ISO TS 4958-2024 PDF

Full title and description

St ISO TS 4958-2024 — Nanotechnologies — Vocabulary — Liposomes. This Technical Specification establishes standardized terminology and definitions for liposomes as a class of lipid‑based nanomaterials used in biological systems and biomedical applications; it is intended to harmonize language used by researchers, regulators, manufacturers and other stakeholders.

Abstract

This document defines terms related to liposomes in the context of nanotechnologies, focusing on their identity, structural features (e.g., lamellarity, bilayer characteristics), common types (small unilamellar, large unilamellar, multilamellar, multivesicular), components and functional aspects relevant to biomedical applications. It explicitly excludes terms that are specific to other lipid‑based particles such as solid lipid nanoparticles.

General information

• Status: Published.
• Publication date: 1 March 2024 (Edition 1, 2024).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 07.120 (Nanotechnology); 01.040.07 (Mathematics. Natural sciences — Nomenclature and terminology).
• Edition / version: Edition 1 (2024), Technical Specification (ISO/TS).
• Number of pages: 8 pages (official ISO publication).

Scope

ISO/TS 4958:2024 provides authoritative definitions for terms describing liposomes used in nanotechnology and biomedical contexts, with the aim of improving clarity in research, product development, regulation and communication between disciplines. The scope covers nomenclature for vesicle types, structural attributes, components and functional descriptors, while excluding terminology unique to other lipid‑based nanoparticle classes.

Key topics and requirements

• Standardized definitions for liposome types (e.g., small unilamellar vesicle (SUV), large unilamellar vesicle (LUV), multilamellar vesicle (MLV), multivesicular liposome (MVL)).
• Terms describing lipid components and regions (phospholipid, cholesterol, hydrophobic/hydrophilic compartments, trapping agents, fusogens).
• Descriptors of bilayer structure and phase behaviour (lamellarity, bilayer thickness, liquid‑ordered vs liquid‑disordered vs gel phases).
• Size‑range terminology and related descriptive metrics commonly used in biomedical and nanotechnology contexts.
• Cross‑references to core nanotechnology vocabulary (links to the ISO nanotechnologies vocabulary work, e.g., ISO 80004 series) to ensure compatibility with established nanoscale definitions.
• Vocabulary‑type deliverable: the document provides definitions and guidance rather than prescriptive test methods or performance requirements.

Typical use and users

Researchers in nanobiotechnology and pharmaceutical sciences, formulation scientists, regulatory authorities, standards bodies, quality and regulatory affairs professionals, manufacturers of liposomal products (drugs, vaccines, cosmetics), and metrology organisations use this specification to align terminology across research, development, regulation and reporting. The U.S. participated in and led project activity for this work item, with contributors from industry and NIST, reflecting broad stakeholder input.

Related standards

ISO/TS 4958:2024 is part of ISO/TC 229's nanotechnologies vocabulary effort and is intended to be used alongside the ISO 80004 series (Nanotechnologies — Vocabulary) which provides core and domain‑specific nanotechnology terminology. Users should also consider other guidance and technical reports on nanomaterial risk evaluation and characterization when applying liposome terminology in safety, regulatory or technical contexts.

Keywords

liposome; liposomal vesicle; nanotechnologies; lipid‑based nanomaterial; unilamellar; multilamellar; lamellarity; bilayer; encapsulation; nomenclature; vocabulary; ISO/TC 229.

FAQ

Q: What is this standard?

A: ISO/TS 4958:2024 is a Technical Specification that defines vocabulary and terms for liposomes within the field of nanotechnologies to harmonize terminology used by science, industry and regulators.

Q: What does it cover?

A: It covers definitions for liposome types, structural descriptors (lamellarity, bilayer phases), components (lipids, cholesterol, cargo), size‑related terminology and other terms needed for clear communication in biomedical and nanotechnology contexts; it does not provide test methods or requirements for other lipid nanoparticles.

Q: Who typically uses it?

A: Formulation scientists, nanotechnology researchers, pharmaceutical and vaccine developers, regulators, standards committees, metrology institutes and manufacturers use this vocabulary standard to ensure consistent terminology across publications, regulatory filings and product specifications.

Q: Is it current or superseded?

A: ISO/TS 4958:2024 was published on 1 March 2024 and is current as published. Users should check the ISO catalog or national standards bodies for any amendments, national adoptions (endorsements) or later revisions.

Q: Is it part of a series?

A: Yes — it complements the ISO vocabulary work for nanotechnologies (the ISO 80004 series and related parts) and was developed under ISO/TC 229 (Nanotechnologies), Joint Working Group 1 on terminology and nomenclature.

Q: What are the key keywords?

A: Liposome, liposomal vesicle, nanotechnology vocabulary, unilamellar, multilamellar, lamellarity, bilayer, encapsulation, lipid‑based nanomaterial.