ISO 8472-1:2024

International
Standard
ISO 8472-1
First edition
Biotechnology — Data
2024-07
interoperability for stem cell data —
Part 1:
Framework
Biotechnologie — Interopérabilité des données associées à des
cellules souches —
Partie 1: Cadre
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 .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Interoperability requirements and recommendations for stem cell data . 4
4.1 General .4
4.2 Characteristics.5
4.3 Technologies .5
4.4 Ethics .5
4.5 Security .5
4.6 Regulation .5
4.7 Risk .6
4.8 Data searchability .6
4.9 Data accessibility .6
4.10 Data usability .6
5 Framework for interoperable systems based on existing architectures . 6
5.1 Context for interoperability within and between systems.6
5.2 General description .6
5.3 Interoperability of entries .6
5.4 Flexibility of interoperability .6
Annex A (informative) Document(s) or scheme for data sharing and data exchange . 7
Annex B (informative) Database list as example(s) . 9
Bibliography .10

iii
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.

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 handling and data exchange carry hidden costs for persons and the organizations
who are impacted by such data. Most people lack agency when it comes to the data that they generate. 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 data sets is unrealized.
Stem cell research using human embryonic stem cells (hESC), as well as induced pluripotent stem cells (iPSC)
or tissue stem cells, is conducted within ethical and regulatory governance frameworks, which can be highly
variable between countries. Stem cells offer unique opportunities to develop therapies for a wide variety of
currently intractable conditions. 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. Furthermore, stem cell research has now reached the stage of clinical
testing, with hESC and iPSC–based clinical trials commencing. Moreover, projects provide important ‘proof
of concept’ data for the use of pluripotent stem cell- and tissue stem cell - based therapies in regenerative
medicine. Finally, stem cells are becoming a key tool for in vitro disease and tissue modelling, drug and
toxicity screening for utilization in the pharma-, chemical-, environmental- and other industries.
In the past decades, research, clinical trials, and industrial developments have greatly increased in scope,
diversity and breadth. Moreover, in recent years, many stem cell biobanks have been established. Cross-
sector collaborations between academic research institutes, enterprises, governments, industries, etc. [such
as Chinese Alliance for Stem Cell Resource Centers, European bank for induced pluripotent stem cells (EBiSC),
human pluripotent stem cell registry (PSCreg), International alliance for biological standardization (IABS),
International stem cell banking initiative (ISCBI).] have been initiated. Presently, due to the increasing
amounts of data associated with stem cell biobanking, it is critical that common approaches to working with
data (such as data sharing, storage, analysis, etc.) are standardized. This requires a diverse community of
data providers, processors and data consumers to work together and exchange data under same structure
and framework. Data interoperability standards aim to help stakeholders and the people who create, manage
and use the data to address the shared research requirements and industrial/market needs.

v
International Standard ISO 8472-1:2024(en)
Biotechnology — Data interoperability for stem cell data —
Part 1:
Framework
1 Scope
This document specifies a framework for data interoperability of data systems, such as databases, data
management systems, web interfaces, API, etc. that manage stem cell data.
It is applicable to all human stem cell types. This document does not apply to other animal stem cells or plant
stem cells.
This document specifies considerations and requirements of stem cell data for data interoperability, such as
cell characteristics, applied technologies, ethical requirements, and data sharing, analysis, and accessibility.
This document describes an interoperable framework for stem cell data, which can be used for existing
systems or existing architectures.
The intended audiences for this document are data generators, implementors of IT infrastructure to handle
the data, data providers and data consumers.
2 Normative references
There are no normative references in this document.
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/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
interoperability
ability of systems to provide services to and accept services from other systems and to use the services so
exchanged to enable them to operate effectively together
[SOURCE: ISO 21007-1:2005, 2.30]
3.2
data interoperability
interoperability concerning the creation, meaning, computation, use, transfer, and exchange of data
[SOURCE: ISO/IEC 20944-1:2013, 3.21.12.4]

3.3
access
to obtain the use of a resource
[SOURCE: ISO/IEC 2382:2015, 2121274]
3.4
accessibility
ease of reaching and using a service or facility
[SOURCE: ISO 16439:2014, 3.3]
3.5
data access
process that enables users to retrieve or read published data
[SOURCE: ISO 5127:2017, 3.1.11.17]
3.6
operating system
software to control program operation and to provide the services for resource allocation, task scheduling,
I/O control, and data management
[SOURCE: ISO 16484-2:2004, 3.140]
3.7
application
software application program
software or a program that is specific to the solution of an application problem
[SOURCE: ISO/IEC 20944-1:2013, 3.6.3.1, modified — "application" added as the preferred term.]
3.8
database
collection of interrelated data stored together with controlled redundancy according to a schema to serve
one or more applications
[SOURCE: ISO/IEC 10027:1990, 3.3.11]
3.9
system schema structure
structure behind the scenes that computer systems access for timely and consistent service
3.10
metadata
data that define and describe other data
[SOURCE: ISO/IEC 11179-1:2023, 3.2.26]
3.11
hardware
all or part of the physical components of an information processing system
[SOURCE: ISO/IEC 2382:2015, 2121277]
3.12
software
all or part of the programs, procedures, rules, and associated documentation of an information
processing system
[SOURCE: ISO/IEC 2382:2015, 2121278, modified — Notes 1 to 3 to entry have been deleted.]

3.13
development language
computer programming language used to express the sequence of operations to be performed by a computer
[SOURCE: ISO/IEC/IEEE 24765:2017, 3.3034]
3.14
data provenance
data provenance record
record of the ultimate derivation and passage of a piece of data through its various owners or custodians
Note 1 to entry: A data provenance record can include information about creation, update, transcription, abstraction,
validation, and transferring ownership of data.
[SOURCE: ISO 8000-2:2022, 3.8.4, modified — "data provenance" added as the preferred term.]
3.15
raw data
data in its originally acquired, direct form from its source before subsequent processing
[SOURCE: ISO 5127:2017, 3.1.10.04]
3.16
data set
dataset
identifiable collection of data
3.17
data sharing
making data (numerical, textual, images, etc.) available to, and findable by, others
Note 1 to entry: Data is not truly shared, if it cannot be found.
3.18
data exchange
storing, accessing, transferring, and archiving of data
[SOURCE: ISO 10303-1:2021, 3.1.31]
3.19
data quality
assessment of the fitness of the data and information to serve its purpose in a given context
[SOURCE: ISO 23952:2020, 3.4.46]
3.20
IT infrastructure
design of an IT system
3.21
application programming interface
API
standard interface and set of function calls between application software and data access libraries of vehicle
navigation systems
[SOURCE: ISO 17267:2009, 2.4, modified – “in accordance with this international standard” was deleted
from term.]
3.22
stem cell
non-specialized cells with the capacity for self-renewal and differentiation potential, which can differentiate
into one or more different types of specialized cells
Note 1 to entry: Most adult stem cells are multipotent stem cells.
[SOURCE: ISO/TS 22859:2022, 3.24]
4 Interoperability requirements and recommendations for stem cell data
4.1 General
4.1.1 The stem cel
...