ISO/PRF TS 5568

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

Titre manque

General Information

• Status: Not Published
• 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: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Completion Date: 25-Aug-2022

Standards Content (sample)

ISO/TS 5568:2022(E) Style Definition: Normal: Font: (Asian) Japanese, Line
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2022-08-24
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ISO /TC 215 Style Definition: Heading 2: Font: Bold, Tab stops: Not at
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Health Informatics —informatics — Traditional Chinese medicine labelling—

Labelling metadata of human biological sample information Style Definition: zzCopyright

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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

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utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or

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posting on the internet or an intranet, without prior written permission. Permission can be requested

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from either ISO at the address below or ISO's member body in the country of the requester.

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ISO copyright office
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Contents
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ISO TS 5568

Foreword .......................................................................................................................................................................... 4 Formatted: Don't adjust space between Latin and Asian text,

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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)
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ISO/DTS 5568:2022(E)
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Foreword
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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.
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The committee responsible for this document is ISO/TC 215.
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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.
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© ISO 2022 – All rights reserved v
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ISO/DTS 5568:2022(E)
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Introduction
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between Asian text and numbers

Biobanks play an integral role in research and precision medicine by acquiring, processing, storing, and

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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

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can be utilized in Europe and USAthe US. The construction of bio-sample databases for traditional Chinese

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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
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- — improve the completeness, accuracy and safety of clinical information labelling of TCM biological

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samples,
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- — establish a communication platform for basic research and clinical research of TCM, and

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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

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and promote the modernization of TCM.
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This document defines the metadata within the field of TCM sample labelling to address these problems.

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vi © ISO 2022 – All rights reserved
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TECHNICAL SPECIFICATION ISO/DTS 5568:2022(E)
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Health Informatics —traditionalinformatics — Traditional Chinese medicine
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labelling— Labelling metadata of human biological sample information single, No page break before

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1 Scope
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This document provides the definition ofdefines the metadata elements to accurately and consistency

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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

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usedapplicable for bioinformatics labelling of biological samples. Human biological samples obtained to

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support the clinical application of biomedical products of human origin are outoutside the scope of this

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scopedocument.
numbers
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2 Normative references
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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

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references, the latest edition of the referenced document (including any amendments) applies.

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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
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For the purposes of this document, the following terms and definitions apply.
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ISO and IEC maintain terminologicalterminology databases for use in standardization at the following

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addresses:
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— ISO Online browsing platform: available at http://www.iso.org/obphttps://www.iso.org/obp Formatted: Font: (Default) Cambria, 11 pt

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— IEC Electropedia: available at http://www.electropedia.org/https://www.electropedia.org/

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3.1
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metadata Formatted
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data that defines and describes other data
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[SOURCE: ISO/IEC 11179--1:2015, 3.2.16]
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3.2
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dataset
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identifiable collection of data
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[SOURCE: ISO 19115-1:2014, 4.3, modified note— Note to entry removed].]
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biological sample
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specimen
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discrete portion of a body fluid (e.g. blood, urine, saliva), breath, hair or tissue taken from the human

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body, which is assumed to represent the whole patient, to support the assessment, diagnosis, treatment,

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mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms.

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© ISO 2022 – All rights reserved 1
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ISO/DTS 5568:2022(E)
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Note 1 to entry: Human biological samples obtained to support the clinical application of biomedical products of

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human origin are out of this scope.
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[SOURCE: ISO/TS 22583:2019, 3.13, modified, “for POCT” removed, added “to support the assessment, ...

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diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its

...
symptoms,” original notes removed, Note 1 to entry added]
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3.4
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biological sample bank
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biobank
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legal entity or part of a legal entity that performs biobanking (3.12)
...
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Note 1 to entry: Biobanking means process of acquisitioning and storing, together with some or all of the

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activities related to collection, preparation, preservation, testing, analysing and distributing defined

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biological material as well as related information and data
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Formatted

[SOURCE: ISO 20387:2018, 3.5, modified preferred— Preferred term changed to “"biological sample ...

bank,” note added]".]
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3.5
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clinical information
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information about a person, relevant to his or hertheir health or healthcare
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3.6 Formatted
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labelling
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process of applying a classification, name or data to describe a sample
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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

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comprehensive labelling is beneficial for identifcationidentification, use, storage and retrievalofretrieval of samples.

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3.7
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traditional Chinese medicine
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TCM ...

traditional medicine that originated in china, and is characterized by holism and treatment based on Formatted

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pattern identification/syndrome differentiation
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[SOURCE: ISO/TS 17948:2014, 2.2]
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3.8
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metadata element
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resource property name that can be used in metadata and that can be given a value ...

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Note 1 to entry: A metadata element is referred to as metadata attribute in other communities.

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[SOURCE: ISO 24622-1:2015, 2.12], modified — Example deleted.]
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3.9 Formatted
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metadata entity
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set of metadata elements (3.8) describing the same aspect of data
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2 © ISO 2022 – All rights reserved
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ISO/DTS 5568:2022(E)
Note 1 to entry: Can contain one or more metadata entities.
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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
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3.10
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metadata section
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subset of metadata (3.1) which consists of a collection of related metadata entities (3.9) and metadata

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elements (3.8)
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Form
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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
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

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.
PROOF/ÉPREUVE © ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
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.
© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 5 ----------------------
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".]

© ISO 2022 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 6 ----------------------
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
...