SIST EN ISO 16638-2:2022
(Main)Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2: Ingestion of uranium compounds (ISO 16638-2:2019)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2: Ingestion of uranium compounds (ISO 16638-2:2019)
This document specifies the minimum requirements for the design of professional programmes to monitor workers exposed to a risk of ingestion to uranium compounds. This document establishes principles for the development of compatible goals and requirements for monitoring programmes and dose assessment for workers occupationally exposed to internal contamination. It establishes procedures and assumptions for risk analysis, monitoring programmes and the standardized interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its compounds. It sets limits for the applicability of the procedures in respect to dose levels above which more sophisticated methods need to be applied.
This document addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns.
This document addresses, for ingestion of uranium and its compounds, the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) suitable methods for monitoring and criteria for their selection;
d) information that is collected for the design of a monitoring programme;
e) procedures for dose assessment based on reference levels for special monitoring programmes;
f) criteria for determining the significance of monitoring results;
g) uncertainties arising from dose assessment and interpretation of bioassays data;
h) reporting/documentation;
i) quality assurance;
j) record keeping requirements.
It is not applicable to the following items:
a) detailed descriptions of measuring methods and techniques for uranium;
b) modelling for the improvement of internal dosimetry;
c) potential influence of counter-measures (e.g. administration of chelating agents);
d) investigation of the causes or implications of an exposure;
e) dosimetry for inhalation exposures and for contaminated wounds.
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 2: Ingestion von Uranverbindungen (ISO 16638-2:2019)
Dieses Dokument legt die Mindestanforderungen für die Auslegung von professionellen Programmen zur Überwachung von Beschäftigten fest, die einem Risiko der Ingestion von Uranverbindungen ausgesetzt sind. Dieses Dokument legt Grundsätze für die Entwicklung kompatibler Ziele und Anforderungen für Überwachungsprogramme und die Dosisabschätzung für Beschäftigte fest, die beruflich einer internen Kontamination ausgesetzt sind. Es legt Verfahren und Annahmen für Risikoanalysen, Überwachungsprogramme und die standardisierte Interpretation von Überwachungsdaten fest, um akzeptable Zuverlässigkeitsniveaus für Uran und seine Verbindungen zu erreichen. Es legt Grenzwerte für die Anwendbarkeit der Verfahren in Bezug auf Dosiswerte fest, oberhalb derer anspruchsvollere Methoden angewendet werden müssen.
Dieses Dokument behandelt solche Umstände, unter denen die Exposition durch Überlegungen entweder zu radiologischer oder chemischer Toxizität begrenzt werden könnte.
Dieses Dokument behandelt für die Ingestion von Uran und seinen Verbindungen die folgenden Punkte:
a) Zwecke der Überwachung und der Überwachungsprogramme;
b) Beschreibung der verschiedenen Kategorien von Überwachungsprogrammen;
c) geeignete Methoden zur Überwachung und Kriterien für ihre Auswahl;
d) Informationen, die für die Auslegung eines Überwachungsprogramms gesammelt werden;
e) Verfahren für die Dosisabschätzung basierend auf Referenzwerten für besondere Überwachungsprogramme;
f) Kriterien zur Bestimmung der Bedeutsamkeit von Überwachungsergebnissen;
g) Unsicherheiten, die sich aus der Dosisabschätzung und der Interpretation von Ergebnissen der Inkorporationsmessungen ergeben;
h) Befundung/Dokumentation;
i) Qualitätssicherung;
j) Anforderungen an die Aufzeichnung.
Es ist nicht anwendbar auf die folgenden Punkte:
a) detaillierte Beschreibungen der Messmethoden und -techniken für Uran;
b) Modellierung für die Verbesserung der internen Dosimetrie;
c) möglicher Einfluss von Gegenmaßnahmen (z. B. Gabe von Komplexbildnern);
d) Untersuchung der Ursachen oder Implikationen einer Exposition;
e) Dosimetrie für Inhalationsexposition und für kontaminierte Wunden.
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 2: Ingestion de composés d'uranium (ISO 16638-2:2019)
Le présent document décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés à un risque d'ingestion de composés de l'uranium. Le présent document établit les principes pour la mise en œuvre des objectifs et des exigences des programmes de surveillance et de l'estimation dosimétrique des travailleurs exposés, dans le cadre de leur travail, à une contamination interne. Il établit des procédures et des hypothèses relatives à l'analyse des risques, aux programmes de surveillance et à l'interprétation normalisée des résultats de cette surveillance, afin d'atteindre des niveaux acceptables de fiabilité pour l'uranium et ses composés. Il fixe des limites pour l'applicabilité des procédures concernant les niveaux de dose au-delà desquels il est nécessaire d'appliquer des méthodes plus sophistiquées.
Le présent document traite des circonstances dans lesquelles l'exposition peut être assujettie aux problèmes liés à la toxicité radiologique ou chimique.
Le présent document traite, pour l'ingestion d'uranium et de ses composés, des éléments suivants:
a) les objectifs de la surveillance et les programmes de surveillance;
b) la description des différentes catégories de programmes de surveillance;
c) les méthodes valables pour la surveillance et leurs critères de sélection;
d) les informations collectées pour l'élaboration d'un programme de surveillance;
e) les procédures d'estimation dosimétrique basées sur les niveaux de référence utilisés pour les programmes de surveillance spéciale;
f) les critères pour la détermination de l'importance des résultats de la surveillance;
g) les incertitudes liées à l'estimation dosimétrique et l'interprétation des résultats sur échantillons biologiques;
h) la transmission et la documentation;
i) l'assurance de la qualité;
j) les exigences en matière de conservation des enregistrements.
Il ne s'applique pas aux éléments suivants:
a) les descriptions détaillées des méthodes et des techniques de mesurage concernant l'uranium;
b) la modélisation pour l'amélioration de la dosimétrie interne;
c) l'influence potentielle de l'action des agents décorporants (par exemple administration d'agents complexants);
d) l'investigation des causes et des conséquences d'une exposition;
e) la dosimétrie pour les expositions par inhalation et par blessures
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale - 2. del: Zaužitje uranovih spojin (ISO 16638-2:2019)
Ta dokument določa minimalne zahteve za načrtovanje profesionalnih programov za nadzor delavcev, ki so izpostavljeni tveganju za zaužitje uranovih spojin. Ta dokument določa načela za razvoj združljivih ciljev in zahtev za nadzorne programe ter ocenjevanje odmerkov za delavce, ki so poklicno izpostavljeni notranji kontaminaciji. Določa postopke in predpostavke za analizo tveganja, nadzorne programe ter standardizirano interpretacijo nadzornih podatkov za doseganje sprejemljivih ravni zanesljivosti za uran in uranove spojine. Postavlja meje ravni odmerkov za uporabo postopkov, nad katerimi je treba uporabiti naprednejše metode.
Ta dokument obravnava okoliščine, ko je izpostavljenost lahko omejena zaradi radiološke ali kemijske toksičnosti.
Ta dokument v zvezi z zaužitjem urana in njegovih spojin obravnava:
a) namene nadzora in nadzornih programov;
b) opis različnih kategorij nadzornih programov;
c) primerne metode za izvajanje nadzora in kriterije za izbiro metod;
d) informacije, ki se zbirajo za načrtovanje nadzornega programa;
e) postopke za ocenjevanje odmerkov glede na referenčne ravni za posebne nadzorne programe;
f) kriterije za določanje pomena rezultatov nadzora;
g) negotovosti, ki izhajajo iz ocenjevanja odmerkov in interpretacije podatkov bioloških preizkusov;
h) poročanje/dokumentiranje;
i) zagotavljanje kakovosti;
j) zahteve za vodenje evidenc.
Ne uporablja se za:
a) podrobno opisovanje merilnih metod in tehnik za uran;
b) modeliranje za izboljševanje notranje dozimetrije;
c) možne vplive protiukrepov (npr. dovajanja kelatov);
d) raziskovanje razlogov ali vplivov izpostavljenosti;
e) dozimetrijo pri izpostavljenosti ob vdihavanju in kontaminiranih ranah.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16638-2:2022
01-september-2022
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale -
2. del: Zaužitje uranovih spojin (ISO 16638-2:2019)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2:
Ingestion of uranium compounds (ISO 16638-2:2019)
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 2:
Ingestion von Uranverbindungen (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 2:
Ingestion de composés d'uranium (ISO 16638-2:2019)
Ta slovenski standard je istoveten z: EN ISO 16638-2:2022
ICS:
17.240 Merjenje sevanja Radiation measurements
SIST EN ISO 16638-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 16638-2:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 16638-2:2022
EN ISO 16638-2
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2022
EUROPÄISCHE NORM
ICS 17.240
English Version
Radiological protection - Monitoring and internal
dosimetry for specific materials - Part 2: Ingestion of
uranium compounds (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des Strahlenschutz - Überwachung und interne Dosimetrie
éléments spécifiques - Partie 2: Ingestion de composés für bestimmte Stoffe - Teil 2: Ingestion von
d'uranium (ISO 16638-2:2019) Uranverbindungen (ISO 16638-2:2019)
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 16638-2:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 16638-2:2022
EN ISO 16638-2:2022 (E)
Contents Page
European foreword . 3
Annex G (informative) A-deviations . 4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 16638-2:2022
EN ISO 16638-2:2022 (E)
European foreword
The text of ISO 16638-2:2019 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 16638-2:2022 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 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 16638-2:2019 has been approved by CEN as EN ISO 16638-2:2022 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 16638-2:2022
EN ISO 16638-2:2022 (E)
Annex G
(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
clauses 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
11.3 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 16638-2:2022
INTERNATIONAL ISO
STANDARD 16638-2
First edition
2019-11
Radiological protection — Monitoring
and internal dosimetry for specific
materials —
Part 2:
Ingestion of uranium compounds
Radioprotection — Contrôle et dosimétrie interne des éléments
spécifiques —
Partie 2: Ingestion de composés d'uranium
Reference number
ISO 16638-2:2019(E)
©
ISO 2019
---------------------- Page: 7 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 4
4.1 Symbols . 4
4.2 Abbreviated terms . 5
5 Purpose and need for monitoring programmes . 5
6 General aspects . 7
7 Special monitoring programmes . 8
8 Task-related monitoring programmes for individual monitoring . 8
9 Reference values as performance criteria for laboratories . 8
10 Quality assurance and quality control for bioassay laboratories .9
11 Procedure for the assessment of exposures .10
11.1 Assessment of indi vidual monitoring data .10
11.2 Properties of a software tool .10
11.3 Uncertainties .11
11.4 Quality assurance of the assessment process .11
12 Reporting and documentation .12
12.1 Reporting results for in vitro measurements .12
12.2 Documentation of the dose assessment .12
Annex A (informative) Nuclear data of U-238 and U-235 decay .14
Annex B (informative) Default classification of uranium compounds .15
Annex C (informative) Measurement techniques for uranium in case of ingestion .16
Annex D (informative) Excretion rates for ingestion of uranium compounds .19
Annex E (informative) Committed effective dose per unit intake after ingestion of uranium
compounds .21
Annex F (informative) Estimation of uncertainties for internal dose assessments after ingestion 22
Bibliography .25
© ISO 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(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 the parts in the ISO 16638 series can be found on the ISO website.
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 2019 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
Introduction
In the course of employment, individuals may work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against the risks of incorporated
radionuclides needs monitoring for potential intakes and/or quantifying actual intakes and exposures.
Internal radiation exposure caused by the contamination of radioactive substances results in doses,
which cannot be measured directly. Decisions should be made regarding which methods, techniques,
frequencies, etc., to select in order to measure and assess these doses. The criteria for determining the
design of a monitoring programme, i.e. its requirements, methods and schedule, usually depends on
legislation, the purpose of the overall radiation protection programme, the probabilities of potential
radionuclide intakes and the characteristics of the materials handled.
For these reasons, four International Standards addressing monitoring programmes (ISO 20553),
laboratory requirements (ISO 28218), dose assessments (ISO 27048) and special cases of inhalation
of uranium compounds (ISO 16638-1) have been developed and can be applied in a straightforward
manner to many radionuclides for accreditation purposes.
This document has been developed to address the specific issue of monitoring and internal dosimetry
for ingestion of uranium compounds. It contributes to harmonizing the practices in the monitoring
of occupationally exposed persons while remaining complementary to ISO 16638-1. Occupational
intakes solely by ingestion are rare however they may need to be considered in some circumstances,
for example; external contamination of the mouth or lips; in cases of poor working practices such as
food being eaten in contamination areas. Intakes by ingestion can also occur alongside inhalation
depending on the circumstances of the event. Monitoring and dose assessment for intakes by inhalation
(ISO 16638-1) are covered in a separate document and would take precedence over the requirements
for assessing intakes by ingestion. However, the monitoring requirements are very similar. Uranium is
both radiologically and chemically toxic. Hence, the scientific bases of current occupational exposure
standards are reviewed in addition to radiation exposure limits.
This document describes the need for a monitoring and internal dosimetry programme for the different
compounds of uranium in case of a risk of ingestion and offers guidance on its design. The design of
the workplace, the work practices and hygiene practices followed and the protective equipment worn,
may all be essential in controlling exposure to this risk. The development of this document has taken
into account recommendations from international expert bodies and persons with international
experience of the practical application of its recommendations in radiological protection programmes.
Its application facilitates the exchanges of information between authorities, supervisory institutions
and employers.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 16638-2:2022
---------------------- Page: 12 ----------------------
SIST EN ISO 16638-2:2022
INTERNATIONAL STANDARD ISO 16638-2:2019(E)
Radiological protection — Monitoring and internal
dosimetry for specific materials —
Part 2:
Ingestion of uranium compounds
1 Scope
This document specifies the minimum requirements for the design of professional programmes to
monitor workers exposed to a risk of ingestion to uranium compounds. This document establishes
principles for the development of compatible goals and requirements for monitoring programmes
and dose assessment for workers occupationally exposed to internal contamination. It establishes
procedures and assumptions for risk analysis, monitoring programmes and the standardized
interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its
compounds. It sets limits for the applicability of the procedures in respect to dose levels above which
more sophisticated methods need to be applied.
This document addresses those circumstances when exposure could be constrained by either
radiological or chemical toxicity concerns.
This document addresses, for ingestion of uranium and its compounds, the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) suitable methods for monitoring and criteria for their selection;
d) information that is collected for the design of a monitoring programme;
e) procedures for dose assessment based on reference levels for special monitoring programmes;
f) criteria for determining the significance of monitoring results;
g) uncertainties arising from dose assessment and interpretation of bioassays data;
h) reporting/documentation;
i) quality assurance;
j) record keeping requirements.
It is not applicable to the following items:
a) detailed descriptions of measuring methods and techniques for uranium;
b) modelling for the improvement of internal dosimetry;
c) potential influence of counter-measures (e.g. administration of chelating agents);
d) investigation of the causes or implications of an exposure;
e) dosimetry for inhalation exposures and for contaminated wounds.
© ISO 2019 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
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 15189, Medical laboratories — Requirements for quality and competence
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/
3.1
absorption
movement of material to blood regardless of mechanism
Note 1 to entry: Absorption generally applies to the uptake 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
clearance
the action that results in the movement of radioactive material from the site of deposition in tissues
and organs
Note 1 to entry: This action can be natural or induced by therapeutic means.
Note 2 to entry: The clearance rate is the rate at which this occurs.
3.4
contamination
radioactive substances on surfaces or within solids, liquids or gases (including the human body), where
its presence is unintended or undesirable, or the process giving rise to its presence in such places
2 © ISO 2019 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
3.5
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.
3.6
detection limit
smallest true value of the measurand which ensures a specified probability of being detectable by the
measurement procedure
3.7
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.
Note 2 to entry: The committed effective dose is expressed in Sievert (Sv).
3.8
excretion function
function describing the fraction of an intake excreted per day after a given time has elapsed since the
intake occurred
Note 1 to entry: The excretion function is expressed in becquerels per day (Bq/d).
3.9
event
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not negligible from the point of view of protection
or safety
3.10
intake
activity (3.2) of a radionuclide taken into the body in a given time period or as a result of a given event (3.9)
Note 1 to entry: The intake is expressed in becquerels (Bq).
3.11
in vitro analyses
analyses that include measurements of radionuclides present in biological samples taken from an
individual
Note 1 to entry: These include urine, faeces and nasal samples; in special monitoring programmes, samples of
other materials such as blood and hair may be taken.
3.12
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results
Note 1 to entry: This document distinguishes three different categories of monitoring programmes, namely
confirmatory monitoring programme (3.13), special monitoring programme (3.14) and task-related monitoring
programme (3.15), as well as one type of monitoring, namely individual monitoring (3.16), which features in each
category.
© ISO 2019 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
3.13
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions and that a
routine monitoring programme for dose assessment purposes is not required
3.14
special monitoring programme
monitoring programme performed to quantify suspect significant exposures following an event (3.9)
3.15
task-related monitoring programme
monitoring programme related to a specific operation, or providing information on a specific operation
of limited duration, or following major modifications applied to the installations or operating
procedures, or confirming that the routine monitoring programme is suitable
3.16
individual monitoring
monitoring (3.12) 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
3.17
quality assurance
planned and 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
3.18
quality control
part of quality assurance (3.17) intended to verify that systems and components correspond to
predetermined requirements
3.19
reference level
value of measured quantities above which some specified action or decision should be taken
3.20
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
4 Symbols and abbreviated terms
4.1 Symbols
D committed effective dose due to annual intake (Sv) such that lower doses may be
v
discounted for the purpose of the monitoring programme
E(50) committed effective dose (Sv) for an integration period of 50 years
−1
e(50) dose coefficient: committed effective dose per unit intake (Sv·Bq ), for an integration
period of 50 years
f alimentary tract transfer factor, fraction of activity entering the alimentary tract that
A
is absorbed from the gut in the absence of both radioactive decay losses and
endogenous input to the tract
4 © ISO 2019 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 16638-2:2022
ISO 16638-2:2019(E)
I intake in Bq (3.13)
−1
m(t ) predicted value of the measured quantity (Bq/d/Bq = d ) at time, t , for unit intake
i i
(excretion or retention function, for unit intake)
m (t ) predicted value of the quantity measured after a period of t , days of a chronic unit
c i i
intake per day (excretion or retention function at time, t , for chronic unit intake per
i
day)
4.2 Abbreviated terms
[2]
CRM certified reference material (see ISO 28218 )
DU depleted uranium (uranium with an assay of U-235 that is lower than its content in natural
uranium)
HEU high enriched uranium (uranium with an assay of U-235 equal to or more than 20 %)
IARC International Agency for Research on Cancer
ICRP International Commission on Radiological Protection
LDH lactate dehydrogenase
LEU low enriched uranium (uranium with an assay of U-235 from the natural level to 20 %)
LOAEL lowest-observed-adverse-effect level
NOAEL no-observed-adverse-effect level
[2]
TRS transfer reference standard (see ISO 28218 )
U-nat uranium compound with natural isotopic composition
5 Purpose and need for monitoring programmes
Uranium compounds are considered a mixture of three major isotopes: U-234, U-235 and U-238; but
in certain cases U-236, U-233 and U-232 are also included. This document describes four different
isotopic compositions, as examples, representing natural (U-nat), depleted (DU), low (LEU) and high
(HEU) enriched uranium forms (see Table 1) based on their typical uranium isotopic compositions
encountered in the nuclear industry.
...
SLOVENSKI STANDARD
oSIST prEN ISO 16638-2:2022
01-maj-2022
Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale -
2. del: Zaužitje uranovih spojin (ISO 16638-2:2019)
Radiological protection - Monitoring and internal dosimetry for specific materials - Part 2:
Ingestion of uranium compounds (ISO 16638-2:2019)
Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 2:
Ingestion von Uranverbindungen (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 2:
Ingestion de composés d'uranium (ISO 16638-2:2019)
Ta slovenski standard je istoveten z: prEN ISO 16638-2
ICS:
17.240 Merjenje sevanja Radiation measurements
oSIST prEN ISO 16638-2:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 16638-2:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 16638-2:2022
DRAFT
EUROPEAN STANDARD
prEN ISO 16638-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 17.240
English Version
Radiological protection - Monitoring and internal
dosimetry for specific materials - Part 2: Ingestion of
uranium compounds (ISO 16638-2:2019)
Radioprotection - Contrôle et dosimétrie interne des
éléments spécifiques - Partie 2: Ingestion de composés
d'uranium (ISO 16638-2:2019)
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 16638-2:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 16638-2:2022
prEN ISO 16638-2:2022 (E)
Contents Page
European foreword . 3
Annex 1 A-Deviation for EN ISO 16638-2 (Germany) . 4
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 16638-2:2022
prEN ISO 16638-2:2022 (E)
European foreword
The text of ISO 16638-2:2019 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 16638-2:2022 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 16638-2:2019 has been approved by CEN as prEN ISO 16638-2:2022 without any
modification.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 16638-2:2022
prEN ISO 16638-2:2022 (E)
Annex 1
A-Deviation for EN ISO 16638-2 (Germany)
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
clauses 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
11.3 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
4
---------------------- Page: 6 ----------------------
oSIST prEN ISO 16638-2:2022
INTERNATIONAL ISO
STANDARD 16638-2
First edition
2019-11
Radiological protection — Monitoring
and internal dosimetry for specific
materials —
Part 2:
Ingestion of uranium compounds
Radioprotection — Contrôle et dosimétrie interne des éléments
spécifiques —
Partie 2: Ingestion de composés d'uranium
Reference number
ISO 16638-2:2019(E)
©
ISO 2019
---------------------- Page: 7 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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 2019 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 4
4.1 Symbols . 4
4.2 Abbreviated terms . 5
5 Purpose and need for monitoring programmes . 5
6 General aspects . 7
7 Special monitoring programmes . 8
8 Task-related monitoring programmes for individual monitoring . 8
9 Reference values as performance criteria for laboratories . 8
10 Quality assurance and quality control for bioassay laboratories .9
11 Procedure for the assessment of exposures .10
11.1 Assessment of indi vidual monitoring data .10
11.2 Properties of a software tool .10
11.3 Uncertainties .11
11.4 Quality assurance of the assessment process .11
12 Reporting and documentation .12
12.1 Reporting results for in vitro measurements .12
12.2 Documentation of the dose assessment .12
Annex A (informative) Nuclear data of U-238 and U-235 decay .14
Annex B (informative) Default classification of uranium compounds .15
Annex C (informative) Measurement techniques for uranium in case of ingestion .16
Annex D (informative) Excretion rates for ingestion of uranium compounds .19
Annex E (informative) Committed effective dose per unit intake after ingestion of uranium
compounds .21
Annex F (informative) Estimation of uncertainties for internal dose assessments after ingestion 22
Bibliography .25
© ISO 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(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 the parts in the ISO 16638 series can be found on the ISO website.
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 2019 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
Introduction
In the course of employment, individuals may work with radioactive materials that, under certain
circumstances, could be taken into the body. Protecting workers against the risks of incorporated
radionuclides needs monitoring for potential intakes and/or quantifying actual intakes and exposures.
Internal radiation exposure caused by the contamination of radioactive substances results in doses,
which cannot be measured directly. Decisions should be made regarding which methods, techniques,
frequencies, etc., to select in order to measure and assess these doses. The criteria for determining the
design of a monitoring programme, i.e. its requirements, methods and schedule, usually depends on
legislation, the purpose of the overall radiation protection programme, the probabilities of potential
radionuclide intakes and the characteristics of the materials handled.
For these reasons, four International Standards addressing monitoring programmes (ISO 20553),
laboratory requirements (ISO 28218), dose assessments (ISO 27048) and special cases of inhalation
of uranium compounds (ISO 16638-1) have been developed and can be applied in a straightforward
manner to many radionuclides for accreditation purposes.
This document has been developed to address the specific issue of monitoring and internal dosimetry
for ingestion of uranium compounds. It contributes to harmonizing the practices in the monitoring
of occupationally exposed persons while remaining complementary to ISO 16638-1. Occupational
intakes solely by ingestion are rare however they may need to be considered in some circumstances,
for example; external contamination of the mouth or lips; in cases of poor working practices such as
food being eaten in contamination areas. Intakes by ingestion can also occur alongside inhalation
depending on the circumstances of the event. Monitoring and dose assessment for intakes by inhalation
(ISO 16638-1) are covered in a separate document and would take precedence over the requirements
for assessing intakes by ingestion. However, the monitoring requirements are very similar. Uranium is
both radiologically and chemically toxic. Hence, the scientific bases of current occupational exposure
standards are reviewed in addition to radiation exposure limits.
This document describes the need for a monitoring and internal dosimetry programme for the different
compounds of uranium in case of a risk of ingestion and offers guidance on its design. The design of
the workplace, the work practices and hygiene practices followed and the protective equipment worn,
may all be essential in controlling exposure to this risk. The development of this document has taken
into account recommendations from international expert bodies and persons with international
experience of the practical application of its recommendations in radiological protection programmes.
Its application facilitates the exchanges of information between authorities, supervisory institutions
and employers.
© ISO 2019 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 16638-2:2022
---------------------- Page: 12 ----------------------
oSIST prEN ISO 16638-2:2022
INTERNATIONAL STANDARD ISO 16638-2:2019(E)
Radiological protection — Monitoring and internal
dosimetry for specific materials —
Part 2:
Ingestion of uranium compounds
1 Scope
This document specifies the minimum requirements for the design of professional programmes to
monitor workers exposed to a risk of ingestion to uranium compounds. This document establishes
principles for the development of compatible goals and requirements for monitoring programmes
and dose assessment for workers occupationally exposed to internal contamination. It establishes
procedures and assumptions for risk analysis, monitoring programmes and the standardized
interpretation of monitoring data in order to achieve acceptable levels of reliability for uranium and its
compounds. It sets limits for the applicability of the procedures in respect to dose levels above which
more sophisticated methods need to be applied.
This document addresses those circumstances when exposure could be constrained by either
radiological or chemical toxicity concerns.
This document addresses, for ingestion of uranium and its compounds, the following items:
a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) suitable methods for monitoring and criteria for their selection;
d) information that is collected for the design of a monitoring programme;
e) procedures for dose assessment based on reference levels for special monitoring programmes;
f) criteria for determining the significance of monitoring results;
g) uncertainties arising from dose assessment and interpretation of bioassays data;
h) reporting/documentation;
i) quality assurance;
j) record keeping requirements.
It is not applicable to the following items:
a) detailed descriptions of measuring methods and techniques for uranium;
b) modelling for the improvement of internal dosimetry;
c) potential influence of counter-measures (e.g. administration of chelating agents);
d) investigation of the causes or implications of an exposure;
e) dosimetry for inhalation exposures and for contaminated wounds.
© ISO 2019 – All rights reserved 1
---------------------- Page: 13 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
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 15189, Medical laboratories — Requirements for quality and competence
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/
3.1
absorption
movement of material to blood regardless of mechanism
Note 1 to entry: Absorption generally applies to the uptake 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
clearance
the action that results in the movement of radioactive material from the site of deposition in tissues
and organs
Note 1 to entry: This action can be natural or induced by therapeutic means.
Note 2 to entry: The clearance rate is the rate at which this occurs.
3.4
contamination
radioactive substances on surfaces or within solids, liquids or gases (including the human body), where
its presence is unintended or undesirable, or the process giving rise to its presence in such places
2 © ISO 2019 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
3.5
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.
3.6
detection limit
smallest true value of the measurand which ensures a specified probability of being detectable by the
measurement procedure
3.7
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.
Note 2 to entry: The committed effective dose is expressed in Sievert (Sv).
3.8
excretion function
function describing the fraction of an intake excreted per day after a given time has elapsed since the
intake occurred
Note 1 to entry: The excretion function is expressed in becquerels per day (Bq/d).
3.9
event
any unintended occurrence, including operating error, equipment failure or other mishap, the
consequences or potential consequences of which are not negligible from the point of view of protection
or safety
3.10
intake
activity (3.2) of a radionuclide taken into the body in a given time period or as a result of a given event (3.9)
Note 1 to entry: The intake is expressed in becquerels (Bq).
3.11
in vitro analyses
analyses that include measurements of radionuclides present in biological samples taken from an
individual
Note 1 to entry: These include urine, faeces and nasal samples; in special monitoring programmes, samples of
other materials such as blood and hair may be taken.
3.12
monitoring
measurements made for the purpose of assessment or control of exposure to radioactive material and
the interpretation of the results
Note 1 to entry: This document distinguishes three different categories of monitoring programmes, namely
confirmatory monitoring programme (3.13), special monitoring programme (3.14) and task-related monitoring
programme (3.15), as well as one type of monitoring, namely individual monitoring (3.16), which features in each
category.
© ISO 2019 – All rights reserved 3
---------------------- Page: 15 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
3.13
confirmatory monitoring programme
monitoring programme carried out to confirm assumptions about working conditions and that a
routine monitoring programme for dose assessment purposes is not required
3.14
special monitoring programme
monitoring programme performed to quantify suspect significant exposures following an event (3.9)
3.15
task-related monitoring programme
monitoring programme related to a specific operation, or providing information on a specific operation
of limited duration, or following major modifications applied to the installations or operating
procedures, or confirming that the routine monitoring programme is suitable
3.16
individual monitoring
monitoring (3.12) 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
3.17
quality assurance
planned and 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
3.18
quality control
part of quality assurance (3.17) intended to verify that systems and components correspond to
predetermined requirements
3.19
reference level
value of measured quantities above which some specified action or decision should be taken
3.20
scattering factor
geometric standard deviation of the lognormal distribution of bioassay measurements
4 Symbols and abbreviated terms
4.1 Symbols
D committed effective dose due to annual intake (Sv) such that lower doses may be
v
discounted for the purpose of the monitoring programme
E(50) committed effective dose (Sv) for an integration period of 50 years
−1
e(50) dose coefficient: committed effective dose per unit intake (Sv·Bq ), for an integration
period of 50 years
f alimentary tract transfer factor, fraction of activity entering the alimentary tract that
A
is absorbed from the gut in the absence of both radioactive decay losses and
endogenous input to the tract
4 © ISO 2019 – All rights reserved
---------------------- Page: 16 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
I intake in Bq (3.13)
−1
m(t ) predicted value of the measured quantity (Bq/d/Bq = d ) at time, t , for unit intake
i i
(excretion or retention function, for unit intake)
m (t ) predicted value of the quantity measured after a period of t , days of a chronic unit
c i i
intake per day (excretion or retention function at time, t , for chronic unit intake per
i
day)
4.2 Abbreviated terms
[2]
CRM certified reference material (see ISO 28218 )
DU depleted uranium (uranium with an assay of U-235 that is lower than its content in natural
uranium)
HEU high enriched uranium (uranium with an assay of U-235 equal to or more than 20 %)
IARC International Agency for Research on Cancer
ICRP International Commission on Radiological Protection
LDH lactate dehydrogenase
LEU low enriched uranium (uranium with an assay of U-235 from the natural level to 20 %)
LOAEL lowest-observed-adverse-effect level
NOAEL no-observed-adverse-effect level
[2]
TRS transfer reference standard (see ISO 28218 )
U-nat uranium compound with natural isotopic composition
5 Purpose and need for monitoring programmes
Uranium compounds are considered a mixture of three major isotopes: U-234, U-235 and U-238; but
in certain cases U-236, U-233 and U-232 are also included. This document describes four different
isotopic compositions, as examples, representing natural (U-nat), depleted (DU), low (LEU) and high
(HEU) enriched uranium forms (see Table 1) based on their typical uranium isotopic compositions
encountered in the nuclear industry. Specific isotopic compositions should be used if available.
Table 1 — Isotopic composition of natural uranium (U-nat), depleted uranium (DU), low
enriched uranium (LEU) and high enriched uranium (HEU), by mass and total uranium alpha
[12]
activities, based on specific activity values in ICRP 107
U-238 U-235 U-234
Isotopic Total Isotopic Total Isotopic Total Total Alpha
composition alpha composition alpha composition alpha alpha activity ratio
by mass activity by mass activity by mass activity activity U-234/U-238
% % % % % % Bq/g
U-nat 99,275 48,26 0,72 2,25 0,005 5 49,49 2,56E+04 1,03
DU 99,799 83,45 0,2 1,07 0,001 0 15,48 1,49E+04 0,186
LEU 96,471 14,78 3,5 3,45 0,028 84 81,78 8,12E+04 5,54
HEU 6,41 0,042 92,8 3,92 0,79 96,04 1,89E+06 2287
© ISO 2019 – All rights reserved 5
---------------------- Page: 17 ----------------------
oSIST prEN ISO 16638-2:2022
ISO 16638-2:2019(E)
The general population is exposed to ubiquitous uranium in the environment with ingestion of food
and drinking water being the primary contributors to body burden. In industry, uranium can be
present in a variety of chemical forms, often in association with other radionuclides. In general, there
is insufficient high-quality data regarding ingestion by workers to
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.