EN ISO 13304-2:2022

Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR) spectroscopy for retrospective dosimetry of ionizing radiation - Part 2: Ex vivo human tooth enamel dosimetry (ISO 13304-2:2020)

The purpose of this document is to provide minimum criteria required for quality assurance and quality control, evaluation of the performance and to facilitate the comparison of measurements related to absorbed dose estimation obtained in different laboratories applying ex vivo X-band EPR spectroscopy with human tooth enamel.
This document covers the determination of absorbed dose in tooth enamel (hydroxyapatite). It does not cover the calculation of dose to organs or to the body.
This document addresses:
a)   responsibilities of the customer and laboratory;
b)   confidentiality and ethical considerations;
c)   laboratory safety requirements;
d)   the measurement apparatus;
e)   preparation of samples;
f)    measurement of samples and EPR signal evaluation;
g)   calibration of EPR dose response;
h)   dose uncertainty and performance test;
i)     quality assurance and control.

Strahlenschutz - Mindestanforderungen an die Elektronenspinresonanz (EPR-Spektroskopie) für die retrospektive Dosimetrie ionisierender Strahlung - Teil 2: Ex-vivo-Dosimetrie des menschlichen Zahnschmelzes (ISO 13304-2:2020)

Zweck dieses Dokuments ist es, Mindestkriterien für die Qualitätssicherung und  kontrolle sowie die Leistungsbewertung festzulegen und den Vergleich von Messungen zur Abschätzung der Energiedosis zu erleichtern, die in verschiedenen Labors unter Anwendung der ex vivo-X Band-EPR Spektroskopie am menschlichen Zahnschmelz durchgeführt werden.
Dieses Dokument befasst sich mit der Bestimmung der Energiedosis in Zahnschmelz (Hydroxylapatit). Die Berechnung der Dosis für die Organe oder den Körper wird nicht behandelt.
Dieses Dokument behandelt Folgendes:
a)   Verantwortlichkeiten des Kunden und Labors;
b)   Vertraulichkeit und ethische Betrachtungen;
c)   Sicherheitsanforderungen im Labor;
d)   die Messeinrichtung;
e)   Probenvorbereitung;
f)   Messung von Proben und Auswertung von EPR Signalen;
g)   Kalibrieren der EPR Dosiswirkung;
h)   Dosisunsicherheit und Leistungsprüfung;
i)   Qualitätssicherung und  kontrolle.

Radioprotection - Critères minimaux pour la spectroscopie par résonance paramagnétique électronique (RPE) pour la dosimétrie rétrospective des rayonnements ionisants - Partie 2: Dosimétrie ex vivo à partir de l’émail dentaire humain (ISO 13304-2:2020)

Le présent document vise à spécifier les critères minimaux exigés pour l’assurance qualité et le contrôle qualité, l’évaluation des performances, et vise à faciliter la comparaison des mesures associées à l’estimation de dose absorbée obtenues par différents laboratoires en appliquant la spectroscopie RPE ex vivo dans la bande X sur de l’émail dentaire humain.
Le présent document couvre la détermination de la dose absorbée dans l’émail dentaire (hydroxyapatite). Il ne couvre pas le calcul de la dose délivrée aux organes ou à l’organisme entier.
Le présent document traite:
a)     des responsabilités du client et du laboratoire;
b)    de la confidentialité et des considérations déontologiques;
c)     des exigences de sécurité relatives aux laboratoires;
d)    de l’appareillage de mesure;
e)     de la préparation des échantillons;
f)     du mesurage des échantillons et de l’analyse du signal RPE;
g)     de l’étalonnag de la relation dose-réponse RPE;
h)    de l’incertitude associée à la dose et des essais de performance;
i)      de l’assurance qualité et du contrôle qualité.

Radiološka zaščita - Minimalna merila za spektroskopijo z elektronsko paramagnetno resonanco (EPR) za retrospektivno dozimetrijo ionizirnega sevanja - 2. del: Dozimetrija človeške zobne sklenine ex vivo (ISO 13304-2:2020)

Namen tega dokumenta je podati minimalna merila, ki so potrebna za zagotavljanje in nadzor kakovosti, oceno lastnosti ter olajšanje primerjave meritev v zvezi z oceno absorbirane doze, pridobljenih v drugih laboratorijih, z uporabo spektroskopije človeške zobne sklenine z elektronsko paramagnetno resonanco (EPR) ex vivo v pasu X.
Ta dokument obravnava določevanje absorbirane doze v zobni sklenini (hidroksiapatit). Ne obravnava izračuna doze, ki jo prejmejo organi ali telo.
Ta dokument obravnava:
a) odgovornosti stranke in laboratorija;
b) zaupnost in etične vidike;
c) zahteve za varnost laboratorija;
d) napravo za merjenje;
e) pripravo vzorcev;
f) meritve vzorcev in oceno signalov elektronske paramagnetne resonance (EPR);
g) kalibracijo odziva na dozo elektronske paramagnetne resonance;
h) negotovost doze in delovni preskus;
h) zagotavljanje in nadzor kakovosti.

General Information

• Status: Published
• Publication Date: 20-Dec-2022
• ICS: 13.280 - Radiation protection
• ICS: 17.240 - Radiation measurements
• Technical Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Drafting Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 21-Dec-2022
• Due Date: 30-Sep-2024
• Completion Date: 21-Dec-2022
• Ref Project: SIST EN ISO 13304-2:2023 - Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR) spectroscopy for retrospective dosimetry of ionizing radiation - Part 2: Ex vivo human tooth enamel dosimetry (ISO 13304-2:2020)

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2023
Radiološka zaščita - Minimalna merila za spektroskopijo z elektronsko
paramagnetno resonanco (EPR) za retrospektivno dozimetrijo ionizirnega sevanja
- 2. del: Dozimetrija človeške zobne sklenine ex vivo (ISO 13304-2:2020)
Radiological protection - Minimum criteria for electron paramagnetic resonance (EPR)
spectroscopy for retrospective dosimetry of ionizing radiation - Part 2: Ex vivo human
tooth enamel dosimetry (ISO 13304-2:2020)
Strahlenschutz - Mindestanforderungen an die Elektronenspinresonanz (EPR-
Spektroskopie) für die retrospektive Dosimetrie ionisierender Strahlung - Teil 2: Ex-vivo-
Dosimetrie des menschlichen Zahnschmelzes (ISO 13304-2:2020)
Radioprotection - Critères minimaux pour la spectroscopie par résonance
paramagnétique électronique (RPE) pour la dosimétrie rétrospective des rayonnements
ionisants - Partie 2: Dosimétrie ex vivo à partir de l’émail dentaire humain (ISO 13304-
2:2020)
Ta slovenski standard je istoveten z: EN ISO 13304-2:2022
ICS:
13.280 Varstvo pred sevanjem Radiation protection
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 13304-2
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 2: Ex
vivo human tooth enamel dosimetry (ISO 13304-2:2020)
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 2: Dosimétrie ex 2: Ex-vivo-Dosimetrie des menschlichen
vivo à partir de l'émail dentaire humain (ISO 13304- Zahnschmelzes (ISO 13304-2:2020)
2:2020)
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 13304-2:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 13304-2:2020 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 13304-2:2022 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 13304-2:2020 has been approved by CEN as EN ISO 13304-2:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 13304-2
First edition
2020-07
Radiological protection — Minimum
criteria for electron paramagnetic
resonance (EPR) spectroscopy for
retrospective dosimetry of ionizing
radiation —
Part 2:
Ex vivo human tooth enamel
dosimetry
Radioprotection — Critères minimaux pour la spectroscopie par
résonance paramagnétique électronique (RPE) pour la dosimétrie
rétrospective des rayonnements ionisants —
Partie 2: Dosimétrie ex vivo à partir de l’émail dentaire humain
Reference number
ISO 13304-2:2020(E)
©
ISO 2020
ISO 13304-2:2020(E)
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 13304-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Apparatus . 5
4.1 Specifications for EPR spectrometer. 5
4.2 Spectrometer sensitivity . 5
4.3 Microwave bridge . 5
4.4 Magnetic field . 5
4.5 Microwave resonator . 6
5 Preparation of tooth enamel samples . 6
5.1 General . 6
5.2 Applicable grain size . 7
6 Measurement of the EPR spectrum . 7
6.1 Description of spectrum . 7
6.2 Applicable measurement parameters and conditions . 8
6.2.1 General. 8
6.2.2 Microwave power . 8
6.2.3 Magnetic centre field . 8
6.2.4 Magnetic field sweep width . 8
6.2.5 Magnetic field sweep time . 8
6.2.6 Time constant of signal channel receiver . 9
6.2.7 EPR spectrum resolution . 9
6.2.8 Conversion time of spectrum acquisition . 9
6.2.9 Magnetic field modulation amplitude . 9
6.2.10 Number of spectrum accumulations . 9
6.2.11 Sample positioning and loading .10
6.2.12 Dependence of EPR signal intensity on sample mass .10
6.2.13 Use of standard samples .10
6.2.14 Number of measurement repetitions .11
7 Assessment of the RIS intensity .11
7.1 General .11
7.2 Intrinsic EPR signals from microwave resonator and sample tube .12
8 Irradiation of tooth enamel calibration samples for low linear energy transfer
(LET) exposure .12
9 Conversion of the RIS intensity into an estimate of absorbed dose .13
10 Calculation of uncertainty on dose estimate .14
11 Minimum detectable dose .15
12 Confidentiality and ethical considerations .16
13 Laboratory safety requirements .16
13.1 General .
...