CEN ISO/TS 5387:2024
(Main)Nanotechnologies - Lung burden mass measurement of nanomaterials for inhalation toxicity tests (ISO/TS 5387:2023)
Nanotechnologies - Lung burden mass measurement of nanomaterials for inhalation toxicity tests (ISO/TS 5387:2023)
The document provides information on the measurement of nanomaterial mass in tissue after inhalation exposure, which can inform on lung clearance behaviour and translocation.
Nanotechnologien - Messung der Massenbelastung der Lunge durch Nanomaterialien für Inhalationstoxizitätstests (ISO/TS 5387:2023)
Das Dokument enthält Informationen zu Messungen der Masse von Nanomaterialien in Gewebe nach der inhalativen Exposition, die Hinweise zum Lungenausscheidungsverhalten (en: lung clearance behaviour) und zur Translokation geben können.
Nanotechnologies - Mesure de la masse de la charge pulmonaire des nanomatériaux pour les études de toxicité par inhalation (ISO/TS 5387:2023)
Nanotehnologije - Merjenje mase nanomaterialov pri obremenitvi pljuč z nanomateriali za inhalacijske teste toksičnosti (ISO/TS 5387:2023)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nanotehnologije - Merjenje mase nanomaterialov pri obremenitvi pljuč z
nanomateriali za inhalacijske teste toksičnosti (ISO/TS 5387:2023)
Nanotechnologies - Lung burden mass measurement of nanomaterials for inhalation
toxicity tests (ISO/TS 5387:2023)
Nanotechnologien - Messung der Massenbelastung der Lunge durch Nanomaterialien
für Inhalationstoxizitätstests (ISO/TS 5387:2023)
Nanotechnologies - Mesure de la masse de la charge pulmonaire des nanomatériaux
pour les études de toxicité par inhalation (ISO/TS 5387:2023)
Ta slovenski standard je istoveten z: CEN ISO/TS 5387:2024
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 5387
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
September 2024
TECHNISCHE SPEZIFIKATION
ICS 07.120
English Version
Nanotechnologies - Lung burden mass measurement of
nanomaterials for inhalation toxicity tests (ISO/TS
5387:2023)
Nanotechnologies - Mesure de la masse de la charge Nanotechnologien - Messung der Massenbelastung der
pulmonaire des nanomatériaux pour les études de Lunge durch Nanomaterialien für
toxicité par inhalation (ISO/TS 5387:2023) Inhalationstoxizitätstests (ISO/TS 5387:2023)
This Technical Specification (CEN/TS) was approved by CEN on 16 September 2024 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 5387:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO/TS 5387:2023 has been prepared by Technical Committee ISO/TC 229
"Nanotechnologies” of the International Organization for Standardization (ISO) and has been taken over
as CEN ISO/TS 5387:2024 by Technical Committee CEN/TC 352 “Nanotechnologies” the secretariat of
which is held by AFNOR.
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 announce this Technical Specification: 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/TS 5387:2023 has been approved by CEN as CEN ISO/TS 5387:2024 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 5387
First edition
2023-10
Nanotechnologies — Lung burden
mass measurement of nanomaterials
for inhalation toxicity tests
Nanotechnologies — Mesure de la masse de la charge pulmonaire des
nanomatériaux pour les études de toxicité par inhalation
Reference number
ISO/TS 5387:2023(E)
ISO/TS 5387:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO/TS 5387:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Use of lung burden measurements for risk assessment of nanomaterials .4
6 Inhalation exposure and tissue sampling to determine lung burden .5
6.1 Inhalation exposure . 5
6.2 Lung burden evaluation in single or multiple lobes . 5
6.3 Post-exposure observation points . 6
7 Available methods for lung burden measurements . 7
7.1 General . 7
7.2 Carbon nanomaterials . 8
7.3 Metal-based nanomaterials . 8
7.4 Polymeric nanomaterials and others . 9
8 Application of lung burden data to toxicokinetics of nanomaterials .9
8.1 General . 9
8.2 Sampling points . 9
8.3 Particle lung clearance and retention kinetics . 10
8.3.1 General . 10
8.3.2 One-compartment first-order clearance model . 10
8.3.3 Two-compartment first-order model . 11
Annex A (informative) Option A for test scheme for 28-d and 90-d studies — Gases,
vapours, liquid aerosols, and fast dissolution solid aerosols.15
Annex B (informative) Option B for test schemes for 28-d and 90-d studies — Poorly
soluble aerosols .16
Annex C (informative) Lung burden measurement methods .17
Bibliography .21
iii
ISO/TS 5387:2023(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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 229, Nanotechnologies.
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/TS 5387:2023(E)
Introduction
Inhalation is a primary route of exposure to aerosolized nanomaterials and therefore appropriate
inhalation toxicity tests are required to address risk assessment needs for these materials. For this
reason, the Organisation for Economic Cooperation and Development (OECD) recently updated its
inhalation toxicity test guidelines 412 (subacute) and 413 (subchronic) to make them applicable to
[1][2]
nanomaterials. These revised test guidelines require post-exposure lung burden measurements
to be undertaken when a range-finding study or other relevant information suggests that inhaled test
nanomaterials are poorly soluble with low dissolution rate and likely to be retained in the lung. The
measurements of lung burden inform on pulmonary deposition and retention of nanomaterials in the
lung. At least three lung burden measurements are needed to evaluate clearance kinetics.
This document gives information on how to derive clearanc
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