ISO 5058-1-2021 amd1-2022 PDF

Full title and description

ISO 5058-1:2021/Amd 1:2022 — Biotechnology — Genome editing — Part 1: Vocabulary — Amendment 1. This published amendment updates and clarifies specific vocabulary and definitions used in ISO 5058-1:2021 to reflect developments and agreed terminology in the genome‑editing community, ensuring consistent use of terms such as artificial nuclease and off‑target modification across standards, literature and regulatory communications.

Abstract

This document is Amendment 1 to ISO 5058-1:2021 (Part 1: Vocabulary) and contains editorial and technical updates to selected definitions used for genome‑editing technologies. The amendment is concise (one page) and is intended to be read together with ISO 5058-1:2021; it refines wording and adds precision to terms to reduce ambiguity in scientific, regulatory and standards contexts.

General information

• Status: Published
• Publication date: July 2022 (published 21 July 2022)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 01.040.07; 07.080
• Edition / version: Amendment 1 to ISO 5058-1:2021 (Edition 1)
• Number of pages: 1 (amendment document)

Bibliographic and technical details above are taken from ISO’s bibliographic record and standard distributors; the underlying base document ISO 5058-1:2021 (Part 1: Vocabulary) comprises 11 pages.

Scope

This amendment updates and clarifies selected terms in the vocabulary for genome‑editing technologies given in ISO 5058-1:2021. Its scope is limited to vocabulary: it does not introduce new testing methods or procedural requirements but refines definitions (for example, for types of nucleases and for the notion of off‑target modifications) so that they better reflect current technical consensus and reduce ambiguity when applied across research, regulation and industry. The amendment is intended to be used together with the main ISO 5058-1:2021 text.

Key topics and requirements

• Refinement and clarification of key vocabulary entries related to genome editing (e.g., artificial nuclease definitions, off‑target modification terminology).
• Editorial corrections and precision wording to align terminology with current practice in genome‑editing research and applications.
• Guidance to use the amended definitions together with ISO 5058-1:2021; the amendment does not stand alone but modifies the base vocabulary document.
• Support for harmonized communication among researchers, regulatory bodies, standards developers and industry practitioners working on genome editing.

Typical use and users

Primary users include standards developers, technical committees, vocabulary and terminology experts, researchers in genome editing, quality and regulatory affairs professionals in biotech and pharma, and regulatory agencies that reference standardized terms in guidance or rules. The amendment is used when precise, harmonized definitions are required for technical reports, regulatory submissions, standardization work and cross‑disciplinary communication.

Related standards

This amendment applies to and must be read with ISO 5058-1:2021 (Biotechnology — Genome editing — Part 1: Vocabulary). It is produced under ISO/TC 276 (Biotechnology) and is related conceptually to other ISO and national documents addressing genome editing, biotechnology terminology, and quality/terminology work from ISO/TC 276 subcommittees. National adoptions (for example DIN ISO 5058-1 incorporating the amendment) reflect its integration into national collections.

Keywords

genome editing; vocabulary; terminology; artificial nuclease; off‑target modification; biotechnology; ISO 5058; ISO/TC 276; amendment; definitions.

FAQ

Q: What is this standard?

A: This publication is Amendment 1 to ISO 5058-1:2021 — a one‑page amendment document that updates and clarifies vocabulary entries for genome‑editing technologies contained in the Part 1 vocabulary standard.

Q: What does it cover?

A: It covers editorial and technical updates to selected vocabulary terms used in ISO 5058-1:2021 (Part 1: Vocabulary), refining definitions such as those for artificial nucleases and off‑target modifications to improve clarity and consistency. The amendment is appended to and used with the base standard rather than replacing it.

Q: Who typically uses it?

A: Terminologists, standards developers, genome‑editing researchers, biotech and pharmaceutical quality/regulatory staff, and agencies or committees that reference standardized terminology for technical communications and regulatory purposes.

Q: Is it current or superseded?

A: The document is a published amendment (July 2022) to ISO 5058-1:2021. It is current as an amendment to the 2021 base standard and should be applied together with ISO 5058-1:2021; it does not supersede the base standard in full but modifies specific entries in it. Users should consult both the base standard and this amendment.

Q: Is it part of a series?

A: Yes — it is Part 1 (Vocabulary) of the ISO 5058 series addressing genome editing (ISO 5058-1:2021 with this Amendment 1:2022). Part 1 provides the terminology backbone used across related documents and projects under ISO/TC 276 addressing biotechnology and genome‑editing topics.

Q: What are the key keywords?

A: Genome editing, vocabulary, terminology, artificial nuclease, off‑target modification, biotechnology, ISO 5058, amendment.