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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
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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
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The procedures used to develop this document and those intended for its further maintenance are described
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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
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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 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 in
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