SIST EN ISO 20031:2022
(Main)Radiological protection - Monitoring and dosimetry for internal exposures due to wound contamination with radionuclides (ISO 20031:2020)
Radiological protection - Monitoring and dosimetry for internal exposures due to wound contamination with radionuclides (ISO 20031:2020)
This document specifies the requirements for personal contamination monitoring and dose assessment following wounds involving radioactive materials. It includes requirements for the direct monitoring at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and systemic doses following the wound event.
It does not address:
— details of monitoring and assessment methods for specific radionuclides;
— monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds, including hot particles;
— therapeutic protocols. However, the responsible entity needs to address the requirements for decontamination and decorporation treatments if appropriate.
Strahlenschutz - Überwachung und Dosimetrie für innere Expositionen aufgrund von Wundkontaminationen mit Radionukliden (ISO 20031:2020)
Dieses Dokument legt die Anforderungen für die Überwachung der Kontamination bei Personen und die Dosisermittlung bei Wunden im Zusammenhang mit radioaktiven Stoffen fest. Es schließt Anforderungen für die direkte Überwachung am Wundort, die Überwachung der Aufnahme von Radionukliden in den Körper und die Ermittlung der Ortsdosen und systemischen Dosen im Anschluss an ein Wundereignis ein.
Es behandelt nicht:
Einzelheiten der Überwachungs- und Ermittlungsverfahren für bestimmte Radionuklide;
Überwachung und Dosisermittlung für Stoffe, die in Kontakt mit unversehrter Haut oder vorher bestehenden Wunden kommen, einschließlich heiße Partikel;
therapeutische Protokolle. Jedoch muss die verantwortliche Stelle ggf. auf die Anforderungen für Dekontaminations- und Dekorporationsbehandlungen eingehen.
Radioprotection - Surveillance et dosimétrie en cas d'exposition interne due à la contamination d'une plaie par radionucléides (ISO 20031:2020)
Le présent document spécifie les exigences relatives à la surveillance de la contamination individuelle et l'évaluation de la dose à la suite de plaies impliquant des matériaux radioactifs. Il inclut les exigences relatives à la surveillance directe du site de la plaie, la surveillance du transfert des radionucléides dans l'organisme et l'évaluation des doses locales et systémiques après un événement de type plaie.
Elle ne traite pas des aspects suivants:
— détails des méthodes de surveillance et d'évaluation pour des radionucléides spécifiques;
— surveillance et évaluation de la dose pour les matériaux en contact avec la peau intacte ou des plaies préexistantes, y compris les particules contaminées;
— protocoles thérapeutiques. Toutefois, il est nécessaire que l'entité responsable réponde aux exigences en matière de traitements de décontamination et de décorporation s'il y a lieu.
Radiološka zaščita - Nadzorovanje in dozimetrija notranje izpostavljenosti zaradi kontaminacije rane z radionuklidi (ISO 20031:2020)
Ta dokument določa zahteve za nadzorovanje osebne kontaminacije in ocenjevanje odmerkov pri ranah, ki so bile izpostavljene radioaktivnim snovem. Vključuje zahteve za neposredno nadzorovanje mesta rane, nadzorovanje vnosa radionuklidov v telo ter oceno lokalnih in sistemskih odmerkov po nastanku rane.
Ta dokument ne obravnava:
– podrobnosti o metodah nadzorovanja in ocenjevanja za posamezne radionuklide;
– nadzorovanja in ocenjevanja odmerkov za snovi, ki pridejo v stik z nepoškodovano kožo ali predhodno obstoječimi ranami, vključno z vročimi delci;
– terapevtskih protokolov. Vendar pa mora odgovorni subjekt po potrebi preučiti zahteve za dekontaminacijo in terapije za odstranjevanje radioaktivnih snovi iz telesa.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 20031:2022
01-september-2022
Radiološka zaščita - Nadzorovanje in dozimetrija notranje izpostavljenosti zaradi
kontaminacije rane z radionuklidi (ISO 20031:2020)
Radiological protection - Monitoring and dosimetry for internal exposures due to wound
contamination with radionuclides (ISO 20031:2020)
Strahlenschutz - Überwachung und Dosimetrie für innere Expositionen aufgrund von
Wundkontaminationen mit Radionukliden (ISO 20031:2020)
Radioprotection - Surveillance et dosimétrie en cas d'exposition interne due à la
contamination d'une plaie par radionucléides (ISO 20031:2020)
Ta slovenski standard je istoveten z: EN ISO 20031:2022
ICS:
13.280 Varstvo pred sevanjem Radiation protection
SIST EN ISO 20031:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 20031:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 20031:2022
EN ISO 20031
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 13.280
English Version
Radiological protection - Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides (ISO 20031:2020)
Radioprotection - Surveillance et dosimétrie en cas Strahlenschutz - Überwachung und Dosimetrie für
d'exposition interne due à la contamination d'une plaie innere Expositionen aufgrund von
par radionucléides (ISO 20031:2020) Wundkontaminationen mit Radionukliden (ISO
20031:2020)
This European Standard was approved by CEN on 24 July 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 20031:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 20031:2022
EN ISO 20031:2022 (E)
Contents Page
European foreword . 3
Annex H (informative) A-deviations . 4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 20031:2022
EN ISO 20031:2022 (E)
European foreword
The text of ISO 20031:2020 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 20031:2022 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 February 2023, and conflicting national standards
shall be withdrawn at the latest by February 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 20031:2020 has been approved by CEN as EN ISO 20031:2022 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 20031:2022
EN ISO 20031:2022 (E)
Annex H
(informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being
outside the competence of the CEN-CENELEC national member.
This European Standard does not fall under any Directive/Regulation of the EU.
In the relevant CEN-CENELEC countries, these A-deviations are valid instead of the respective
provisions of the European Standard until the national situation causing the A-deviation has
changed.
Clause Deviation
General Germany
Incorporation monitoring in Germany is legally regulated by the German
Guidelines on physical radiation protection control for determination of
the body dose part 2: Determination of the body dose of internal
exposition (incorporation monitoring) of January 12, 2007.
Regarding the measurements and the quality control described in this
standard shall comply with the guideline on physical radiation protection
control for determination of the body dose part 2: Determination of the
body dose of internal exposition (incorporation monitoring) of January 12,
2007
9.5 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 20031:2022
INTERNATIONAL ISO
STANDARD 20031
First edition
2020-02
Radiological protection — Monitoring
and dosimetry for internal exposures
due to wound contamination with
radionuclides
Radioprotection — Surveillance et dosimétrie en cas d'exposition
interne due à la contamination d'une plaie par radionucléides
Reference number
ISO 20031:2020(E)
©
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 5
4.1 Symbols . 5
4.2 Abbreviated terms . 5
5 Purpose and need for special monitoring programmes for internal exposures due
to wound contamination with radionuclides . 5
6 General aspects of wound contamination . 6
6.1 Introduction . 6
6.2 Category of wound contaminants . 6
6.3 Types of wounds and their specific retention of radionuclides. 7
7 Monitoring programmes to assess contamination via a wound . 7
7.1 Introduction . 7
7.2 Main steps for the monitoring and dosimetry for internal exposures due to wound
contamination with radionuclides . 7
7.3 Collection of information to characterize the contaminated wound . 8
7.3.1 General. 8
7.3.2 Information concerning the type of wound . . 9
7.3.3 Information concerning the radioactive contaminant . 9
7.4 In vivo wound measurements . 9
7.5 Systemic activity monitoring .10
8 Performance criteria for radiobioassay measurements .11
9 Procedure for local and systemic dose assessment .11
9.1 Local (wound site) dose assessment .11
9.2 Systemic dose assessment .11
9.3 Impact of medical intervention on dose assessment .13
9.3.1 Local chelation therapy and/or the excision of contaminated tissue from
the wound .13
9.3.2 Decorporation therapy .13
9.4 Software tools for bioassay data interpretation .13
9.5 Uncertainties .14
9.5.1 General.14
9.5.2 Uncertainties on local dose assessment .14
9.5.3 Uncertainties on internal dose assessment .14
9.6 Quality assurance.14
10 Recording .15
10.1 Recording in vivo measurement results.15
10.2 Recording in vitro radiobioassay and treatment waste results .15
11 Documentation of the dose assessment .16
12 Reporting .16
Annex A (informative) Schematic representation of NCRP wound model, default
parameters for retention equations and default transfer rates for the wound
model for the various categories of radionuclides in wounds (adapted from NCRP
[3]
report 156 (2007) ) .17
Annex B (informative) Types of wounds and their specific retention of radionuclides .20
© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
Annex C (informative) Example of a summary sheet that should follow the contaminated
worker during his initial care .23
Annex D (informative) Overview of typical methods used for in vitro bioassay measurements .24
−1 −1
Annex E (informative) Equivalent dose rate in a contaminated wound (mSv·h ·kBq )
−1 −1 2
and equivalent dose rate received by the skin (mSv·h ·kBq ·cm ) for selected
radionuclides .25
Annex F (informative) Committed effective dose coefficients for intake of selected
radionuclides via a contaminated wound for all wound model categories (adapted
[11]
from Toohey RE et al., 2014 ) .27
[14]
Annex G (informative) The IDEAS Guidelines provide guidelines for the estimation of
committed doses from incorporation monitoring data in case of wound .30
Bibliography .31
iv © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(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 on 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 the following
URL: 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.
© ISO 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
Introduction
In the course of their employment, radiation workers may be exposed to radioactive materials that
could be incorporated into the body. Intakes of radionuclides need to be monitored to determine that
any exposures are at expected levels. Internal doses resulting from intakes of radionuclides cannot be
measured directly. Estimating the dose requires decisions to be made about the monitoring techniques
and frequencies along with methodologies for dose assessment. The criteria governing the regimes of
such a monitoring programme or for the selection of methods and frequencies of monitoring usually
depends upon regulations, the purpose of the radiation protection programme, the probabilities of
potential radionuclide intakes, and the characteristics of the materials handled.
[1]
For these reasons, ISO standards for monitoring programmes (ISO 20553 ), laboratory requirements
[2]
(ISO 28218), and dose assessment (ISO 27048 ) have been developed and can be applied to many
workplaces where internal contamination may occur. Their application for internal exposures due to
wound contamination with radionuclides requires account to be taken of special aspects resulting from
the type of wound and the associated specific biokinetics of radionuclides at the origin of contamination.
This document offers guidance for the design of a special monitoring programme and for dose
assessment in the case of wound contamination with radionuclides. Recommendations of international
expert bodies and international experience with the practical application of these recommendations
in radiological protection programmes have been considered in the development of this document. Its
application facilitates the exchange of information between authorities, supervisory institutions and
employers.
vi © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 20031:2022
INTERNATIONAL STANDARD ISO 20031:2020(E)
Radiological protection — Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides
1 Scope
This document specifies the requirements for personal contamination monitoring and dose assessment
following wounds involving radioactive materials. It includes requirements for the direct monitoring
at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and
systemic doses following the wound event.
It does not address:
— details of monitoring and assessment methods for specific radionuclides;
— monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds,
including hot particles;
— therapeutic protocols. However, the responsible entity needs to address the requirements for
decontamination and decorporation treatments if appropriate.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
ISO 28218, Radiation protection — Performance criteria for radiobioassay
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 5725-1,
ISO 5725-2, ISO 5725-3 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
3.1
absorption
movement of material into blood regardless of mechanism, generally applied to the uptake (3.32) into
blood of soluble substances and material dissociated from particles
3.2
activity
number of spontaneous nuclear disintegrations per unit time
Note 1 to entry: The activity is stated in becquerels (Bq), i.e. the number of disintegrations per second.
3.3
biokinetic model
model describing the time course of absorption (3.1), distribution, metabolism and excretion of a
substance introduced into the body of an organism
3.4
clearance
net effect of the biological processes by which radionuclides are removed from the body or from a
tissue, organ or region of the body
3.5
contamination
activity (3.2) of radionuclides present on surfaces, or within solids, liquids or gases (including the
human body), where the presence of such radioactive material is unintended or undesirable
3.6
decision threshold
value of the estimator of the measurand which, when exceeded by the result of an actual measurement
using a given measurement procedure of a measurand quantifying a physical effect or quantity, it is
decided that the physical effect or quantity is present
Note 1 to entry: Otherwise, this effect is assumed to be absent.
3.7
decontamination
complete or partial removal of radioactive contamination (3.5) by a deliberate physical, chemical, or
biological process
3.8
decorporation
method aiming to accelerate the elimination from the body of an incorporated radionuclide
3.9
detection limit
smallest true value of the measurand which ensures a specified probability of being detectable by the
measurement procedure
Note 1 to entry: With the decision threshold, the detection limit is the smallest true value of the measurand for
which the probability of wrongly deciding that the true value of the measurand is zero is equal to a specified
value, β, when, in fact, the true value of the measurand is not zero. The probability of being detectable is
consequently (1 − β).
Note 2 to entry: The terms detection limit and decision threshold are used in an ambiguous way in different
standards (e.g. standards related to chemical analysis or quality assurance). If these terms are referred to one
has to state according to which standard they are used.
3.10
dose coefficient
committed tissue equivalent dose per unit acute intake h (τ) or committed effective dose per unit acute
T
intake e(τ), where τ is the time period in years over which the dose is calculated [e.g. e(50)]
2 © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
3.11
effective dose
sum of weighted equivalent doses (3.13) in all tissues and organs of the body
3.12
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue
weighting factors
Note 1 to entry: In the context of this document, the integration time is 50 years following any intake.
3.13
equivalent dose
product of the absorbed dose and the radiation weighting factor for the specific radiations at this point
3.14
local dose
equivalent dose (3.13) in a defined volume or area at the wound site
3.15
systemic dose
committed effective dose (3.12) excluding the local dose at the wound site
3.16
event
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not or suspected not to be negligible from the
point of view of protection or safety
3.17
internal exposure
exposure to radiation from a source inside the body
3.18
intake
act or process of taking radionuclides into the body by inhalation, ingestion, absorption (3.1)
through the skin or through wounds
3.19
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results of such measurements
3.20
incorporation monitoring
monitoring (3.19) of radionuclides incorporated into the bodies of individual workers by measurement
of the quantities of radioactive materials in the bodies of individual workers, or by measurement of
radioactive material excreted by individual workers
3.21
individual monitoring
monitoring (3.19) by means of equipment worn by individual workers, by measurement of the quantities
of radioactive materials in or on the bodies of individual workers, or by measurement of radioactive
material excreted by individual workers
3.22
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected
abnormal events (3.16)
© ISO 2020 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 20031:2022
ISO 20031:2020(E)
3.23
quality assurance
planned systematic actions necessary to provide adequate confidence that a process, measurement or
service satisfy given requirements for quality such as those specified in a licence
3.24
quality control
part of quality assurance (3.23) intended to verify that systems and components correspond to
predetermined requirements
3.25
radiobioassay
procedure used to determine the nature, activity (3.2), location or retention of radionuclides in the body
by direct (in vivo) measurement or by indirect (in vitro) analysis of material excreted or otherwise
removed from the body
3.26
in vitro radiobioassay measurement
analyses that include measurements of radioactivity present in biological samples taken from an
individual
3.27
in vivo radiobi
...
SLOVENSKI STANDARD
oSIST prEN ISO 20031:2022
01-maj-2022
Radiološka zaščita - Nadzorovanje in dozimetrija notranje izpostavljenosti zaradi
kontaminacije rane z radionuklidi (ISO 20031:2020)
Radiological protection - Monitoring and dosimetry for internal exposures due to wound
contamination with radionuclides (ISO 20031:2020)
Strahlenschutz - Überwachung und Dosimetrie für innere Expositionen aufgrund von
Wundkontaminationen mit Radionukliden (ISO 20031:2020)
Radioprotection - Surveillance et dosimétrie en cas d'exposition interne due à la
contamination d'une plaie par radionucléides (ISO 20031:2020)
Ta slovenski standard je istoveten z: prEN ISO 20031
ICS:
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN ISO 20031:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 20031:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 20031:2022
DRAFT
EUROPEAN STANDARD
prEN ISO 20031
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 13.280
English Version
Radiological protection - Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides (ISO 20031:2020)
Radioprotection - Surveillance et dosimétrie en cas Strahlenschutz - Überwachung und Dosimetrie für
d'exposition interne due à la contamination d'une plaie innere Expositionen aufgrund von
par radionucléides (ISO 20031:2020) Wundkontaminationen mit Radionukliden (ISO
20031:2020)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 430.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
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. prEN ISO 20031:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
Contents Page
European foreword . 3
Annex 1 A-Deviation for EN ISO 20031 . 4
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
European foreword
The text of ISO 20031:2020 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 prEN ISO 20031:2022 by Technical Committee CEN/TC 430 “Nuclear
energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
Endorsement notice
The text of ISO 20031:2020 has been approved by CEN as prEN ISO 20031:2022 without any
modification.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
Annex 1
A-Deviation for EN ISO 20031
Clause Deviation
General Germany
Incorporation monitoring in Germany is legally regulated by the German
Guidelines on physical radiation protection control for determination of
the body dose part 2: Determination of the body dose of internal
exposition (incorporation monitoring) of January 12, 2007.
Regarding the measurements and the quality control described in this
standard shall comply with the guideline on physical radiation protection
control for determination of the body dose part 2: Determination of the
body dose of internal exposition (incorporation monitoring) of January 12,
2007
9.5 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
4
---------------------- Page: 6 ----------------------
oSIST prEN ISO 20031:2022
INTERNATIONAL ISO
STANDARD 20031
First edition
2020-02
Radiological protection — Monitoring
and dosimetry for internal exposures
due to wound contamination with
radionuclides
Radioprotection — Surveillance et dosimétrie en cas d'exposition
interne due à la contamination d'une plaie par radionucléides
Reference number
ISO 20031:2020(E)
©
ISO 2020
---------------------- Page: 7 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 5
4.1 Symbols . 5
4.2 Abbreviated terms . 5
5 Purpose and need for special monitoring programmes for internal exposures due
to wound contamination with radionuclides . 5
6 General aspects of wound contamination . 6
6.1 Introduction . 6
6.2 Category of wound contaminants . 6
6.3 Types of wounds and their specific retention of radionuclides. 7
7 Monitoring programmes to assess contamination via a wound . 7
7.1 Introduction . 7
7.2 Main steps for the monitoring and dosimetry for internal exposures due to wound
contamination with radionuclides . 7
7.3 Collection of information to characterize the contaminated wound . 8
7.3.1 General. 8
7.3.2 Information concerning the type of wound . . 9
7.3.3 Information concerning the radioactive contaminant . 9
7.4 In vivo wound measurements . 9
7.5 Systemic activity monitoring .10
8 Performance criteria for radiobioassay measurements .11
9 Procedure for local and systemic dose assessment .11
9.1 Local (wound site) dose assessment .11
9.2 Systemic dose assessment .11
9.3 Impact of medical intervention on dose assessment .13
9.3.1 Local chelation therapy and/or the excision of contaminated tissue from
the wound .13
9.3.2 Decorporation therapy .13
9.4 Software tools for bioassay data interpretation .13
9.5 Uncertainties .14
9.5.1 General.14
9.5.2 Uncertainties on local dose assessment .14
9.5.3 Uncertainties on internal dose assessment .14
9.6 Quality assurance.14
10 Recording .15
10.1 Recording in vivo measurement results.15
10.2 Recording in vitro radiobioassay and treatment waste results .15
11 Documentation of the dose assessment .16
12 Reporting .16
Annex A (informative) Schematic representation of NCRP wound model, default
parameters for retention equations and default transfer rates for the wound
model for the various categories of radionuclides in wounds (adapted from NCRP
[3]
report 156 (2007) ) .17
Annex B (informative) Types of wounds and their specific retention of radionuclides .20
© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Annex C (informative) Example of a summary sheet that should follow the contaminated
worker during his initial care .23
Annex D (informative) Overview of typical methods used for in vitro bioassay measurements .24
−1 −1
Annex E (informative) Equivalent dose rate in a contaminated wound (mSv·h ·kBq )
−1 −1 2
and equivalent dose rate received by the skin (mSv·h ·kBq ·cm ) for selected
radionuclides .25
Annex F (informative) Committed effective dose coefficients for intake of selected
radionuclides via a contaminated wound for all wound model categories (adapted
[11]
from Toohey RE et al., 2014 ) .27
[14]
Annex G (informative) The IDEAS Guidelines provide guidelines for the estimation of
committed doses from incorporation monitoring data in case of wound .30
Bibliography .31
iv © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(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 on 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 the following
URL: 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.
© ISO 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Introduction
In the course of their employment, radiation workers may be exposed to radioactive materials that
could be incorporated into the body. Intakes of radionuclides need to be monitored to determine that
any exposures are at expected levels. Internal doses resulting from intakes of radionuclides cannot be
measured directly. Estimating the dose requires decisions to be made about the monitoring techniques
and frequencies along with methodologies for dose assessment. The criteria governing the regimes of
such a monitoring programme or for the selection of methods and frequencies of monitoring usually
depends upon regulations, the purpose of the radiation protection programme, the probabilities of
potential radionuclide intakes, and the characteristics of the materials handled.
[1]
For these reasons, ISO standards for monitoring programmes (ISO 20553 ), laboratory requirements
[2]
(ISO 28218), and dose assessment (ISO 27048 ) have been developed and can be applied to many
workplaces where internal contamination may occur. Their application for internal exposures due to
wound contamination with radionuclides requires account to be taken of special aspects resulting from
the type of wound and the associated specific biokinetics of radionuclides at the origin of contamination.
This document offers guidance for the design of a special monitoring programme and for dose
assessment in the case of wound contamination with radionuclides. Recommendations of international
expert bodies and international experience with the practical application of these recommendations
in radiological protection programmes have been considered in the development of this document. Its
application facilitates the exchange of information between authorities, supervisory institutions and
employers.
vi © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 20031:2022
INTERNATIONAL STANDARD ISO 20031:2020(E)
Radiological protection — Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides
1 Scope
This document specifies the requirements for personal contamination monitoring and dose assessment
following wounds involving radioactive materials. It includes requirements for the direct monitoring
at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and
systemic doses following the wound event.
It does not address:
— details of monitoring and assessment methods for specific radionuclides;
— monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds,
including hot particles;
— therapeutic protocols. However, the responsible entity needs to address the requirements for
decontamination and decorporation treatments if appropriate.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General
principles and definitions
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determination of repeatability and reproducibility of a standard measurement method
ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate
measures of the precision of a standard measurement method
ISO 28218, Radiation protection — Performance criteria for radiobioassay
ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated
terms (VIM)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 5725-1,
ISO 5725-2, ISO 5725-3 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
---------------------- Page: 13 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.1
absorption
movement of material into blood regardless of mechanism, generally applied to the uptake (3.32) into
blood of soluble substances and material dissociated from particles
3.2
activity
number of spontaneous nuclear disintegrations per unit time
Note 1 to entry: The activity is stated in becquerels (Bq), i.e. the number of disintegrations per second.
3.3
biokinetic model
model describing the time course of absorption (3.1), distribution, metabolism and excretion of a
substance introduced into the body of an organism
3.4
clearance
net effect of the biological processes by which radionuclides are removed from the body or from a
tissue, organ or region of the body
3.5
contamination
activity (3.2) of radionuclides present on surfaces, or within solids, liquids or gases (including the
human body), where the presence of such radioactive material is unintended or undesirable
3.6
decision threshold
value of the estimator of the measurand which, when exceeded by the result of an actual measurement
using a given measurement procedure of a measurand quantifying a physical effect or quantity, it is
decided that the physical effect or quantity is present
Note 1 to entry: Otherwise, this effect is assumed to be absent.
3.7
decontamination
complete or partial removal of radioactive contamination (3.5) by a deliberate physical, chemical, or
biological process
3.8
decorporation
method aiming to accelerate the elimination from the body of an incorporated radionuclide
3.9
detection limit
smallest true value of the measurand which ensures a specified probability of being detectable by the
measurement procedure
Note 1 to entry: With the decision threshold, the detection limit is the smallest true value of the measurand for
which the probability of wrongly deciding that the true value of the measurand is zero is equal to a specified
value, β, when, in fact, the true value of the measurand is not zero. The probability of being detectable is
consequently (1 − β).
Note 2 to entry: The terms detection limit and decision threshold are used in an ambiguous way in different
standards (e.g. standards related to chemical analysis or quality assurance). If these terms are referred to one
has to state according to which standard they are used.
3.10
dose coefficient
committed tissue equivalent dose per unit acute intake h (τ) or committed effective dose per unit acute
T
intake e(τ), where τ is the time period in years over which the dose is calculated [e.g. e(50)]
2 © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.11
effective dose
sum of weighted equivalent doses (3.13) in all tissues and organs of the body
3.12
committed effective dose
sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue
weighting factors
Note 1 to entry: In the context of this document, the integration time is 50 years following any intake.
3.13
equivalent dose
product of the absorbed dose and the radiation weighting factor for the specific radiations at this point
3.14
local dose
equivalent dose (3.13) in a defined volume or area at the wound site
3.15
systemic dose
committed effective dose (3.12) excluding the local dose at the wound site
3.16
event
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not or suspected not to be negligible from the
point of view of protection or safety
3.17
internal exposure
exposure to radiation from a source inside the body
3.18
intake
act or process of taking radionuclides into the body by inhalation, ingestion, absorption (3.1)
through the skin or through wounds
3.19
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results of such measurements
3.20
incorporation monitoring
monitoring (3.19) of radionuclides incorporated into the bodies of individual workers by measurement
of the quantities of radioactive materials in the bodies of individual workers, or by measurement of
radioactive material excreted by individual workers
3.21
individual monitoring
monitoring (3.19) by means of equipment worn by individual workers, by measurement of the quantities
of radioactive materials in or on the bodies of individual workers, or by measurement of radioactive
material excreted by individual workers
3.22
special monitoring programme
monitoring programme performed to quantify significant exposures following actual or suspected
abnormal events (3.16)
© ISO 2020 – All rights reserved 3
---------------------- Page: 15 ----------------------
oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.23
quality assurance
planned systematic actions necessary to provide adequate confidence that a process, measurement or
service satisfy given requirements for quality such as those specified in a licence
3.24
quality control
part of quality assurance (3.23) intended to verify that systems and components correspond to
predetermined requirements
3.25
radiobioassay
procedure used to determine the nature, activity (3.2), location or retention of radionuclides in the body
by direct (in vivo) measurement or by indirect (in vitro) analysis of material excreted or otherwise
removed from the body
3.26
in vitro radiobioassay measurement
analyses that include measurements of radioactivity present in biological samples taken from an
individual
3.27
in vivo radiobioassay measurement
measurement of radioactive material in the human body utilizing instrumentation that detects
radiation emitted from the radioactive material in the body
Note 1 to entry: Normally, the measurement devices are whole-body or partial-body (e.g., lung, thyroid) counters.
3.28
responsible entity
person, body or service that is in charge of the monitoring (3.19) and dosimetry
3.29
retention function
function describing the fraction of an intake present in a biological compartment (whole body, tissue,
organ or excreta) after a given time has elapsed since the intake occurred
3.30
time of measurement
time at which the biological sample (e.g. urine, faeces) is taken from the individual
concerned
3.31
time of measurement
time at which the in vivo measurement begins
3.32
uptake
translocation of material from deposition site [wound (3.33), lung, etc.] into blood and subsequently to
systemic organs and tissues
3.33
wound
injury to the body in which the skin or other tissue is broken, cut, pierced, torn, scraped, burned, etc.
4 © ISO 2020 – All rights reserved
------------
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.