National foreword

This British Standard is the UK implementation of ISO 8472‑2:2026.

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 28 February 2026.

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.

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.

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.

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

3 Terms and definitions

4 General key characteristics of stem cell data for data interoperability

5 Key characteristic of stem cell data

5.1 General

5.2 Cell morphology

5.3 Cell authentication

5.4 Cell viability

5.5 Cell markers

5.6 Chromosome karyotype

5.7 Membrane potential or field potential

5.8 Calcium flux

5.9 Contractility

5.10 Genetic stability

5.11 In vitro differentiation

5.12 Identify testing

5.13 Functional testing

5.14 Pharmacological action

5.15 Microorganisms

6 Extra information for stem cells

Bibliography

BS ISO 8472-2:2026

Biotechnology. Data interoperability for stem cell data - Key characteristics of stem cell data

Current

Published:

28 Feb 2026