1、BSI Standards PublicationBS ISO 16637:2016Radiological protection Monitoring and internaldosimetry for staff membersexposed to medicalradionuclides as unsealedsourcesBS ISO 16637:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16637:2016.The UK participati
2、on in its preparation was entrusted to TechnicalCommittee NCE/2, Radiation protection and measurement.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are res
3、ponsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 81983 4ICS 13.280Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards P
4、olicy and Strategy Committee on 31 March 2016.Amendments issued since publicationDate Text affectedBS ISO 16637:2016 ISO 2016Radiological protection Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sourcesRadioprotection Surveillance et dosimtrie inter
5、ne des travailleurs exposs lors des utilisations mdicales des radiolments en sources non scellesINTERNATIONAL STANDARDISO16637First edition2016-02-15Reference numberISO 16637:2016(E)BS ISO 16637:2016ISO 16637:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in S
6、witzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be
7、 requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 16637:2016ISO 16637:2016(E)Foreword vIntrod
8、uction vi1 Scope . 12 Normative references 23 Terms and definitions . 24 Symbols and abbreviated terms . 55 Purpose and need for monitoring programmes in nuclear medical diagnosis and therapy 65.1 General . 65.2 Assessment of the level of likely exposures . 65.3 Monitoring programmes 75.3.1 General
9、75.3.2 Confirmatory monitoring programmes . 75.3.3 Routine monitoring programmes 85.3.4 Triage monitoring programmes . 85.3.5 Task-related monitoring programmes 85.3.6 Special monitoring programmes . 85.3.7 Implementation of a monitoring programme. 96 Common radionuclides .107 Reference levels 108 R
10、outine monitoring programmes 118.1 General aspects 118.2 Individual monitoring 128.3 Methods and monitoring intervals . 129 Triage monitoring programmes 1310 Special Monitoring programmes 1310.1 General aspects 1310.2 Workplace monitoring .1410.3 Individual monitoring 1411 Confirmatory monitoring pr
11、ogrammes .1511.1 General aspects 1511.2 Workplace monitoring . 1511.3 Individual monitoring 1512 Measurement techniques and performance criteria .1512.1 General 1512.2 Measurements performed in a laboratory specialised for radiobioassay 1612.2.1 In vitro.1612.2.2 In vivo 1612.2.3 Quality assurance a
12、nd quality control for bioassay laboratories .1612.3 Measurements performed in nuclear medicine service .1713 Procedure for the assessment of exposures .1713.1 Interpretation of individual monitoring data for dose assessment .1713.1.1 General. 1713.1.2 Dose assessment based on routine monitoring .17
13、13.1.3 Dose assessment based on special monitoring 1713.2 Software tools . 2213.3 Uncertainties . 2213.4 Quality assurance of the assessment process . 2214 Reporting and documentation 23 ISO 2016 All rights reserved iiiContents PageBS ISO 16637:2016ISO 16637:2016(E)14.1 Reporting results for in vitr
14、o measurements . 2314.2 Reporting results for in vivo measurements . 2314.3 Documentation of the dose assessment .24Annex A (informative) IAEA Safety Guide RS-G-1.2 “decision factor” 25Bibliography .27iv ISO 2016 All rights reservedBS ISO 16637:2016ISO 16637:2016(E)ForewordISO (the International Org
15、anization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establi
16、shed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardizatio
17、n.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with t
18、he editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any pate
19、nt rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For a
20、n explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for thi
21、s document is ISO/TC 85, Nuclear energy, nuclear technologies, and radiological protection, Subcommittee SC 2, Radiological protection. ISO 2016 All rights reserved vBS ISO 16637:2016ISO 16637:2016(E)IntroductionIn the course of employment, individuals might work with radioactive materials that, und
22、er certain circumstances, could be taken into the body. Protecting workers against risks of incorporated radionuclides requires the monitoring of potential intakes and/or the quantification of actual intakes and exposures. The doses resulting from internal radiation exposure arising from contaminati
23、on by radioactive substances cannot be measured directly. The selection of measures and programmes for this purpose requires decisions concerning methods, techniques, frequencies, etc. for activity measurements and dose assessment. The criteria permitting the evaluation of the necessity of such a mo
24、nitoring programme or for the selection of methods and frequencies of monitoring usually depend upon the legislation, the purpose of the radiation protection programme, the probabilities of potential radionuclide intakes, and the characteristics of the materials handled.For these reasons, ISO standa
25、rds establishing requirements for monitoring programmes (ISO 20553), laboratory requirements (ISO 28218), and dose assessment (ISO 27048) have been developed. These can be applied in a straightforward manner to many workplaces where internal contamination may occur. In order to apply these standards
26、 to staff involved in diagnostic or therapeutic uses of radionuclides in medicine, the short effective half-life of radionuclides commonly used for these purposes and the distance between nuclear medicine department and in vivo counting facilities or radio-analytical laboratories shall be taken into
27、 account. Consequently, guidance on the application of the three International Standards cited above to nuclear medicine staff was requested by a number of countries.This International Standard establishes criteria to determine whether intake monitoring is required for staff exposed to medical radio
28、nuclides as unsealed sources. It also establishes requirements on the design of such monitoring programmes, associated dose assessments, and laboratory requirements. Recommendations of international expert bodies and international experience with the practical application of these recommendations in
29、 radiological protection programmes have been considered in the development of this International Standard. Its application facilitates the exchange of information between authorities, supervisory institutions, and employers. This International Standard is not a substitute for legal requirements.vi
30、ISO 2016 All rights reservedBS ISO 16637:2016Radiological protection Monitoring and internal dosimetry for staff members exposed to medical radionuclides as unsealed sources1 ScopeThis International Standard specifies the minimum requirements for the design of professional programmes to monitor work
31、ers exposed to the risk of internal contamination via inhalation by the use of radionuclides as unsealed sources in nuclear medicine imaging and therapy departments. It establishes principles for the development of compatible goals and requirements for monitoring programmes and, when adequate, dose
32、assessment. It presents procedures and assumptions for the risk analysis, for the monitoring programmes, and for the standardized interpretation of monitoring data.This International Standard addresses the following items:a) purposes of monitoring and monitoring programmes;b) description of the diff
33、erent categories of monitoring programmes;c) quantitative criteria for conducting monitoring programmes;d) suitable methods for monitoring and criteria for their selection;e) information that has to be collected for the design of a monitoring programme;f) general requirements for monitoring programm
34、es (e.g. detection limits, tolerated uncertainties);g) frequencies of measurements;h) procedures for dose assessment based on reference levels for routine and special monitoring programmes;i) assumptions for the selection of dose-critical parameter values;j) criteria for determining the significance
35、 of individual monitoring results;k) interpretation of workplace monitoring results;l) uncertainties arising from dose assessments and interpretation of bioassays data;m) reporting/documentation;n) quality assurance.This International Standard does not address the following: monitoring and internal
36、dosimetry for the workers exposed to laboratory use of radionuclides such as radioimmunoassay techniques; monitoring and internal dosimetry for the workers involved in the operation, maintenance, and servicing of PET cyclotrons; detailed descriptions of measuring methods and techniques; dosimetry fo
37、r litigation cases; modelling for the improvement of internal dosimetry;INTERNATIONAL STANDARD ISO 16637:2016(E) ISO 2016 All rights reserved 1BS ISO 16637:2016ISO 16637:2016(E) the potential influence of medical treatment of the internal contamination; the investigation of the causes or implication
38、s of an exposure; dosimetry for ingestion exposures and for contaminated wounds.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated
39、 references, the latest edition of the referenced document (including any amendments) applies.ISO 20553, Radiation protection Monitoring of workers occupationally exposed to a risk of internal contamination with radioactive materialISO 27048:2011, Radiation protection Dose assessment for the monitor
40、ing of workers for internal radiation exposureISO 28218, Radiation protection Performance criteria for radiobioassayISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)3 Terms and definitionsFor the purposes of this document, the terms and def
41、initions given in ISO/IEC Guide 99, ISO 20553, ISO 28218 and ISO 27048 and the following apply.3.1absorptionmovement of material to blood regardless of mechanism, generally applied to dissociation of particles and uptake into blood of soluble substances and material dissociated from particles3.2abso
42、rption type Fas defined by ICRP, deposited materials that have high (fast) rates of absorption (3.1) into body fluids from the respiratory tract3.3absorption type Mas defined by ICRP, deposited materials that have intermediate (moderate) rates of absorption (3.1) into body fluids from the respirator
43、y tract3.4activitynumber of spontaneous nuclear transformations per unit timeNote 1 to entry: The activity is stated in becquerel (Bq), i.e. the number of transformations per second.3.5activity median aerodynamic diameterAMADvalue of aerodynamic diameter such that 50 % of the airborne activity (3.4)
44、 in a specified aerosol is associated with particles smaller than the AMAD, and 50 % of the activity is associated with particles larger than the AMADNote 1 to entry: The aerodynamic diameter of an airborne particle is the diameter that a sphere of unit density would need to have in order to have th
45、e same terminal velocity when settling in air as the particle of interest.2 ISO 2016 All rights reservedBS ISO 16637:2016ISO 16637:2016(E)3.6contaminationactivity (3.4) of radionuclides present on surfaces, or within solids, liquids or gases (including the human body), where the presence of such rad
46、ioactive material is unintended or undesirable3.7decision thresholdfixed value of the measurand by which, when exceeded by the result of an actual measurement of a measurand quantifying a physical effect, it is decided that the physical effect is present3.8detection limitsmallest true value of the m
47、easurand which is detectable by the measuring method3.9annual dosecommitted effective dose (3.11) resulting from all intakes (3.14) occurring during a calendar yearNote 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding intakes.3.10committed eq
48、uivalent dosesum of the products of the total doses absorbed by an organ or a tissue from radiation types, integrated over the commitment period following the intake (3.14) of a radionuclide, and the appropriate radiation weighting factors3.11committed effective dosesum of the products of the commit
49、ted organ or tissue equivalent doses and the appropriate tissue weighting factorsNote 1 to entry: In the context of this International Standard, the commitment period integration time following the intake (3.14) is taken to be 50 years.3.12excretion functionfunction describing the fraction of an intake (3.14) excreted per day after a given time has elapsed since the intake occurred3.13event = incidentany unintended occurrence, including operating error, equipment failure or other mishap, the consequences or potential consequences
