ISO/TS 5118:2022

Health informatics — Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine

This document specifies the categorial structure within the field of TCMCPG application evaluation by defining a set of domain constraints of sanctioned characteristics each composed of a relationship. The development clinical practice guidelines is outside the scope of this document.

Informatique de santé — Structure catégorielle de représentation pour l'évaluation des lignes directrices de pratique clinique en médecine traditionnelle chinoise

General Information

• Status: Published
• Publication Date: 10-Jul-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: 11-Jul-2022
• Due Date: 12-Sep-2023
• Completion Date: 11-Jul-2022

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 5118
First edition
2022-07
Health informatics — Categorial
structure of representation for
evaluation of clinical practice
guidelines of traditional Chinese
medicine
Informatique de santé — Structure catégorielle de représentation
pour l'évaluation des lignes directrices de pratique clinique en
médecine traditionnelle chinoise
Reference number
ISO/TS 5118:2022(E)
© ISO 2022

---------------------- Page: 1 ----------------------
ISO/TS 5118:2022(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

---------------------- Page: 2 ----------------------
ISO/TS 5118:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Characterizing categories . 1
4 Categorial structure of TCMCPG evaluation . 5
4.1 Overview . 5
4.2 Semantic link . 5
4.2.1 is evaluated of . 5
4.2.2 is part of . 5
4.2.3 is manifested of . 6
4.2.4 is preceded by . 6
4.2.5 is based on . 6
4.2.6 according to . 6
Bibliography . 8
iii
© ISO 2022 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/TS 5118:2022(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 Technical Committee 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

---------------------- Page: 4 ----------------------
ISO/TS 5118:2022(E)
Introduction
Clinical practice guideline (CPG) is one of the important measures to improve the quality of medical
services and standardize of diagnosis and treatment. The evaluation of clinical practice guidelines
for biomedicine has been shown to be useful. The appraisal of guidelines for research and evaluation
(AGREE) tool was published in 2003 and upgraded in 2009, which includes 23 items and covers six
quality assessment areas. It is widely used for the quality assessment of clinical practice guidelines.
However, AGREE doesn't cover the application evaluation of CPG.
Traditional Chinese medicine clinical practice guideline (TCMCPG) is mainly divided into consensus-
based guideline and evidence-based guideline. Consensus guideline is the main body of TCM Clinical
practice guidelines and evidence-based guideline is still in its infancy. Out of the 527 TCM and
acupuncture clinical practice guidelines/consensuses issued by December 2019, 403 (76,47 %) were
based on the expert consensus approach and 124 (23,53 %) were based on the evidence-based guide-
making approach. Different from evidence-based guidelines of biomedicine, the clinical promotion and
application effects of a large number of expert consensus-based guidelines need to be evaluated.
Furthermore, the application evaluation of the guidelines is an indispensable basic work, which is
different from the evaluation of the quality of guideline. No unified semantic information framework
exists in the application evaluation of TCMCPG, which affects the data exchange and sharing among
different institutions and databases. From the perspective of categorical structure, an overall
framework involving the whole process of application evaluation of the guidelines is needed so that the
exchange and utilization of data can be more convenient. Categorical structure of application evaluation
of TCMCPG is an essential part among this process. This document was developed to standardize the
effect of application evaluation of CPG in order to promote the implementation, popularization, further
revision and perfection of TCMCPG.
To sum up, evaluating the application effect of clinical practice guidelines can provide a basis for the
implementation, promotion and revision of the guidelines, which can promote the application effect of
TCMCPG and is beneficial to developers and practitioners of clinical guidelines. The establishment of a
unified categorial structure for the application evaluation of TCMCPG is necessary, which will greatly
improve the effect of the application evaluation of TCMCPG, establish a communication platform for the
research of TCMCPG, and lay a solid foundation for future sharing and utilization.
v
© ISO 2022 – All rights reserved

---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 5118:2022(E)
Health informatics — Categorial structure of
representation for evaluation of clinical practice
guidelines of traditional Chinese medicine
1 Scope
This document specifies the categorial structure within the field of TCMCPG application evaluation by
defining a set of domain constraints of sanctioned characteristics each composed of a relationship.
The development clinical practice guidelines is 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 General terms
3.1.1
concept
general notion or idea of something
[SOURCE: ISO/TS 18876-1:2003, 3.1.3]
3.1.2
relationship
association between two or more entities that is significant for some intended purpose
Note 1 to entry: Can also be known as an association when the information model is based upon object classes.
[SOURCE: ISO 19440:2020, 3.64, modified — Note to entry added.]
3.2 Characterizing categories
3.2.1
traditional Chinese medicine clinical practice guidelines
TCMCPG
set of systematically developed statements to assist the decisions made by healthcare actors of TCM
about healthcare activities performed with regard to specified health issues
1
© ISO 2022 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/TS 5118:2022(E)
3.2.2
evaluation
action that assesses the value of traditional Chinese medicine clinical practice guidelines
Note 1 to entry: The rationality and accuracy of the contents of the guidelines and developing method, the
coordination of guidelines and clinical practice.
Note 2 to entry: The application effect and the application conformity of the guidelines.
3.2.3
applicability evaluation
internal characteristics of the guideline elements, the specific scope of the external environment and
the relationship between them
Note 1 to entry: The evaluation results determine whether a guideline should be used in whole or in part.
Note 2 to entry: It evaluates the applicability of
...

TECHNICAL ISO/TS
SPECIFICATION 5118
First edition
Health informatics — Categorial
structure of representation for
evaluation of clinical practice
guidelines of traditional Chinese
medicine
Informatique de santé — Structure catégorielle de représentation
pour l'évaluation des lignes directrices de pratique clinique en
médecine traditionnelle chinoise
PROOF/ÉPREUVE
Reference number
ISO/TS 5118:2022(E)
© ISO 2022

---------------------- Page: 1 ----------------------
ISO/TS 5118:2022(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 5118:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Characterizing categories . 1
4 Categorial structure of TCMCPG evaluation . 5
4.1 Overview . 5
4.2 Semantic link . 5
4.2.1 is evaluated of . 5
4.2.2 is part of . 6
4.2.3 is manifested of . 6
4.2.4 is preceded by . 6
4.2.5 is based on . 6
4.2.6 according to . 6
Bibliography . 8
iii
© ISO 2022 – All rights reserved PROOF/ÉPREUVE

---------------------- Page: 3 ----------------------
ISO/TS 5118:2022(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.
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
PROOF/ÉPREUVE © ISO 2022 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/TS 5118:2022(E)
Introduction
Clinical practice guideline (CPG) is one of the important measures to improve the quality of medical
services and standardize of diagnosis and treatment. The evaluation of clinical practice guidelines
for biomedicine has been shown to be useful. The appraisal of guidelines for research and evaluation
(AGREE) tool was published in 2003 and upgraded in 2009, which includes 23 items and covers six
quality assessment areas. It is widely used for the quality assessment of clinical practice guidelines.
However, AGREE doesn't cover the application evaluation of CPG.
Traditional Chinese medicine clinical practice guideline (TCMCPG) is mainly divided into consensus-
based guideline and evidence-based guideline. Consensus guideline is the main body of TCM Clinical
practice guidelines and evidence-based guideline is still in its infancy. Out of the 527 TCM and
acupuncture clinical practice guidelines/consensuses issued by December 2019, 403 (76,47 %) were
based on the expert consensus approach and 124 (23,53 %) were based on the evidence-based guide-
making approach. Different from evidence-based guidelines of biomedicine, the clinical promotion and
application effects of a large number of expert consensus-based guidelines need to be evaluated.
Furthermore, the application evaluation of the guidelines is an indispensable basic work, which is
different from the evaluation of the quality of guideline. No unified semantic information framework
exists in the application evaluation of TCMCPG, which affects the data exchange and sharing among
different institutions and databases. From the perspective of categorical structure, an overall
framework involving the whole process of application evaluation of the guidelines is needed so that the
exchange and utilization of data can be more convenient. Categorical structure of application evaluation
of TCMCPG is an essential part among this process. This document was developed to standardize the
effect of application evaluation of CPG in order to promote the implementation, popularization, further
revision and perfection of TCMCPG.
To sum up, evaluating the application effect of clinical practice guidelines can provide a basis for the
implementation, promotion and revision of the guidelines, which can promote the application effect of
TCMCPG and is beneficial to developers and practitioners of clinical guidelines. The establishment of a
unified categorial structure for the application evaluation of TCMCPG is necessary, which will greatly
improve the effect of the application evaluation of TCMCPG, establish a communication platform for the
research of TCMCPG, and lay a solid foundation for future sharing and utilization.
v
© ISO 2022 – All rights reserved PROOF/ÉPREUVE

---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 5118:2022(E)
Health informatics — Categorial structure of
representation for evaluation of clinical practice
guidelines of traditional Chinese medicine
1 Scope
This document specifies the categorial structure within the field of TCMCPG application evaluation by
defining a set of domain constraints of sanctioned characteristics each composed of a relationship.
The development clinical practice guidelines is 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 General terms
3.1.1
concept
general notion or idea of something
[SOURCE: ISO/TS 18876-1:2003, 3.1.3]
3.1.2
relationship
association between two or more entities that is significant for some intended purpose
Note 1 to entry: Can also be known as an association when the information model is based upon object classes.
[SOURCE: ISO 19440:2020, 3.64, modified — Note to entry added.]
3.2 Characterizing categories
3.2.1
traditional Chinese medicine clinical practice guidelines
TCMCPG
set of systematically developed statements to assist the decisions made by healthcare actors of TCM
about healthcare activities performed with regard to specified health issues
1
© ISO 2022 – All rights reserved PROOF/ÉPREUVE

---------------------- Page: 6 ----------------------
ISO/TS 5118:2022(E)
3.2.2
evaluation
action that assesses the value of clinical practice guidelines of traditional Chinese medicine
Note 1 to entry: The rationality and accuracy of the contents of the guidelines and developing method, the
coordination of guidelines and clinical practice.
Note 2 to entry: The application effect and the application conformity of the guidelines.
3.2.3
applicability evaluation
internal characteristics of the guideline elements, the specific scope of the external environment and
the relationship between them
Note 1 to entry: The evaluation results determine whether a guideline should be used in whole or in part.
Note 2 to entry: It evaluates the applicability of the guidelines from technical level, coordination, structure and
content, etc.
[SOURCE: Applicability evaluation tool of Medic
...

ISO/TS 5118:2022(E)
2022-04-20
ISO TC 215
Secretariat: ANSI
Health Informatics —
informatics — Categorial Structurestructure for Representationrepresentation for
Evaluationevaluation of Clinical Practice Guidelinesclinical practice guidelines in
Traditionaltraditional Chinese Medicinemedicine

---------------------- Page: 1 ----------------------
ISO/TS 5118:2022(E)



Publication

ii © ISO 2022 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 5118:2022(E)
© ISO 20142022
All rights reserved. Unless otherwise specified, 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
Case postale 56 •• CH-1211 Geneva 20
Tel.+ 41 22 749 01 11
Fax+ 41 22 749 09 47
[e-mail]
Webwww.iso.org
Published in Switzerland.
© ISO 2022 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/TS 5118:2022(E)
Contents
Foreword . 5iv
Introduction. 6v
1 Scope . 71
2 Normative references . 71
3 Terms and definitions . 71
4 List of authorized representation of relationships for TCM guideline evaluation . 126
Bibliography . 38
iv © ISO 2022 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/TS 5118:2022(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.
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.

© ISO 2022 – All rights reserved v

---------------------- Page: 5 ----------------------
ISO/TS 5118:2022(E)
Introduction
Clinical practice guideline (CPG) is one of the important measures to improve the quality of medical
services and standardize of diagnosis and treatment. The evaluation of clinical practice guidelines for
biomedicine has been relatively proven.shown to be useful. The appraisal of guidelines for research and
evaluation (AGREE) tool was published in 2003 and upgraded in 2009, which includes 23 items and
covers 6six quality assessment areas and be. It is widely used for the quality assessment of clinical
practice guidelines. ButHowever, AGREE doesn't cover the application evaluation of CPG.
Traditional Chinese Medicine Clinicalmedicine clinical practice guideline (TCMCPG) is mainly divided
into consensus-based guideline and evidence-based guideline. Consensus guideline is the main body of
TCM Clinical practice guidelines and evidence-based guideline is still in its infancy. OfOut of the 527 TCM
and acupuncture clinical practice guidelines/consensuses issued by December 2019, 403 (76.,47 %)
were based on the expert consensus approach, and 124 (23.,53 %) were based on the evidence-based
guide-making approach. Different from evidence-based guidelines of biomedicine, the clinical promotion
and application effects of a large number of expert consensus-based guidelines need to be evaluated.
Furthermore, the application evaluation of the guidelines is an indispensable basic work, which is
different from the evaluation of the quality of guideline. No unified semantic information framework
exists in the application evaluation of TCMCPG, which affects the data exchange and sharing among
different institutions and databases. From the perspective of categorical structure, an overall framework
involving the whole process of application evaluation of the guidelines is needed so that the exchange
and utilization of data can be more convenient. Categorical structure of application evaluation of TCMCPG
is an essential part among this process. This document was developed to standardize the effect of
application evaluation of CPG in order to promote the implementation, popularization, further revision
and perfection of TCMCPG.
To sum up, evaluating the application effect of clinical practice guidelines can provide a basis for the
implementation, promotion and revision of the guidelines, which can promote the application effect of
TCMCPG and is beneficial to developers and practitioners of clinical guidelines. The establishment of a
unified categorial structure for the application evaluation of TCMCPG is vitalnecessary, which will greatly
improve the effect of the application evaluation of TCMCPG, establish a communication platform for the
research of TCMCPG and international standards, and lay a solid foundation for future sharing and
utilization.
vi © ISO 2022 – All rights reserved

---------------------- Page: 6 ----------------------
ISO/TS 5118:2022(E)
Health Informaticsinformatics — Categorial structure for
representation of the evaluation of clinical practice
guidelines in traditional Chinese medicine
1 Scope
This documentspecifiesdocument specifies the categorial structure within the subject field of TCMCPG
application evaluation by defining a set of domain constraints of sanctioned characteristics each
composed of a relationship.
The development ofclinical practice guidelines is outside the guideline is outscope of this
scope.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 terminologicalterminology databases for use in standardization at the following
addresses:
— ISO Online browsing platform: http://www.iso.org/obpavailable at https://www.iso.org/obp
— IEC Electropedia: http://www.electropedia.org/available at https://www.electropedia.org/
3.1General
3.1 General terms
3.1.1
concept

internal conception of something; general notion or idea of something
[SOURCE: ISO/TS 18876-21:2003, 3.1.3]
3.1.2
relationship
association between two or more entities that is significant for some intended purpose
Note 1 to entry: Can also be known as an association when the information model is based upon object classes.
[SOURCE: ISO 19440:2020, 3.64, modified, note — Note to entry added].]
3.13.2 3.2CharacterizingCharacterizing categories
3.2.1
Clinical Practice Guidelines of Traditional3.2.1
© ISO 2022 – All rights reserved vii

---------------------- Page: 7 ----------------------
ISO/TS 5118:2022(E)
traditional Chinese Medicine
medicine clinical practice guidelines
TCMCPG
set of systematically developed statements to assist the decisions made by healthcare actors of TCM about
healthcare activities to be performed with regard to specified health issues
3.2.2
evaluation
action that assesses the value of clinical practice guidelines of TCMtraditional Chinese medicine
Note 1 to entry: theThe rationality and accuracy of the contents of the guidelines and developing method, the
coordination of guidelines and clinical practice.
Note 2 to entry: theThe application effect and the application conformity of the guidelines.
3.2.3
applicability evaluation
internal characteristics of the guideline elements, the specific scope of the external environment and the
relationship between them
Note 1 to entry: The evaluation results determine whether the guidelinesa guideline should be used in whole or in
part.
Note 2 to entry: It evaluates the applicability of the guidelines from technical level, coordination, structure and
content, etc.
[SOURCE: Applicability evaluation tool of Medical Guidelines (Guozuo Dengzi-, 2013-A00103587)]]
3.2.4
consistency evaluation
degree of implementation uniformity between CPGclinical practice guidelines and real clinical practice
scenarios in many conditions such as clinical diagnosis, syndrome differentiation, drug use
Note 1 to entry: whether there are tools Tools or other relevant resources to support the recommendations and
evaluation criteria for monitoring or auditing provided by the guidelines can improve consistency.
Note 2to 2 to entry:whether they describe the The promotion and impediment factors in the application
Note 3 to entry: whether they consider the relevant resources that may could be neededdescribed in the application
of recommendationsguideline.
Note 4 to entry: whether they provide evaluation criteria for monitoring or auditing.
3.2.5
technical level
accuracy, clarity and rigor of TCMclinical practice guidelines of traditional Chinese medicine clinical
practice guidelines in disease, syndrome diagnosis and suggestion of treatment
3.2.6
structure and contents
concrete clauses and details whichincluded in a TCMCPG should have traditional Chinese medicine
clinical practice guideline
3.2.7
coordination and matching
viii © ISO 2022 – All rights reserved

---------------------- Page: 8 ----------------------
ISO/TS 5118:2022(E)
not contradict or conflictconflicting with other standard documents, can enabling several documents to
be used in conjunction with each other
3.2.8
clarity
property of being clear, unambiguous and operable
Note 1 to entry: Different health problems and different choices have been listed clearly.
Note 2 to entry: The diagnostic points are accurate.
Note 3 to entry: The physical and chemical examinations are reasonable.
Note 4 to entry: The scope of application of the guidelines is clear.
3.2.9
preciseness
quality of being reproducible in amount or performance
Note 1 to entry: precisenessPreciseness can be shown in development, application and revision.
3.2.10
matching degree
degree of coordination and integration between the technical level of the guidelines and the hospital itself
3.2.11
normalization
imposition of standards or regulations
Note 1 to entry: Normalization is manifested in the process of making the guideline.
3.2.12
integrity

undivided or unbroken completeness or totality with nothing wanting in content and structure
Note 1 to entry: Integrity means the guidelines meets
...