1、BS ISO21243:2008ICS 13.280; 27.120.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDRadiation protection Performance criteriafor laboratoriesperforming cytogenetictriage for assessmentof mass casualtiesin radiological ornuclear emergencies General principles an
2、dapplication to dicentricassayThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30September 2008 BSI 2008ISBN 978 0 580 54586 3Amendments/corrigenda issued since publicationDate CommentsBS ISO 21243:2008National forewordThis British Standard is the
3、 UK implementation of ISO 21243:2008.The UK participation in its preparation was entrusted to TechnicalCommittee NCE/2, Radiation protection and measurement.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include a
4、ll the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS ISO 21243:2008Reference numberISO 21243:2008(E)ISO 2008INTERNATIONAL STANDARD ISO21243First edition2008-09-01Radiation protec
5、tion Performance criteria for laboratories performing cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies General principles and application to dicentric assay Radioprotection Critres de performance pour les laboratoires pratiquant le tri par cytogntique en ca
6、s daccident radiologique ou nuclaire affectant un grand nombre de personnes Principes gnraux et application aux dicentriques BS ISO 21243:2008ISO 21243:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed
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9、use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized i
10、n any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 2
11、2 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reservedBS ISO 21243:2008ISO 21243:2008(E) ISO 2008 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Abbreviated term
12、s 4 5 Pre-planning 4 5.1 Awareness of the standard 4 5.2 Roles and responsibilities of health care facilities . 4 5.3 Roles and responsibilities of the biodosimetry laboratories. 5 6 Communication and information 5 6.1 Biological dosimetry request and confidentiality . 5 6.2 Educational programme Fo
13、rmation, training and exercises . 6 7 Biological dosimetry process in radiological or nuclear mass-casualty incidents. 6 8 Emergency response of the reference laboratory. 6 9 Design of laboratory network 7 9.1 Overview 7 9.2 Preparedness of the laboratory network 7 9.3 Laboratory network operation.
14、8 10 Expected results . 9 10.1 General. 9 10.2 Whole-body exposure 9 10.3 Inhomogeneous exposure . 10 11 Quality assurance and quality control 10 11.1 Overview 10 11.2 Quality control. 10 Annex A (normative) Interactions between physicians and biological dosimetry laboratories 13 Annex B (informativ
15、e) Initial contact information form 14 Annex C (informative) Guidance for threshold of detection 15 Annex D (informative) Estimates of dose and 95 % confidence limits for selected observations of numbers of dicentrics and cells 16 Annex E (informative) Instructions for customers 17 Annex F (informat
16、ive) Example group sample report. 18 Bibliography . 20 BS ISO 21243:2008ISO 21243:2008(E) iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International S
17、tandards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, als
18、o take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committe
19、es is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possi
20、bility 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. ISO 21243 was prepared by Technical Committee ISO/TC 85, Nuclear energy, Subcommittee SC 2, Radiation protection. BS ISO 21243:2008I
21、SO 21243:2008(E) ISO 2008 All rights reserved vIntroduction The potential for nuclear and radiological emergencies involving mass casualties from accidental or malicious acts or terrorism requires generic procedures for emergency dose assessment to help the development of medical response capabiliti
22、es. A mass-casualties incident is defined here as an event that exceeds the local medical resources. Biological dosimetry, based on cytogenetic analysis using the dicentric assay, typically applied for accidental dose assessment, has been defined in ISO 19238. Cytogenetic triage is the use of chromo
23、some damage to evaluate and assess approximately and rapidly radiation doses received by individuals in order to supplement the clinical categorization of casualties. This International Standard focuses on the use of the dicentric assay for rapid cytogenetic triage involving mass-casualty incidents.
24、 After a large-scale radiation emergency or malevolent act with involvement of radioactive materials, physicians are primarily concerned with preserving life and evaluating medical signs and symptoms for early treatment decisions. It is expected that patients have already been assessed clinically an
25、d triaged on the basis of any prodromal signs and symptoms of overexposure plus available information concerning their involvement in the incident. In this early-response phase of a radiological emergency, the initial purpose of cytogenetic triage is to rapidly estimate the dose for each referred pa
26、tient to supplement this early clinical assessment. The role of a secondary triage by cytogenetics is to confirm whether displayed symptoms can really be attributed to radiation rather than being a false positive response to some other cause. It is expected that the cytogenetic report be sufficientl
27、y informative to provide guidance to medical staff as they proceed to clinical management of the patients. This management can range from rapid identification of concerned but not radiation-exposed public (worried well), giving patients advice and reassurance before sending home lightly irradiated p
28、atients who do not need out-patient observation (i.e. dose below 0,5 Gy) or clinical intervention (i.e. dose below 1,0 Gy), through to active treatment of potentially life-threatening injury and optimized use of limited medical resources. Several clinical triage systems have been developed where, ba
29、sed on severity of prodromal reactions, irradiated patients are allocated to one of 4 dose ranges (1 Gy to 2 Gy, 2 Gy to 4 Gy, 4 Gy to 6 Gy and 6 Gy) or acute-radiation-sickness (ARS) response categories (RC-01, RC-02, RC-03, RC-04) representing mild to very severe injuries. Enough experience with u
30、sing clinical triage schemes (e.g., from Chernobyl) has been gained to show that the early sorting of persons into these dose or response category cohorts was adequate for the initial planning of the patients management. However, as time progresses clinicians are looking for more accurate estimation
31、s of doses both in the low-dose range, where irradiated persons require counselling on risks of late stochastic effects, and also for higher doses, for anticipating the shorter-term sequelae of severe tissue reactions. It should be noted that the initial clinical triage interprets the symptoms in te
32、rms of response to acute, more-or-less whole-body exposure. Protracted and fractionated exposures, of course, require higher doses in order to produce the same severity of responses. It is expected that the cytogenetic triage achieve a rapid estimate of dose or response categories, quantitatively mo
33、re precise than the four clinically derived categories, and also take account of any evidence that the exposure might not have been received acutely or involved the whole body. It is expected that the need for precision be set against the competing requirement for rapid results and it is necessary t
34、hat this judgement be made at the time, depending on the anticipated number of patients, the surge capacity of the laboratory and the rate at which the blood samples are received at the laboratory. Expert cytogenetic biodosimetry laboratories typically function to support national radiation-protecti
35、on programmes and emergency-response schemes. Several of these reference cytogenetic biodosimetry laboratories have independently and successfully performed rapid dose assessment in actual and simulated mass-casualty incidents. Their approaches included pre-planning, reagent stockpiling, simplified
36、sample processing, automation, as well as modifying some of the ISO 19238 scoring criteria. Recently, several of these national reference cytogenetic biodosimetry laboratories have also established networks of BS ISO 21243:2008ISO 21243:2008(E) vi ISO 2008 All rights reservedsupplementary, satellite
37、 cytogenetic laboratories, both nationally as well as internationally. Building upon their experience, this International Standard is intended to define criteria for performing quality-assured cytogenetic triage. The primary purpose of this International Standard is to provide a guideline to all lab
38、oratories in order to perform the dicentric-bioassay - cytogenetic triage for dose assessment using documented and validated procedures. Secondly, it can facilitate the application of cytogenetic biodosimetry networks to permit comparison of results obtained in different laboratories. Finally, it is
39、 expected that laboratories newly commissioned to carry out the cytogenetic triage conform to this International Standard in order to perform the triage reproducibly and accurately. This International Standard is written in the form of procedures to adopt for dicentric-bioassay - cytogenetic triage
40、biological dosimetry for overexposures involving mass radiological casualties. The criteria required for such measurements usually depend on the application of the results: medical management when appropriate, radiation-protection management, record keeping and medical/legal requirements. For exampl
41、e, selected cases can be analysed to produce a more accurate evaluation of high partial-body exposure; secondly, doses can be estimated for persons exposed below the threshold for deterministic effects, by using the ISO 19238 criteria. These latter data also assist in counselling for the risk of lat
42、e stochastic disease. Part of the information in this International Standard is contained in other international guidelines and scientific publications, primarily in ISO 19238 and the International Atomic Energy Agencys Technical Report No.405, on Biological Dosimetry4. However, this International S
43、tandard details and standardizes the quality assurance and quality control of performance criteria for cytogenetic assessment of individual exposures in radiological or nuclear mass casualties. This International Standard is generally compliant with ISO/IEC 17025, with particular consideration given
44、 to the specific needs of rapid, emergency biological dosimetry. The expression of uncertainties in dose estimations given in this International Standard complies with the ISO Guide 98 and ISO 5725 (all parts). BS ISO 21243:2008INTERNATIONAL STANDARD ISO 21243:2008(E) ISO 2008 All rights reserved 1R
45、adiation protection Performance criteria for laboratories performing cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies General principles and application to dicentric assay 1 Scope The purpose of this International Standard is to give an overview of the mini
46、mum requirements of process and quality-control components of the cytogenetic response for triage of mass casualties. Cytogenetic triage is the use of chromosome damage to evaluate approximately and rapidly radiation doses received by individuals in order to supplement the early clinical categorizat
47、ion of casualties. This International Standard concentrates on organizational aspects of applying the dicentric assay for operation in a triage mode. The technical aspects of the dicentric assay can be found in ISO 19238. This International Standard is applicable either to an experienced biological
48、dosimetry laboratory working alone or to a network of collaborating laboratories (as defined in Clause 9). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, t
49、he latest edition of the referenced document (including any amendments) applies. ISO 19238, Radiation protection Performance criteria for service laboratories performing biological dosimetry by cytogenetics 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 acute radiation syndrome or sickness ARS acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time (usually a matter of minutes) 3.2 a
