ISO 8472-2

2025-08-20
ISO/DIS FDIS 8472-2:2024(en)
ISO/TC 276/WG 5
Secretariat: DIN
Date:
Biotechnology — Data interoperability for stem cell data —

Part 2:
Key characteristics of stem cell data
Biotechnologie — Interopérabilité des données associées à des cellules souches —
Partie 2: Caractéristiques clés des données associées à des cellules souches
FDIS stage
ISO/DIS FDIS 8472-2:2024(E2025(en)
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
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2024 2025 – All rights reserved
ii
ISO/DIS FDIS 8472-2:20242025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General key characteristics of stem cell data for data interoperability . 2
5 Key characteristic of stem cell data . 3
6 Extra information for stem cells . 5
Annex A (informative) Database list example(s) . 7
Bibliography . 8

Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General key characteristics of stem cell data for data interoperability . 2
5 Key characteristic of stem cell data . 3
5.1 General . 3
5.2 Cell morphology . 3
5.3 Cell authentication . 3
5.4 Cell viability . 3
5.5 Cell markers . 3
5.6 Chromosome karyotype . 4
5.7 Membrane potential or field potential . 4
5.8 Calcium flux . 4
5.9 Contractility . 4
5.10 Genetic stability . 4
5.11 In vitro differentiation . 4
5.12 Identify testing . 5
5.13 Functional testing . 5
5.14 Pharmacological action . 5
5.15 Microorganisms . 5
6 Extra information for stem cells . 5
Annex A (informative) Database list example(s) . 7
Bibliography . 8

© ISO 2025 – All rights reserved
iii
ISO/DIS FDIS 8472-2:2024(E2025(en)
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.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.htmlwww.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
A list of all parts in the ISO 8472 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.
Field Code Changed
iv © ISO 2024 2025 – All rights reserved
iv
ISO/DIS FDIS 8472-2:20242025(en)
Introduction
Data interoperability addresses the ability of systems and services that create, exchange and consume data to
have clear, shared expectations for the contents, context and meaning of that data.
One-off approaches to data carry hidden costs felt by people and the organizations who are impacted by such
data. Most people lack experience or technical support when it comes to the data generated about them. Many
organizations lack access to the data within their own firewalls. The value of the insights gained from such
data is limited because the real potential of such datasets is unknowable.
Stem cell research using human embryonic stem cells, as well as other induced and adult stem cells, within
strong ethical and regulatory governance frameworks in various countries. Within this field, it has been
recognised that it is premature to focus on any one stem cell type, and that research across a broad front is
important to moving the entire field towards application and clinical impact. Stem cell research has reached
to a new level. For example, human embryonic stem cell research has now reached the stage of clinical testing,
with clinical trials commencing or soon to start that can provide important ‘proof of concept’ for the use of
pluripotent stem cell-based therapies in delivering regenerative medicine.
In the past decades, many research projects, clinical trials, and industrial developments have been performed
successfully. In recent years, there are many stem cell biobanks establishing as well. Collaborations across
research institutes, enterprises, governments, industries, etc. (such as Chinese Alliance for Stem Cell Resource
Centers, EBiSC, hPSCreg, IABS, ISCBI etc.). Stem cell research offers unique opportunities to develop therapies
for a wide variety of currently untreatable conditions. But right now, due to the increasing data and stem cell
biobanking, it is critical that common clean approaches to working with data (such as data sharing, storage,
analysis, etc.) are standardized. This requires a diverse community of vendors, customers and practitioners to
work together and exchange under the same structure and framework. Data interoperability standards can
help stakeholders and people who create, manage and use the data to address the shared needs and
industrial/market needs.
© ISO 2025 – All rights reserved
v
ISO/FDIS 8472-2:2025(en)
Biotechnology — Data interoperability for stem cell data —

Part 2:
Key characteristiccharacteristics of stem cell data
1 Scope
This document specifies the key characteristics of stem cell data for data interoperability of stem cell data
systems, which includes several biological characteristics, safety, stability, efficacy, etc.
This document is applicable to stem cell database developers, stem cell data/system users, those who are
generating, sending, receiving or sharing stem cell data, as well as information technology specialists focussing
on system design or maintenance.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 20691, Biotechnology — Requirements for data formatting and description in the life sciences
ISO  8472--1, Biotechnology — Data interoperability for stem cell data — Part 1: Framework
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/https://www.ele
...