CEN ISO/TS 19807-2:2023
(Main)Nanotechnologies - Magnetic nanomaterials - Part 2: Specification of characteristics and measurement methods for nanostructured magnetic beads for nucleic acid extraction (ISO/TS 19807-2:2021)
Nanotechnologies - Magnetic nanomaterials - Part 2: Specification of characteristics and measurement methods for nanostructured magnetic beads for nucleic acid extraction (ISO/TS 19807-2:2021)
This document specifies characteristics to be measured of magnetic beads in suspension and powder forms for nucleic acid extraction applications. This document deals with magnetic beads that contain a substantial amount of magnetic nanoparticles (which can be superparamagnetic). Potential applicable measurement methods are listed for the individual characteristics. Specifically, this document lists critical characteristics of magnetic beads and suspensions, and additional characteristics to describe the magnetic beads and the suspension for nucleic acid extraction.
Health, safety and environmental aspects of magnetic beads are not within the scope of this document.
Nanotechnologien - Magnetische Nanopartikel - Teil 2: Festlegung der Merkmale und Messverfahren für nanostrukturierte magnetische Beads zur Nukleinsäureextraktion (ISO/TS 19807‑2:2021)
Dieses Dokument legt die zu messenden Eigenschaften von magnetischen Beads in Suspensions- und Pulverform für Anwendungen der Nukleinsäure-Extraktion fest. Dieses Dokument behandelt magnetische Beads, die eine erhebliche Menge an magnetischen Nanopartikeln enthalten (die superparamagnetisch sein können). Für die einzelnen Eigenschaften werden mögliche Messverfahren angegeben. Im Einzelnen sind in diesem Dokument wesentliche Eigenschaften von magnetischen Beads und Suspensionen sowie zusätzliche Eigenschaften zur Beschreibung der magnetischen Beads und der Suspension für die Nukleinsäure-Extraktion aufgeführt.
Gesundheits-, Sicherheits- und Umweltaspekte von magnetischen Beads gehören nicht zum Anwendungs¬bereich dieses Dokuments.
Nanotechnologies - Nanomatériaux magnétiques - Partie 2: Spécification des caractéristiques et des méthodes de mesure pour les billes magnétiques nanostructurées pour l’extraction d’acide nucléïque (ISO/TS 19807-2:2021)
Nanotehnologije - Magnetni nanomateriali - 2. del: Specifikacija lastnosti in merilnih metod za nanostrukturirane magnetne kroglice za ekstrakcijo nukleinskih kislin (ISO/TS 19807-2:2021)
Ta dokument določa lastnosti, ki se jih meri pri magnetnih nizih v suspenziji in praških za ekstrakcijo nukleinske kisline. Ta dokument obravnava magnetne nize, ki vsebujejo bistveno količino magnetnih nanodelcev (ki so lahko superparamagnetni nanodelci). Potencialno uporabne merilne metode so navedene za posamezne lastnosti. Ta dokument posebej navaja ključne lastnosti magnetnih nizov in suspenzij in dodatne lastnosti za opis magnetnih nizov in suspenzije za ekstrakcijo nukleinske kisline.
V področje uporabe tega dokumenta niso vključeni vidiki zdravja, varnosti in varstva okolja magnetnih nizov.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Nanotehnologije - Magnetni nanomateriali - 2. del: Specifikacija lastnosti in
merilnih metod za nanostrukturirane magnetne kroglice za ekstrakcijo nukleinskih
kislin (ISO/TS 19807-2:2021)
Nanotechnologies - Magnetic nanomaterials - Part 2: Specification of characteristics and
measurement methods for nanostructured magnetic beads for nucleic acid extraction
(ISO/TS 19807-2:2021)
Nanotechnologies - Nanomatériaux magnétiques - Partie 2: Spécification des
caractéristiques et des méthodes de mesure pour les billes magnétiques
nanostructurées pour l’extraction d’acide nucléïque (ISO/TS 19807-2:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 19807-2:2023
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 19807-2
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
March 2023
TECHNISCHE SPEZIFIKATION
ICS 07.120
English Version
Nanotechnologies - Magnetic nanomaterials - Part 2:
Specification of characteristics and measurement methods
for nanostructured magnetic beads for nucleic acid
extraction (ISO/TS 19807-2:2021)
Nanotechnologies - Nanomatériaux magnétiques -
Partie 2: Spécification des caractéristiques et des
méthodes de mesure pour les billes magnétiques
nanostructurées pour l'extraction d'acide nucléïque
(ISO/TS 19807-2:2021)
This Technical Specification (CEN/TS) was approved by CEN on 17 March 2023 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19807-2:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO/TS 19807-2:2021 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 19807-2:2023 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 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/TS 19807-2:2021 has been approved by CEN as CEN ISO/TS 19807-2:2023 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 19807-2
First edition
2021-10
Nanotechnologies — Magnetic
nanomaterials —
Part 2:
Specification of characteristics
and measurement methods for
nanostructured magnetic beads for
nucleic acid extraction
Nanotechnologies — Nanomatériaux magnétiques —
Partie 2: Spécification des caractéristiques et des méthodes de mesure
pour les billes magnétiques nanostructurées pour l’extraction d’acide
nucléïque
Reference number
ISO/TS 19807-2:2021(E)
ISO/TS 19807-2:2021(E)
© ISO 2021
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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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 19807-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 3
5 Characteristics to be measured and measurement methods . 4
5.1 General . 4
5.2 Descriptions of characteristics and their measurement methods . 5
5.2.1 Bead mass concentration . 5
5.2.2 Bead size distribution . 5
5.2.3 Nucleic acid binding capacity . 5
5.2.4 Remanent mass magnetization . 6
5.2.5 Surface functional group type . 7
5.2.6 Saturation mass magnetization . 7
5.2.7 Initial magnetic mass susceptibility . 8
5.2.8 Iron ion concentration . 8
5.2.9 Mass specific surface area . 8
5.2.10 Size of primary magnetic nanoparticles . 9
5.2.11 Surface functional group density . 9
6 Sample preparation .10
7 Test report .10
Annex A (informative) Schematics of magnetic beads .11
Bibliography .12
iii
ISO/TS 19807-2:2021(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 World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
A list of all parts in the ISO/TS 19807 series can be found on the ISO website.
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 19807-2:2021(E)
Introduction
Magnetic beads are composed of a large number of magnetic nanoparticles immobilized within a
nonmagnetic matrix with a size range between tens of nanometres and hundreds of micrometres (see
Annex A). The immobilization matrix is typically based on silica or organic polymers. The beads are
commonly supplied while dispersed in a liquid suspension, for example, ethanol, isopropanol, sodium
azide solutions, pure water. Magnetic beads in liquid suspension have become one of the most widely
used nanomaterials in the biological and chemical fields, due to their unique magnetic properties and
interactions with applied magnetic fields.
When the size of a magnetic object is small enough, it will form a single magnetic domain, behaving as
[1]
a single large macrospin. At yet smaller sizes (for iron oxide, typically less than 30nm ), the thermal
energy of the object can be sufficient to result in frequent reorientations of the magnetization direction
of the object. If the timescale of these reorientations is shorter than the timescale of the measurement,
the term ‘superparamagnetism’ is used to describe this behaviour and the magnetic nano-objects are
said to be superparamagnetic. In large non-interacting ensembles of such particles, the thermally
induced switching events will result in the average magnetization of the ensembles being zero in the
absence of an applied magnetic field. In the presence of an appli
...
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