ISO 8472-2:2026

International
Standard
ISO 8472-2
First edition
Biotechnology — Data
2026-02
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
Reference number
© ISO 2026
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ii
Contents Page
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 .4
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

iii
Foreword
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iv
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.

v
International Standard ISO 8472-2:2026(en)
Biotechnology — Data interoperability for stem cell data —
Part 2:
Key characteristics 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 o
...