz International Brotherhood of Electrical Workers Will Paul Manuel Mederos (alt.) Nuclear Energy Institute Ralp
26、h Andersen Oil, Chemical and Atomic Workers International Union Mark Griffon Dave Ortlieb (alt.) U.S. Department of Commerce Lester Slaback, Jr. Timothy Mengers (alt.) U.S. Department of Energy Robert Loesch Joel Rabovsky (alt.) U.S. Department of Defense John Esterl Pat Keller (alt.) U.S. Environme
27、ntal Protection Agency Frank Marcinowski Mike Boyd (alt.) U.S. Nuclear Regulatory Commission Donald Cool U.S. Navy Paul Blake Karl Mendenhall (alt.) Individual John Auxier Individual Ronald Kathren Individual Edward Reitler, Jr. Individual L. Max Scott Individual Kenneth Swinth Individual Al Tschaec
28、he Individual McDonald Wrenn AMERICAN NATIONAL STANDARD HPS N13.39-2001 1 Design of Internal Dosimetry Programs 1. Introduction Internal dosimetry is the science of assessing the amount and distribution of radionuclides in the body, and calculating resulting radiation doses to internal organs or tis
29、sues over specific time periods. Because the ionizing radiation energy deposited in a particular organ from radionuclides incorporated in the body cannot be measured directly, internal doses are estimated or inferred from in vivo or in vitro bioassay or from air concentration measurements. During wo
30、rk at nuclear facilities, the potential for intake of radionuclides by ingestion, inhalation, wound, or absorption through the skin often exists. Therefore, internal dosimetry programs are instituted to monitor the type and magnitude of such intakes and radiation dose associated with them. 2. Scope,
31、 Purpose, and Application In the past, internal dosimetry standards have focused on providing guidance for detection and dose assessment for specific radionuclides or groups of radionuclides (e.g., tritium, uranium, and fission and activation products). Frequently, however, these standards provided
32、conflicting or uneven treatment of the programmatic elements that are basic to monitoring for and assessing the dose from any radionuclide. Therefore, this standard was developed to provide uniform and consistent guidance on programmatic issues that are universally applicable to all radionuclides an
33、d all occupational intake pathways. This standard contains the essential elements of the internal dosimetry component of a radiation protection program. It provides general policies and the framework for the design and imple-mentation of an acceptable internal dosimetry program. The topics included
34、herein are definitions, organization, staffing and training, program documentation, quality assurance, personnel participation, internal dose assess-ment, incident response, and records and reports. Other than those examples necessary for clarification, this standard does not address bioassay or int
35、ernal dose assessment methodologies for specific radionuclides.(a)It is intended that the development and imple-mentation of radionuclide-specific dosimetry programs be consistent with the broad-scoped guidance provided herein. By its very nature, internal dosimetry is a complex task with varying de
36、grees of difficulty, depending upon the radionuclide and the means by which the radionuclide is metabolized. For some radionuclides, such as tritium, it is relatively easy to monitor for and assess intakes that result in small doses. For others, such as (a) Also excluded is information on dosimetric
37、 quantities and units, regulatory interactions, regulatory or administrative dose limits, methods of and recommendations on decorporation therapy, performance require-ments for bioassay methodologies, bioassay frequencies, and uncertainties in assess-ment results. The reader is referred to the Refer
38、ences for information on these and related topics. HPS N13.39-2001 2 239Pu, the task is significantly more difficult. Therefore, while this standard provides the minimal acceptable elements of an internal dosimetry program regardless of the radio-nuclide, it should not be used to restrict the level
39、of excellence readily achievable for some radionuclides. This standard provides guidance for programs where monitoring for possible intakes by workers is part of the radiation protection program. Engineered containment and administrative controls are used to minimize the probability of an intake due
40、 to normal operations and accident releases. Workplace surveillance practices identify that the containment and administrative controls are effective. Routine bioassay monitoring provides verification that radiological controls are being maintained and work effectively. Special bioassay is performed
41、 in response to indications of an abnormal condition that might have resulted in an intake. This standard focuses on establishing intake monitoring programs, identifying intakes, and assessing internal dose. It does not address equally important aspects of radiation protection involving minimizing i
42、ntakes or implementing as-low-as-reasonably-achievable total dose control programs. A graded approach is presented to account for programs involving only a small risk of intake through programs with a risk of intake that might result in an exposure above regulatory limits or even potential radiation
43、-induced health effects. Although most of the standard addresses details relevant to programs with known or substantial risks of intakes, it is recognized that one important purpose of internal dosimetry programs is to document that workplace controls are adequate and no recordable intakes are occur
44、ring. Therefore, some guidance is provided for programs (or a part of a program) that would not be expected to involve dose assessment. 2.1 Normative References The following standards contain provisions that, through reference in this text, constitute provisions of this American National Standard.
45、At the time of publication, the editions indicated were valid. All standards are subject to revisions, and parties to agreements, based on this American National Standard, are encouraged to investigate the possibility of applying the most recent edition(s) of the standards indicated below: 1) An Ame
46、rican National Standard Perform-ance Criteria for Radiobioassay, HPS N13.30-1996. 2) An American National Standard Practice for Occupational Radiation Exposure Records System, ANSI/HPS N13.6-1999. 3. Definitions for this Standard Definitions are grouped by subject matter and are arranged alphabetica
47、lly within each grouping. 3.1 Bioassay Bioassay. In this standard, bioassay is synonymous with radiobioassay; measurement of amount or concentration of radioactive material in the body or in biological material excreted or removed from the body and analyzed for purposes of estimating the intake or a
48、mount of radioactive material in the body. Bioassay, baseline. Measurements performed prior to the commencement of duties involving risk of intake of radioactive material. HPS N13.39-2001 3 Bioassay, in vitro (or indirect). Measurements to determine the presence of or to estimate the amount of radio
49、active material in excreta or other biological materials removed from the body. Bioassay, in vivo (or direct). Measurements of radioactive material in the body using instru-ments that detect radiation emitted from the radioactive material in the body. Bioassay, termination (or ending work assignment). Measurements performed after the worker has ceased working where there was risk of an intake or because a confirmatory measurement is desired. Termination bioassay is specific for radionuclides to which the worker was at risk of intake, not to radiation work in general. For instance, if
