Radiological protection - Performance criteria for service laboratories performing biological dosimetry by cytogenetics (ISO 19238:2014)

ISO 19238:2014 provides criteria for quality assurance and quality control, evaluation of the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories.
ISO 19238:2014 addresses
a)    the confidentiality of personal information, for the customer and the service laboratory,
b)    the laboratory safety requirements,
c)    the calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves that contribute to the dose estimation from chromosome aberration frequency and the minimum resolvable doses,
d)    the scoring procedure for unstable chromosome aberrations used for biological dosimetry,
e)    the criteria for converting a measured aberration frequency into an estimate of absorbed dose,
f)     the reporting of results,
g)    the quality assurance and quality control,
h)    informative annexes containing sample instructions for customer, sample questionnaire, sample of report, fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of dose estimate, odds ratio method for cases of suspected exposure to a low dose, and sample data sheet for recording aberrations.

Strahlenschutz - Durchführungskriterien für Dienstleistungslaboratorien zur Anwendung der biologischen Dosimetrie mittels zytogenetischer Verfahren (ISO 19238:2014)

Diese Internationale Norm stellt Kriterien für die Qualitätssicherung und Qualitätskontrolle, Validierung der Durchführung und Akkreditierung der biologischen Dosimetrie durch zytogenetische Dienstleistungslaboratorien bereit.
Diese Internationale Norm behandelt
a) die Vertraulichkeit von persönlichen Angaben, in Bezug auf den Auftraggeber und das Dienstleistungslaboratorium,
b) die Laboratorium-Sicherheitsanforderungen,
c) die sinnvollen Kalibrierquellen (Kalibrierstrahler) und Kalibrierdosisbereiche zur Erstellung der Referenz-Dosis-Wirkungs-Kurven, die zur Dosisabschätzung anhand der Häufigkeit von Chromosomenaberrationen beitragen, und die niedrigsten nachweisbaren Dosen,
d) das Auswerteverfahren für instabile Chromosomenaberrationen, die für die biologische Dosimetrie verwendet werden,
e) die Kriterien für die Abschätzung der absorbierten Dosis, anhand der Häufigkeit von beobachteten Aberrationen,
f) die Berichterstattung der Ergebnisse,
g) die Qualitätssicherung und Qualitätskontrolle,
h) informative Anhänge mit Musteranweisungen für Auftraggeber, Musterfragebogen, Musterbericht, Anpassung der Niedrigdosis-Wirkungs-Kurve nach dem Maximum-Likelihood-Verfahren und Berechnung des Fehlers der Dosisschätzung, odds ratio-Verfahren für Fälle einer vermuteten Exposition mit geringer Dosis, sowie ein Musterdatenblatt für die Erfassung der Aberrationen.

Radioprotection - Critères de performance pour les laboratoires de service pratiquant la dosimétrie biologique par cytogénétique (ISO 19238:2014)

L'ISO 19238:2014 fournit des critères pour l'assurance de la qualité et le contrôle de la qualité, l'évaluation des performances et l'accréditation des laboratoires de service pratiquant la dosimétrie biologique par cytogénétique.
L'ISO 19238:2014 porte sur
a)    la confidentialité des informations personnelles pour le demandeur et le laboratoire de service,
b)    les exigences de sécurité du laboratoire,
c)    les sources d'étalonnage et les gammes de doses d'étalonnage utiles pour établir les courbes dose-effet de référence qui contribuent à l'estimation de dose à partir de la fréquence des aberrations chromosomiques, et les doses minimum détectables,
d)    la procédure de dénombrement des aberrations chromosomiques instables utilisées pour la dosimétrie biologique,
e)    les critères pour convertir une fréquence mesurée d'aberrations en une estimation de dose absorbée,
f)     la présentation des résultats,
g)    l'assurance de la qualité et le contrôle de la qualité,
h)    les annexes informatives contenant des exemples: d'instructions pour le client, de questionnaire, de rapport, d'ajustement de la courbe dose-réponse aux faibles doses par la méthode du maximum de vraisemblance et en tenant compte de l'erreur de l'estimation de dose, de méthode du rapport des odds pour les cas d'exposition suspectée à une faible dose, et de tableau type pour le dénombrement des aberrations chromosomiques.

Radiološka zaščita - Merila za delovanje laboratorijev, ki izvajajo biološko dozimetrijo s citogenetiko (ISO 19238:2014)

Standard ISO 19238:2014 določa merila za zagotavljanje in nadzor kakovosti, vrednotenje delovanja in akreditacijo biološke dozimetrije s pomočjo laboratorijev za storitve s področja citogenetike.
ISO 19238:2014 obravnava:
a) zaupnost osebnih podatkov naročnika in laboratorija, ki ponuja storitve;
b) zahteve za varnost laboratorija;
c) vire umerjanja in razpone odmerkov umerjanja, ki so koristni za določanje referenčnih krivulj učinkov odmerka za umerjanje, ki omogočajo ocenjevanje odmerka na podlagi frekvence kromosomskih aberacij in minimalnega razločljivega odmerka;
d) postopek ocenjevanja nestabilnih kromosomskih aberacij, ki se uporabljajo za biološko dozimetrijo;
e) merila za pretvorbo izmerjene frekvence aberacije v oceno absorbiranega odmerka;
f) poročanje o rezultatih;
h) zagotavljanje in nadzor kakovosti;
h) informativne dodatke, ki vsebujejo vzorčna navodila za kupca, vzorčni vprašalnik, vzorčno poročilo, primernost krivulje odziva na majhen odmerek z metodo največje verjetnosti ter izračun napake pri oceni razmerja obetov v primerih domnevne izpostavljenosti nizkemu odmerku in vzorec podatkovnega lista za beleženje aberacij.

General Information

Status
Published
Publication Date
17-Oct-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
18-Oct-2017
Completion Date
18-Oct-2017

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SLOVENSKI STANDARD
SIST EN ISO 19238:2018
01-februar-2018
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GR]LPHWULMRVFLWRJHQHWLNR ,62

Radiological protection - Performance criteria for service laboratories performing

biological dosimetry by cytogenetics (ISO 19238:2014)

Radioprotection - Critères de performance pour les laboratoires de service pratiquant la

dosimétrie biologique par cytogénétique (ISO 19238:2014)
Ta slovenski standard je istoveten z: EN ISO 19238:2017
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
SIST EN ISO 19238:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 19238:2018
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SIST EN ISO 19238:2018
EN ISO 19238
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 13.280; 17.240
English Version
Radiological protection - Performance criteria for service
laboratories performing biological dosimetry by
cytogenetics (ISO 19238:2014)
Radioprotection - Critères de performance pour les
laboratoires de service pratiquant la dosimétrie
biologique par cytogénétique (ISO 19238:2014)
This European Standard was approved by CEN on 13 September 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19238:2017 E

worldwide for CEN national Members.
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SIST EN ISO 19238:2018
EN ISO 19238:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 19238:2018
EN ISO 19238:2017 (E)
European foreword

The text of ISO 19238:2014 has been prepared by Technical Committee ISO/TC 85 “Nuclear energy,

nuclear technologies, and radiological protection” of the International Organization for Standardization

(ISO) and has been taken over as EN ISO 19238:2017 by Technical Committee CEN/TC 430 “Nuclear

energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by April 2018, and conflicting national standards shall be

withdrawn at the latest by April 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 19238:2014 has been approved by CEN as EN ISO 19238:2017 without any modification.

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SIST EN ISO 19238:2018
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SIST EN ISO 19238:2018
INTERNATIONAL ISO
STANDARD 19238
Second edition
2014-02-01
Radiological protection —
Performance criteria for service
laboratories performing biological
dosimetry by cytogenetics
Radioprotection — Critères de performance pour les laboratoires de
service pratiquant la dosimétrie biologique par cytogénétique
Reference number
ISO 19238:2014(E)
ISO 2014
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All 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 requested from either ISO at the address below or ISO’s 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 copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Terms and definitions ..................................................................................................................................................................................... 1

3 Dicentric assay ........................................................................................................................................................................................................ 3

4 Responsibility of the customer .............................................................................................................................................................. 3

5 Responsibility of the service laboratory...................................................................................................................................... 4

5.1 Setup and sustainment of the QA program ..................................................................................................................... 4

5.2 Responsibility during service ..................................................................................................................................................... 4

6 Confidentiality of personal information ...................................................................................................................................... 5

6.1 Overview ...................................................................................................................................................................................................... 5

6.2 Applications of the principle of confidentiality .......................................................................................................... 5

7 Laboratory safety requirements .......................................................................................................................................................... 6

7.1 Overview ...................................................................................................................................................................................................... 6

7.2 Microbiological safety requirements ................................................................................................................................... 6

7.3 Chemical safety ....................................................................................................................................................................................... 6

7.4 Optical safety requirements ........................................................................................................................................................ 8

7.5 Safety plan ................................................................................................................................................................................................... 8

8 Calibration curve(s) .......................................................................................................................................................................................... 9

8.1 Culturing ....................................................................................................................................................................................................... 9

8.2 Calibration source(s) ......................................................................................................................................................................10

8.3 Establishment of calibration curve(s) .............................................................................................................................10

8.4 Minimum resolvable dose measurement ......................................................................................................................11

9 Scoring unstable chromosome aberrations ..........................................................................................................................11

9.1 Procedure for scoring first-division metaphases ...................................................................................................11

9.2 Criteria for scoring ............................................................................................................................................................................11

10 Criteria for converting a measured aberration frequency into an estimate of

absorbed dose ......................................................................................................................................................................................................12

10.1 Overview ...................................................................................................................................................................................................12

10.2 Comparison with controls ..........................................................................................................................................................12

10.3 Testing the distribution of aberrations per cell .......................................................................................................12

10.4 Determination of estimated whole-body dose and confidence limits .................................................12

10.5 Acute and non-acute exposure cases ................................................................................................................................13

10.6 Partial-body and prior-exposure cases ...........................................................................................................................13

11 Reporting of results ........................................................................................................................................................................................15

11.1 General ........................................................................................................................................................................................................15

11.2 Content of the report (see Annex C for a standard form) ...............................................................................15

11.3 Interpretation of the results .....................................................................................................................................................16

12 Quality assurance and quality control ........................................................................................................................................16

12.1 Overview ...................................................................................................................................................................................................16

12.2 Specific requirements ....................................................................................................................................................................17

Annex A (informative) Sample instructions for customer ..........................................................................................................19

Annex B (informative) Sample questionnaire .........................................................................................................................................20

Annex C (informative) Sample of report ........................................................................................................................................................22

Annex D (informative) Fitting of the low-LET dose-response curve by the method of maximum

likelihood and calculating the error of dose estimate ...............................................................................................23

Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose .......................26

© ISO 2014 – All rights reserved iii
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SIST EN ISO 19238:2018
ISO 19238:2014(E)

Annex F (informative) Sample data sheet for recording aberrations .............................................................................27

Bibliography .............................................................................................................................................................................................................................28

iv © ISO 2014 – All rights reserved
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
Foreword

ISO (the International Organization 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 established 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 standardization.

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 the

editorial rules of the ISO/IEC Directives, Part 2. 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 patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received. 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.

The committee responsible for this document is ISO/TC 85, Nuclear energy, nuclear technologies, and

radiological protection, Subcommittee SC 2, Radiological protection.

This second edition cancels and replaces the first edition (ISO 19238:2004), of which it constitutes a

minor revision.
© ISO 2014 – All rights reserved v
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
Introduction

The wide use of ionising radiations for medical, industrial, agricultural, research, and military purposes

increases the risk of overexposure of radiation workers and individuals of the general population.

Biological dosimetry, based on the study of chromosomal aberrations, mainly the dicentric assay, has

become a routine component of accidental dose assessment. Experience with its application in hundreds

of cases of suspected or verified overexposures has proved the value of this method and also defined its

limitations. It should be emphasized that cytogenetic analysis is used as a dosimeter and provides one

input into the compendium of information needed for assessment of a radiological accident.

Many studies in animals and man have shown that one can establish a good correlation between the

results obtained in vivo and in vitro, so that in vitro established dose-effect relationships from irradiated

blood samples can be used as calibration curves. The dicentric yield is dependent on radiation quality

and dose rate so that information about these variables needs to be established for each investigation.

If known, these exposure characteristics are important for refining the dose estimates. The specificity

of this technique is enhanced by the fact that generally 1 dicentric is observed per 1 000 metaphase

spreads in the normal population, and that this frequency is approximatively independent of age and

sex. The precision of the technique thus depends on the number of cells observed, the background level,

and the calibration curve used. Theoretically, it is possible to detect exposure as low as 0,01 Gy. However,

for these very low doses, it is necessary to analyse tens of thousands of metaphase spreads. In practice,

this level of detection is neither feasible nor necessary. The upper limits to dose detection extend well

into the range of doses that are lethal to humans.

The primary purpose of this International Standard is to provide a guideline to all laboratories in order

to perform the dicentric assay using documented and validated procedures. Secondly, it can facilitate

the comparison of results obtained in different laboratories, particularly for international collaborations

or intercomparisons. Finally, laboratories newly commissioned to carry out the dicentric assay should

conform to this International Standard in order to perform it reproducibly and accurately.

This International Standard is written in the form of procedures to be adopted for biological dosimetry

for overexposures involving, at most, a few casualties. The criteria required for such measurements

will usually depend upon the application of the results: radiation protection management, medical

management when appropriate, record keeping, and legal requirements. In the special situation of a mass

radiation casualty and limited resources, the technique can be applied for emergency triage analysis.

The standard recommended scoring criteria would then be relaxed as appropriate to the situation.

A part of the information in this International Standard is contained in other international guidelines and

scientific publications, primarily in the International Atomic Energy Agency’s (IAEA) Technical Reports

Series on Biological Dosimetry. However, this International Standard expands and standardizes the

quality assurance and quality control, the criteria of accreditation, and the evaluation of performance.

This International Standard is generally compliant with ISO/IEC 17025, with particular consideration

given to the specific needs of biological dosimetry. The expression of uncertainties in dose estimations

given in this International Standard comply with the ISO guide to the expression of uncertainty

in measurement (ISO/IEC Guide 98-1) and the ISO 5725 on accuracy (trueness and precision) of

measurement methods and results.
vi © ISO 2014 – All rights reserved
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SIST EN ISO 19238:2018
INTERNATIONAL STANDARD ISO 19238:2014(E)
Radiological protection — Performance criteria for
service laboratories performing biological dosimetry by
cytogenetics
1 Scope

This International Standard provides criteria for quality assurance and quality control, evaluation of

the performance, and the accreditation of biological dosimetry by cytogenetic service laboratories.

This International Standard addresses

a) the confidentiality of personal information, for the customer and the service laboratory,

b) the laboratory safety requirements,

c) the calibration sources and calibration dose ranges useful for establishing the reference dose-effect

curves that contribute to the dose estimation from chromosome aberration frequency and the

minimum resolvable doses,

d) the scoring procedure for unstable chromosome aberrations used for biological dosimetry,

e) the criteria for converting a measured aberration frequency into an estimate of absorbed dose,

f) the reporting of results,
g) the quality assurance and quality control,

h) informative annexes containing sample instructions for customer, sample questionnaire, sample of

report, fitting of the low dose-response curve by the method of maximum likelihood and calculating

the error of dose estimate, odds ratio method for cases of suspected exposure to a low dose, and

sample data sheet for recording aberrations.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
acentric

terminal or interstitial chromosome fragment of varying size, referred to as an excess acentric fragment

when it is formed independently of a dicentric or centric ring chromosome aberration

2.2
background level

spontaneous frequency (or number) of chromosome aberrations recorded in control samples or

individuals
2.3
bias

statistical sampling or testing error caused by systematically favouring some outcomes over others

2.4
centric ring

aberrant circular chromosome resulting from the joining of two breaks on separate arms of the same

chromosome
Note 1 to entry: It is generally accompanied by an acentric fragment.
© ISO 2014 – All rights reserved 1
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
2.5
centromere

specialized constricted region of a chromosome that appears during mitosis and joins together the

chromatid pair
2.6
confidence interval

statistical range about an estimated quantity within which the value of the quantity is expected to occur,

with a specified probability
2.7
chromosome

structure that comprises discrete packages of DNA and proteins that carries genetic information which

condense to form characteristically shaped bodies during nuclear division
2.8
chromatid

either of the two strands of a duplicated chromosome that are joined by a single centromere and separate

during cell division to become individual chromosomes
2.9
dicentric

aberrant chromosome bearing two centromeres derived from the joining of parts from two broken

chromosomes
Note 1 to entry: It is generally accompanied by an acentric fragment.
2.10
FISH
fluorescence in situ hybridization

technique that uses specific sequences of DNA as probes to particular parts of the genome, allowing

the chromosomal regions to be highlighted or “painted” in different colours by attachment of various

fluorochromes
2.11
interphase
period of a cell cycle between the mitotic divisions
2.12
LET
linear energy transfer

quotient of dE/dl, as defined by the International Commission on Radiation Units and Measurements

(ICRU), where dE is the average energy locally imparted to the medium by a charged particle of specific

energy in traversing a distance of dl
2.13
lower threshold of dose

smallest measurable amount (e.g. frequency or dose) that is detected with a probability β of non-

detection (Type II error) while accepting a probability α of erroneously deciding that a positive (non-

zero) quantity is present in an appropriate background sample (Type I error)
2.14
metaphase

stage of mitosis when the nuclear membrane is dissolved, the chromosomes condensed to their minimum

lengths and aligned for division
2.15
minimum resolvable dose

lowest additional dose for which the lower 95 % Poisson confidence limit is greater than 0, so that there

is a 97,5 % chance that the dose received in excess of normal background is greater than 0

2 © ISO 2014 – All rights reserved
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SIST EN ISO 19238:2018
ISO 19238:2014(E)
2.16
precision

concept employed to describe dispersion of measurements with respect to a measure of location or

central tendency
2.17
quality assurance

planned and systematic actions necessary to provide adequate confidence that a process, measurement,

or service satisfies given requirements for quality in, for example, those specified in a licence

2.18
quality control

part of quality assurance intended to verify that systems and components conform to predetermined

requirements
2.19
service laboratory
laboratory performing biological dosimetry measurements
3 Dicentric assay

The frequency of unstable chromosomal aberrations seen at metaphase in cultured human peripheral

blood lymphocytes is the recommended method for biological dosimetry. The chromosome aberrations

to be used are dicentrics or dicentrics and centric rings. For the application of this International Standard,

the service laboratory shall choose which type of aberrations to score for the purpose of assessing dose

estimates and shall be consistent throughout. Hereafter, chromosome aberrations are referred to as

dicentrics but may include centric rings if determined by the service laboratory.

Lymphocytes are cultured by a method that permits first-division metaphases to be recognized for

analysis (see 9.1). This requires whole blood, or lymphocytes separated from the other blood components,

to be incubated in a culture medium that would enable scoring of first-generation metaphase cells. A

mitotic blocking agent, colcemid or colchicine, is added to arrest dividing lymphocytes in metaphase.

The duration of the cell culture and the timing of addition of the arresting agent are optimised to ensure

an adequate mitotic index and predominance of first-division metaphases.

Metaphases are recovered from the cultures by centrifugation, placing in a hypotonic salt solution and

fixing in a mixture of alcohol and acetic acid. Fixed cells are placed on microscope slides and stained. The

exact protocol for cell culture, harvesting metaphases, and staining employed by a service laboratory

shall be formally documented (see Clause 12).

Microscope slides containing stained cells are methodically scanned to identify suitable first-division

metaphases to score dicentric aberrations (see 9.2). The frequency of dicentrics observed in an

appropriate number of scored metaphases is converted to an estimate of radiation dose by reference to

calibration data (see Clause 10).
4 Responsibility of the customer

This clause includes items that are not controlled by the service laboratory. Prior to blood sampling,

coordination between the customer and the service laboratory should occur. Essential requirements

should be explained to the customer and this may be by a standardised instruction sheet as illustrated

in Annex A. The essential features are:

a) Blood sampling should use the collection system containing lithium heparin as anticoagulant which

has been sent or specified by the service laboratory.

b) Blood should be collected (ideally about 10 ml), labelled accurately and unambiguously, maintained

at room temperature (around 20 °C), and sent to the service laboratory as soon as possible.

© ISO 2014 – All rights reserved 3
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SIST EN ISO 19238:2018
ISO 19238:2014(E)

c) Precautions to ensure the integrity of the container and prevent leakage during shipment shall be

observed. Blood samples should be kept cool during shipping (i.e. 6° C to 30 °C). A temperature

recording could be included to document that the temperature during shipment is controlled.

Packaging and labelling shall conform to national and international regulations. If air transportation

is involved, a physical dosimeter could be included to monitor whether the sample was irradiated in

transit.

d) A questionnaire provided by the service laboratory should be completed and returned promptly.

e) The service laboratory should be alerted of biologically cont
...

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