Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR) spectroscopy for retrospective dosimetry of ionizing radiation - Part 1: General principles (ISO 13304-1:2020)

The primary purpose of this document is to provide minimum acceptable criteria required to establish a procedure for retrospective dosimetry by electron paramagnetic resonance spectroscopy and to report the results.
The second purpose is to facilitate the comparison of measurements related to absorbed dose estimation obtained in different laboratories.
This document covers the determination of absorbed dose in the measured material. It does not cover the calculation of dose to organs or to the body. It covers measurements in both biological and inanimate samples, and specifically:
a)   based on inanimate environmental materials like glass, plastics, clothing fabrics, saccharides, etc., usually made at X-band microwave frequencies (8 GHz to 12 GHz);
b)   in vitro tooth enamel using concentrated enamel in a sample tube, usually employing X-band frequency, but higher frequencies are also being considered;
c)   in vivo tooth dosimetry, currently using L-band (1 GHz to 2 GHz), but higher frequencies are also being considered;
d)   in vitro nail dosimetry using nail clippings measured principally at X-band, but higher frequencies are also being considered;
e)   in vivo nail dosimetry with the measurements made at X-band on the intact finger or toe;
f)    in vitro measurements of bone, usually employing X-band frequency, but higher frequencies are also being considered.
For biological samples, in vitro measurements are carried out in samples after their removal from the person or animal and under laboratory conditions, whereas the measurements in vivo are carried out without sample removal and may take place under field conditions.
NOTE    The dose referred to in this document is the absorbed dose of ionizing radiation in the measured materials.

Strahlenschutz - Mindestanforderungen an die Elektronenspinresonanz (EPR-Spektroskopie) für die retrospektive Dosimetrie ionisierender Strahlung - Teil 1: Allgemeine Grundsätze (ISO 13304-1:2020)

Radioprotection - Critères minimaux pour la spectroscopie par résonance paramagnétique électronique (RPE) pour la dosimétrie rétrospective des rayonnements ionisants - Partie 1: Principes généraux (ISO 13304-1:2020)

Le but principal du présent document est de fournir un ensemble de critères minimaux acceptables requis pour établir un mode opératoire pour la dosimétrie rétrospective par spectroscopie par résonance paramagnétique électronique et pour présenter les résultats dans un rapport.
Son second objectif est de faciliter la comparaison des mesures associées à l'estimation de la dose absorbée de différents laboratoires.
Le présent document couvre la détermination de la dose absorbée dans le matériau mesuré. Il ne couvre pas le calcul de la dose délivrée aux organes ou à l'organisme entier. Il ne concerne que les mesurages de dosimétrie effectués sur des échantillons biologiques et des échantillons inertes, et plus particulièrement:
a)   les mesurages de matériaux environnementaux inertes, tels que les verres, les polymères, les tissus pour vêtements, les saccharides, etc. généralement réalisés avec des fréquences micro‑ondes dans la bande X (8 GHz à 12 GHz);
b)   les mesurages in vitro de prélèvement d'émail dentaire, placé dans un tube porte‑échantillon, et mesuré en général en bande X, mais des fréquences micro‑ondes plus élevées sont également considérées;
c)   les mesurages in vivo de dents, réalisés actuellement en bande L (1 GHz à 2 GHz), mais des fréquences micro‑ondes plus élevées sont également considérées;
d)   les mesurages in vitro de prélèvements d'ongles, effectués principalement en bande X, mais des fréquences micro‑ondes plus élevées sont également considérées;
e)   les mesurages in vivo des ongles, effectués en bande X sur les ongles des doigts ou des orteils;
f)    les mesurages in vitro de tissus osseux, réalisés en général en bande X, mais des fréquences micro‑ondes plus élevées sont également considérées.
En ce qui concerne les échantillons biologiques, les mesurages in vitro sont effectués sur des échantillons prélevés sur une personne ou un animal et dans des conditions de laboratoire, tandis que les mesurages in vivo sont réalisés sans prélèvement d'échantillon et peuvent s'effectuer sur le terrain.
NOTE    La dose mentionnée dans le présent document est la dose absorbée de rayonnement ionisant dans les matériaux mesurés.

Radiološka zaščita - Minimalna merila za spektroskopijo z elektronsko paramagnetno resonanco (EPR) za retrospektivno dozimetrijo ionizirnega sevanja - 1. del: Splošna načela (ISO 13304-1:2020)

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Publication Date
20-Dec-2022
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
21-Dec-2022
Due Date
30-Sep-2024
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21-Dec-2022

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SLOVENSKI STANDARD
SIST EN ISO 13304-1:2023
01-marec-2023
Radiološka zaščita - Minimalna merila za spektroskopijo z elektronsko
paramagnetno resonanco (EPR) za retrospektivno dozimetrijo ionizirnega sevanja
- 1. del: Splošna načela (ISO 13304-1:2020)

Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR)

spectroscopy for retrospective dosimetry of ionizing radiation - Part 1: General principles

(ISO 13304-1:2020)
Strahlenschutz - Mindestanforderungen an die Elektronenspinresonanz (EPR-

Spektroskopie) für die retrospektive Dosimetrie ionisierender Strahlung - Teil 1:

Allgemeine Grundsätze (ISO 13304-1:2020)
Radioprotection - Critères minimaux pour la spectroscopie par résonance

paramagnétique électronique (RPE) pour la dosimétrie rétrospective des rayonnements

ionisants - Partie 1: Principes généraux (ISO 13304-1:2020)
Ta slovenski standard je istoveten z: EN ISO 13304-1:2022
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
SIST EN ISO 13304-1:2023 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 13304-1:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 13304-1:2023
EN ISO 13304-1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 13.280; 17.240
English Version
Radiological protection - Minimum criteria for electron
paramagnetic resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing radiation - Part 1:
General principles (ISO 13304-1:2020)

Radioprotection - Critères minimaux pour la Strahlenschutz - Mindestanforderungen an die

spectroscopie par résonance paramagnétique Elektronenspinresonanz (EPR-Spektroskopie) für die

électronique (RPE) pour la dosimétrie rétrospective retrospektive Dosimetrie ionisierender Strahlung - Teil

des rayonnements ionisants - Partie 1: Principes 1: Allgemeine Grundsätze (ISO 13304-1:2020)

généraux (ISO 13304-1:2020)
This European Standard was approved by CEN on 18 December 2022.

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

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13304-1:2022 E

worldwide for CEN national Members.
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SIST EN ISO 13304-1:2023
EN ISO 13304-1:2022 (E)
Contents Page

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

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SIST EN ISO 13304-1:2023
EN ISO 13304-1:2022 (E)
European foreword

The text of ISO 13304-1:2020 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 13304-1:2022 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 June 2023, and conflicting national standards shall be

withdrawn at the latest by June 2023.

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.

Any feedback and questions on this document should be directed to the users’ national standards body.

A complete listing of these bodies can be found on the CEN website.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the

United Kingdom.
Endorsement notice

The text of ISO 13304-1:2020 has been approved by CEN as EN ISO 13304-1:2022 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 13304-1:2023
---------------------- Page: 6 ----------------------
SIST EN ISO 13304-1:2023
INTERNATIONAL ISO
STANDARD 13304-1
Second edition
2020-07
Radiological protection — Minimum
criteria for electron paramagnetic
resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing
radiation —
Part 1:
General principles
Radioprotection — Critères minimaux pour la spectroscopie par
résonance paramagnétique électronique (RPE) pour la dosimétrie
rétrospective des rayonnements ionisants —
Partie 1: Principes généraux
Reference number
ISO 13304-1:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Confidentiality and ethical considerations ............................................................................................................................... 2

5 Laboratory safety requirements .......................................................................................................................................................... 3

5.1 Magnetic field ........................................................................................................................................................................................... 3

5.2 Electromagnetic frequency .......................................................................................................................................................... 3

5.2.1 in vitro measurement .................................................................................................................................................. 3

5.2.2 in vivo measurement .................................................................................................................................................... 3

5.3 Biohazards from samples .............................................................................................................................................................. 3

6 Collection/selection and identification of samples ......................................................................................................... 3

7 Transportation and storage of samples ....................................................................................................................................... 4

8 Preparation of samples.................................................................................................................................................................................. 4

9 Apparatus ..................................................................................................................................................................................................................... 5

9.1 Principles of EPR spectroscopy ................................................................................................................................................ 5

9.2 Requirements for EPR spectrometers ................................................................................................................................ 6

9.3 Requirements for the resonator ............................................................................................................................................... 6

9.4 Measurements of the background signals ....................................................................................................................... 6

9.5 Spectrometer stability and monitoring/control of environmental conditions ............................... 6

9.6 Baseline drift ............................................................................................................................................................................................. 7

10 Measurements of the samples ................................................................................................................................................................ 7

10.1 General principles ................................................................................................................................................................................ 7

10.2 Choice and optimization of the measurement parameters .............................................................................. 7

10.2.1 General...................................................................................................................................................................................... 7

10.2.2 Microwave-related parameters ........................................................................................................................... 8

10.2.3 Magnetic field parameters ....................................................................................................................................... 8

10.2.4 Signal channel parameters ...................................................................................................................................... 8

10.3 Sample positioning and loading ............................................................................................................................................... 9

10.4 Microwave bridge tuning ............................................................................................................................................................10

10.5 Use of standard samples as field markers and amplitude monitors .....................................................10

10.6 Monitoring reproducibility ........................................................................................................................................................10

10.7 Procedure to measure anisotropic samples ...............................................................................................................10

10.8 Coding of spectra and samples ...............................................................................................................................................11

11 Determination of the absorbed dose in the samples ...................................................................................................11

11.1 Determination of the radiation-induced signal intensity ................................................................................11

11.2 Conversion of the EPR signal into an estimate of absorbed dose ............................................................11

11.2.1 Conversion of the EPR signal into an estimate of absorbed dose for in

vitro dosimetry ........................................................................................................................................... ....................11

11.2.2 Conversion of the EPR signal into an estimate of absorbed dose for in vivo

tooth dosimetry .............................................................................................................................................................12

12 Measurement uncertainty .......................................................................................................................................................................12

13 Investigation of dose that has been questioned ................................................................................................................12

14 Quality assurance (QA) and quality control (QC) ............................................................................................................13

15 Minimum documentation requirements ..................................................................................................................................14

Bibliography .............................................................................................................................................................................................................................16

© ISO 2020 – All rights reserved iii
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SIST EN ISO 13304-1:2023
ISO 13304-1:2020(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 (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 patent 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 an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,

and radiological protection, Subcommittee SC 2, Radiological protection.
A list of all parts in the ISO 13304 series can be found on the ISO website.

This second edition cancels and replaces the first edition (ISO 13304-1:2013), of which it constitutes a

minor revision. The changes compared to the previous edition are as follows:
— inclusion of bibliographic references in the text;
— informative reference to ISO 13304-2 added;
— update of Bibliography.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)
Introduction

Electron paramagnetic resonance (EPR) has become an important approach for retrospective dosimetry

in any situation where dosimetric information is potentially incomplete or unknown for an individual.

It is now applied widely for retrospective evaluation of doses that were delivered at considerable times

in the past (e.g. EPR dosimetry is one of the methods of choice for retrospective evaluation of doses to

the involved populations from the atomic weapon exposures in Japan and after the Chernobyl accident)

and has received attention for use for triage after an incident in which large numbers of people have

[1] to [12]

potentially been exposed to clinically significant levels of radiation . Various materials may be

[13] to [41]

analysed by EPR to provide information on dose . Thus, EPR is a versatile tool for retrospective

dosimetry, pertinent as well for acute exposures (past or recent, whole or partial body) and prolonged

exposures. Doses estimated with EPR were mainly used to correlate the biological effect of ionizing

radiation to received dose, to validate other techniques or methodologies, to manage casualties, or

[42]

for forensic expertise for judicial authorities . It uses mainly biological tissues of the person as the

dosimeter and also can use materials from personal objects as well as those located in the immediate

environment. EPR dosimetry is based on the fundamental properties of ionizing radiation: the generation

of unpaired electron species (often but not exclusively free radicals) proportional to absorbed dose.

The technique of EPR specifically and sensitively detects the amount of unpaired electrons that have

sufficient stability to be observed after their generation; while the amount of the detectable unpaired

electrons is usually directly proportional to the amount that was generated, these species can react,

and therefore, the relationship between the intensity of the EPR signal and the radiation dose needs

to be established for each type of use. The most extensive use of the technique has been with calcified

[43] to [50]

tissue, especially with enamel from teeth . An IAEA technical report was published on the use

[51]

for tooth enamel . To extend the possibility of EPR retrospective dosimetry, new materials possibly

suitable for EPR dosimetry are regularly studied and associated protocols established. This document

is aimed to make this technique more widely available, more easily applicable and useful for dosimetry.

Specifically, this document proposes a methodological frame and recommendations to set up, validate,

and apply protocols from sample collection to dose reporting. The application of this document to ex

[52]
vivo human tooth enamel dosimetry is described in ISO 13304-2 .
© ISO 2020 – All rights reserved v
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SIST EN ISO 13304-1:2023
---------------------- Page: 12 ----------------------
SIST EN ISO 13304-1:2023
INTERNATIONAL STANDARD ISO 13304-1:2020(E)
Radiological protection — Minimum criteria for electron
paramagnetic resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing radiation —
Part 1:
General principles
1 Scope

The primary purpose of this document is to provide minimum acceptable criteria required to establish

a procedure for retrospective dosimetry by electron paramagnetic resonance spectroscopy and to

report the results.

The second purpose is to facilitate the comparison of measurements related to absorbed dose

estimation obtained in different laboratories.

This document covers the determination of absorbed dose in the measured material. It does not cover

the calculation of dose to organs or to the body. It covers measurements in both biological and inanimate

samples, and specifically:

a) based on inanimate environmental materials like glass, plastics, clothing fabrics, saccharides, etc.,

usually made at X-band microwave frequencies (8 GHz to 12 GHz);

b) in vitro tooth enamel using concentrated enamel in a sample tube, usually employing X-band

frequency, but higher frequencies are also being considered;

c) in vivo tooth dosimetry, currently using L-band (1 GHz to 2 GHz), but higher frequencies are also

being considered;

d) in vitro nail dosimetry using nail clippings measured principally at X-band, but higher frequencies

are also being considered;

e) in vivo nail dosimetry with the measurements made at X-band on the intact finger or toe;

f) in vitro measurements of bone, usually employing X-band frequency, but higher frequencies are

also being considered.

For biological samples, in vitro measurements are carried out in samples after their removal from the

person or animal and under laboratory conditions, whereas the measurements in vivo are carried out

without sample removal and may take place under field conditions.

NOTE The dose referred to in this document is the absorbed dose of ionizing radiation in the measured

materials.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
retrospective dosimetry (including early or emergency response)

dosimetry, usually at the level of the individual, carried out after an exposure using methods other than

conventional radiation dosimeters
3.2
electron paramagnetic resonance
EPR
electron spin resonance
ESR

magnetic resonance technique, which is similar to nuclear magnetic resonance (NMR) but based on the

net spin of unpaired electrons, such as free radicals and electron defects centres in matrices

Note 1 to entry: The terms EPR and ESR are essentially equivalent and are widely used. The term electron

magnetic resonance (EMR) also sometimes is used because it is analogous to nuclear magnetic resonance (NMR).

3.3
radical/paramagnetic centre
species with unpaired electron(s)

Note 1 to entry: Paired electrons have the same quantum state except for opposite spins; unpaired electrons

do not have a “partner” with the opposite spin. When the unpaired spin is on a molecule, it is usually termed a

radical; when the unpaired electron is in a matrix, it often is termed a paramagnetic centre.

3.4
in vivo measurement

measurement carried out within the living system, such as measurements of paramagnetic centres (3.3)

in teeth within the mouth
3.5
in vitro measurement
measurement carried out on materials outside the organism

Note 1 to entry: The term ex vivo also has been used in the literature for sample measured in vitro but irradiated

within the organism.
3.6
quality assurance

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

or service satisfies given requirements for quality
3.7
quality control

planned and systematic actions intended to verify that systems and components conform with

predetermined requirements
4 Confidentiality and ethical considerations

All individual identifying information of persons who provided samples should not be attached to the

information on the samples and kept only in a secured place. The corresponding samples should be

identified by codes with indication only of parameters that are useful for scientific purposes and for

making decisions. Data linking the code to the person can be kept if they are done so in a secure manner,

with access limited to the persons in charge of the data.
2 © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)

Where appropriate, permission for obtaining and measuring the samples should be obtained under the

rules of the jurisdiction where the samples are obtained.
5 Laboratory safety requirements
5.1 Magnetic field

With conventional EPR spectrometers, the magnetic field (for EPR signals with g-factor near 2,0,

typically 350 mT for X-band and 1 200 mT for Q-band) is restricted to the region between the pole caps

of the magnets, and therefore, there is no associated health risk (can affect watches or credit cards if

brought very close to the pole gap).

Due to the open nature of some in vivo EPR spectrometers, the magnetic field (for EPR signals with

g-factor near 2,0, 40 mT for L-band) combined with large gaps between the poles has the potential

to project the 0,5 mT line beyond the confines of the room. This line needs to be determined and

appropriate shielding placed for areas that exceed this limit and that are accessed by the general public.

The establishment of the 0,5 mT limit is based on concerns about potential effects on pacemakers,

which could pose a significant hazard from the magnetic fields that are employed with open in vivo EPR

spectrometers. The conventional limit is 0,5 mT (which is very conservative) and surveys should be

[53]

made to confirm that this field is not exceeded where a person with a pacemaker could be positioned .

Effects of modulation fields on tissues or tooth restorations are not a significant hazard.

5.2 Electromagnetic frequency
5.2.1 in vitro measurement

The configurations used for in vitro measurements have no hazard for exposure of operators, as

the spectrometer usually fully constrains the microwave to the sample with no significant amount

distributed outside of the resonator.
5.2.2 in vivo measurement

Measurements in vivo have the potential hazard of local heating of tissue. The operative safety limit

is that established for NMR in terms of permissible rates of energy absorption. In practice, this is a

potential hazard only at high incident microwave power levels — typically >1 W, which is at least a

factor of 3 greater than that in existing instruments.
5.3 Biohazards from samples

Biological samples measured in vitro should be handled in conformance to the rules of the jurisdiction

for routine practice for handling biological samples.

Measurements of teeth in vivo should follow the routines practiced for ordinary dentistry in regard to

potential contamination from subjects to operators or other subjects.
6 Collection/selection and identification of samples

All samples should be collected in as uniform manner as possible and the circumstances of the collection

noted, although this may not always be able to be controlled by the measuring laboratory. If prior

coordination between the collecting and the measuring laboratories is possible, requirements about the

sample collection, selection (of donors, location, or materials) and storage (sample holder, integrity of

the sample and of the container, temperature, light, UV) should be given. If information about samples

is available, keep record of them (this information can be about the location of the sample, origin or

history of the sample, information about donor, etc.). All samples should have a unique identifying code

associated with them.
© ISO 2020 – All rights reserved 3
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SIST EN ISO 13304-1:2023
ISO 13304-1:2020(E)
7 Transportation and storage of samples
If sample coll
...

SLOVENSKI STANDARD
oSIST prEN ISO 13304-1:2022
01-oktober-2022
Radiološka zaščita - Minimalna merila za spektroskopijo elektronske
paramagnetne resonance (EPR) za retrospektivno dozimetrijo ionizirnega sevanja
- 1. del: Splošna načela (ISO 13304-1:2020)

Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR)

spectroscopy for retrospective dosimetry of ionizing radiation - Part 1: General principles

(ISO 13304-1:2020)
Strahlenschutz - Mindestanforderungen an die Elektronenspinresonanz (EPR-

Spektroskopie) für die retrospektive Dosimetrie ionisierender Strahlung - Teil 1:

Allgemeine Grundsätze (ISO 13304-1:2020)
Radioprotection - Critères minimaux pour la spectroscopie par résonance

paramagnétique électronique (RPE) pour la dosimétrie rétrospective des rayonnements

ionisants - Partie 1: Principes généraux (ISO 13304-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 13304-1
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
oSIST prEN ISO 13304-1:2022 en,fr,de

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

---------------------- Page: 1 ----------------------
oSIST prEN ISO 13304-1:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 13304-1:2022
INTERNATIONAL ISO
STANDARD 13304-1
Second edition
2020-07
Radiological protection — Minimum
criteria for electron paramagnetic
resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing
radiation —
Part 1:
General principles
Radioprotection — Critères minimaux pour la spectroscopie par
résonance paramagnétique électronique (RPE) pour la dosimétrie
rétrospective des rayonnements ionisants —
Partie 1: Principes généraux
Reference number
ISO 13304-1:2020(E)
ISO 2020
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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(E)
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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Confidentiality and ethical considerations ............................................................................................................................... 2

5 Laboratory safety requirements .......................................................................................................................................................... 3

5.1 Magnetic field ........................................................................................................................................................................................... 3

5.2 Electromagnetic frequency .......................................................................................................................................................... 3

5.2.1 in vitro measurement .................................................................................................................................................. 3

5.2.2 in vivo measurement .................................................................................................................................................... 3

5.3 Biohazards from samples .............................................................................................................................................................. 3

6 Collection/selection and identification of samples ......................................................................................................... 3

7 Transportation and storage of samples ....................................................................................................................................... 4

8 Preparation of samples.................................................................................................................................................................................. 4

9 Apparatus ..................................................................................................................................................................................................................... 5

9.1 Principles of EPR spectroscopy ................................................................................................................................................ 5

9.2 Requirements for EPR spectrometers ................................................................................................................................ 6

9.3 Requirements for the resonator ............................................................................................................................................... 6

9.4 Measurements of the background signals ....................................................................................................................... 6

9.5 Spectrometer stability and monitoring/control of environmental conditions ............................... 6

9.6 Baseline drift ............................................................................................................................................................................................. 7

10 Measurements of the samples ................................................................................................................................................................ 7

10.1 General principles ................................................................................................................................................................................ 7

10.2 Choice and optimization of the measurement parameters .............................................................................. 7

10.2.1 General...................................................................................................................................................................................... 7

10.2.2 Microwave-related parameters ........................................................................................................................... 8

10.2.3 Magnetic field parameters ....................................................................................................................................... 8

10.2.4 Signal channel parameters ...................................................................................................................................... 8

10.3 Sample positioning and loading ............................................................................................................................................... 9

10.4 Microwave bridge tuning ............................................................................................................................................................10

10.5 Use of standard samples as field markers and amplitude monitors .....................................................10

10.6 Monitoring reproducibility ........................................................................................................................................................10

10.7 Procedure to measure anisotropic samples ...............................................................................................................10

10.8 Coding of spectra and samples ...............................................................................................................................................11

11 Determination of the absorbed dose in the samples ...................................................................................................11

11.1 Determination of the radiation-induced signal intensity ................................................................................11

11.2 Conversion of the EPR signal into an estimate of absorbed dose ............................................................11

11.2.1 Conversion of the EPR signal into an estimate of absorbed dose for in

vitro dosimetry ........................................................................................................................................... ....................11

11.2.2 Conversion of the EPR signal into an estimate of absorbed dose for in vivo

tooth dosimetry .............................................................................................................................................................12

12 Measurement uncertainty .......................................................................................................................................................................12

13 Investigation of dose that has been questioned ................................................................................................................12

14 Quality assurance (QA) and quality control (QC) ............................................................................................................13

15 Minimum documentation requirements ..................................................................................................................................14

Bibliography .............................................................................................................................................................................................................................16

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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(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 (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 patent 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 an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,

and radiological protection, Subcommittee SC 2, Radiological protection.
A list of all parts in the ISO 13304 series can be found on the ISO website.

This second edition cancels and replaces the first edition (ISO 13304-1:2013), of which it constitutes a

minor revision. The changes compared to the previous edition are as follows:
— inclusion of bibliographic references in the text;
— informative reference to ISO 13304-2 added;
— update of Bibliography.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(E)
Introduction

Electron paramagnetic resonance (EPR) has become an important approach for retrospective dosimetry

in any situation where dosimetric information is potentially incomplete or unknown for an individual.

It is now applied widely for retrospective evaluation of doses that were delivered at considerable times

in the past (e.g. EPR dosimetry is one of the methods of choice for retrospective evaluation of doses to

the involved populations from the atomic weapon exposures in Japan and after the Chernobyl accident)

and has received attention for use for triage after an incident in which large numbers of people have

[1] to [12]

potentially been exposed to clinically significant levels of radiation . Various materials may be

[13] to [41]

analysed by EPR to provide information on dose . Thus, EPR is a versatile tool for retrospective

dosimetry, pertinent as well for acute exposures (past or recent, whole or partial body) and prolonged

exposures. Doses estimated with EPR were mainly used to correlate the biological effect of ionizing

radiation to received dose, to validate other techniques or methodologies, to manage casualties, or

[42]

for forensic expertise for judicial authorities . It uses mainly biological tissues of the person as the

dosimeter and also can use materials from personal objects as well as those located in the immediate

environment. EPR dosimetry is based on the fundamental properties of ionizing radiation: the generation

of unpaired electron species (often but not exclusively free radicals) proportional to absorbed dose.

The technique of EPR specifically and sensitively detects the amount of unpaired electrons that have

sufficient stability to be observed after their generation; while the amount of the detectable unpaired

electrons is usually directly proportional to the amount that was generated, these species can react,

and therefore, the relationship between the intensity of the EPR signal and the radiation dose needs

to be established for each type of use. The most extensive use of the technique has been with calcified

[43] to [50]

tissue, especially with enamel from teeth . An IAEA technical report was published on the use

[51]

for tooth enamel . To extend the possibility of EPR retrospective dosimetry, new materials possibly

suitable for EPR dosimetry are regularly studied and associated protocols established. This document

is aimed to make this technique more widely available, more easily applicable and useful for dosimetry.

Specifically, this document proposes a methodological frame and recommendations to set up, validate,

and apply protocols from sample collection to dose reporting. The application of this document to ex

[52]
vivo human tooth enamel dosimetry is described in ISO 13304-2 .
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oSIST prEN ISO 13304-1:2022
INTERNATIONAL STANDARD ISO 13304-1:2020(E)
Radiological protection — Minimum criteria for electron
paramagnetic resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing radiation —
Part 1:
General principles
1 Scope

The primary purpose of this document is to provide minimum acceptable criteria required to establish

a procedure for retrospective dosimetry by electron paramagnetic resonance spectroscopy and to

report the results.

The second purpose is to facilitate the comparison of measurements related to absorbed dose

estimation obtained in different laboratories.

This document covers the determination of absorbed dose in the measured material. It does not cover

the calculation of dose to organs or to the body. It covers measurements in both biological and inanimate

samples, and specifically:

a) based on inanimate environmental materials like glass, plastics, clothing fabrics, saccharides, etc.,

usually made at X-band microwave frequencies (8 GHz to 12 GHz);

b) in vitro tooth enamel using concentrated enamel in a sample tube, usually employing X-band

frequency, but higher frequencies are also being considered;

c) in vivo tooth dosimetry, currently using L-band (1 GHz to 2 GHz), but higher frequencies are also

being considered;

d) in vitro nail dosimetry using nail clippings measured principally at X-band, but higher frequencies

are also being considered;

e) in vivo nail dosimetry with the measurements made at X-band on the intact finger or toe;

f) in vitro measurements of bone, usually employing X-band frequency, but higher frequencies are

also being considered.

For biological samples, in vitro measurements are carried out in samples after their removal from the

person or animal and under laboratory conditions, whereas the measurements in vivo are carried out

without sample removal and may take place under field conditions.

NOTE The dose referred to in this document is the absorbed dose of ionizing radiation in the measured

materials.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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ISO 13304-1:2020(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
retrospective dosimetry (including early or emergency response)

dosimetry, usually at the level of the individual, carried out after an exposure using methods other than

conventional radiation dosimeters
3.2
electron paramagnetic resonance
EPR
electron spin resonance
ESR

magnetic resonance technique, which is similar to nuclear magnetic resonance (NMR) but based on the

net spin of unpaired electrons, such as free radicals and electron defects centres in matrices

Note 1 to entry: The terms EPR and ESR are essentially equivalent and are widely used. The term electron

magnetic resonance (EMR) also sometimes is used because it is analogous to nuclear magnetic resonance (NMR).

3.3
radical/paramagnetic centre
species with unpaired electron(s)

Note 1 to entry: Paired electrons have the same quantum state except for opposite spins; unpaired electrons

do not have a “partner” with the opposite spin. When the unpaired spin is on a molecule, it is usually termed a

radical; when the unpaired electron is in a matrix, it often is termed a paramagnetic centre.

3.4
in vivo measurement

measurement carried out within the living system, such as measurements of paramagnetic centres (3.3)

in teeth within the mouth
3.5
in vitro measurement
measurement carried out on materials outside the organism

Note 1 to entry: The term ex vivo also has been used in the literature for sample measured in vitro but irradiated

within the organism.
3.6
quality assurance

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

or service satisfies given requirements for quality
3.7
quality control

planned and systematic actions intended to verify that systems and components conform with

predetermined requirements
4 Confidentiality and ethical considerations

All individual identifying information of persons who provided samples should not be attached to the

information on the samples and kept only in a secured place. The corresponding samples should be

identified by codes with indication only of parameters that are useful for scientific purposes and for

making decisions. Data linking the code to the person can be kept if they are done so in a secure manner,

with access limited to the persons in charge of the data.
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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(E)

Where appropriate, permission for obtaining and measuring the samples should be obtained under the

rules of the jurisdiction where the samples are obtained.
5 Laboratory safety requirements
5.1 Magnetic field

With conventional EPR spectrometers, the magnetic field (for EPR signals with g-factor near 2,0,

typically 350 mT for X-band and 1 200 mT for Q-band) is restricted to the region between the pole caps

of the magnets, and therefore, there is no associated health risk (can affect watches or credit cards if

brought very close to the pole gap).

Due to the open nature of some in vivo EPR spectrometers, the magnetic field (for EPR signals with

g-factor near 2,0, 40 mT for L-band) combined with large gaps between the poles has the potential

to project the 0,5 mT line beyond the confines of the room. This line needs to be determined and

appropriate shielding placed for areas that exceed this limit and that are accessed by the general public.

The establishment of the 0,5 mT limit is based on concerns about potential effects on pacemakers,

which could pose a significant hazard from the magnetic fields that are employed with open in vivo EPR

spectrometers. The conventional limit is 0,5 mT (which is very conservative) and surveys should be

[53]

made to confirm that this field is not exceeded where a person with a pacemaker could be positioned .

Effects of modulation fields on tissues or tooth restorations are not a significant hazard.

5.2 Electromagnetic frequency
5.2.1 in vitro measurement

The configurations used for in vitro measurements have no hazard for exposure of operators, as

the spectrometer usually fully constrains the microwave to the sample with no significant amount

distributed outside of the resonator.
5.2.2 in vivo measurement

Measurements in vivo have the potential hazard of local heating of tissue. The operative safety limit

is that established for NMR in terms of permissible rates of energy absorption. In practice, this is a

potential hazard only at high incident microwave power levels — typically >1 W, which is at least a

factor of 3 greater than that in existing instruments.
5.3 Biohazards from samples

Biological samples measured in vitro should be handled in conformance to the rules of the jurisdiction

for routine practice for handling biological samples.

Measurements of teeth in vivo should follow the routines practiced for ordinary dentistry in regard to

potential contamination from subjects to operators or other subjects.
6 Collection/selection and identification of samples

All samples should be collected in as uniform manner as possible and the circumstances of the collection

noted, although this may not always be able to be controlled by the measuring laboratory. If prior

coordination between the collecting and the measuring laboratories is possible, requirements about the

sample collection, selection (of donors, location, or materials) and storage (sample holder, integrity of

the sample and of the container, temperature, light, UV) should be given. If information about samples

is available, keep record of them (this information can be about the location of the sample, origin or

history of the sample, information about donor, etc.). All samples should have a unique identifying code

associated with them.
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ISO 13304-1:2020(E)
7 Transportation and storage of samples

If sample collection is made in a place other than the measuring laboratory, then samples should

be transported and stored under specified environmental conditions. These conditions should be

coordinated between the collecting and the measuring laboratories. Conditions of transportation

and storage of the sample may affect the integrity of the sample and also modify the quantity of

paramagnetic centres or the nature of the paramagnetic centres in the samples. Environmental

parameters such as light and other types of radiations (UV, X-rays, gamma), temperature, humidity,

oxygen, sample conditionings in water or disinfectant solution, for example, contamination (e.g. dust),

may significantly affect the nature and quantity of paramagnetic centres in the samples. Therefore,

specific attention should be paid as to the conditions of transportation and storage to avoid or limit as

much as possible the influence of environmental parameters on the samples. Details for transport and

[52]
storage of tooth samples for ex vivo measurements are provided in ISO 13304-2 .

If possible, the influence of these parameters on the radiation-induced signal line shape and intensity

should be investigated to establish the optimum conditions for transportation or storage and to avoid

unnecessary precautions. When samples are known to be sensitive to one or several environmental

conditions or the influence of these parameters or samples is not known, it is highly recommended that

precautions are taken so as to avoid conditions that could affect the samples.

Transportation conditions, including dates, ways of transportation, and mode of control of

transportation conditions, should be recorded. Appropriate sample packaging should always be used to

prevent sample physical damage.

Procedures to avoid X-ray exposure of the sample during airport controls should be implemented. The

dose at the X-ray hand luggage control is of the order of the microgray, so it can be considered negligible

for some applications. If not, when the sample is transported in hand luggage, then authorization for

X-ray exemption should be obtained in advance in order to avoid hindrance at the airport security

controls. X-ray dose to the hold luggage can be higher. For shipping, appropriate labelling (including a

note that the package contains radiation-sensitive dosimeters and, therefore, should not be irradiated)

should be used. When this is not possible, unirradiated identical control samples or dosimeters should

be placed in the package.

After the samples are received, they should be stored under stable conditions and the temperature and

humidity should be monitored and recorded. Exposure to light should always be avoided.

8 Preparation of samples

Sample preparation should be performed according to an established and explicit protocol. Details for

[52]

creation of a protocol for ex vivo measurements of tooth samples are provided in ISO 13304-2 .

For in vitro and ex vivo measurements, sample preparation is usually needed to accomplish several

goals, including: achieving a sample size that fits in the measurement tube; reducing anisotropy;

ensuring disinfection; eliminating paramagnetic impurities from the sample; drying the sample; and

stabilizing the EPR signals.

When required, preparation of the sample can be done by grinding, crushing, cutting, drilling, or other

mechanical treatments. During these operations, sample overheating should be avoided by using water

irrigation or other cooling systems. Metal contamination of the sample can be avoided by using hard

alloy tools.

Water irrigation of nails can influence the radiation-induced signal (RIS) and should be applied with care.

As needed, sterilization, cleaning, deproteination, and/or delipidation are performed using chemical

agents. Thermal treatment (annealing, freezing) can be used to accelerate or slow down recombination

of the radicals. Samples with significant amounts of moisture can be dried before the EPR measurements

to improve signal-to-noise ratio.

The setup of a protocol for sample preparation shall ensure no disturbing effect of the protocol on the

EPR signals (lineshape and intensity) used for dose estimation, and no generation of additional EPR

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oSIST prEN ISO 13304-1:2022
ISO 13304-1:2020(E)
signals. When employing the additive dose method (see 11.2.1), it is very
...

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