ISO 24479:2024
(Main)Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features
Biotechnology — Cellular morphological analysis — General requirements and considerations for cell morphometry to quantify cell morphological features
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.
Biotechnologie — Analyse morphologique cellulaire — Exigences générales et considérations pour la morphométrie cellulaire afin de quantifier les caractéristiques morphologiques des cellules
General Information
Standards Content (Sample)
International
Standard
ISO 24479
First edition
Biotechnology — Cellular
2024-10
morphological analysis — General
requirements and considerations
for cell morphometry to quantify
cell morphological features
Biotechnologie — Analyse morphologique cellulaire — Exigences
générales et considérations pour la morphométrie cellulaire afin
de quantifier les caractéristiques morphologiques des cellules
Reference number
© ISO 2024
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
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 4
5 General Concept . 5
5.1 Cell morphometry .5
5.2 Steps for cell morphometry .5
6 Target of interest (TOI) . 5
7 Image capture . 6
7.1 Microscopic observation method . .6
7.1.1 General .6
7.1.2 Cell properties to be observed .7
7.1.3 Sample preparation .7
7.2 Microscope system and its settings .9
7.2.1 General .9
7.2.2 Light source .11
7.2.3 Objective lens and condenser lens .11
7.2.4 Components in optical path .11
7.2.5 Image capture device . 12
7.2.6 Image data . 12
7.2.7 Environmental conditions . 12
7.2.8 Observing position . 12
7.2.9 Image capturing conditions . 13
7.3 Execution of image capture . 13
7.3.1 Single image capture. 13
7.3.2 Multiple image capture . 13
8 Segmentation of the TOI .13
9 Quantification . 14
9.1 General .14
9.2 Procedure to quantify morphological features of segmented object .14
10 Qualification of Measurement . 14
11 Reporting .15
11.1 General . 15
11.2 Reporting of sample properties and sample preparation . 15
11.3 Reporting of the microscopic observation method . 15
11.4 Reporting of the image data, image pre-processing, and image analysis for
morphometric analysis .16
11.5 Reporting of the morphological features for morphometric analysis .17
Annex A (informative) Check sheet regarding selection of contrast-enhancing techniques for
optical microscopy .18
Annex B (informative) Check sheet regarding selection of microscope system .20
Annex C (informative) List of cell morphological descriptors, definitions and formulae for cell
shape, size .21
Annex D (informative) List of cell morphological descriptors, definitions and formulae for cell
texture .29
iii
Annex E (informative) Points to consider when acquiring phase-contrast images of cells
suitable for image analysis .34
Bibliography .43
iv
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).
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.
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.
v
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.