Biotechnology -- Genome editing

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

Biotechnologie -- Édition génomique

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Status
Published
Publication Date
09-Nov-2021
Technical Committee
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
09-Oct-2021
Completion Date
08-Oct-2021
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INTERNATIONAL ISO
STANDARD 5058-1
First edition
2021-11
Biotechnology — Genome editing —
Part 1:
Vocabulary
Biotechnologie — Édition génomique —
Partie 1: Vocabulaire
Reference number
ISO 5058-1:2021(E)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO 5058-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 5058-1:2021(E)
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
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 5058-1:2021(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 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.
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.
© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 5058-1:2021(E)
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.

© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
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).
© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 5058-1:2021(E)
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).
© ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 5058-1:2021(E)
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
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 5058-1
ISO/TC 276
Biotechnology — Genome editing —
Secretariat: DIN
Voting begins on:
Part 1:
2021-08-13
Vocabulary
Voting terminates on:
2021-10-08
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 5058-1:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 5058-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 5058-1:2021(E)
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 ................................................................................................................................................................... 5

3.2.6 ZFN specific .......................................................................................................................................................................... 6

3.3 Genome editing outcomes ............................................................................................................................................................. 7

4 Abbreviated terms .............................................................................................................................................................................................. 8

Bibliography ................................................................................................................................................................................................................................ 9

Index .................................................................................................................................................................................................................................................10

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 5058-1:2021(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 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.
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 © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 5058-1:2021(E)
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 and clarify 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.

© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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).
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).
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/FDIS 5058-1:2021(E)
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, intended target is defined, action or outcome is

measured and reported, and limits of detection are reported.
2 © ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/FDIS 5058-1:2021(E)
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 (3.2.6.6).

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
...

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