日前，中国中医科学院中医药信息研究所牵头研制的“健康信息学—针灸表达的语义分类结构—第6部分：针刺效应”由国际标准化组织(ISO)正式发布。

该标准详细定义了针刺效应的语义分类结构，通过定义特征类及其之间的语义连接，构成约束，来表达针刺效应概念体系，为针刺效应信息的计算机表达与处理提供了技术标准。

【资料图】

“针灸表达的语义分类结构”系列国际标准由6个部分组成，包括第1部分腧穴(Acupuncturepoints)、第2部分进针(Needling)、第3部分艾灸(Moxibustion)、第4部分经络(Meridianandcollateralchannels)、第5部分拔罐(Cupping)、第6部分针刺效应(Acupunctureeffects)，分别由中国、韩国、日本牵头完成，其中第2部分、第4部分和第6部分由我国牵头研制。

据了解，中国中医科学院中医药信息研究所多年来一直致力于中医药信息标准研究，其专家团队长期主导及参加中医药信息学领域的国际标准、国家标准及团体标准研制，在中医药信息标准领域具有较强的实力与国际知名度。截至目前，中国中医科学院中医药信息研究所主持研制并由ISO发布了10项国际标准，推动了中医药信息的国际传播和标准化工作，提高了我国在中医药信息化领域的国际话语权。

ISO/TS 16843-6:2022(en)

Health informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects

This document was prepared by Technical Committee ISO/TC215,Health informatics, in collaboration with Technical Committee ISO/TC249,Traditional Chinese medicine.

A list of all parts in the ISO16843 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at.

Introduction

Acupuncture therapy is being widely practiced in many countries. Acupuncture therapy is used to treat many diseases by regulating the physiological functions of the internal organs (zang-fu) and body systems. Stimulating the acupoints with an acupuncture needle or with electro acupuncture can directly or indirectly cause changes in organs, tissues, cells, molecules and other chemical substances, then affects physiological or pathological functions in human body or experimental animals. The effects of acupuncture can be measured by laboratory tests or clinical observations.

A large number of clinical research studies and animal experiments have been conducted to assess the mechanism of acupuncture therapy. However, the descriptions of acupuncture effects in clinical reports or experimental reports tend to be insufficient or inconsistent for interpretation of heterogeneity, thus causing difficulties in synthesizing data for analysis. This arises from two reasons:

a)An appropriate categorial structure for the acupuncture effect has not been formulated;

b)Semantic associations between the concepts of the acupuncture effect need to be made more explicit.

This document aims at solving these existing problems.

1Scope

This document specifies the categorial structure within the field of acupuncture effects by defining a set of domain constraints of sanctioned characteristics, each consisting of a semantic link and an applicable characterizing category.

2Normative references

There are no normative references in this document.

3Terms 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/obp

—IEC Electropedia: available at

3.1General

3.1.1

concept

unit of knowledge created by a unique combination of characteristics

Note 1 to entry:A concept can have one or more names. It can be represented using one or more terms, pictures, icons or sounds.

[SOURCE:ISO/TS 16843-2:2015, 3.1]

3.1.2

categorial structure

minimal set of domain constraints for representing concept systems in a subject field

[SOURCE:ISO 17115:2020, 3.1.1, modified]

3.1.3

category

division of sets of entities regarded as having particular shared characteristics

EXAMPLE:

Oral route, subcutaneous route and all other routes share characteristics particular to the category route.

Note 1 to entry:Categories can be more or less general. Where one category is subsumed by another, the "is a’ relation is asserted to obtain a hierarchy between the more specific or subsumed category and the more general or subsuming category. For example, parenteral route is more general than intravenous route.

[SOURCE:ISO/TS 16843-2:2015, 3.3]

3.1.4

characterizing category

category(3.1.3)of characteristics which serves as the criterion of subdivision when establishing concept systems

EXAMPLE:

The type of characteristics "colour’ includes being red, blue, green, etc. The type of characteristics "material’ includes made of wood, metal, etc.

[SOURCE:ISO 17115:2020, 3.1.3, modified]

3.1.5

semantic link

formal representation of a directed associative relation or partitive relation between two concepts

EXAMPLE:

is Cause Of (with inverse has Cause); has Location (with inverse is Location Of).

Note 1 to entry:This includes all relations except the generic relation.

Note 2 to entry:A semantic link always has an inverse, i.e. another semantic link with the opposite direction.

[SOURCE:ISO/TS 16843-2:2015, 3.5]

3.2Characterizing categories

3.2.1

acupuncture therapy

treatment of disease by inserting needles along specific pathways or meridians at an acupuncture point

Note 1 to entry:The placement of the acupuncture needle varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.

EXAMPLE:

Electro-acupuncture, ear acupuncture, Transcutaneous Electrical Nerve Stimulation (TENS).

[SOURCE:MeSH Heading, modified]

3.2.2

needling method

use of a specially made needle to stimulate the acupoints or parts of the body to treat disease

EXAMPLE:

Piercing Method, Encircling needling.

[SOURCE:MeSH Heading, modified]

3.2.3

acupuncture point

anatomical zone to which a stimulus is applied with the intention to induce reaction(s) for diagnosis or therapy

EXAMPLE:

GUANYUAN point, ZUSANLI point.

[SOURCE:ISO/TS 16843-1:2016, 3.7, modified]

3.2.4

anatomical structure

structure of organisms, including body regions, cellular component, cells, tissues, organs, and body systems

EXAMPLE:

Brain, neurons.

[SOURCE:Human Anatomy and Histoembryology Terms Review Committee, 2014]

3.2.5

disorder

condition which represents a set of dysfunction with associated body manifestations and is often defined by typical chief symptom, sequential pathological process body state or aetiology.

EXAMPLE:

Atherosclerosis model, chronic fatigue syndrome, Spleen Deficiency.

3.2.6

biological process

specific objective that the organism is genetically programmed to achieve

EXAMPLE:

Angiogenesis, neuroprotection, cortical excitability.

[SOURCE:Gene Ontology: 0008150, modified]

3.2.6.1

cellular process

process that occurs at the cellular level, but not necessarily restricted to a single cell

Note 1 to entry:For example, cell communication occurs among more than one cell, but occurs at the cellular level.

EXAMPLE:

autophagy, glial cell activation, mesenchymal stem cell migration, neuron apoptotic process.

[SOURCE:Gene Ontology: 0009987, modified]

3.2.6.2

behaviour

internally coordinated responses (actions or inactions) of animals (individuals or groups) to internal or external stimuli, via a mechanism that involves nervous system activity

EXAMPLE:

Learning, memory, motor behaviour.

[SOURCE:Gene Ontology: 0007610, modified]

3.2.6.3

response to stimulus

process that results in a change of state or activity of a cell or an organism (in terms of movement, secretion, enzyme production, gene expression, etc.) as a result of a stimulus

Note 1 to entry:The process begins with detection of the stimulus and ends with a change in state or activity of the cell or organism.

EXAMPLE:

Inflammation.

[SOURCE:Gene Ontology: 0050896, modified]

3.2.6.4

biological regulation

process that modulates a measurable attribute of any biological process, quality or function

EXAMPLE:

Regulation of hormone levels, regulation of blood pressure, MyD88-dependent toll-like receptor 4 signalling pathway, toll-like receptor 4 signalling pathway.

[SOURCE:Gene Ontology: 0065007, modified]

3.2.6.5

developmental process

biological process whose specific outcome is the progression of an integrated living unit: an anatomical structure (which can be a subcellular structure, cell, tissue, or organ), or organism over time from an initial condition to a later condition

EXAMPLE:

Angiogenesis.

[SOURCE:Gene Ontology: 0032502, modified]

3.2.6.6

metabolic process

chemical reactions and pathways, including anabolism and catabolism, by which living organisms transform chemical substances

Note 1 to entry:Metabolic processes typically transform small molecules, but also include macromolecular processes such as DNA repair and replication, and protein synthesis and degradation.

EXAMPLE:

Glucose metabolic process, regulation of blood-brain barrier permeability, digestion, gastric emptying.

[SOURCE:Gene Ontology: 0008152, modified]

3.2.6.7

multicellular organismal process

biological process occurring at the level of a multicellular organism, pertinent to its function

EXAMPLE:

Gastric motility.

[SOURCE:Gene Ontology: 0032501, modified]

3.2.6.8

localization

process in which a cell, a substance, or a cellular entity, such as a protein complex or organelle, is transported, tethered to or otherwise maintained in a specific location

Note 1 to entry:In the case of substances, localization can also be achieved via selective deg

SO/TC 249 platform promotes the development of international standardization and trade for the Chinese medicines industry

Yu-FengHuangab1,FanHea1,YingXiea1,LiangLiuac,HuaZhouac

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Abstract

The trade of Chinese medicines (CMs) has developed rapidly worldwide. There is an urgent need for international standards of CMs in international trade. A newly established technical committee TC249 in the International Organization for Standardization (ISO) provides a platform for developing the international standards oftraditional Chinese medicine. This article introduces the overview and development strategy of the international standardization of CMs. A quality assurance system for the entire industrial chain was well designed in the fields of seedlings, medicinal materials, and manufactured products. The general standards, testing method standards, and standards for single herbal medicines meet the urgent needs of the market and should be developed with high priority to promote the international trade of CMs and guarantee the quality and safety of clinical use. This article also introduces the significance, classification, and procedures for developing international standards of CMs and helps us better understand the international standardization work of CMs.

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Section snippets

Internationalization of traditional Chinese medicine

In recent decades, traditional Chinese medicine (TCM) has become a new area of global development. TCM has widely spread and been applied in 183 countries and regions around the world by the trend of economic globalization [1]. The output of Chinese materia medica was estimated to amount to US $83.1 billion in 2012 [2]. In China, the total volume of export trade for Chinese medicines (CMs) grew steadily in 2018, with the export value reaching US $3.909 billion, triple the value exported a

Current status of CMs in ISO/TC249

ISO, also known as a United Nations body in the field of technology, is the largest and most authoritative nongovernmental international organization for standardization in the world [11]. In 2009, a new technical committee entitled “Traditional Chinese medicine” and coded “249″ was established in the ISO family. It focuses on standardization in the field of medical systems derived from ancient Chinese medicine and aims to apply one common set of standards to CMs. Forty-three members from

Key principles

The development of ISO international standards for CMs must comply with the fundamental principles in ISO standard management. A new project (NP) should respond to the international market needs based on the full consideration of global experts’ opinions and achieve consensus among multiple stakeholders [10,[16], [17], [18]]. The technical committee usually prioritizes mature proposals that have a significant influence on international trade.

Construction of the quality assurance system for the entire process of CMs

The scientifically based and feasible standard

Conclusion and prospects

The quality assurance system for the entire process of CMs is beneficial to the standardized management of CMs throughout the entire industrial chain. WG1 and WG2 play an essential role in ISO/TC249 and prioritize the development of ISO standards in this system. These ISO standards guarantee the quality and safety control of CMs and promote the international trade of the CMs industry. In the future, it would be promising to form a collection of standards, such as an international pharmacopoeia

Author contributions

HZ and LL designed the experiment and worked on the ISO/TC249 project; YFH performed the experiments; YFH, HZ, YX, and FH analyzed the data; and YFH and HZ wrote the manuscript.

Declaration of Competing Interest

The authors declare no conflicts of interest.

Acknowledgments

This research was funded by theScience and Technology Development Fund, Macau SAR(File no.0061/2019/AGJand0027/2017/AMJ).

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China Chamber of Commerce for Import and Export of Medicines and Health Products, the Export of Chinese Medicines Has Steadily Increased, and the Export Value Has Tripled From a Decade Ago

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Development and current situation of Japanese Kampo Preparations and its meaning for Chinese materia

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Highly efficient glucose production from raw non-pretreated Chinese medicinal herbal residues via the synergism of cellulase and amylolytic enzymes

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Gui et al. (2013) pretreated Glycyrrhiza uralensis residue with fungus combined in sequence with dilute acid (sulfuric acid and acetic acid). It is well believed that there are more than 400 commonly used herbs in Chinese herbal medicine (Huang et al., 2020). The number of CHMRs that have been subject to pretreatment for facilitating bioconversion is too limited to provide valuable information about determining the suitability of a certain pretreatment method.

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While some countries have their own operating standards for TCM practitioners, and regulations for TCM products, the industry remains fragmented. Thus, the International Organization for Standardization/Technical Committee on Traditional Chinese Medicine (ISO/TC 249) was approved in 2009 [11]. Each standard published by the ISO is classified by the International Classification for Standards (ICS), a hierarchical classification method [12], aiming to recommend a universally applicable taxonomy to countries worldwide, regardless of their existing standard catalogs and database classification systems.