BS ISO 28218-2010 Radiation protection Performance criteria for radiobioassay《辐射保护 放射生物测定用性能标准》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 28218:2010Radiation protection Performance criteria forradiobioassayBS ISO 28218:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of IS

2、O 28218:2010.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 beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisio

3、ns of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 57330 9ICS 13.280Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 Octo

4、ber 2010.Amendments issued since publicationDate Text affectedBS ISO 28218:2010Reference numberISO 28218:2010(E)ISO 2010INTERNATIONAL STANDARD ISO28218First edition2010-10-01Radiation protection Performance criteria for radiobioassay Radioprotection Critres de performance pour lanalyse radiotoxicolo

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9、ng 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 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 2821

10、8:2010ISO 28218:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references2 3 Terms and definitions .2 4 Symbols6 5 Performance measures.7 5.1 Decision threshold (y*) and detection limit (y#)7 5.2 Relative bias and bias performance criteria.10 5.

11、3 Repeatability performance criteria 12 6 Performance criteria for in vivo radiobioassay12 6.1 General .12 6.2 Responsibilities of the customer that could impact the service laboratorys performance .12 6.3 Service laboratory criteria 12 6.4 Identification of radionuclides .13 6.5 Quantification 13 6

12、.6 Reporting results.14 6.7 Records retention15 7 Performance criteria for in vitro radiobioassay .15 7.1 General .15 7.2 Responsibilities of the customer that could impact the service laboratorys performance .15 7.3 Analytical methodology16 7.4 Reporting results.17 7.5 Records retention17 8 Quality

13、 assurance and quality control for radiobioassay laboratories .18 8.1 General .18 8.2 Quality assurance18 8.3 Quality assurance plan .19 8.4 Quality control .20 9 Performance testing programme.21 9.1 General .21 9.2 In vivo radiobioassay22 9.3 In vitro radiobioassay .25 Annex A (informative) Detecti

14、on limit Models for applications.29 Annex B (informative) Detection limit Application examples 32 Bibliography45 BS ISO 28218:2010ISO 28218:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

15、(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 established has the right to be represented on that committee. International organizations, g

16、overnmental 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 standardization. International Standards are drafted in accordance with the rules given in the ISO/I

17、EC Directives, Part 2. The main 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 mem

18、ber bodies casting a vote. 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. ISO 28218 was prepared by Technical Committee ISO/TC 85, Nuclear energy, n

19、uclear technologies, and radiological protection, Subcommittee SC 2, Radiological protection. This first edition of ISO 28218 cancels and replaces ISO 12790-1:2001, which has been technically revised. BS ISO 28218:2010ISO 28218:2010(E) ISO 2010 All rights reserved vIntroduction In the course of empl

20、oyment, individuals might work with radioactive materials that, under certain circumstances, could be taken into the body. Radiation protection programmes for these individuals can include means for in vivo or in vitro measurements of radioactive material that has entered the body. The performance c

21、riteria required for such measurements usually depend upon the purpose for the radiobioassay measurement, which can include determining the internal human burden of radioactive material, estimating doses and dose commitments, radiation protection management, medical management when appropriate, and

22、providing the necessary data for legal and record-keeping requirements. Analytical methods for radiobioassay are not currently standardized, but are available in the literature. Guidance on the evaluation of data from the monitoring of workers occupationally exposed to the risk of internal contamina

23、tion by radioactive substances is provided in ISO 27048 as well as other publications of national and international regulations and guides, the International Commission on Radiological Protection (ICRP), the National Council on Radiation Protection and Measurement (NCRP), the International Atomic En

24、ergy Agency (IAEA) and the International Commission on Radiological Units and Measurements (ICRU). Recommendations of the ICRP, NCRP, IAEA and ICRU, as well as experience with the practical application of these recommendations to the conduct of radiobioassay services and the interpretation and use o

25、f radiobioassay results in radiation protection programmes, have been considered in the development of this International Standard. In addition to superseding ISO 12790-1:2001, this International Standard complements the requirements of ISO 20553. This International Standard develops, expands and ap

26、plies the principles defined in the aforementioned standards for radiobioassay laboratories. It also provides a consensus on the statistical definitions and formulations of the quantitative performance criteria of decision threshold, detection limit, relative bias and repeatability. These concepts f

27、ollow the requirements of ISO 11929. In particular, the concept of minimum detectable amount (MDA) used in ISO 12790-1:2001 has been abandoned in favour of detection limit (y#). Clauses 5 to 8 primarily provide guidance for radiobioassay service laboratories, whereas Clause 9 relates to testing labo

28、ratories and provides criteria for performance testing. The information in these clauses provides beneficial insight for service laboratories, for users of the laboratorys services, and for testing laboratories, and it provides a possible basis for an inter-laboratory quality assurance plan. In this

29、 International Standard, the following verbal forms apply: “shall” is used to denote a requirement; “should” is used to denote a recommendation; “may” is used to denote permission (neither a requirement nor a recommendation). To conform with this International Standard, all radiobioassay needs to be

30、 performed in accordance with its requirements, but not necessarily with its recommendations; however, justification needs to be documented for deviations from recommendations. BS ISO 28218:2010BS ISO 28218:2010INTERNATIONAL STANDARD ISO 28218:2010(E) ISO 2010 All rights reserved 1Radiation protecti

31、on Performance criteria for radiobioassay 1 Scope This International Standard provides criteria for quality assurance and control, and evaluation of performance of radiobioassay service laboratories. Criteria and guidance for in vivo radiobioassay and in vitro radiobioassay are given in separate cla

32、uses. The following are within the scope of this International Standard: the accuracy of in vivo measurements of activity and quantities of selected important radionuclides in test phantoms, and in vitro measurements of activity and quantities of selected important radionuclides in test samples; min

33、imal requirements for detection limit; minimum testing levels and testing ranges; requirements for reporting radiobioassay results by service laboratories; quality assurance in service laboratories; quality control in service laboratories; protocol for reporting test evaluations by service laborator

34、ies to the testing laboratory; default procedures when the service laboratory customer does not specify the performance criteria; applications of y#for different methods (see Annexes A and B). The following are not within the scope of this International Standard: detailed radiochemical methods for s

35、eparating radionuclides from biological samples; detailed procedures for in vivo and in vitro radioactivity measurements; biokinetic data and mathematical models for converting radiobioassay results into dose (dose assessment); procedures for the preparation and distribution of test samples and phan

36、toms by the testing laboratories. BS ISO 28218:2010ISO 28218:2010(E) 2 ISO 2010 All rights reserved2 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, the lates

37、t edition of the referenced document (including any amendments) applies. ISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM) ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and defin

38、itions ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results Part 3: Intermedia

39、te measures of the precision of a standard measurement method 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 5725-1, ISO 5725-2, ISO 5725-3 and the following apply. 3.1 accuracy characteristic of an analysis or determination that e

40、nsures that both the bias and repeatability of the resulting quantity remain within specified limits 3.2 activity number of spontaneous nuclear disintegrations per unit time 3.3 aliquot in vitro radiobioassay representative portion of a whole 3.4 appropriate blank uncontaminated sample, unexposed pe

41、rson or phantom that is ideally identical in physiochemically and radiologically significant ways with the sample, person or phantom to be analysed 3.5 background ambient signal response recorded by measurement instruments that is independent of radioactivity contributed by the radionuclides concern

42、ed 3.6 bias systematic error of the indication of a measuring instrument 3.7 freedom from bias ability of a measuring instrument to give indications free from systematic error 3.8 blind testing testing of capabilities when the service laboratory is not aware that they are being tested for conformanc

43、e BS ISO 28218:2010ISO 28218:2010(E) ISO 2010 All rights reserved 33.9 certified reference material CRM reference material, characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its asso

44、ciated uncertainty and a statement of the metrological traceability 3.10 concentration activity or mass per unit volume or per unit mass 3.11 confidence interval interval about an estimate of a stated quantity, within which the expected value of the quantity is expected to lie (with a specified prob

45、ability) 3.12 decision threshold fixed 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 present NOTE The decision threshold is the critical value of a statistical test for the

46、 decision between the hypothesis that the physical effect is not present and the alternative hypothesis that it is present. When the critical value is exceeded by the result of an actual measurement, this is taken to indicate that the hypothesis should be rejected. The statistical test is designed i

47、n such a way that the probability of wrongly rejecting the hypothesis (error of the first kind) is at most equal to a given value, . 3.13 detection limit smallest true value of the measurand that is detectable by the measuring method NOTE The detection limit is the smallest true value of the measura

48、nd that is associated with the statistical test and hypothesis in accordance with the decision threshold (3.12) by the following characteristics: if in reality the true value is equal or exceeds the detection limit, the probability of wrongly not rejecting the hypothesis (error of the second kind) i

49、s at most equal to a given value, . 3.14 in vitro radiobioassay measurements to determine the presence of, or to estimate the amount of, radioactive material in the excreta or in other biological materials removed from the body 3.15 in vivo radiobioassay measurements of radioactive material in the human body utilizing instrumentation that detects radiation emitted from the radioactive material in the body 3.16 measurand particular quantity subject to measurement 3.17 monitoring measurements m