SIST-TS CEN ISO/TS 4958:2024
(Main)Nanotechnologies - Vocabulary - Liposomes (ISO/TS 4958:2024)
Nanotechnologies - Vocabulary - Liposomes (ISO/TS 4958:2024)
This document defines terms related to liposomes in nanotechnologies, within the context of biological systems and biomedical applications. In this context, liposomes are one form of lipid-based nanomaterials. This document does not address terms that can be relevant to other types of lipid-based particles (e.g. solid lipid nanoparticles).
Nanotechnologien - Terminologie der Liposomen (ISO/TS 4958:2024)
Nanotechnologies - Vocabulaire - Liposomes (ISO/TS 4958:2024)
Le présent document définit les termes relatifs aux liposomes dans les nanotechnologies, dans le contexte des systèmes biologiques et des applications biomédicales. Dans ce contexte, les liposomes correspondent à une forme de nanomatériaux lipidiques. Le présent document ne traite pas des termes qui peuvent être liés à d’autres types de particules lipidiques (par exemple les nanoparticules lipidiques solides).
Nanotehnologije - Slovar - Liposomi (ISO/TS 4958:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2024
Nanotehnologije - Slovar - Liposomi (ISO/TS 4958:2024)
Nanotechnologies - Vocabulary - Liposomes (ISO/TS 4958:2024)
Nanotechnologien - Terminologie der Liposomen (ISO/TS 4958:2024)
Nanotechnologies - Vocabulaire - Liposomes (ISO/TS 4958:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 4958:2024
ICS:
01.040.07 Naravoslovne in uporabne Natural and applied sciences
vede (Slovarji) (Vocabularies)
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 4958
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
October 2024
TECHNISCHE SPEZIFIKATION
ICS 01.040.07; 07.120
English Version
Nanotechnologies - Vocabulary - Liposomes (ISO/TS
4958:2024)
Nanotechnologies - Vocabulaire - Liposomes (ISO/TS Nanotechnologien - Terminologie der Liposomen
4958:2024) (ISO/TS 4958:2024)
This Technical Specification (CEN/TS) was approved by CEN on 20 October 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 4958:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO/TS 4958:2024 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 4958:2024 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/national committee. 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 4958:2024 has been approved by CEN as CEN ISO/TS 4958:2024 without any
modification.
Technical
Specification
ISO/TS 4958
First edition
Nanotechnologies — Vocabulary —
2024-03
Liposomes
Nanotechnologies — Vocabulaire — Liposomes
Reference number
ISO/TS 4958:2024(en) © ISO 2024
ISO/TS 4958:2024(en)
© ISO 2024
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
ii
ISO/TS 4958:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Core terms related to liposomes .1
3.2 Terms related to lipid-bilayer vesicles .2
3.3 Terms related to the components and regions of liposomes .3
3.4 Terms related to the characteristics and formation of liposomes .4
Bibliography . 7
Index . 8
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ISO/TS 4958:2024(en)
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 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 4958:2024(en)
Introduction
Lipid-based nanomaterials represent an important class of carriers for the in vivo transport and delivery of
active pharmaceutical ingredients (APIs). By encapsulating the API inside a lipid-based structure, payloads
can be protected from degradation while potent APIs can be delivered with reduced adverse physiological
effects. These lipid-based carriers are carefully formulated to achieve specific properties and are generally
well tolerated and biocompatible.
Lipid particles include different structural forms or subclasses that can be differentiated by structure,
composition and chemistry (e.g. liposomes, solid lipid nanoparticles). The first lipid-based nanomaterial
product to obtain regulatory approval in the US and EU was liposomal doxorubicin, approved in 1995 in
the US for the treatment of ovarian cancer and AIDS-related Kaposi sarcoma. More recently, cationic lipid-
containing nanoparticles complexed with mRNA were formulated as highly effective vaccines against the
coronavirus SARS-CoV-2. This document aims to standardize the terminology associated with the most
studied and mature form of lipid-based carriers, namely liposomes.
Liposomes are synthetic vesicles composed of a single bilayer (most common form for drug delivery) or of
multiple concentric or non-concentric bilayers separated by aqueous compartments. Figure 1 schematically
illustrates these basic structural forms of liposome as used within a biomedical context. An example of
pharmaceutical relevance (e.g. a drug product) is provided for each vesicle form defined in 3.2.
a) Small unilamellar b) Large unilamellar c) Multilamellar d) Multivesicular
vesicle ≤100 nm vesicle >100 nm vesicle ≥500 nm liposome >1 000 nm
NOTE Images are not drawn to scale.
SOURCE Scientific Publications, Graphics and Media, Frederick National Laboratory for Cancer Research.
Figure 1 — Schematic illustration showing lamellar structure of different vesicle types
The bilayers are formed by amphipathic molecules, primarily phospholipids, but can include other
molecular components necessary for membrane integrity (e.g. cholesterol) or avoidance of opsonization and
reticuloendothelial clearance [e.g. polyethylene glycol (PEG)].
The size of liposomes can range from approximately 20 nm to over 1 000 nm, though therapeutic delivery
most commonly involves particles in the 50 nm to 200 nm diameter range. Therefore, while not all liposomes
are nano-objects as defined in this document, all liposomes consist of bilayers of nanoscale thickness and
are therefore generally considered both nanomaterials and nanostructured materials.
Figure 2 depicts a 3D cross-sectional perspective of an idealized unilamellar liposome, a lipid bilayer and a
liposomal drug formulation showing the location of compartments and APIs.
Figure 3 illustrates the three principal structural phases associated with lipid bilayers. These phases are
principally dependent on composition and temperature, but other factors such as pH can also play a role.
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ISO/TS 4958:2024(en)
a) 3D hemispherical view b) Cross-section of bilayer c) Liposome cross-section show-
segment ing bilayer with details
Key
1 hydrophobic compartment (lipid bilayer)
2 hydrophilic compartment (aqueous phase core)
3 hydrophilic active pharmaceutical ingredient (API)
4 hydrophobic API
5 amphiphilic API
6 polyethylene glycol (PEG)
NOTE 1 Images are not drawn to scale.
NOTE 2 Polar headgroups are shown in green and hydrophobic tails are shown in black.
SOURCE Scientific Publications, Graphics and Media, Frederick National Laboratory for Cancer Research.
Figure 2 — Idealized unilamellar liposome showing phospholipid bilayer structure, internal
compartments and representative details
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ISO/TS 4958:2024(en)
Key
1 liquid disordered phase (above phase transition temperature)
2 liquid ordered phase (induced by cholesterol)
3 gel phase (below phase transition temperature)
4 phospholipid fatty acid tails
5 phos
...
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