National foreword

This British Standard is the UK implementation of ISO 16921‑1:2026.

The UK participation in its preparation was entrusted to Technical Committee BTI/1, Biotechnologies.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2026.

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).

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 ISO/TC 276, Biotechnology, Subcommittee SC 1, Analytical methods.

A list of all parts in the ISO 16921 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.

Introduction

Modern and emerging biotechnology is underpinned by the ability to manipulate the genes and genomes of living systems. Gene delivery systems are foundational to genome engineering. Gene delivery technology is evolving rapidly with numerous types of gene delivery systems providing a comprehensive set of tools and capabilities for in vitro or in vivo targeted delivery.

The ISO I6921 series consists of multiple parts to provide common understanding, guides, and analytical methods for characterizing these emerging biotechnology tools. This document provides terms and definitions to enable common understanding. Other parts of the ISO I6921 series will focus on measurements for various gene delivery systems.

1 Scope

This document defines terms related to gene transfer for mammalian systems, including the use of viral and non-viral gene delivery systems and via mechanical mechanisms.

This document is applicable to the development, measurement, and use of gene delivery systems for all applications.

2 Normative references

3 Terms and definitions

3.1 General terms

3.2 Gene delivery system attributes and function

3.3 General terms for viral vectors

3.4 General terms for lipid nanoparticles

3.5 Analytical methods

Bibliography

BS ISO 16921-1:2026

Biotechnology — Gene delivery systems - Vocabulary

Current

Published:

31 Jan 2026