National foreword

This British Standard is the UK implementation of ISO 24479:2024.

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 October 2024.

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 document 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).

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This document was prepared by Technical Committee ISO/TC 276, Biotechnology, Subcommittee SC 1, Analytical methods.

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

Optical microscopy is a widely practiced technique for characterization of processed cells. Morphology of cells, such as shape, size, texture of whole or parts of cells, can provide information about various aspects of cells including identity, phenotype, viability, doubling time, as well as the states of stress and drug responses. Morphological evaluation of cells is widely employed in basic research, drug discovery, in-process control and release testing for cell manufacturing and cell banks for cell-based therapeutic products.

Therefore, it is desired to establish a common understanding of definitions and formulae regarding cell morphological descriptors in which specialists in research and business fields can refer to and compare information, within an institution, and with other interested parties.

The current situation is that characteristics of cell morphology obtained from microscopic images are frequently described qualitatively in expressions such as "unevenness around", "elongated", "rounded". Even when cell morphological descriptors characterizing the morphology of the cell are measured and quantified from the cell image, these cell morphological descriptors are not consistently used.

This document allows to check whether the numerical values assigned as cell morphological descriptors are calculated by an appropriate method, and to improve the reliability of the measured value and the evaluation result. It is expected that the "common language of definitions and mathematical formulae" based on this document will enable the accumulation of more reliable data, and such language will provide a basis for assessment whether individually acquired data can be quantitatively compared to each other.

This document is intended primarily for users, both in academia and industry, who evaluate cell characteristics. However, it can also be referred to by suppliers of tools such as microscopes, image processing devices, and software, suppliers of database that handle information on cell morphology and users who write scientific papers regarding cell morphology.

1 Scope

This document provides general requirements for cell morphometry to quantify cell morphological features including cell shape, size and texture.

This document addresses aspects of cell image capture using optical microscopy and image processing for morphometry.

This document does not address the statistics associated with a morphological analysis of a cellular sample.

This document also gives terms and definitions corresponding to cell morphological descriptors, and lists examples and their formulae, that represent quantitative cellular morphological features for evaluation of cell morphology in cell analysis.

This document primarily applies to morphological analysis of cultured mammalian cells.

This document is not intended for imaging used in clinical diagnostics.

2 Normative references

3 Terms and definitions

4 Abbreviations

5 General Concept

5.1 Cell morphometry

5.2 Steps for cell morphometry

6 Target of interest (TOI)

7 Image capture

7.1 Microscopic observation method

7.2 Microscope system and its settings

7.3 Execution of image capture

8 Segmentation of the TOI

9 Quantification

9.1 General

9.2 Procedure to quantify morphological features of segmented object

10 Qualification of Measurement

11 Reporting

11.1 General

11.2 Reporting of sample properties and sample preparation

11.3 Reporting of the microscopic observation method

11.4 Reporting of the image data, image pre-processing, and image analysis for morphometric analysis

11.5 Reporting of the morphological features for morphometric analysis

Bibliography

BS ISO 24479:2024

Biotechnology. Cellular morphological analysis. General requirements and considerations for cell morphometry to quantify cell morphological features

Current

Published:

31 Oct 2024