ISO/TS 5568:2022

Health informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information

This document defines the metadata elements to accurately and consistency label clinical information in traditional Chinese medicine human biological samples. Animal biological samples are outside the scope of this document. This document is not applicable for bioinformatics labelling of biological samples. Human biological samples obtained to support the clinical application of biomedical products of human origin are outside the scope of this document.

Informatique de santé — Médecine traditionnelle chinoise — Étiquetage de métadonnées des informations relatives aux échantillons biologiques humains

General Information

• Status: Published
• Publication Date: 02-Nov-2022
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 03-Nov-2022
• Due Date: 31-Aug-2023
• Completion Date: 03-Nov-2022

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 5568
First edition
2022-11
Health informatics — Traditional
Chinese medicine — Labelling
metadata of human biological sample
information
Reference number
ISO/TS 5568:2022(E)
© ISO 2022

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ISO/TS 5568:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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ISO/TS 5568:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Structure . 3
5 Standard table of traditional Chinese medicine labelling metadata of human
biological sample information .3
6 Element dictionary . 5
6.1 General . 5
6.2 Sample information Labelling . . 5
6.2.1 Demographic information . 5
6.2.2 Basic information. 5
6.2.3 Collecting and distribution information . 5
6.2.4 Storage information . . 6
6.3 Clinical information labelling . 7
6.3.1 Medical history . 7
6.3.2 Observation information. 7
6.3.3 Diagnosis of diseases and syndromes in TCM . 7
6.3.4 Biomedicine diagnosis. 8
6.3.5 Intervention methods . 8
Bibliography . 9
iii
© ISO 2022 – All rights reserved

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ISO/TS 5568:2022(E)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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 215, Health informatics, in collaboration
with ISO/TC 249, Traditional Chinese medicine.
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
  © ISO 2022 – All rights reserved

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ISO/TS 5568:2022(E)
Introduction
Biobanks play an integral role in research and precision medicine by acquiring, processing, storing,
and distributing high-quality, clinically annotated biological material. There are a lot of mature
biobanks that can be utilized in Europe and the US. The construction of bio-sample databases for
traditional Chinese medicine (TCM) is still evolving. Such databases imitate the labelling methods
used in biomedicine samples. Information loss and ambiguity is unavoidable in these systems because
of inconsistent content of labelling information for samples. For example, loss of TCM syndrome and
physique information. There is no unified semantic information framework for labelling sample
information, especially for clinical information of bio-samples in the TCM field. This lack of framework
affects the effectiveness, safety and efficiency of data exchange and sharing between different
organizations and databases and researchers.
The establishment of a unified semantic classification framework for clinical information labelling of
TCM biological samples will greatly
— improve the completeness, accuracy and safety of clinical information labelling of TCM biological
samples,
— establish a communication platform for basic research and clinical research of TCM, and
— lay a solid foundation for future information sharing and use.
At the same time, it can enhance the level of international scientific and technological cooperation of
TCM and promote the modernization of TCM.
v
© ISO 2022 – All rights reserved

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TECHNICAL SPECIFICATION ISO/TS 5568:2022(E)
Health informatics — Traditional Chinese medicine
— Labelling metadata of human biological sample
information
1 Scope
This document defines the metadata elements to accurately and consistency label clinical information
in traditional Chinese medicine human biological samples.
Animal biological samples are outside the scope of this document. This document is not applicable
for bioinformatics labelling of biological samples. Human biological samples obtained to support the
clinical application of biomedical products of human origin are outside the scope of this document.
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
metadata
data that defines and describes other data
[SOURCE: ISO/IEC 11179-1:2015, 3.2.16]
3.2
dataset
identifiable collection of data
[SOURCE: ISO 19115-1:2014, 4.3, modified — Note to entry removed.]
3.3
biological sample
specimen
discrete portion of a body fluid (e.g. blood, urine, saliva), breath, hair or tissue taken from the human
body, which is assumed to represent the whole patient, to support the assessment, diagnosis, treatment,
mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms.
Note 1 to entry: Human biological samples obtained to support the clinical application of biomedical products of
human origin are out of this scope.
3.4
biological sample bank
biobank
legal entity or part of a legal entity that performs biobanking (3.12)
[SOURCE: ISO 20387:2018, 3.5, modified — Preferred term changed to "biological sample bank".]
1
© ISO 2022 – All rights reserved

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ISO/TS 5568:2022(E)
3.5
clinical information
information about a person relevant to their health or healthcare
3.6
labelling
process of applying a classification, name or data to describe a sample
Note 1 to entry: Labelling of information includes health information, disease information and treatment
information of samples related to traditional Chinese medicine. Accurate and comprehensive
...

ISO/TS 5568:2022(E) Style Definition: Normal: Font: (Asian) Japanese, Line
spacing: At least 12 pt
Style Definition: Heading 1: Font color: Auto, Indent: Left:
2022-08-24
0 pt, First line: 0 pt, Tab stops: 20 pt, Left + Not at 21.6 pt
ISO /TC 215 Style Definition: Heading 2: Font: Bold, Tab stops: Not at
18 pt
Secretariat: ANSI Style Definition: Heading 3: Font: 11 pt, Bold, (Asian)
Japanese, Left, Space Before: 3 pt, After: 12 pt, Line
spacing: Exactly 11.5 pt, Don't keep lines together, Don't
hyphenate, Tab stops: 44 pt, Left
Health Informatics —informatics — Traditional Chinese medicine labelling—
Labelling metadata of human biological sample information Style Definition: zzCopyright
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spacing: At least 12 pt

Style Definition: Footer: Font: (Asian) Japanese, Line
spacing: At least 12 pt
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English (United Kingdom), Line spacing: At least 11 pt, Tab

stops: 48.25 pt, Left + Not at 48 pt
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Style Definition: Body Text: Tab stops: 19.85 pt, Left +
Publication stage
39.7 pt, Left + 59.55 pt, Left + 79.4 pt, Left + 99.25 pt, Left
+ 119.05 pt, Left + 138.9 pt, Left + 158.75 pt, Left +
178.6 pt, Left + 198.45 pt, Left

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39.7 pt, Left + 59.55 pt, Left + 79.4 pt, Left + 99.25 pt, Left
+ 119.05 pt, Left + 138.9 pt, Left + 158.75 pt, Left +
178.6 pt, Left + 198.45 pt, Left
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© ISO 20142022
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All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or
Formatted: Border: Top: (No border), Left: (No border),
utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or
Right: (No border)
posting on the internet or an intranet, without prior written permission. Permission can be requested
Formatted: std_publisher, Font: Cambria, Font color: Blue
from either ISO at the address below or ISO's member body in the country of the requester.
Formatted: Font: Cambria, Font color: Blue
ISO copyright office
Case postale 56 •• CH-1211 Geneva 20 Formatted: Font: Cambria, Font color: Blue
Tel.+ 41 22 749 01 11 Formatted: Font: Cambria, Font color: Blue, English (United
Kingdom)
Fax+ 41 22 749 09 47
[e-mail]
Webwww.iso.org
Published in Switzerland.







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Contents
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ISO TS 5568

Foreword . 4 Formatted: Don't adjust space between Latin and Asian text,
Don't adjust space between Asian text and numbers
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Structure . 8
5 Standard table of traditional Chinese medicine labelling metadata of human biological sample
information . 9
6 Element dictionary . 11
Bibliography . 16 Formatted: Hyperlink, Font: Cambria, 11 pt, Bold, English
(United Kingdom)
Formatted: Font: Cambria

Formatted: TOC 1, Don't adjust space between Latin and
Asian text, Don't adjust space between Asian text and
numbers, Tab stops: 487.1 pt, Right,Leader: …
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ISO/DTS 5568:2022(E)
Formatted: Font: Cambria
Foreword
Formatted: Foreword Title, Don't adjust space between Latin
and Asian text, Don't adjust space between Asian text and
ISO (the International Organization for Standardization) is a worldwide federation of national standards
numbers
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. Formatted: Font: Cambria
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 Formatted: Font: (Default) Cambria
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2.www.iso.org/directives (see www.iso.org/directives). Formatted: Font: Cambria
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received.www.iso.org/patents (see www.iso.org/patents). Formatted: Font: Cambria
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement. Formatted: Font: Cambria
For an explanation onof the voluntary nature of standards, the meaning of ISO specific terms and Formatted: Font: Cambria
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 the following URL: Formatted: Font: Cambria
Foreword - Supplementary informationwww.iso.org/iso/foreword.html.
Formatted: Font: Cambria
Formatted: Font: Cambria
The committee responsible for this document is ISO/TC 215.
Formatted: Font: Cambria
iv © ISO 2022 – All rights reserved

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ISO/DTS 5568:2022(E)
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with ISO/TC 249, Traditional Chinese medicine.
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.
Formatted: Font: Cambria
Formatted: Foreword Text, Don't adjust space between Latin
and Asian text, Don't adjust space between Asian text and
numbers
© ISO 2022 – All rights reserved v

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ISO/DTS 5568:2022(E)
Formatted: Intro Title, Space Before: 0 pt, Don't adjust
Introduction
space between Latin and Asian text, Don't adjust space
between Asian text and numbers
Biobanks play an integral role in research and precision medicine by acquiring, processing, storing, and
Formatted: Body Text, Don't adjust space between Latin and
Asian text, Don't adjust space between Asian text and
distributing high-quality, clinically annotated biological material. There are a lot of mature biobanks that
numbers
can be utilized in Europe and USAthe US. The construction of bio-sample databases for traditional Chinese
Formatted: Font: (Default) Cambria
medicine (TCM) is still evolving. Such databases imitate the labelling methods used in biomedicine
samples. Information loss and ambiguity is unavoidable in these systems because of inconsistent content Formatted: Font: (Default) Cambria
of labelling information for samples. For example, loss of TCM syndrome and physique information. There
is no unified semantic information framework for labelling sample information, especially for clinical
information of bio-samples in the TCM field. This lack of framework affects the effectiveness, safety and
efficiency of data exchange and sharing between different organizations and databases and researchers.
While related western medical biological sample information base was built 30 years ago, which is
experienced in the labelling of biological samples and formed a relatively perfect labelling framework.
Especially, the standards for collecting, preserving, transporting and destroying physical samples,
including organ tissues and body fluids, tends to be mature.
The establishment of a unified semantic classification framework for clinical information labelling of TCM Formatted: Font: (Default) Cambria
biological samples will greatly
Formatted: Body Text, Don't adjust space between Latin and
Asian text, Don't adjust space between Asian text and
- — improve the completeness, accuracy and safety of clinical information labelling of TCM biological
numbers
samples,
Formatted: Font: Cambria
Formatted: List Continue 1, No bullets or numbering, Don't
- — establish a communication platform for basic research and clinical research of TCM, and
adjust space between Latin and Asian text, Don't adjust space
between Asian text and numbers, Tab stops: 19.85 pt, Left +
39.7 pt, Left + 59.55 pt, Left + 79.4 pt, Left + 99.25 pt, Left
- — lay a solid foundation for future information sharing and use.
+ 119.05 pt, Left + 138.9 pt, Left + 158.75 pt, Left +
178.6 pt, Left + 198.45 pt, Left
At the same time, it can enhance the level of international scientific and technological cooperation of TCM
Formatted: Font: Cambria
and promote the modernization of TCM.
Formatted: Font: Cambria
This document defines the metadata within the field of TCM sample labelling to address these problems.
Formatted: Font: Cambria
Formatted: Font: Cambria

Formatted: Font: Cambria
Formatted: Font: Cambria
Formatted: Body Text, Don't adjust space between Latin and
Asian text, Don't adjust space between Asian text and
numbers
vi © ISO 2022 – All rights reserved

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TECHNICAL SPECIFICATION ISO/DTS 5568:2022(E)

Formatted: Font: Cambria, 11 pt
Health Informatics —traditionalinformatics — Traditional Chinese medicine
Formatted: zzSTDTitle, Space After: 0 pt, Line spacing:
labelling— Labelling metadata of human biological sample information single, No page break before
Formatted
...
Formatted: Different first page header
1 Scope
Formatted: Font: Cambria
This document provides the definition ofdefines the metadata elements to accurately and consistency
Formatted: No bullets or numbering, Don't adjust space
between Latin and Asian text, Don't adjust space between
label clinical information in traditional Chinese medicine human biological samples.
Asian text and numbers
Animal biological samples are outoutside the scope of this scopedocument. This document is not
Formatted
...
usedapplicable for bioinformatics labelling of biological samples. Human biological samples obtained to
Formatted: Body Text, Don't adjust space between Latin and
support the clinical application of biomedical products of human origin are outoutside the scope of this
Asian text, Don't adjust space between Asian text and
scopedocument.
numbers
Formatted
...
2 Normative references
Formatted: Font: Cambria
Formatted: Don't adjust space between Latin and Asian text,
The following documents, in whole or in part, are normatively referenced in this document and are
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indispensable for its application. For dated references, only the edition cited applies. For undated
Formatted: Font: Cambria
references, the latest edition of the referenced document (including any amendments) applies.
Formatted: List Continue 1, Tab stops: 19.85 pt, Left +
39.7 pt, Left + 59.55 pt, Left + 79.4 pt, Left + 99.25 pt, Left
There are no normative references in this document.
+ 119.05 pt, Left + 138.9 pt, Left + 158.75 pt, Left +
178.6 pt, Left + 198.45 pt, Left
3 Terms and definitions Formatted: Font: Cambria
Formatted: Font: Cambria
For the purposes of this document, the following terms and definitions apply.
Formatted: Font: (Default) Cambria
ISO and IEC maintain terminologicalterminology databases for use in standardization at the following
Formatted: Font: Cambria
addresses:
Formatted: Font: Cambria, 11 pt
— ISO Online browsing platform: available at http://www.iso.org/obphttps://www.iso.org/obp Formatted: Font: (Default) Cambria, 11 pt
Formatted
...
— IEC Electropedia: available at http://www.electropedia.org/https://www.electropedia.org/
Formatted: Font: Cambria, 11 pt, Not Bold
Formatted: Font: (Default) Cambria
3.1
Formatted
.
metadata Formatted
...
data that defines and describes other data
Formatted: Font: Cambria, 11 pt
Formatted: Font: (Default) Cambria, 11 pt
[SOURCE: ISO/IEC 11179--1:2015, 3.2.16]
Formatted
...
Formatted: Font: Cambria, 11 pt, Not Bold
3.2
Formatted: Font: (Default) Cambria
dataset
Formatted
...
identifiable collection of data
Formatted
...
Formatted: Font: (Default) Cambria, 11 pt
[SOURCE: ISO 19115-1:2014, 4.3, modified note— Note to entry removed].]
Formatted
...
3.3 Formatted: Font: Cambria, 11 pt, Not Bold
biological sample
Formatted
...
specimen
Formatted: Font: Cambria, 11 pt, Not Bold
discrete portion of a body fluid (e.g. blood, urine, saliva), breath, hair or tissue taken from the human
Formatted: Font: (Default) Cambria
body, which is assumed to represent the whole patient, to support the assessment, diagnosis, treatment,
Formatted
...
mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms.
Formatted: Font: (Default) Cambria
© ISO 2022 – All rights reserved 1

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Formatted
...
Formatted
...
Formatted
...
ISO/DTS 5568:2022(E)
Formatted
...
Note 1 to entry: Human biological samples obtained to support the clinical application of biomedical products of
Formatted
...
human origin are out of this scope.
Formatted
...
Formatted
[SOURCE: ISO/TS 22583:2019, 3.13, modified, “for POCT” removed, added “to support the assessment, .
Formatted
diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its
...
symptoms,” original notes removed, Note 1 to entry added]
Formatted
...
Formatted
...
3.4
Formatted
...
biological sample bank
Formatted
...
biobank
Formatted
legal entity or part of a legal entity that performs biobanking (3.12)
...
Formatted
...
Note 1 to entry: Biobanking means process of acquisitioning and storing, together with some or all of the
Formatted
...
activities related to collection, preparation, preservation, testing, analysing and distributing defined
Formatted
...
biological material as well as related information and data
Formatted
...
Formatted
[SOURCE: ISO 20387:2018, 3.5, modified preferred— Preferred term changed to “"biological sample .
bank,” note added]".]
Formatted
...
Formatted
...
3.5
Formatted
...
clinical information
Formatted
...
information about a person, relevant to his or hertheir health or healthcare
Formatted
...
3.6 Formatted
...
labelling
Formatted
...
process of applying a classification, name or data to describe a sample
Formatted
...
Formatted
...
Note 1 to entry: In this document the labellingLabelling of information includes health information, disease
information and treatment information of samples related to TCM.traditional Chinese medicine. Accurate and Formatted
...
comprehensive labelling is beneficial for identifcationidentification, use, storage and retrievalofretrieval of samples.
Formatted
...
Formatted
...
3.7
Formatted
...
traditional Chinese medicine
Formatted
TCM .
traditional medicine that originated in china, and is characterized by holism and treatment based on Formatted
...
pattern identification/syndrome differentiation
Formatted
...
Formatted
...
[SOURCE: ISO/TS 17948:2014, 2.2]
Formatted
...
Formatted
.
Formatted
...

Formatted
...
Formatted
...
3.8
Formatted
...
metadata element
Formatted
resource property name that can be used in metadata and that can be given a value .
Formatted
...
Note 1 to entry: A metadata element is referred to as metadata attribute in other communities.
Formatted
...
Formatted
...
[SOURCE: ISO 24622-1:2015, 2.12], modified — Example deleted.]
Formatted
...
3.9 Formatted
...
metadata entity
Formatted
...
set of metadata elements (3.8) describing the same aspect of data
Formatted
...
Formatted
...
Formatted
...
2 © ISO 2022 – All rights reserved
Formatted
...
Formatted
...
Formatted
...

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Formatted: Right
ISO/DTS 5568:2022(E)
Note 1 to entry: Can contain one or more metadata entities.
Formatted: Note, Don't adjust space between Latin and Asian
text, Don't adjust space between Asian text and numbers, Tab
stops: 19.85 pt, Left + 39.7 pt, Left + 59.55 pt, Left + 79.4
Note 2 to entry: Equivalent to a class in UML terminology.
pt, Left + 99.25 pt, Left + 119.05 pt, Left + 138.9 pt, Left +
158.75 pt, Left + 178.6 pt, Left + 198.45 pt, Left
EXAMPLE sampleSample type;, sample test method
Formatted
...
[SOURCE: ISO 19115-1:2014, 4.12], modified — Example added.]
Formatted
...
Formatted: Source, Don't adjust space between Latin and
3.10
Asian text, Don't adjust space between Asian text and
metadata section
numbers
subset of metadata (3.1) which consists of a collection of related metadata entities (3.9) and metadata
Formatted: Font: (Default) Cambria, 11 pt
elements (3.8)
Formatted: TermNum, Space Before: 0 pt, Don't keep with
next, Don't adjust space between Latin and Asian text, Don't
Note 1 to entry: equivalent to a package in UML terminology.
adjust space between Asian text and numbers
Form
...

TECHNICAL ISO/TS
SPECIFICATION 5568
First edition
Health informatics — Traditional
Chinese medicine — Labelling
metadata of human biological sample
information
PROOF/ÉPREUVE
Reference number
ISO/TS 5568:2022(E)
© ISO/TS 2022

---------------------- Page: 1 ----------------------
ISO/TS 5568:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 5568:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Structure . 3
5 Standard table of traditional Chinese medicine labelling metadata of human
biological sample information .3
6 Element dictionary . 5
6.1 General . 5
6.2 Sample information Labelling . . 5
6.2.1 Demographic information . 5
6.2.2 Basic information. 5
6.2.3 Collecting and distribution information . 6
6.2.4 Storage information . . 6
6.3 Clinical information labelling . 7
6.3.1 Medical history . 7
6.3.2 Observation information. 7
6.3.3 Diagnosis of diseases and syndromes in TCM . 8
6.3.4 Biomedicine diagnosis. 8
6.3.5 Intervention methods . 8
Bibliography . 9
iii
© ISO 2022 – All rights reserved PROOF/ÉPREUVE

---------------------- Page: 3 ----------------------
ISO/TS 5568:2022(E)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
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on the ISO list of patent declarations received (see www.iso.org/patents).
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This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with ISO/TC 249, Traditional Chinese medicine.
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ISO/TS 5568:2022(E)
Introduction
Biobanks play an integral role in research and precision medicine by acquiring, processing, storing,
and distributing high-quality, clinically annotated biological material. There are a lot of mature
biobanks that can be utilized in Europe and the US. The construction of bio-sample databases for
traditional Chinese medicine (TCM) is still evolving. Such databases imitate the labelling methods
used in biomedicine samples. Information loss and ambiguity is unavoidable in these systems because
of inconsistent content of labelling information for samples. For example, loss of TCM syndrome and
physique information. There is no unified semantic information framework for labelling sample
information, especially for clinical information of bio-samples in the TCM field. This lack of framework
affects the effectiveness, safety and efficiency of data exchange and sharing between different
organizations and databases and researchers.
The establishment of a unified semantic classification framework for clinical information labelling of
TCM biological samples will greatly
— improve the completeness, accuracy and safety of clinical information labelling of TCM biological
samples,
— establish a communication platform for basic research and clinical research of TCM, and
— lay a solid foundation for future information sharing and use.
At the same time, it can enhance the level of international scientific and technological cooperation of
TCM and promote the modernization of TCM.
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TECHNICAL SPECIFICATION ISO/TS 5568:2022(E)
Health informatics — Traditional Chinese medicine
— Labelling metadata of human biological sample
information
1 Scope
This document defines the metadata elements to accurately and consistency label clinical information
in traditional Chinese medicine human biological samples.
Animal biological samples are outside the scope of this document. This document is not applicable
for bioinformatics labelling of biological samples. Human biological samples obtained to support the
clinical application of biomedical products of human origin are outside the scope of this document.
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
metadata
data that defines and describes other data
[SOURCE: ISO/IEC 11179-1:2015, 3.2.16]
3.2
dataset
identifiable collection of data
[SOURCE: ISO 19115-1:2014, 4.3, modified — Note to entry removed.]
3.3
biological sample
specimen
discrete portion of a body fluid (e.g. blood, urine, saliva), breath, hair or tissue taken from the human
body, which is assumed to represent the whole patient, to support the assessment, diagnosis, treatment,
mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms.
Note 1 to entry: Human biological samples obtained to support the clinical application of biomedical products of
human origin are out of this scope.
3.4
biological sample bank
biobank
legal entity or part of a legal entity that performs biobanking (3.12)
[SOURCE: ISO 20387:2018, 3.5, modified — Preferred term changed to "biological sample bank".]
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ISO/TS 5568:2022(E)
3.5
clinical information
information about a person relevant to their health or healthcare
3.6
labelling
process of applying a classification, name or data to describe a sample
Note 1 to entry: Labelling of information includes health information, disease
...