SIST 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)
Ta dokument opisuje značilnosti delovnih suspenzij nanoobjektov, ki jih je treba upoštevati pri izvajanju in vitro testov za oceno inherentne toksičnosti nanoobjektov. Dokument poleg tega opredeljuje ustrezne merilne metode za te značilnosti.
Ta dokument se uporablja za nanoobjekte ter njihove agregate in aglomerate, večje od 100 nm.
Namen tega dokumenta je pomagati razjasniti, ali ugotovljeni toksični učinki izhajajo iz samih nanoobjektov, ki se preskušajo, ali iz nenadzorovanih virov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-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: EN ISO 19337:2024
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 19337
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 07.120
English Version
Nanotechnologies - Characteristics of working suspensions
of nano-objects for in vitro assays to evaluate inherent
nano-object toxicity (ISO 19337:2023)
Nanotechnologies - Caractéristiques des suspensions Nanotechnologien - Eigenschaften von
de nano-objets utilisées pour les tests in vitro évaluant Arbeitssuspensionen von Nanoobjekten für In-vitro-
la toxicité inhérente aux nano-objets (ISO 19337:2023) Assays zur Bewertung der inhärenten Nanoobjekt-
Toxizität (ISO 19337:2023)
This European Standard was approved by CEN on 9 September 2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19337:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 19337:2023 has been prepared by Technical Committee ISO/TC 229 "Nanotechnologies”
of the International Organization for Standardization (ISO) and has been taken over as
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 March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
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 19337:2023 has been approved by CEN as EN ISO 19337:2024 without any modification.
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)
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
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
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
iii
ISO 19337:2023(E)
Foreword
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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 follo
...
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