1、 American National Standard ANSI/HPS N13.6-2010 Practice for Occupational Radiation Exposure Records Systems Approved: August 3, 2010 American National Standards Institute, Inc. Published by Health Physics Society 1313 Dolley Madison Blvd. Suite 402 McLean, VA 22101 Copyright 2010 by the Health Phys
2、ics 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 N13.6-2010 iii The 2010 version of this standard is a re-af
3、firmation of the 1999 version, performed under the authority of the Health Physics Society Accredited Standards Committee (ASC) N13, Radiation Protection. The Working Group responsible for this standard had the following members: Steven C. Baker, Chairperson (Pacific Northwest National Laboratory) P
4、aul Neeson (U.S. Department of Energy) Richard Piccolo (Varian Medical Systems, Inc.) Billy P. Smith (M. H. Chew demonstrate and facilitate compliance with contractual obligations and applicable legislative and regulatory requirements; reconstruct, if needed for medical or legal purposes, situations
5、 and conditions for analysis of an individuals radiation dose; facilitate coordination and compliance with other programmatic concerns, quality assurance/quality control, vital records, controlled documents, and sensitive records (e.g., Privacy Act of 1979); provide timely, readily retrievable infor
6、mation to enhance organizational efficiency. 1.2 Scope This standard considers records that are necessary to describe the occupational radiation exposure of individuals and the conditions under which the exposure occurred. Any individual for whom individual monitoring is performed to measure exposur
7、e to radiological conditions shall have the monitoring results, including zero doses, recorded in the facility records so that the results are readily retrievable. To accomplish this, comprehensive records should be generated and retained in the following categories: radiological records that are re
8、lated to an individual (e.g., records of bioassay data, results from individually worn do-simeters, skin contaminations, and involvement in radiological incidents); radiological records that are related to the status of work areas (e.g., air-sampling results and radiation surveys); records that desc
9、ribe work requirements, such as protective clothing and equipment, dosimeters to be worn, special criteria and guidelines, etc., for work in radiological areas (e.g., radiological work permits and technical work documents); records that describe the technical and administrative basis for the radiolo
10、gical protection and dosimetry programs (e.g., standards, policies, procedures, and methods of evaluation); records that identify and describe the radiological protection training received by individuals who work in radiological areas. 1.3 Exclusions 1.3.1 Medical exposure records Records of radiati
11、on exposure to the patients or human research subjects resulting from medical diagnostic and therapeutic procedures are not within the scope of this standard. ANSI/HPS N13.6-1999 2 1.3.2 Background exposure Exposure from natural background radiation is normally excluded. Exposure from man-made backg
12、round (e.g., nuclear weapons fallout) is also excluded if it is not a normal part of the workplace conditions. However, enhanced radiation from natural sources that is a result of workplace conditions is included. 1.3.3 Records related to radiological environmental surveillance programs Records of s
13、urveillance and measurement activities to determine the degree and extent of environmental and public sector radiation levels are not within the scope of this standard. 1.3.4 Radiological protection practices Methods that are to be used to obtain radiological measurements or to promote radiological
14、protection are not prescribed in this standard. It is difficult, however, to describe a radiological records system without making some reference to commonly used radiological measurement and control systems and procedures. Nevertheless, it is stressed that any reference in the standard to specific
15、procedures for radiological measurement or control is illustrative only. 1.3.5 Employee coverage Each facility is responsible for identifying which individuals are “occupationally exposed“ or for whom individual exposure record files are required. However, records for all individuals who are monitor
16、ed for radiation exposure, whether they receive any or not, should be included in the radiological records system. 1.3.6 Non-ionizing radiation Non-ionizing radiation hazards such as microwave and laser radiation, and non-radiation hazards, such as chemical exposures are not within the scope of this
17、 standard. 2 Definitions 2.1 Absorbed dose: The energy absorbed per unit mass of irradiated material at the place of interest in the material. 2.2 Bioassay (radiobioassay) The determination, for the purpose of estimating intakes, of kinds, quantities, or concentrations and, in some cases, the locati
18、ons of radioactive material in the human body, whether by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the body (in vitro). 2.3 Dose or radiation dose: A generic term that means absorbed dose, dose equivalent, committed dose equivalent, ef
19、fective dose equivalent, total effective dose equivalent, committed effective dose equivalent, or other dose terms as defined in the regulations applicable to the particular program. 2.4 Dose equivalent The product of the absorbed dose in tissue, the quality factor, and all other necessary modifying
20、 factors 2.5 Dosimeter A device used for measuring or evaluating the absorbed dose, exposure, or similar radiation quantity. 2.6 Exposure limits The maximum effective dose or dose equivalent permitted under specified circumstances. 2.7 Intake The amount of radionuclide taken into the body by inhalat
21、ion, absorption, through intact skin, injection, ingestion, or through wounds. 2.8 Linked or linkable: The referencing, either by listing on the paperwork or by computerized means, of all ANSI/HPS N13.6-1999 3 other documents or database entries associated with an individual record, so that a comple
22、te package of information for that record can be readily assembled. 2.9 Facility: In this standard facility means any workplace where individuals are exposed to radiation or radioactive material to an extent that they are monitored for exposure. 2.10 Facility operator The management of the facility.
23、 2.11 Occupational radiation exposure Radiation exposure resulting from and received in the course of an individuals employment. 2.12 Radiation In the context of this standard, radiation refers to ionizing radiation. Ionizing radiation is any electromagnetic or particulate radiation capable of produ
24、cing ions, directly or indirectly, by interaction with matter. 2.13 Radiation exposure In the context of this standard, “exposure“ refers very broadly to the act or state of being irradiated by ionizing radiation. 2.14 Shall Shall, in this text, indicates an action required by this standard. 2.15 Sh
25、ould Should, in this text, indicates an action that is to be included when practical. 2.16 Survey Evaluation of the radiological conditions incident to the production, use, release, disposal, or presence of sources of ionizing radiation. When appropriate, such evaluation includes a physical survey o
26、f materials and equipment and levels of radiation or concentrations of radioactive material or airborne radioactivity present. 3 General 3.1 Application This standard is intended to provide guidance to all operators of facilities where individuals (employees or non-employees) are monitored for occup
27、ational exposure to ionizing radiation. Application of this standard to a specific situation will be dependent upon the kinds of work performed, the types of radiation exposure encountered, and the nature of the radiation sources. A graded approach, based on the risk of radiation exposure associated
28、 with the facility, may be used. The radiological protection program should be designed to systematically create and then administer the records described in this standard that are applicable to the facility 3.2 Records management practices 3.2.1 Life cycle-approach Each facility operator should est
29、ablish procedures that are based on the records management life cycle approach (i.e., controlling records from creation through disposition). The first step in the life-cycle approach is the identification of all radiological protection program records that are produced in the regular course of busi
30、ness. These records are then managed through the stages of creation, distribution, use, arrangement, storage, retrieval, media conversion (if necessary), and disposition. 3.2.2 Individual personnel records The facility operator should establish and maintain a consolidated record for each individual.
31、 Records related to individuals shall be indexed so that all data for the individual can be readily retrieved by a defined identifier (e.g., Social Security Number, employee number). Although records of medical examinations, chemical exposures, non-ionizing radiation exposures, or other occupational
32、 health and safety records are not within the scope of this ANSI/HPS N13.6-1999 4 standard, consideration should be given to consolidating all individual health hazard case files within a common records management system. 3.2.3 Records format No specific record format is specified by this standard.
33、A combination of formats may be needed and used for a comprehensive records system for a radiological protection program. Regardless of the format, all records shall be: identifiable by responsible facility operator and facility; identifiable by function or purpose; dated intelligible to a person wi
34、th training and experience equivalent to that of a person with a B.S. in health physics; for the life of the record; legible; complete; accurate. Black ink should be used for completion of records. Corrections shall be made with single line-out and initialed by the individual making the correction.
35、Opaque substances shall not be used for making corrections. 3.2.4 Records media No specific records media is specified by this standard. A combination of media (paper, microfilm, magnetic, optical) may be needed and used for a comprehensive records system for a radiological protection program. For r
36、ecords that have long-term retention requirements and reside on a more transitory and vulnerable medium (electronic or magnetic), the records system shall provide for conversion to a more stable medium. This conversion should occur systematically at some designated point in the life cycle of the spe
37、cific record. 3.2.5 Records admissibility into evidence Records of radiological protection programs may be required for litigation support. To meet the requirements for admissibility in court as evidence, the radiological protection records shall be created routinely in the course of regularly condu
38、cted business at the time the activity, event, or condition occurs. The programs records shall be retained and disposed of in accordance with written and approved retention schedules. Procedures should address legal admissibility for all types of media. 3.2.6 Responsibilities for records of purchase
39、d services Facility operators who purchase radiological protection services (e.g., dosimetry or bioassay) from another firm shall have a clear agreement regarding records responsibility, both during and subsequent to the performance of the services. The facility operator should ensure that both reco
40、rd and quality assurance/quality control requirements are being met. These requirements should include the retention of documents showing the service firms policies, procedures, and methods of evaluation. Furnished data and computed results should be validated and provided in a timely manner. Where
41、a recognized accreditation program (e.g., National Voluntary Laboratory Accreditation Program (NVLAP), Department of Energy Laboratory Accreditation Program (DOELAP) exists for a program, the verification that the firm is accredited is sufficient assurance that the firms policies, procedures, and me
42、thods of evaluation are adequate. 3.2.7 Terminology and units Generally accepted terminology shall be employed and the use of colloquialisms and non-standard abbreviations shall be avoided. Throughout the radiation records system, quantities and units of radiation measurement, as defined by the Nati
43、onal Council on Radiation Protection and Measurements or the International ANSI/HPS N13.6-1999 5 Commission on Radiological Units and Measurements, should be used. However, units required by applicable regulations shall be used. Quality factors, weighting factors, and other conversion factors used s
44、hould be included in the records of the radiation protection program to show the quantitative relationship between the absorbed dose and the dose equivalent. These records should also include the period of time that the particular factors were applicable in the radiation protection program. 3.2.8 Ac
45、cess to individual exposure records Federal and state laws set forth requirements for access to an individuals records, as well as protection of the records. The applicable laws shall be identified and referenced in records maintenance procedures. 4 Records related to an individual The principal pur
46、pose of records related to an individual is to enable the facility operator to provide an accurate, quantitative description of the occupational radiation dose received by the individual. Examples are records of: external radiation dose (e.g., individually worn dosimeter measurements); internal radi
47、ation dose (e.g., bioassay data and evaluations); supplementary information on individual exposures (e.g., radiation incident investigation reports and skin contamination reports); radiation surveys and air monitoring results when dosimetry is based on these techniques. 4.1 Identification of the ind
48、ividual Positive identification of the individual shall be required. In view of such factors as multiple employment, duplication of common names, and legal changes of names, the use of one continuously valid identifier is necessary. The Social Security Number should be used for this purpose. However
49、, it may not be convenient to place the Social Security Number on all records pertinent to the individual. If a local employee identification system is used for the record system, a readily available, permanent cross-reference to the Social Security Number shall be maintained. If an identifier other than the Social Security Number is used, it shall be defined. The birth date and sex should also be included in the identification of an individual. For those cases where Social Security Numbers are not available (e.g., foreign nationals), the indiv
