CEN ISO/TS 21362:2021

Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation (ISO/TS 21362:2018)

This document identifies parameters and conditions, as part of an integrated measurement system, necessary to develop and validate methods for the application of asymmetrical-flow and centrifugal field-flow fractionation to the analysis of nano-objects and their aggregates and agglomerates dispersed in aqueous media. In addition to constituent fractionation, analysis can include size, size distribution, concentration and material identification using one or more suitable detectors. General guidelines and procedures are provided for application, and minimal reporting requirements necessary to reproduce a method and to convey critical aspects are specified.

Nanotechnologien - Analyse von Nanoobjekten mit Hilfe von Asymmetrischer-Fluss-Feldflussfraktionierung und zentrifugaler Feldflussfraktionierung (ISO/TS 21362:2018)

Dieses Dokument identifiziert als Teil eines integrierten Messsystems Parameter und Bedingungen, die zur Entwicklung und Validierung von Methoden für die Anwendung der Asymmetrischer-Fluss-Feldflussfraktionierung und zentrifugaler Feldflussfraktionierung zur Analyse von Nanoobjekten und ihren in wässrigen Medien dispergierten Aggregaten und Agglomeraten erforderlich sind. Zusätzlich zur Fraktionierung der Bestandteile kann die Analyse die Größe, Größenverteilung, Konzentration und Materialidentifizierung mit einem oder mehreren geeigneten Detektoren umfassen. Für die Anwendung werden allgemeine Anleitungen und Verfahren bereitgestellt, und es werden Mindestanforderungen an die Berichterstattung festgelegt, die zur Reproduzierung einer Methode und zur Vermittlung kritischer Aspekte erforderlich sind.

Nanotechnologies - Analyse des nano-objets par fractionnement par couplage flux-force asymétrique et à force centrifuge (ISO/TS 21362:2018)

Le présent document identifie, dans le cadre d'un système de mesures intégrées, les paramètres et conditions nécessaires au développement et à la validation de méthodes pour l'application des systèmes de fractionnement par couplage flux-force asymétrique et à force centrifuge à l'analyse de nano-objets et de leurs agrégats et agglomérats en dispersion dans des milieux aqueux. Outre le fractionnement des composants, l'analyse peut porter sur la taille, la distribution granulométrique, la concentration et l'identification des matériaux à l'aide d'un ou plusieurs détecteurs appropriés. Le présent document fournit des lignes directrices et procédures générales pour l'application et spécifie les exigences de rapport minimales afin de reproduire une méthode et de rendre compte des aspects critiques.

Nanotehnologije - Analiza nanoobjektov s frakcioniranjem asimetričnega in centrifugalnega poljskega pretoka (ISO/TS 21362:2018)

General Information

• Status: Published
• Publication Date: 06-Apr-2021
• ICS: 07.120 - Nanotechnologies
• Technical Committee: CEN/TC 352 - Nanotechnologies
• Drafting Committee: CEN/TC 352 - Nanotechnologies
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 07-Apr-2021
• Completion Date: 07-Apr-2021
• Ref Project: SIST-TS CEN ISO/TS 21362:2021 - Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation (ISO/TS 21362:2018)

Relations

• Revised: prEN ISO 21362 - Nanotechnologies - Analysis of nano-objects using asymmetrical flow and centrifugal field-flow fractionation (ISO/DIS 21362:2024)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2021
Nanotehnologije - Analiza nanoobjektov s frakcioniranjem asimetričnega in
centrifugalnega poljskega pretoka (ISO/TS 21362:2018)
Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal
field-flow fractionation (ISO/TS 21362:2018)
Nanotechnologien - Analyse von Nanoobjekten mit Hilfe von Asymmetrischer-Fluss-
Feldflussfraktionierung und zentrifugaler Feldflussfraktionierung (ISO/TS 21362:2018)
Nanotechnologies - Analyse des nano-objets par fractionnement par couplage flux-force
asymétrique et à force centrifuge (ISO/TS 21362:2018)
Ta slovenski standard je istoveten z: CEN ISO/TS 21362:2021
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 21362
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
April 2021
TECHNISCHE SPEZIFIKATION
ICS 07.120
English Version
Nanotechnologies - Analysis of nano-objects using
asymmetrical-flow and centrifugal field-flow fractionation
(ISO/TS 21362:2018)
Nanotechnologies - Analyse des nano-objets par Nanotechnologien - Analyse von Nanoobjekten mit
fractionnement par couplage flux-force asymétrique et Hilfe von Asymmetrischer-Fluss-
à force centrifuge (ISO/TS 21362:2018) Feldflussfraktionierung und zentrifugaler
Feldflussfraktionierung (ISO/TS 21362:2018)
This Technical Specification (CEN/TS) was approved by CEN on 19 March 2021 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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 21362:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TS 21362:2018 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 21362:2021 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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 21362:2018 has been approved by CEN as CEN ISO/TS 21362:2021 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 21362
First edition
2018-06
Nanotechnologies — Analysis of nano-
objects using asymmetrical-flow and
centrifugal field-flow fractionation
Nanotechnologies — Analyse des nano-objets par fractionnement flux
asymétrique et flux force centrifuge
Reference number
ISO/TS 21362:2018(E)
©
ISO 2018
ISO/TS 21362:2018(E)
© ISO 2018
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO/TS 21362:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 7
5 Principles of operation . 8
5.1 Field-flow fractionation (General) . 8
5.2 Specific applications by applied field .10
5.2.1 Flow field .10
5.2.2 Centrifugal field .11
6 Method development for AF4 .13
6.1 General .13
6.2 Sample specifications .14
6.3 Mobile phase specifications .14
6.4 Fractionation .15
6.4.1 Channel and membrane selection .15
6.4.2 Injection and relaxation .17
6.4.3 Optimizing flow conditions .18
6.4.4 Elution programme .18
6.4.5 Using FFF theory to select initial flow settings .19
7 Method development for CF3 .19
7.1 General .19
7.2 Choice of mobile phase .20
7.3 Field strength selection .20
7.4 Field decay programme .20
7.5 Channel flow rate selection .21
7.6 Calculation of the relaxation time.21
7.7 Calculation of sample injection dela y .21
8 Analysis of nano-objects .21
8.1 General .21
8.2 Online size analysis .22
8.3 Online concentration analysis.23
8.3.1 General.23
8.3.2 Mass-based methods .23
8.3.3 Number-based methods .24
8.4 Online material identification or composition .25
8.5 Off-line analysis (Fraction collection) .26
9 Qualification, performance criteria and measurement uncertainty .26
9.1 System qualification and quality control .26
9.1.1 Basic system qualification .26
9.1.2 Focusing performance . .27
9.1.3 Flow rate of the carrier liquid .28
9.1.4 Separation field .28
9.2 Method performance criteria .28
9.2.1 Recovery .28
9.2.2 Selectivity .29
9.2.3 Retention .
...