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1、a Date: 27 April 2007 Origin: International Latest date for receipt of comments: 31 July 2007 Project no.: 2004/02080 Responsible committee: NCE/2 Radiation protection and measurement Interested committees: Title: Draft ISO 21243 Radiation protection - Performance criteria for service laboratories p
2、erforming cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies - General principles Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a curren
3、t national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 31 July 2007. This draft is issued to allow comments from interested parties; all comments
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7、ittees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/www.bsi-. Direct t
8、el: 0113 278 5373 Responsible Committee Secretary: Mr A Richards 8 Spen Drive;Leeds;LS16 5AH;GB E-mail: Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 7.0 DPC: 07/30118981 DC Licensed Copy: London South
9、 Bank University, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the preparation
10、 of the consequent standard. Comments submitted will be reviewed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If no comments are received to the cont
11、rary, then the UK will approve this draft. If the international standard is approved, it is possible the text will be published as an identical British Standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The
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15、t: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition
16、is ambiguous and needs clarifying. Amend to read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft a
17、nd MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THER
18、EFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT O
19、F THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. DRAFT INTERNATIONAL STANDARD ISO/DIS 21243 International Organization for Standardization, 2007 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION ORGANISATION INTERNATIONALE DE NORMALISATION ISO/TC 85/SC 2 Vot
20、ing begins on: 2007-05-02 Secretariat: AFNOR Voting terminates on: 2007-10-02 Radiation protection Performance criteria for service laboratories performing cytogenetic triage for assessment of mass casualties in radiological or nuclear emergencies General principles Radioprotection Critres de perfor
21、mance pour laboratoires de services accomplissant du tri cytogntique pour lvaluation des masses occasionnelles dans les urgences radiologiques ou nuclaires Principes gnraux ICS 13.280; 27.120.20 To expedite distribution, this document is circulated as received from the committee secretariat. ISO Cen
22、tral Secretariat work of editing and text composition will be undertaken at publication stage. Pour acclrer la distribution, le prsent document est distribu tel quil est parvenu du secrtariat du comit. Le travail de rdaction et de composition de texte sera effectu au Secrtariat central de lISO au st
23、ade de publication. Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 21243 ii ISO 2007 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing
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28、cured. Requests for permission to reproduce should be addressed to 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 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduc
29、tion may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 21243 ISO 2007 All rights reserved iii Contents Page Forewo
30、rdiv Introduction.v 1 Scope 1 2 Terms and definitions.1 3 Pre-planning4 3.1 Awareness of the standard4 3.2 Roles and responsibilities of health care facilities4 3.3 Roles and responsibilities of the biodosimetry laboratories.4 4 Communication and information.5 4.1 Biological dosimetry request and co
31、nfidentiality5 4.2 Sustainment educational programme, training and exercises6 5 Biological dosimetry process in radiological or nuclear mass casualties incidents.6 6 Emergency response of the reference laboratory .6 7 Design of laboratory network7 7.1 Overview.7 7.2 Choice of cytogenetic bioassays 7
32、 7.3 Preparedness of the laboratory network.7 7.4 Laboratory network operation.8 8 Expected results .9 8.1 Whole body exposure9 8.2 Inhomogeneous exposure.9 9 Quality Assurance and Quality Control.10 9.1 Overview.10 9.2 Quality Control10 9.2.1 Quality Control Procedures10 9.2.2 Performance Checks of
33、 Sample Transport Integrity.10 9.2.3 Performance Checks of Sample Integrity by Service Laboratory11 9.2.4 Performance Checks of Instrumentation11 9.2.5 Performance Checks of Sample Protocol.11 9.2.6 Performance Checks of Sample Scoring11 9.2.7 Performance Checks of Dose and Confidence Limits Estimat
34、ion.11 9.2.8 Performance Checks of Result Report Generation11 9.2.9 Performance of the Network.12 Annex A (informative) .14 Annex B (informative) .15 Annex C (informative) .16 Annex D (informative) .17 Annex E (informative)18 Annex F (informative)19 Bibliography21 Licensed Copy: London South Bank Un
35、iversity, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 21243 iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
36、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 established has the right to be represented on that committee. International organizations, governmental and non-government
37、al, in liaison with ISO, also 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 mai
38、n task of technical committees 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. Att
39、ention 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. ISO 21243 was prepared by Technical Committee ISO/TC 85, Nuclear Energy, Subcommittee SC 2, Radiation Pr
40、otection. Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:50:21 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ISO/DIS 21243 ISO 2007 All rights reserved v Introduction The potential for nuclear and radiological emergencies involving mass casualties from accident
41、al or malicious acts or terrorism requires generic procedures for emergency dose assessment to help the development of medical response capabilities. A mass casualties incident is defined here as an event that exceeds the local medical resources. Biological dosimetry, based on cytogenetic analysis u
42、sing the dicentric assay, typically applied for accidental dose assessment has been defined in the ISO 19238 standard. Cytogenetic triage is the use of chromosome damage to evaluate approximately and rapidly assess radiation doses received by individuals in order to supplement the clinical categoriz
43、ation of casualties. This document focuses of the use of the dicentric assay for rapid cytogenetic triage involving mass casualty incidents. After a large scale radiation emergency or malevolent act with involvement of radioactive materials, physicians are primarily concerned with preserving life an
44、d evaluating medical signs and symptoms for early treatment decisions. Patients should have already been assessed clinically and 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 ph
45、ase of a radiological emergency, the initial purpose of cytogenetic triage is to rapidly estimate the dose on each referred patient to supplement this early clinical assessment. The role of secondary triage by cytogenetics is to confirm whether displayed symptoms can really be attributed to radiatio
46、n rather than being a false positive response to some other cause. The cytogenetic report should be sufficiently informative to provide guidance to medical staff as they proceed to clinical management of the patients. This management may range from rapid identification of concerned but not radiation
47、 exposed public (worried well), giving patients advice and reassurance before sending home lightly irradiated patients who will not need out-patient observation (ie. below 0.5-Gy) or clinical intervention (ie. below 1.0 Gy), through to active treatment of potentially life-threatening injury and opti
48、mized use of limited medical resources. Several clinical triage systems have been developed where, based on severity of prodromal reactions, irradiated patients are allocated to one of 4 dose ranges; 1-2, 2-4, 4-6 and 6 Gy or acute radiation sickness (ARS) response categories (RC-01, RC-02, RC-03, R
49、C-04) representing mild to very severe injuries. Enough experience with using clinical triage schemes (eg., at Chernobyl) was gained to show that early sorting of persons into these dose or response category cohorts was adequate for beginning planning of the patients management. However as time progresses clinicians would wish for more accurate estimations of doses both in the low-