ISO 5058-1:2021

Biotechnology - Genome editing - Part 1: Vocabulary

This document defines terms related to genome editing technology. This document is applicable to general use of genome editing across species.

Biotechnologie — Édition génomique — Partie 1: Vocabulaire

General Information

• Status: Published
• Publication Date: 09-Nov-2021
• ICS: 01.040.07 - Natural and applied sciences (Vocabularies)
• ICS: 07.080 - Biology. Botany. Zoology
• Technical Committee: ISO/TC 276 - Biotechnology
• Drafting Committee: ISO/TC 276/WG 1 - Terminology
• Current Stage: 6060 - International Standard published
• Start Date: 10-Nov-2021
• Due Date: 12-May-2023
• Completion Date: 10-Nov-2021

Relations

• Amended By: ISO 5058-1:2021/Amd 1:2022 - Biotechnology - Genome editing - Part 1: Vocabulary - Amendment 1
• Effective Date: 01-Jan-2022

Overview

ISO 5058-1:2021, titled "Biotechnology - Genome editing - Part 1: Vocabulary", is an international standard developed by ISO Technical Committee ISO/TC 276 focused on biotechnology. This standard provides a unified and comprehensive vocabulary for terms related to genome editing technology, applicable across species. As genome editing continues to evolve rapidly, standardized terminology is essential for clear communication, data reporting, and interpretation within the biotechnology sector.

The scope of ISO 5058-1:2021 includes defining terms associated with genome editing concepts, tools, and outcomes. It is designed to support a wide range of applications involving site-specific modifications of nucleic acids, including DNA and RNA. However, specific application requirements in agriculture or food are outside its scope.

Key Topics

The standard structures its vocabulary into well-defined categories to enhance clarity in genome editing discussions:

• Genome editing concepts
  Definitions cover foundational ideas such as gene editing, genome editing, genome engineering, off-target effects, specificity, and targets. These form the conceptual framework for understanding how genome editing operates, including the biochemical mechanisms and the intended genetic targets.

• Genome editing tools
  The standard details terminology for various genome editing tools categorized as:

  • General tools, including repair templates and site-directed nucleases
  • CRISPR specific terms such as Cas nucleases (Cas9, Cas12a), guide RNAs (gRNA, crRNA, tracrRNA), PAM (protospacer adjacent motif), and single-guide RNAs (sgRNA)
  • Meganuclease specific terms describing engineered homing endonucleases and their target sites
  • megaTAL specific vocabulary related to chimeric nucleases combining TALE arrays and meganucleases
  • TALEN specific language for transcription activator-like effector nucleases, including DNA-binding domain specifics and target sites
  • ZFN specific terms (though details are part of the full document)

• Genome editing outcomes
  Terminology related to the results of the editing process, including intended and unintended modifications, helps standardize how outcomes are described and evaluated.

• Abbreviated terms
  A glossary section supports consistent abbreviation use across genome editing literature.

Applications

ISO 5058-1:2021 serves as a foundational reference for biotechnology stakeholders working in research, clinical therapeutics, agriculture, synthetic biology, and biomanufacturing, including:

• Human cell-based therapeutics: Improved clarity in terminology enhances the development and regulation of gene therapies.
• Agricultural biotechnology: Consistent vocabulary supports molecular innovations in crop and livestock genome engineering.
• Microbial therapeutics and synthetic biology: Precise language facilitates the description of engineered microbes for health and industrial applications.
• Biomanufacturing: Standard terms aid in describing genetic modifications used to optimize production organisms.

By harmonizing vocabulary, the standard enables effective communication between researchers, regulators, and industry professionals, accelerating innovation and ensuring quality and safety in genome editing technologies.

Related Standards

Users of ISO 5058-1:2021 may also refer to complimentary ISO technical committees and standards for comprehensive coverage of molecular and biotechnological methods:

• ISO/TC 34/SC 16: Horizontal methods for molecular biomarker analysis, relevant for agricultural and food safety applications involving genome editing.
• ISO/TC 215: Health informatics, which addresses terminology and standards for clinical applications potentially involving genome editing-related patient data.
• Additional parts of the ISO 5058 series (not covered in Part 1), which provide further details on genome editing practices and safety protocols.

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Keywords: genome editing, ISO 5058-1, biotechnology standard, CRISPR vocabulary, gene editing terminology, genome engineering, genome editing tools, Cas nuclease, TALEN, meganuclease, megaTAL, genome editing outcomes, biotechnology applications, standardized genome editing terms, genome editing definitions.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 5058-1
First edition
2021-11
Biotechnology — Genome editing —
Part 1:
Vocabulary
Biotechnologie — Édition génomique —
Partie 1: Vocabulaire
Reference number
© 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
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or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
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Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Genome editing concepts . 1
3.2 Genome editing tools . 3
3.2.1 General . 3
3.2.2 CRISPR specific . 3
3.2.3 Meganuclease specific . 5
3.2.4 megaTAL specific . 5
3.2.5 TALEN specific . 6
3.2.6 ZFN specific . . 6
3.3 Genome editing outcomes . 7
4 Abbreviated terms . 8
Bibliography . 9
Index .10
iii
Foreword
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electrotechnical standardization.
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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
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
A list of all parts in the ISO 5058 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
Introduction
Genome editing technology is a fast-growing and rapidly advancing global bioscience field with
applications in many biotechnology sectors. Genome editing is used to modify the nucleic acids of a
genetic code, which can be composed of DNA or RNA, in a site-specific manner. Modifications can include
insertion, deletion or alteration of nucleic acids. The technology operates by biochemical principles
generally applicable to every kind of cell. Examples of genome editing technology applications with
global significance include human cell-based therapeutics, agriculture, microbial based therapeutics,
synthetic biology and biomanufacturing.
While genome editing technology is being actively utilized, there is a need for international
standardization in terms and definitions for this field, so as to enhance interpretation and
communication of concepts, data and results.
This document has been developed to provide a unified standard set of terms and definitions that serve
the needs of biotechnology stakeholders and act as a reference for genome editing technology. Standards
in the field of genome editing are intended to harmonize and accelerate effective communication,
technology development, qualification and evaluation of genome editing products. This document is
expected to improve confidence in and clarity of scientific communication, data reporting and data
interpretation in the genome editing field. Specific requirements for the application of genome editing
technologies in agriculture and food are not included. For specific requirements, users can consult
standards developed by appropriate ISO Technical Committees, e.g. ISO/TC 34/SC 16 Horizontal
methods for molecular biomarker analysis, or ISO/TC 215 Health informatics.
This document provides a vocabulary that standardizes the use and meaning of terms associated with
genome editing. This document is organized into categories and sub-categories as follows:
— genome editing concepts (see 3.1);
— genome editing tools (see 3.2):
— general (see 3.2.1);
— CRISPR specific (see 3.2.2);
— meganuclease specific (see 3.2.3);
— megaTAL specific (see 3.2.4);
— TALEN specific (see 3.2.5);
— ZFN specific (see 3.2.6);
— genome editing outcomes (see 3.3).
Terms within categories are listed alphabetically. The sub-category “General” contains terms that
apply to all types of genome editing tools. Additional sub-categories contain terms specific to the sub-
category of genome editing technology: “CRISPR specific”, “Meganuclease specific”, “megaTAL specific”,
“TALEN specific” and “ZFN specific”. An alphabetical list of all terms is given in the index. Definitions
follow English word order wherever possible.
It is also recognized that genome editing is a rapidly developing and evolving biotechnology, and
additional terms and definitions will be needed as genome editing technologies mature.
v
INTERNATIONAL STANDARD ISO 5058-1:2021(E)
Biotechnology — Genome editing —
Part 1:
Vocabulary
1 Scope
This document defines terms related to genome editing technology.
This document is applicable to general use of genome editing across species.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 Genome editing concepts
3.1.1
gene editing
techniques for genome engineering (3.1.3) that involve nucleic acid damage, repair mechanisms,
replication and/or recombination for incorporating site-specific modification(s) into a gene or genes
Note 1 to entry: Gene editing is a subclass of genome editing (3.1.2).
Note 2 to entry: There are various genome editing tools (see 3.2 and Figure 1).
3.1.2
genome editing
techniques for genome engineering (3.1.3) that involve nucleic acid damage, repair mechanisms,
replication and/or recombination for incorporating site-specific modification(s) into a genomic DNA
Note 1 to entry: Gene editing (3.1.1) is a subclass of genome editing.
Note 2 to entry: There are various genome editing tools (see 3.2 and Figure 1).
Figure 1 — Examples for genome editing technologies/tools
3.1.3
genome engineering
process of introducing intentional changes to genomic nucleic acid
Note 1 to entry: Gene editing (3.1.1) and genome editing (3.1.2) are techniques used in genome engineering.
3.1.4
off-target
genome editing off-target
genomic position and/or nucleic acid sequence distinct from the target (3.1.6)
EXAMPLE Off-target binding, off-target cleavage, off-target edit, off-target sequence change.
Note 1 to entry: An off-target edit is an example of an unintended edit (3.3.7).
3.1.5
specificity
genome editing target specificity
extent to which an editing agent or procedure acts only on its intended target (3.1.6)
Note 1 to entry: When using this term, the procedure is defined, the intended target is defined, the action or
outcome is measured and reported, and limits of detection are reported.
3.1.6
target
genome editing target
nucleic acid sequence subject to intentional binding, modification and/or cleavage during a genome
editing (3.1.2) process
Note 1 to entry: See also off-target (3.1.4), Cas nuclease target site (3.2.2.2), meganuclease target site (3.2.3.4),
megaTAL target site (3.2.4.3), TALEN target site (3.2.5.4) and ZFN target site (3.2.6.5).
3.2 Genome editing tools
3.2.1 General
3.2.1.1
repair template
nucleic acid sequence used to direct cellular DNA repair pathways to incorporate specific DNA sequence
changes at or near a target (3.1.6)
3.2.1.2
site-directed DNA modification enzyme
enzyme capable of modifying DNA at a specific sequence
EXAMPLE Site-directed nuclease (3.2.1.3), site-directed adenosine deaminase.
3.2.1.3
site-directed nuclease
sequence-specific nuclease
enzyme capable of cleaving the phosphodiester bond between adjacent nucleotides in a nucleic acid
polymer at a specific sequence
3.2.2 CRISPR specific
3.2.2.1
Cas nuclease
CRISPR associated nuclease
enzyme that is a component of CRISPR systems that is capable of breaking the phosphodiester bonds
between nucleotides
EXAMPLE Cas3, Cas9, Cas12a, Cas13, CasX.
Note 1 to entry: Some but
...