EN ISO 19337:2024
(Main)Nanotechnologies - Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity (ISO 19337:2023)
Nanotechnologies - Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity (ISO 19337:2023)
This document describes the characteristics of working suspensions of nano-objects to be considered when conducting in vitro assays to evaluate inherent nano-object toxicity. In addition, the document identifies applicable measurement methods for these characteristics.
This document is applicable to nano-objects, and their aggregates and agglomerates greater than 100 nm.
This document intends to help clarify whether observed toxic effects come from tested nano-objects themselves or from uncontrolled sources.
Nanotechnologien - Eigenschaften von Arbeitssuspensionen von Nanoobjekten für In-vitro-Assays zur Bewertung der inhärenten Nanoobjekt-Toxizität (ISO 19337:2023)
Dieses Dokument beschreibt die Eigenschaften von Arbeitssuspensionen von Nanoobjekten, die bei der Durchführung von In vitro-Assays zur Bewertung der inhärenten Nanoobjekt-Toxizität zu berücksichtigen sind. Darüber hinaus werden in diesem Dokument anwendbare Messverfahren für diese Eigenschaften identifiziert.
Dieses Dokument ist anwendbar für Nanoobjekte und ihre Aggregate und Agglomerate mit einer Größe von mehr als 100 nm.
Das Dokument ist dafür vorgesehen, zu klären, ob beobachtete toxische Wirkungen von den geprüften Nanoobjekten selbst oder von unkontrollierten Quellen stammen.
Nanotechnologies - Caractéristiques des suspensions de nano-objets utilisées pour les tests in vitro évaluant la toxicité inhérente aux nano-objets (ISO 19337:2023)
Le présent document décrit les caractéristiques des suspensions de nano‑objets à prendre en considération pour les essais in vitro évaluant la toxicité inhérente aux nano‑objets. En outre, il identifie les méthodes de mesure applicables à ces caractéristiques.
Le présent document est applicable aux nano‑objets, ainsi qu’à leurs agrégats et agglomérats d’une taille supérieure à 100 nm.
Le présent document a pour objectif de clarifier si les effets toxiques observés proviennent des nano‑objets soumis à essai ou de sources non contrôlées.
Nanotehnologije - Značilnosti delovnih suspenzij nanoobjektov za in vitro teste za oceno inherentne toksičnosti nanoobjektov (ISO 19337:2023)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 19337:2024
01-julij-2024
Nanotehnologije - Značilnosti delovnih suspenzij nanoobjektov za in vitro teste za
oceno inherentne toksičnosti nanoobjektov (ISO 19337:2023)
Nanotechnologies - Characteristics of working suspensions of nano-objects for in vitro
assays to evaluate inherent nano-object toxicity (ISO 19337:2023)
Nanotechnologien - Eigenschaften von Arbeitssuspensionen von Nanoobjekten für In-
vitro-Assays zur Bewertung der inhärenten Nanoobjekt-Toxizität (ISO 19337:2023)
Nanotechnologies - Caractéristiques des suspensions de nano-objets utilisées pour les
tests in vitro évaluant la toxicité inhérente aux nano-objets (ISO 19337:2023)
Ta slovenski standard je istoveten z: prEN ISO 19337
ICS:
07.120 Nanotehnologije Nanotechnologies
oSIST prEN ISO 19337:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 19337:2024
oSIST prEN ISO 19337:2024
INTERNATIONAL ISO
STANDARD 19337
Second edition
2023-05
Nanotechnologies — Characteristics of
working suspensions of nano-objects
for in vitro assays to evaluate inherent
nano-object toxicity
Nanotechnologies — Caractéristiques des suspensions de nano-objets
utilisées pour les tests in vitro évaluant la toxicité inhérente aux nano-
objets
Reference number
ISO 19337:2023(E)
oSIST prEN ISO 19337:2024
ISO 19337:2023(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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Published in Switzerland
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oSIST prEN ISO 19337:2024
ISO 19337:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Characteristics and measurement methods . 2
5.1 General . 2
5.2 Stability of working suspensions . 3
5.2.1 General . 3
5.2.2 Representative size change of secondary particles of nano-objects . 3
5.2.3 Concentration change of nano-objects . 3
5.3 Concentration of metal ions . 3
5.4 Concentration of culture medium components . 4
5.4.1 General . 4
5.4.2 Proteins . 4
5.4.3 Calcium. 4
5.5 Contamination . 4
6 Reporting . 5
6.1 General . 5
6.2 Name of nano-objects and manufacturing information . 5
6.3 Composition and metallic elements included in the nano-object sample . 5
6.4 Culture medium and serum . 5
6.5 Measurement results . 5
6.6 Optional methods . 6
Annex A (normative) Flow of measurements .7
Annex B (informative) Measurement and evaluation of stability . 8
Annex C (informative) Measurement of metal ions . 9
Annex D (informative) Measurement of culture medium components .11
Annex E (informative) Contamination .12
Bibliography .13
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oSIST prEN ISO 19337:2024
ISO 19337:2023(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.
This second edition cancels and replaces the first edition (ISO/TS 19337:2016) which has been
technically revised.
The main changes are as follows:
— “the flow of measurements” has been improved as shown in Figure A.1;
— the status of Annex A has been changed from informative to normative;
— “5.2 Endotoxin” has been replaced by “5.5 Contamination”.
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.
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ISO 19337:2023(E)
Introduction
Before nano-objects enter onto the market, their possible impact on human health and the environment
should be carefully evaluated.
In vitro toxicity assays using cultured cells are frequently used as a tool in screening materials for
possible hazardous properties. The testing provides essential information for understanding the
mechanisms of biological effects induced by the materials. However, nano-objects require specific
considerations with respect to the in vitro toxicity assays, because of their unique behaviour in cell
culture medium. For example, immediately after the introduction of nano-object samples into the
culture medium, the nano-objects can undergo changes in
a) ionic dissolution,
b) corona formation, or
c) aggregation/agglomeration
leading to alteration in particles size and sedimentation. Therefore, it is critical to consider the above-
mentioned phenomena in clarifying if the observed effects are related to the tested nano-object itself
or from uncontrolled sources and to avoid false interpretation of assay results. For example, the corona
formation, metal ion release from the nano-objects and impurities (residual from the nano-object
[1]
synthesis process) can interfere with some in vitro assays , producing inaccurate results. Additionally,
the formation of agglomerates and aggregates can alter the toxicity of a suspension. It is important to
carefully assess and describe the characteristics of the suspension of nano-objects being tested.
Therefore, the rigorous characterization of the working suspension prior and during in vitro toxicity
assays on these characteristics is essential to exclude the in vitro experimental artefacts. In this
document, the essential characteristics related to these three phenomena and applicable measurement
methods were summarized. On the other hands, this document does not include a strategy to select the
appropriate techniques from the applicable measurement methods because the working suspensions
that contain nano-object samples for in vitro toxicity assays has the different materials components,
concentration and sizes; thus, the appropriate selection is depending on the investigators. While
the related informative annexes and the list of references in the Bibliography are included in this
document to assist with appropriate method selection by investigators to make allowance for the
characterization method selection, optional methods are also given in this document. In Clause 6, the
details of the characterization methods/procedures are described; therefore, the appropriateness of
the characterization can be judged.
The intention of this document is for reliable test results on nano-object toxicity to be shared and
communicated among stakeholders of nano-objects, such as regulators, general public, manufacturers
and end users.
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oSIST prEN ISO 19337:2024
INTERNATIONAL STANDARD ISO 19337:2023(E)
Nanotechnologies — Characteristics of working
suspensions of nano-objects for in vitro assays to evaluate
inherent nano-object toxicity
1 Scope
This document describes the characteristics of working suspensions of nano-objects to be considered
when conducting in vitro assays to evaluate inherent nano-object toxicity. In addition, the document
identifies applicable measurement methods for these characteristics.
This document is applicable to nano-objects, and their aggregates and agglomerates greater than
100 nm.
This document intends to help clarify whether observed toxic effects com
...
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