Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015)

ISO 16638-1:2015 specifies the minimum requirements for the design of professional programmes to monitor workers exposed to uranium compounds. It 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 standardised 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 have to be applied.
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 International Standard addresses those circumstances when exposure could be constrained by either radiological or chemical toxicity concerns.
ISO 16638-1:2015 addresses, for uranium and its compounds, the following items:
a)    purposes of monitoring and monitoring programmes;
b)    description of the different categories of monitoring programmes;
c)    quantitative criteria for conducting monitoring programmes;
d)    suitable methods for monitoring and criteria for their selection;
e)    information that has to be collected for the design of a monitoring programme;
f)     general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);
g)    frequencies of measurements;
h)    procedures for dose assessment based on reference levels for routine and special monitoring programmes;
i)     assumptions for the selection of dose-critical parameter values;
j)     criteria for determining the significance of monitoring results;
k)    interpretation of workplace monitoring results;
l)     uncertainties arising from dose assessment and interpretation of bioassays data;
m)   reporting/documentation;
n)    quality assurance;
o)    record keeping requirements.
It is not applicable to the following items:
a)    monitoring of exposure due to uranium progeny, including radon;
b)    detailed descriptions of measuring methods and techniques for uranium;
c)    dosimetry for litigation cases;
d)    modelling for the improvement of internal dosimetry;
e)    potential influence of counter-measures (e.g. administration of chelating agents);
f)     investigation of the causes or implications of an exposure;
g)    dosimetry for ingestion exposures and for contaminated wounds.

Strahlenschutz - Überwachung und interne Dosimetrie für bestimmte Stoffe - Teil 1: Inhalation von Uranverbindungen (ISO 16638-1:2015)

Diese Internationale Norm legt Mindestanforderungen an die Gestaltung professioneller Programme zur Überwachung von Beschäftigten, die Uranverbindungen ausgesetzt sind, fest. Sie legt Grundsätze für die Entwicklung kompatibler Ziele und Anforderungen für Überwachungsprogramme und Dosisbeurteilung für Beschäftigte fest, die beruflich einer internen Kontamination ausgesetzt sind. Sie legt Verfahren und Annahmen für Risikoanalysen, Überwachungsprogramme und die standardisierte Interpretation von Überwachungsdaten fest, um ein akzeptables Zuverlässigkeitsniveau für Uran und dessen Verbindungen zu erreichen. Sie legt Grenzen für die Anwendbarkeit der Verfahren in Bezug auf Dosiswerte fest, oberhalb derer anspruchsvollere Methoden angewendet werden müssen.
Uran ist sowohl radiologisch als auch chemisch toxisch. Daher werden zusätzlich zu den Strahlenexpositionsgrenzwerten die wissenschaftlichen Grundlagen der aktuellen Standards für die berufsbedingte Exposition überprüft. Diese Internationale Norm behandelt die Umstände, unter denen die Exposition entweder hinsichtlich der radiologischen oder der chemischen Toxizität beschränkt werden könnte.
Diese Internationale Norm behandelt die folgenden Punkte in Bezug auf Uran und dessen Verbindungen:
a) Zwecke von Überwachung und Überwachungsprogrammen;
b) Beschreibung der verschiedenen Kategorien von Überwachungsprogrammen;
c) quantitative Kriterien für die Durchführung von Überwachungsprogrammen;
d) geeignete Verfahren zur Überwachung und Kriterien für deren Auswahl;
e) Informationen, die für die Gestaltung eines Überwachungsprogramms zu sammeln sind;
f) allgemeine Anforderungen an Überwachungsprogramme (z. B. Nachweisgrenzen, tolerierte Unsicherheiten);
g) Häufigkeiten von Messungen;
h) Verfahren zur Beurteilung der Dosis auf der Grundlage von Referenzwerten für Routine- und Sonderüberwachungsprogramme;
i) Annahmen für die Auswahl von dosiskritischen Parameterwerten;
j) Kriterien für die Bestimmung der Signifikanz von Überwachungsergebnissen;
k) Auswertung von Ergebnissen der Arbeitsplatzüberwachung;
l) Unsicherheiten, die sich aus der Beurteilung der Dosis und Auswertung von Biotest-Daten ergeben;
m) Berichterstattung/Dokumentation;
n) Qualitätssicherung;
o) Anforderungen an Aufzeichnungen.
Sie gilt nicht für die folgenden Punkte:
a) Überwachung der Exposition aufgrund von Tochternukliden von Uran, einschließlich Radon;
b) ausführliche Beschreibungen von Messmethoden und -techniken für Uran;
c) Dosimetrie für Rechtsstreitigkeiten;
d) Modellierung für die Verbesserung der internen Dosimetrie;
e) mögliche Einflüsse von Gegenmaßnahmen (z. B. Verabreichung von Komplexbildnern);
f) Untersuchung der Ursachen oder Auswirkungen einer Inkorporation;
g) Dosimetrie bei Inkorporation durch Ingestion und bei kontaminierten Wunden.

Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 1: Inhalation de composés d'uranium (ISO 16638-1:2015)

L'ISO 16638-1:2015 décrit les exigences minimales permettant d'établir des programmes de surveillance professionnelle des travailleurs exposés aux composés de l'uranium. Elle établit les principes pour la mise en ?uvre des objectifs et des exigences des programmes de surveillance et de l'estimation dosimétrique des travailleurs exposés, dans cadre de leur travail, à une contamination interne. Elle 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. Elle fixe des limites pour l'applicabilité des procédures concernant les niveaux de dose au-delà desquels des méthodes plus sophistiquées doivent être appliquées.
L'uranium présente une toxicité à la fois radiologique et chimique. De ce fait, pour une exposition professionnelle, les bases scientifiques des conditions actuelles d'exposition au risque chimique sont revues au vu des limites d'exposition aux rayonnements ionisants. L'ISO 16638-1:2015 traite des circonstances dans lesquelles l'exposition peut être assujettie aux problèmes liés à la toxicité radiologique ou chimique.
L'ISO 16638-1:2015 aborde, pour l'uranium et ses composés, les points suivants:
a)    les objectifs de la surveillance et les programmes de surveillance;
b)    la description des différentes catégories de programmes de surveillance;
c)    les critères quantitatifs pour la conduite des programmes de surveillance;
d)    les méthodes valables pour la surveillance et leurs critères de sélection;
e)    les informations à collecter pour l'élaboration d'un programme de surveillance;
f)     les exigences générales pour les programmes de surveillance (par exemple limites de détection, incertitudes tolérées);
g)    les fréquences des mesurages;
h)    les procédures d'estimation dosimétrique basées sur les niveaux de référence utilisés pour les programmes de surveillance de routine et spéciale;
i)     les hypothèses concernant la sélection des valeurs des paramètres critiques de dose;
j)     les critères pour la détermination de l'importance des résultats de la surveillance;
k)    l'interprétation des résultats de la surveillance aux postes de travail;
l)     les incertitudes liées à l'estimation dosimétrique et l'interprétation des résultats sur échantillons biologiques;
m)   la transmission et la documentation;
n)    l'assurance de la qualité;
o)    les exigences en matière de conservation des enregistrements.
Le domaine d'application de la présente Norme internationale n'inclut pas les éléments suivants:
a)    la surveillance de l'exposition aux descendants de l'uranium, y compris le radon;
b)    les descriptions détaillées des méthodes et des techniques de mesurage concernant l'uranium;
c)    la dosimétrie des cas litigieux;
d)    la modélisation pour l'amélioration de la dosimétrie interne;
e)    l'influence potentielle de l'action des agents décorporants (par exemple, administration d'agents complexants);
f)     l'investigation des causes et des conséquences d'une exposition;
g)    la dosimétrie pour les expositions par ingestion et par blessures contaminées.

Radiološka zaščita - Nadzorovanje in notranja dozimetrija za posebne materiale - 1. del: Inhalacija uranovih spojin (ISO 16638-1:2015)

Standard ISO 16638-1:2015 določa minimalne zahteve za načrtovanje profesionalnih programov za nadzor delavcev, ki so izpostavljeni uranovim spojinam. Določa načela za razvoj združljivih ciljev in zahtev za nadzorne programe in ocenjevanje odmerkov za delavce, ki so poklicno izpostavljeni notranji kontaminaciji. Določa postopke in predpostavke za analizo tveganja, nadzorne programe in standardizirano interpretacijo nadzornih podatkov za doseganje sprejemljivih ravni zanesljivosti za uran in uranove spojine. Določa omejitve ravni odmerkov za uporabo postopkov, nad katerimi je treba uporabiti bolj napredne metode.
Uran je radiološko in kemijsko toksičen. Zato so poleg omejitev izpostavljenosti sevanju revidirane tudi znanstvene osnove trenutnih standardov glede poklicne izpostavljenosti. Ta mednarodni standard obravnava okoliščine, ko je izpostavljenost lahko omejena zaradi radiološke ali kemijske toksičnosti.
Standard ISO 16638-1:2015 v zvezi z uranom in uranovimi spojinami obravnava:
a) namene nadzora in nadzornih programov;
b) opis različnih kategorij nadzornih programov;
c) kvantitativne kriterije za izvajanje nadzornih programov;
d) primerne metode za izvajanje nadzora in kriterije za izbiro metod;
e) informacije, ki jih je treba zbrati za načrtovanje nadzornega programa;
f) splošne zahteve za nadzorne programe (npr. meje zaznavanja, dovoljene negotovosti);
g) pogostosti meritev;
h) postopke za ocenjevanje odmerkov glede na referenčne ravni za rutinske in posebne nadzorne programe;
i) predpostavke za izbiro vrednosti parametrov, ki so ključni za odmerek;
j) merila za določanje pomembnosti rezultatov nadzora;
k) interpretacijo rezultatov nadzora na delovnem mestu;
l) negotovosti, ki izhajajo iz ocenjevanja odmerkov in interpretacije podatkov bioloških preizkusov;
m) poročanje/dokumentiranje;
n) zagotavljanje kakovosti;
o) zahteve za vodenje evidenc.
Ne uporablja se za:
a) nadzor izpostavljenosti potomcem urana, vključno z radonom;
b) podrobno opisovanje merilnih metod in tehnik za uran;
c) dozimetrijo za sporne primere;
d) modeliranje za izboljševanje notranje dozimetrije;
e) možne vplive protiukrepov (npr. dajanja kelatov);
f) raziskovanje razlogov ali vplivov izpostavljenosti;
g) dozimetrijo za izpostavljenosti ob zaužitju in kontaminirane rane.

General Information

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

Buy Standard

Standard
EN ISO 16638-1:2017
English language
52 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 16638-1:2017
01-december-2017
5DGLRORãND]DãþLWD1DG]RURYDQMHLQQRWUDQMDGR]LPHWULMD]DSRVHEQHPDWHULDOH
GHO,QKDODFLMDXUDQRYLKVSRMLQ ,62

Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1:

Inhalation of uranium compounds (ISO 16638-1:2015)

Radioprotection - Contrôle et dosimétrie interne des éléments spécifiques - Partie 1:

Inhalation de composés d'uranium (ISO 16638-1:2015)
Ta slovenski standard je istoveten z: EN ISO 16638-1:2017
ICS:
17.240 Merjenje sevanja Radiation measurements
SIST EN ISO 16638-1:2017 en,fr,de

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

---------------------- Page: 1 ----------------------
SIST EN ISO 16638-1:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 16638-1:2017
EN ISO 16638-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 17.240
English Version
Radiological protection - Monitoring and internal
dosimetry for specific materials - Part 1: Inhalation of
uranium compounds (ISO 16638-1:2015)
Radioprotection - Contrôle et dosimétrie interne des
éléments spécifiques - Partie 1: Inhalation de composés
d'uranium (ISO 16638-1:2015)
This European Standard was approved by CEN on 13 September 2017.

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

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

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

member.

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

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

Centre has the same status as the official versions.

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

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

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

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

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16638-1:2017 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 16638-1:2017
EN ISO 16638-1:2017 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 16638-1:2017
EN ISO 16638-1:2017 (E)
European foreword

The text of ISO 16638-1:2015 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 16638-1:2017 by Technical Committee CEN/TC 430 “Nuclear

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

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

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

withdrawn at the latest by April 2018.

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

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

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

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

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

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

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

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 16638-1:2015 has been approved by CEN as EN ISO 16638-1:2017 without any

modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 16638-1:2017
---------------------- Page: 6 ----------------------
SIST EN ISO 16638-1:2017
INTERNATIONAL ISO
STANDARD 16638-1
First edition
2015-12-15
Radiological protection —
Monitoring and internal dosimetry
for specific materials —
Part 1:
Inhalation of uranium compounds
Radioprotection — Contrôle et dosimétrie interne des éléments
spécifiques —
Partie 1: Inhalation de composés d’uranium
Reference number
ISO 16638-1:2015(E)
ISO 2015
---------------------- Page: 7 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)
Contents Page

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

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

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Symbols and abbreviated terms ........................................................................................................................................................... 6

4.1 Symbols ......................................................................................................................................................................................................... 6

4.2 Abbreviated terms ............................................................................................................................................................................... 7

5 Purpose and need for monitoring programmes .................................................................................................................. 7

6 General aspects ...................................................................................................................................................................................................10

6.1 Radiological aspects ........................................................................................................................................................................10

6.2 Chemical toxicity ................................................................................................................................................................................11

7 Reference levels for uranium ...............................................................................................................................................................12

7.1 Radiological aspects ........................................................................................................................................................................12

7.2 Chemical toxicity ................................................................................................................................................................................15

7.2.1 General...................................................................................................................................................................................15

7.2.2 Exposure limits ..............................................................................................................................................................15

7.3 Application of reference levels ...............................................................................................................................................16

8 Routine monitoring programmes ....................................................................................................................................................16

8.1 General ........................................................................................................................................................................................................16

8.2 Workplace monitoring ......... ..........................................................................................................................................................16

8.3 Individual monitoring ....................................................................................................................................................................17

8.3.1 General...................................................................................................................................................................................17

8.3.2 Dosimetric and radiation .......................................................................................................................................17

8.3.3 Chemical hazard ............................................................................................................................................................18

8.4 Methods and monitoring intervals .....................................................................................................................................18

8.4.1 General...................................................................................................................................................................................18

8.4.2 Time intervals for toxicological risk.............................................................................................................18

8.4.3 Time intervals for radiotoxicological risk ...............................................................................................18

8.4.4 Principles and assumptions ................................................................................................................................19

9 Special monitoring programmes ......................................................................................................................................................20

9.1 Workplace monitoring ......... ..........................................................................................................................................................20

9.2 Individual monitoring ....................................................................................................................................................................20

9.2.1 Recommended monitoring for toxicological risk .............................................................................20

9.2.2 Recommended monitoring and period for radiotoxicological risk ...................................20

10 Task-related monitoring programmes .......................................................................................................................................21

10.1 Workplace monitoring ......... ..........................................................................................................................................................21

10.2 Individual monitoring ....................................................................................................................................................................21

11 Performance criteria for laboratories ........................................................................................................................................22

11.1 General ........................................................................................................................................................................................................22

11.2 Critical values ........................................................................................................................................................................................22

11.3 Reference values .................................................................................................................................................................................23

11.4 Performance criteria for workplace monitoring ....................................................................................................23

12 Quality assurance and quality control for bioassay laboratories ..................................................................24

13 Procedure for the assessment of exposures .........................................................................................................................24

13.1 General ........................................................................................................................................................................................................24

13.2 Assessment of workplace monitoring data .................................................................................................................25

13.3 Assessment of individual monitoring data ..................................................................................................................25

13.4 Properties of a software tool ....................................................................................................................................................25

© ISO 2015 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)

13.5 Uncertainties .........................................................................................................................................................................................26

13.6 Quality assurance of the assessment process ...........................................................................................................27

14 Reporting and documentation ............................................................................................................................................................27

14.1 Reporting results for in vitro measurements ...........................................................................................................27

14.2 Reporting results for in vivo measurements .............................................................................................................28

14.3 Documentation of the dose assessment .........................................................................................................................28

Annex A (informative) Nuclear data of U-238 and U-235 decay ...........................................................................................30

Annex B (informative) Default classification of uranium compounds ...........................................................................31

Annex C (informative) Measurement techniques for uranium ..............................................................................................32

Annex D (informative) Committed effective dose per unit intake for uranium compounds ...................36

Annex E (informative) Estimation of uncertainties for internal dose assessments .........................................37

Bibliography .............................................................................................................................................................................................................................41

iv © ISO 2015 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(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 meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

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

radiological protection, Subcommittee SC 2, Radiological protection.
© ISO 2015 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(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 requires monitoring potential intakes and/or quantifying actual intakes and exposures.

The doses resulting from internal radiation exposure arising from contamination by radioactive

substances cannot be measured directly. Decisions have to 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, three International Standards addressing monitoring programmes (ISO 20553:2006),

laboratory requirements (ISO 28218:2010) and dose assessments (ISO 27048:2011) have been

developed and can be applied in a straightforward manner to many radionuclides. However, for a

number of specific materials, the practical application of these International Standards is complex and

further guidance may be required, e.g. for accreditation purposes.

This International Standard has been developed to address the specific issue of monitoring and internal

dosimetry for inhalation of uranium compounds, which reflects

— the growing interest in nuclear energy production and the associated increase in uranium mining

and fuel production,

— the large variation of isotopic compositions of the uranium compounds that may be encountered in

the workplace, and

— the importance of taking into account both the chemical and the radiological risks arising from

exposures to uranium.

It contributes to harmonizing the practices in the monitoring of occupationally exposed persons while

remaining complementary to ISO 20553:2006, ISO 28218:2010 and ISO 27048:2011.

This International Standard describes the need for a monitoring and internal dosimetry programme

for the different compounds of uranium and offers guidance on its design. Its development 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.
vi © ISO 2015 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 16638-1:2017
INTERNATIONAL STANDARD ISO 16638-1:2015(E)
Radiological protection — Monitoring and internal
dosimetry for specific materials —
Part 1:
Inhalation of uranium compounds
1 Scope

This International Standard specifies the minimum requirements for the design of professional

programmes to monitor workers exposed to uranium compounds. It 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 standardised 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 have

to be applied.

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 International Standard

addresses those circumstances when exposure could be constrained by either radiological or chemical

toxicity concerns.

This International Standard addresses, for uranium and its compounds, the following items:

a) purposes of monitoring and monitoring programmes;
b) description of the different categories of monitoring programmes;
c) quantitative criteria for conducting monitoring programmes;
d) suitable methods for monitoring and criteria for their selection;

e) information that has to be collected for the design of a monitoring programme;

f) general requirements for monitoring programmes (e.g. detection limits, tolerated uncertainties);

g) frequencies of measurements;

h) procedures for dose assessment based on reference levels for routine and special monitoring

programmes;
i) assumptions for the selection of dose-critical parameter values;
j) criteria for determining the significance of monitoring results;
k) interpretation of workplace monitoring results;

l) uncertainties arising from dose assessment and interpretation of bioassays data;

m) reporting/documentation;
n) quality assurance;
o) record keeping requirements.
© ISO 2015 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)
It is not applicable to the following items:
a) monitoring of exposure due to uranium progeny, including radon;
b) detailed descriptions of measuring methods and techniques for uranium;
c) dosimetry for litigation cases;
d) modelling for the improvement of internal dosimetry;

e) potential influence of counter-measures (e.g. administration of chelating agents);

f) investigation of the causes or implications of an exposure;
g) dosimetry for ingestion exposures and for contaminated wounds.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO/IEC Guide 98-3, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in

measurement (GUM:1995)

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated

terms (VIM)

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 20553:2006, Radiation protection — Monitoring of workers occupationally exposed to a risk of internal

contamination with radioactive material
ISO 28218:2010, Radiation protection — Performance criteria for radiobioassay

ISO 27048:2011, Radiation protection — Dose assessment for the monitoring of workers for internal

radiation exposure
ISO 15189:2012, Medical laboratories — Requirements for quality and competence
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.
3.1
absorption

movement of material into blood regardless of mechanism, which generally applies to the dissociation

of particles and the uptake into blood of soluble substances and material dissociated from particles

2 © ISO 2015 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)
3.2
absorption Type F

deposited materials that have high (fast) rates of absorption into body fluids from the respiratory tract

[SOURCE: ICRP 66]
3.3
absorption Type M

deposited materials that have intermediate (moderate) rates of absorption into body fluids from the

respiratory tract
[SOURCE: ICRP 66]
3.4
absorption Type S

deposited materials that have low (slow) rates of absorption into body fluids from the respiratory tract

[SOURCE: ICRP 66]
3.5
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.

3.6
activity median aerodynamic diameter
AMAD

value of aerodynamic diameter such that 50 % of the airborne activity in a specified aerosol is

associated with particles smaller than the AMAD and 50 % of the activity is associated with particles

larger than the AMAD

Note 1 to entry: The aerodynamic diameter of an airborne particle is the diameter that a sphere of unit density

would need to have in order to have the same terminal velocity when settling in air as the particle of interest.

3.7
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
Note 1 to entry: The clearance rate is the rate at which this occurs.
3.8
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

3.9
critical value

maximum value for the result of a single measurement in a monitoring programme where it is safe to

assume that the corresponding extrapolated annual dose does not exceed a predefined dose level

3.10
decision threshold

fixed or a posteriori value of the measurand by which, when exceeded by the result of an actual

measurement of a measurand quantifying a physical effect, it is decided that the physical effect is present

3.11
detection limit
smallest true value of the measurand that is detectable by the measuring method
© ISO 2015 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 16638-1:2017
ISO 16638-1:2015(E)
3.12
annual dose

committed effective dose resulting from all intakes occurring during a calendar year

Note 1 to entry: The term “annual dose” is not used to represent the dose received in a year from all preceding

intakes.
3.13
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 Internationa
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.